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Austrian Listeria infections linked to German meat producer

January 6, 2020 - 3:33am

Austrian officials have linked six Listeria infections to a German meat producer.

Products from Wilke Waldecker Fleisch- und Wurstwaren are suspected to be behind a Listeria outbreak in Germany involving 37 people and three deaths. One infection was recorded in 2014, three in 2016, four in 2017, 21 in 2018 and at least eight in 2019.

Between May 24 and Aug. 8, 2019, six people in Austria contracted an identical Listeria strain identified as Listeria monocytogenes IIa.

Following illnesses in the federal states of Carinthia, Styria, and Vienna the Federal Ministry of Labor, Social Affairs, Health and Consumer Protection (BMASGK) asked the Austrian Agency for Health and Food Safety (AGES) to investigate the outbreak.

Authorities in the Waldeck-Frankenberg district of Germany stopped production at a Wilke facility in Twistetal, Berndorf in October.

The suspected source of infection
The company recalled meat and sausage products from Austria in early October due to the connection with a foodborne outbreak in Germany. At the time, authorities said there had been no related illnesses in Austria.

AGES officials said while it was not possible to prove the source of infection beyond any doubt, epidemiological evidence pointed to the German meat producer as the source of infection.

“The fact that after the closure of the German production plant there were no further illnesses in Austria underlines the hypothesis of AGES.”

The United States is one of more than 20 countries that may have received meat from the German company linked to the outbreak.

A previous Listeria outbreak in Austria with the same sequence type (ST) of 155 and complex type (CT) 1234 affected seven people from November 2015 to September 2017.

The outbreak strain was found among isolates from food samples, collected in September and October 2015. Matching isolates were traced back to a meat processing company in eastern Austria. The outbreak strain was detectable at this unnamed company until May 2018.

Salmonella and E. coli outbreaks
Meanwhile, the number of people ill as part of a Salmonella outbreak solved earlier this year has gone up from 235 to 304.

Investigations by AGES found the source was caged eggs from a Polish producer. Ill people live in the federal states of Styria, Lower Austria, Vienna, Burgenland, Tyrol, Carinthia, Upper Austria, and Salzburg.

Since mid-June, people in Austria contracted the Salmonella Enteritidis strain with Multi Locus Variable-Number Tandem Repeat (MLVA) pattern 3-10-5-4-1.

Austrian authorities have also closed an investigation into a Salmonella Mikawasima outbreak without finding the source of infection.

In 2019, 13 cases in several federal states were confirmed by the National Reference Center for Salmonella at AGES. The increase pointed to a foodborne outbreak as Salmonella Mikawasima is rare in the country.

Officials in the country have also ended an investigation into an E. coli O157 outbreak.

Since April, 10 people contracted Shiga toxin-producing E. coli (STEC) and two had to be treated in hospital. The type of E. coli O157 had not previously been found in humans, animals or food.

Authorities said since no new illnesses have been recorded since late September the outbreak appears to have spontaneously disappeared. While the investigation has been closed if further infections occur in the future it will be reopened.

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No approvals for 3 Food Safety and Inspection Service petitions

January 6, 2020 - 3:30am

The U.S. Department of Agriculture’s Food Safety and Inspection Service answered three more petitions for policy changes before 2019 ended, none favorably.

Import Export Associates, Inc. petitioned the FSIS for changes in permitted safe handling instructions (SHI). Involved are protective coverings of meat products shipped in immediate containers with all mandatory labeling features.

The proposed change, which FSIS denied on Dec.30, would have allowed protective covering on meat without all the mandatory labeling features.

“You state that under current policy FSIS import inspection personnel are refusing entry to packaged products shipped in a fully labeled shipping carton if the products’ protective covering bears SHI without all the required labeling features,” the FSIS denial letter says.

FSIS questions Import Export Associates’ conclusion about whether existing policy prohibits standard handling instructions on protective covers that do not include all mandatory labeling features.

“After careful consideration of the petition, we have determined that it does not contain sufficient information to demonstrate that the requested action would benefit industry, consumers, or improve food safety,” the ruling says.

The petition does not include information on how frequently FSIS import inspection refuses entry for meat products bearing SHI on the protective covering. Nor is any information provided to back up the claim that costs associated with re-labeling are prohibitive.

The Import-Export petition was denied “without prejudice, which means it could be submitted again with more information backing its claims.

Also, getting the boot during December were petitions from the Animal Legal Defense Fund and the Animal Welfare Institute. The petitions, in separate letters, were denied on Dec.10.

The Animal Legal Defense Fund asked FSIS to require meat and poultry labels that disclose routine antibiotic use during animal production. It asked for labels with specific terminology, including “Raised with Antibiotics” or “Raised without Antibiotics.” A disclosure of “Given Antibiotics for Therapeutic Antibiotic Use Only” was also included in the options.

After considering the petition for more than six years, FSIS denied it without prejudice. Agency labeling guidelines were addressed in September 2016, prompting 4,000 public comments, and were re-published last month. FSIS says guidelines address issues raised by ALDF.

FSIS says the absence of certain information on the label does not constitute misbranding under the Federal Meat Inspection Act or the Poultry Product Inspection Act. It also said antibiotic claims do not provide information on the characteristics or components of meat and poultry products themselves. The agency also tests for antibiotics and other chemical residues.

The Animal Welfare Institute’s petition asked FSIS to change poultry product labeling regulations to define “free-range” with criteria for use in defending the claim. Those standards would include giving birds 1.) outdoor access daily during daylight hours during 51 percent of their lives; 2.) access to outdoor space with at least half providing vegetative cover; 3) multiple large access points to the outdoors; 4) natural or artificial shelter in the outdoor area.

The Animal Welfare Institute also wanted FSIS demand signed affidavits from those using any labeling terms like “free-range” or “free-roaming” along with pictures and written protocols.

FSIS also did not approve the “free-range” petition but instead has treated it as addition comments for the rule-making process on labeling guidelines that it was had underway since September 2016.

Warning letters sent to Chinese acidified food facility and Georgia bakery supplier

January 6, 2020 - 3:19am

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.

Lianyungang Aikang Food Co., Ltd — Lianyungang, Jiangsu, China

The Food and Drug Administration sent a warning letter dated Dec. 04, 2019, to Mr. Chuanai Li, President of Lianyungang Aikang Food Co., Ltd.

During an inspection at Lianyungang Aikang Food Co., Ltd, acidified food facility on  July 8-9, FDA investigators found serious violations of the Emergency Permit Control regulation [Title 21 of the Code of Federal Regulations (CFR), Part 108 (21 CFR Part 108)] and the Acidified Foods (AF) regulation (21 CFR Part 114).

In response to these deviations, the FDA issued an FDA-483 Inspectional Observations form that lists deviations observed at the facility.

The violations noted by the FDA:

  1. “Your firm failed to implement appropriate quality control procedures, including frequent testing and recording of results, to ensure that finished foods do not present a health hazard as required by 21 CFR 114.80(a).”
  2. “On July 9, 2019 at 14:29, our investigator observed a pH test result record in the laboratory desk area for canned peaches dated July 9, 2019 that contained entries that could not have been the result of actual testing because the entries reflected contemporaneous and future times (“(redacted)“, “(redacted)“, and “(redacted)“). Your laboratory employee then presented a second record for the same product dated June 9, 2019 completed with times prior to 14:29.”

“During the close out of the inspection, our FDA investigator explained that records have to be documented at the time that the activity is observed or conducted to reflect actual testing results. These pre-filled records demonstrate a lack of appropriate quality control procedures.”

  1. “On July 9, 2019 at 14:29, our investigator observed sweet packing fluid mixing records in the laboratory desk area filled with data and dates ((redacted)) but with no associated product information entered on the records. When the individual dates of the mixing records were compared to manufacturing records in the record room, it was observed that there were either no manufacturing records for such dates or there was a duplicate of the record for that date containing conflicting data. Specifically, the FDA investigator noted a record of the packing fluid mixing record dated “(redacted)” stapled in the complete batch record located in the firm’s record room and compared it with packing fluid mixing records dated “(redacted)” found in the laboratory and determined that the (redacted) records for the packing fluid mixing for the same date contained different testing results. These mixing records with no matching or conflicting manufacturing records demonstrate a lack of appropriate quality control procedures.”

“In a post-inspectional ” Letter of apology to FDA inspection panel” dated July 11, 2019, your firm has implemented “(redacted)” within your processing facility. Your July 30, 2019, response indicated products were re-tested, that you updated management and training Standard Operating Procedures (SOPs) and responsibilities, that you updated Corporate Integrity Management System and Employee Reward and Punishment System procedures, and provided training records, specifically for the canned peach products. We are unable to evaluate the adequacy of your response because you did not provide supporting documentation specific to the issue of pre-filled records and records with no matching manufacturing records.”

  1. “You did not test and examine containers often enough to ensure that the containers suitably protected the food from leakage and contamination as required by 21 CFR 114.80(a)(4). Specifically, your firm is not conducting frequent can examinations to identify dented cans during the different processing steps. On July 8, 2019 and July 9, 2019, we observed multiple cans with significant deformation in close proximity to the can seams. Damaged cans were observed throughout the facility at the following production (redacted): prior to syrup addition, after exiting the lid sealer machine, after the (redacted) step, and in finished product storage.”

“Your July 30, 2019, response indicated you contracted with Shandong Keno Machinery Technology to conduct a field analysis on can deformation and inspection for incoming cans. However, we are unable to evaluate the adequacy of your response because you did not provide supporting documentation. Your response did not include the type of testing being conducted on finished product cans for FDA review. Also, the response did not address the disposition of the deformed cans observed during the inspection and inspected by Shandong Keno Machinery Technology.”

  1. “You did not maintain processing and production records showing adherence to the scheduled process as required by 21 CFR 114.100(b).”
  2. “No production records were available for the manufacture of (redacted) cans, size (redacted) grams, of peach products manufactured on July 5, 2019, and identified as: (redacted) and (redacted) cans of the same product manufactured on July 6, 2019, with the following manufacturing information: (redacted).”
  3. “On July 8, 2019 we conducted a review of your firm’s processing records and identified the following failures to maintain processing and production records:”
  4. “No pH meter calibrations records were available. Processing and production records must include records of pH measurements and other critical factors intended to ensure a safe product.”
  5. “Production records were missing product information including lot number, product name, production date, and/or container size. Processing and production records must include sufficient information such as product code, date, container size, and product, to permit a public health hazard evaluation of the processes applied to each lot, batch, or other portion of production.”

iii. “We observed an employee entering the time of (redacted) when the actual time was (redacted) into a production record at the lid sealing machine area. Records must be documented at the time that the activity is observed or conducted to ensure that the record accurately reflects adherence to the scheduled process.”

Additional comments:

  • “Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR Part 114 and 21 CFR Part 117, Current Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls for Human Foods Subparts to assist your firm in meeting Current Good Manufacturing Practices (CGMP) requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and that the consultant evaluates the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.”
  • “During the inspection, we observed a (redacted) jar labeled with a preparation date of July 7, 2019, and an expiration date of August 6, 2019. Your firm prepares pH buffer solution from a powder but does not have written instructions for pH buffer solution preparation, storage, or pH meter calibration. We note that pH buffer solution prepared from a powder buffer mix appears to expire a few days after preparation according to the pH buffer manufacturer’s website.”

A complete list of the violations can be found in the FDA’s warning letter.

El Molino Bakery Supplies Inc — Duluth, GA

The Food and Drug Administration sent a warning letter dated Dec. 16, 2019, to Diana Ortegon, General Manager of El Molino Bakery Supplies Inc.

FDA investigators conducted a Foreign Supplier Verification Program (FSVP) inspection at El Molino Bakery Supplies Inc on July 10, 2018, and Sept. 12, 2019. The inspection was conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.

The warning letter says that, “During our September 12, 2019 inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the products that you import from your foreign supplier. Your firm did not have FSVPs for the products that you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.”

In response to these deviations, the FDA issued an FDA 483a Inspectional Observations form that lists deviations observed at the facility.

The violations noted by the FDA:

“Your firm did not have FSVPs for the products that you import. This was the case during the September 12, 2019 inspection, as well as the July 10, 2018 inspection. Some of the products for which you did not have an FSVP include Multi-color sprinkles, Strawberry filling, and Bavarian cream manufactured by (redacted).”

“The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.”

“You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of Multi-color sprinkles, Strawberry filling, and Bavarian cream manufactured by (redacted). We may place these foods on detention without physical examination (DWPE) when you import the products.”

A complete list of the violations can be found on the FDA’s warning letter page.

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Ducktrap River of Maine recalls herring with cream sauce that is labelled as wine sauce

January 5, 2020 - 12:16pm

Ducktrap River of Maine says its goal is to “wow” each customer, but a Saturday recall of Herring Center Cuts is more likely just confusing.

Located in Belfast, ME, Ducktrap has been smoking seafood since 1978.

Over the weekend, it announced the recall of Herring Center Cuts in Wine Sauce identified with a sell-by date Jul 29, 2020, because these products contain undeclared milk due to an incorrect label.

No adverse allergic reactions or illnesses are linked to the Herring Center Cuts.

At the time of the recall, sales of the Ducktrap product were underway in Alabama, Georgia, Louisiana, Maine, Massachusetts, Missouri, New Hampshire, New York, North Carolina, Ohio, South Carolina, Tennessee, Vermont, and Virginia.

Here’s where the confusion comes in: The product in the containers is Herring Center Cuts in Creame Sause, which does contain milk, but the “Herring Center Cuts in Wine Sauce” was put on the label.

Ducktrap’s investigation found the mistake involved only one lot of the product. That product comes in a 12-ounce glass container with a sell-by dale of Jul 29, 2020, located on the jar lid.

Ducktrap is known for sourcing premium-grade seafood, using traditional smoking techniques, and combining the natural flavor of custom recipes with the savory smoke from local apple, cherry, maple, and oak woods. Its other various products include Atlantic Salmon, Wild Sockeye, Rainbow Trout, Wild Mackerel, and Shellfish.

Only the Herring Center Cuts in Wine Sauce are involved in the current recall.

Ducktrap is cooperating with the U.S. Food and Drug Administration in managing the recall. The company has apologized for any inconvenience caused by the recall and promises it is taking steps to address the issues that caused it.

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Several ill in Danish Salmonella outbreak ate undercooked sausage

January 5, 2020 - 12:01am

Several people part of a Salmonella outbreak in Denmark tasted or ate raw or undercooked sausage, according to a recently published study.

In November 2018, an outbreak of monophasic Salmonella Typhimurium was detected. It sickened at least 49 people across the country.

A traditional form of raw Danish pork sausage called medister sausage was believed to be the source of illnesses. Product samples were negative for Salmonella and investigations at the production site did not reveal the source of contamination. Medister sausage is often served in the late autumn months and Christmas season. It is a long, thick sausage made from ground pork, seasoned and stuffed into casings.

Due to a control program, Salmonella Enteritidis is all but eliminated in Danish broiler poultry and egg production but Salmonella Typhimurium still exists in pigs and pork.

Risky behavior
In mid-November 2018, Statens Serum Institut (SSI) noted eight cases of monophasic Salmonella Typhimurium belonging to the same WGS cluster. The sequence type (ST) 5296 had not been detected before but was closely related to ST 34 which is often found in pork products.

In eight initial hypothesis generating interviews, seven people said they had eaten a certain type of classic Danish raw pork sausage known as medister sausage, according to a study published in the journal Epidemiology and Infection.

The median age was 65 years with a range from 11 months to 97 years and 53 percent were male. Seven of 49 cases were children less than 18 years of age.

Thirty people were hospitalized and 13 reported bloody diarrhea as one of the symptoms. There were no deaths. The onset date of illness was known for 38 of 49 patients and was between Oct. 14, 2018, and Jan. 17, 2019.

Almost all interviewed patients had eaten fresh pork and 28 of them ate medister sausage in the week prior to becoming ill with Salmonella.

Six patients said they had partly eaten the medister sausage raw or undercooked. Five people said they had failed to boil it prior to frying as is normally recommended on packages and by the Danish Veterinary and Food Administration (DVFA). In one family a child had eaten medister sausage that was not thoroughly cooked.

“Consumers have to make sure that pork is handled correctly, in particular when it comes to raw products that need to be thoroughly cooked before consumption. Tasting raw meat or eating undercooked pork meat should be discouraged,” said researchers.

Attempted trace-back findings
Traceback investigations pointed to one manufacturer of minced meat and prepared meat products. A total of 90 batches of ground meat and of prepared meat, including nine batches of medister sausage, were analyzed for Salmonella. Only one sample from a batch of minced pork patty sampled in January 2019 found Salmonella but it was not related to the outbreak strain. Medister sausages were packed at the production site and no handling of the sausage took place at supermarket level.

“No breaches in procedures or obvious incidents that could explain the presence of a specific type of Salmonella in multiple batches of medister sausage in a prolonged period of several weeks were identified,” according to researchers.

The DVFA also investigated results of routine sampling at the slaughterhouse providing meat to the manufacturer. As part of mandatory sampling, one of every 1,000 carcasses were swap sampled and analyzed for Salmonella. It was detected eight times in these samples, but none were identical to the outbreak strain.

Because shelf life of medister sausage is short and fresh meat is used for production, none of the raw material meat used to produce the batches suspected of having caused illness was available from the manufacturer by the time the outbreak was detected and investigation started.

Researchers said it was likely the bacteria might be present in low numbers and unevenly distributed in the raw material so the chance of detecting it at sampling might be limited. High fat content may also increase thermal resistance of bacteria so it is not fully eliminated by heating.

“It is also likely that only a low Salmonella dose is sufficient for patients to become ill as medister sausage is a product with a high content of fat (10 to 20 percent) that protects the bacteria past the barrier of the gastric acid.”

Samples of medister sausage from more manufacturers, as part of routine surveillance and companies own checks, were positive for Salmonella during the outbreak period. This includes finding the serovars Mbandaka, Typhimurium and its monophasic variant, which was different from the outbreak strain.

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Publisher’s Platform: Marler Clark donates $100,000 to Dave Theno Scholarship at Stop Foodborne Illness

January 4, 2020 - 10:18pm

This fellowship was created in Dave’s honor after his sudden passing in 2017. It is a special opportunity for a young food scientist to work closely with Stop Foodborne Illness and learn from members who have experienced the consequences of failures in food safety firsthand. The Dave Theno Food Safety Fellowship is a partnership between Stop Foodborne Illness and Michigan State University Online Food Safety Program. The Fellow will work full-time for Stop Foodborne Illness and complete a 12-credit Online Food Safety Certificate with Michigan State University.

Salary for the Fellowship is $25,000. Start Date: August 24, 2020 | End Date: August 13, 2021

This is what I wrote about Dave before his untimely death:

In 2013, I wrote a piece on my blog about “Why I Love my Job.”  Its ironic how much of my job and my life over they last 25 years has been intertwined with Dave Theno.  I will miss the occasions we shared a good meal – Dave with a rare steak and mine well-done – with always a very good bottle of wine.  We will all miss his humanity and leadership.

Here is the piece I wrote:

A few months ago I was asked to write something by WSBA about my practice and life as a lawyer.  The ask was something like this:

Mr. Marler, I noted that you are a (“the” – I must admit I added that) preeminent litigator in food poisoning cases in our state (well, actually the “world” – I must admit I added that too). Our members would love an article from you describing a significant case or client that resonated with you, or a description of what it is like to practice in your area of law.

I thought a lot about the ask and my 20 plus years of practice, and the fact that I may well be at the downslope of a job that I truly love.  In a not so often-quite moment, I thought about the beginning of what became both my passion and my job.  Honestly, it has had very little to do with being a lawyer.

I had just turned 35-years-old and was only five years out of Law School, I was a young lawyer in a job that seemed quite dead-end, and then my world changed.

Lauren Beth Rudolph died on December 28, 1992 in her mother’s arms due to complications of an E. coli O157:H7 infection – Hemolytic Uremic Syndrome – also know as acute kidney failure.  She was only 6 years, 10 months, and 10 days old when she died. The autopsy described her perforated bowel as being the consistency of “jelly.”  Her death, the deaths of three other children, and the sicknesses of 600 others, were eventually linked to E. coli O157:H7 tainted hamburger produced by Von’s and served undercooked at Jack in the Box restaurants on the West Coast during late 1992 and January 1993.  I pushed myself to the front of the pack of lawyers.  Roni Rudolph, Lauren’s mom, I have known for nearly 20 years.

Dave Theno became head of Jack in the Box’s food safety shortly after the 1992-1993 outbreak. I too have known Dave for 20 years, mostly because I spent several days deposing (he would say – grilling/torturing) him over the course of the multi-year, multi-state litigation.  However, a decade after spending such quality time (for me anyway) with him, I only recently learned a significant fact about Dave – one that made me admire him even more – one that I think, that all leaders in corporate food safety, or any position of authority, should emulate.

Last year Dave and I shared the stage at the Nation Meat Association (NMA) annual “Meating” in Tampa as an odd pair of keynote speakers. The NMA is an association representing meat processors, suppliers, and exporters.  Dave, spoke just before I did and was rightly lauded as someone who takes food safety to heart.  However, it was his story about Lauren Rudolph and his relationship with Roni that struck me in a physical way.

Dave told the quiet audience about Lauren’s death. He too knew the same autopsy report.  Dave told the audience that the death of Lauren and his friendship with Roni had changed him also in a physical way. He told us all that he had carried a picture of Lauren in his briefcase everyday since he had taken the job at Jack in the Box. He told us that every time he needed to make a food safety decision – who to pick as a supplier, what certain specifications should be – he took out Lauren’s picture and asked, “What would Lauren want me to do?”

I thought how powerful that image was. The thought of a senior executive of any corporation holding the picture of a dead child seeking guidance to avoid the next possible illness or death is stunning, but completely appropriate.

I hugged Dave and we promised to get together again – sometime, someday.

Shortly after leaving Tampa, I spent time with a family in South Carolina whose 4 year old ate cookie dough tainted with E. coli O157:H7 and suffered months of hospitalizations, weeks of dialysis and seizures. She faces a lifetime of complications despite oversight by the Food and Drug Administration of the food she consumed.

After leaving South Carolina I headed to Cleveland, Ohio where I sat across the kitchen table with a family who lost their only daughter, Abby, because she died from an E. coli O157:H7 infection from meat inspected by the United States Department of Agriculture Food Safety Inspection Services.

Neither head of either agency, nor the president of either corporation, whose product took the life of one and nearly the life of the other, ever visited either family, and, that is a shame.

In 20 years of litigation, in 20 years of spending time with Lauren’s or Abby’s family, I am changed.  I see the world far differently than most do now.

If I had any advice to offer to corporate or governmental leaders – run your departments like Dave ran food safety at Jack in the Box. Go meet the families that Dave and I have met.  Sit across their kitchen tables. Go to their child’s hospital room and see more tubes and wires than you can count. Understand what these people have lived though. Take their stories into your heart.

It is hard, very hard, but it will give you a real reason to do your jobs and to love it.

This is what I wrote on the day I spoke at his memorial:

I’m not sure I will get through what I plan on saying today at Dave’s Memorial, so I thought I would put it here:

Funerals are painful, and our hearts go out to Jill and the entire Theno clan. We all share just a small part of your grief.

Funerals are also uncomfortable, because they remind us all of life’s fragile nature and of all the things we should have said too so many.  Especially as we grow older, we think of all the deeds that we have not done, and the ever – decreasing time to do them.

However, we are here today to honor our friend Dave, who unlike most of us, left nothing undone and leaves this life a hero.  Dave was honored by so many.  Here are just a few:

  • NSF Lifetime achievement award
  • American Association of Food Hygiene Veterinarians
  • American Meat Science Association
  • International Association of Food Protection
  • International Meat & Poultry HACCP Alliance
  • Institute of Food Technologists
  • National Advisory Committee on Meat & Poultry Inspection
  • National Advisory Committee for Microbiological Criteria for Foods
  • National Cattlemen’s Beef Association’s Beef Industry Food Safety Council
  • National Meat Association
  • Black Pearl Award by the International Association of Food Protection
  • Innovator of the Year Award from Nation’s Restaurant News
  • California Environmental Health Association’s Mark Nottingham Award
  • Nation’s Restaurant News “Top 50 Players”
  • STOP’s Hero Award and Scholarship

And, this coming year Dave was due for even more deserved recognitions.

Of course, many in the food safety community’s most poignant visual, and most vivid memory, is of Dave asking a picture of Lauren what was the right thing to do.  However, Dave always knew what the right thing to do was, and Lauren was always beside him to confirm it.

In the end, Dave’s profile will not be etched into Mount Rushmore or on the Washington D.C. Mall – but it should be.  Why?  Because Dave’s life’s work saved countless lives and will continue to do so long after all of us have attended our own funerals.

Dave is and will be missed, but he will always be a hero remembered.

Campylobacter and E. coli infections climb in New Zealand; raw milk cited

January 4, 2020 - 12:03am

Campylobacter, Yersinia, E. coli and Listeria infections all went up while Salmonella declined, according to the 2018 report on foodborne disease in New Zealand.

Campylobacter remained the top foodborne pathogen. The country has a performance target to reduce cases of foodborne campylobacteriosis by 10 percent from 88.4 to 79.6 per 100,000 per head of population by the end of 2020. The estimated incidence in 2018 was 78.3 per 100,000.

Click to enlarge Courtesy of NZFS

New Zealand Food Safety (NZFS) is part of the Ministry for Primary Industries (MPI) and leads the country’s food safety system. EpiSurv is the country’s notifiable disease surveillance system.

The shift to culture-independent diagnostic tests (CIDT) using molecular polymerase chain reaction (PCR) methodology for detecting pathogens by medical laboratories in New Zealand continued in 2018.

Shiga toxin-producing E. coli (STEC) infection, shigellosis and cryptosporidiosis notification rates continued to rise sharply as more labs implement CIDT, despite no evidence foodborne sources are increasing.

Rates for campylobacteriosis and salmonellosis remain constant, which may reflect a balance between a possible increase in detection sensitivity using CIDT and reduction in foodborne illness as NZFS and industry implement pathogen control measures, according to the report.

Forty-three foodborne outbreaks with 580 infections occurred in 2018 with the pathogen not identified in 14 instances. Eight were caused by norovirus, seven by Campylobacter, five by Salmonella, three by Hepatitis A, two by histamine and one each by Clostridium perfringens, Shigella, Staphylococcus aureus and Yersinia.

Raw milk link in Campylobacter outbreaks
During 2018, 6,957 cases of campylobacteriosis and no deaths were reported in EpiSurv but 780 people needed hospital treatment. A total of 6,482 Campylobacter infections were recorded in 2017.

It has been estimated by expert consultation that 63.8 percent of campylobacteriosis incidence is due to foodborne transmission, meaning 3,826 infections last year, and 75.4 percent of these are due to poultry.

The number of notifications ranged from 395 in April to 918 in December. The highest age-specific notification rates were for children aged 1 to 4 years and infants less than 1 year. The top hospitalization rates were for the 70 and over age group and infants aged less than 1 year.

Seven of 16 outbreaks caused by Campylobacter spp. and 24 of 92 associated cases were reported as foodborne. Raw milk was confirmed as the vehicle of infection in one outbreak and suspected in three others while duck rillette was implicated in the other outbreak.

During 2009 to 2018, except 2014, the number of foodborne outbreaks has ranged between four and 16 each year with between 19 and 77 outbreak-associated cases.

Salmonella’s slight decline
During 2018, 1,100 cases of salmonellosis and no deaths were reported in EpiSurv but 227 people needed hospital treatment. A total of 1,127 Salmonella infections were recorded in 2017.

It has been estimated by experts that 417 salmonellosis infections were due to foodborne transmission with 19 percent of these due to poultry.

The number of notifications ranged from 63 in July to 139 in August. The rate of notifications were higher for males than females but hospitalization rates were similar for both genders. Notification and hospitalization rates were highest for infants aged less than 1 year.

Five of 14 Salmonella outbreaks with 17 cases were classed as foodborne. Salmonella Bovismorbificans was linked to an outbreak caused by undercooked supermarket chicken prepared at home and Salmonella Weltevreden to one involving raw sea cucumber from Samoa. A Salmonella Typhimurium phage type 195 outbreak may have been caused by supermarket roast leg ham.

The number of foodborne outbreaks between 2009 and 2018 ranged from three in 2015 to 12 in 2016 and associated cases varied between 15 in 2017 and 104 in 2012.

Salmonella Typhimurium and Enteritidis were the most common serotypes. Other common serotypes were Bovismorbificans, Brandenburg, Saintpaul and Stanley with an annual rise for Bovismorbificans since 2015.

Large STEC increase but no foodborne outbreaks
During 2018, 925 cases of STEC infection, 41 hospitalizations and two deaths were reported in EpiSurv compared to 547 cases in 2017.

It has been estimated by experts that 29.9 percent of O157 STEC incidence and 34 percent of non-O157 incidence is due to foodborne transmission. The expert consultation also estimated 30 percent of this was due to red meat.

STEC infections by year. Click to enlarge

There was a large increase in STEC notifications compared to previous years continuing a trend from 2015. The notification rate in 2018 was about twice as high as the previous three-year average. None of 15 outbreaks with 57 cases were classed as foodborne.

The number of notifications ranged from 42 in June to 122 in February. Notification rates were slightly higher for females than males but hospitalizations were slightly higher for males.

STEC infection notification rate was highest for the less than 1 year age group and the 1 to 4 years age group. The number of hospitalizations was most in the 70+ age group and ranged between zero and six in all other age groups.

The number of foodborne STEC outbreaks between 2009 and 2018 ranged from one to four, with no outbreaks for five of the 10 years. Cases associated with outbreaks has varied over the same period with peaks in 2014 at 15 and 2017 with 157 cases.

A total of 632 cases infected with STEC were reported. Of these, 194 isolates were E. coli O157:H7, 376 non-O157 and for 62 isolates the serotype was not identified. The percentage of non-O157 STEC cases has been increasing since 2014 possibly due to changes in lab methods and screening all submitted fecal samples for STEC infection, according to the report.

Thirty cases of listeriosis with two deaths were reported compared to 21 infections in 2017. All patients were hospitalized but there were no Listeria outbreaks. Between 1998 and 2018, the number of notifications has fluctuated between 17 in 1998 and 37 in 2016.

It was estimated by expert consultation that 25 of the 30 infections were due to foodborne transmission and 55 percent of these were because of eating ready-to-eat meats.

Rates for listeriosis were highest in the above 70 years age group for both the notifications and hospitalizations. The number of notifications was similar for females and males.

Norovirus, Yersinia and Shigella
Eight of 171 norovirus outbreaks and 362 of the 4,280 outbreak-associated cases were foodborne. Egg sandwiches served at a camp were the suspected source in one outbreak.

Between 2009 and 2018 the number of foodborne norovirus outbreaks ranged from eight in 2018 to 30 in 2009 and associated cases varied from 177 in 2013 to 552 in 2012.

Yersinia notifications. Click to enlarge

During 2018, 1,202 cases of yersiniosis and no deaths were reported in EpiSurv but 152 people needed hospital treatment. In 2017, 917 yersinia infections were recorded. It has been estimated by experts that 718 of the 1,202 cases were due to foodborne transmission and 70 percent are because of consuming pork.

One outbreak involving two people was linked to pork brawn. Between 2009 and 2018, there were three or less outbreaks each year with associated cases ranging from two to 232 in 2014.

One Shigella outbreak with three infections was thought to be foodborne. The food vehicle was unknown but suspected to be something eaten overseas. The number of foodborne shigellosis outbreaks ranged between zero and five from 2009 to 2018 with two and 39 associated cases.

One foodborne Staphylococcus aureus outbreak was reported with nine cases. The food source was unknown but it came from a restaurant, café or bakery. The number of outbreaks between 2009 and 2018 ranged from zero to two with between two and 14 cases.

Clostridium perfringens, Hepatitis A and fish poisoning
There was one Clostridium perfringens outbreak involving 21 people caused by a pork mince meal with rice and vegetables prepared at home. Between 2009 and 2018, the number of foodborne outbreaks ranged from one in 2016 and 2018 to nine in 2013. The most infections occurred in 2013 with 208 cases.

Three outbreaks caused by hepatitis A virus with eight cases were associated with a food source. The suspected infection source was shellfish for one outbreak and unknown for the other two incidents. Foodborne hepatitis A outbreaks are rare with only seven reported from 2009 to 2018.

Nine cases of histamine (scombroid) fish poisoning were reported during 2018. Two outbreaks involved five cases, two of whom needed hospital treatment. Tuna fish was suspected in one outbreak. Between 2009 and 2018 the number of histamine fish poisoning outbreaks each year ranged from one to four except for 2015, which had none.

Three cases of toxic shellfish poisoning but no deaths were reported although two had to be hospitalized. The toxin type was not specified in any case. All three were adults aged between 20 and 49 and had eaten recreationally collected seafood. Two were male and one female. Two were of Māori ethnicity and one was European or other.

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Cargill recalls mislabeled dark chocolate malted balls sold in Pennsylvania

January 3, 2020 - 8:51pm

Cargill has recalled 39 one-pound bags of packaged Wilbur Dark Chocolate-covered Cashews over an undeclared wheat allergen.

The recall was posted Friday on the Food and Drug Administration website as a public service. The recalled product was sold locally through the Wilbur Chocolate Store in Lititz, PA.

Wheat allergic individuals and/ or those with celiac disease (gluten intolerance) should not consume the incorrectly packaged Dark Chocolate Malted Milk Balls.

The Wilbur Dark Chocolate Malted Milk Balls were mistakenly labeled and packaged as Dark Chocolate Covered Cashews. They contain wheat, not listed among the ingredients on the label. The Dark Chocolate Covered Cashews do, however, bear a “may contain wheat” statement.

The recalled items can be identified as:

Wilbur Dark Chocolate Covered Cashews, lot #19100301WH & Bar Code 200172-16

No allergic reactions or illnesses have yet been associated with this recall. Recalled products can be brought back to the Wilbur Chocolate Store for a full refund.

Cargill is based in Minnetonka, MN.   The company has operations in 70 countries and employs 160,000 around the world.

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Consumer finds noodles in lentil soup; company initiates recall because of allergens

January 3, 2020 - 4:05pm

Following a consumer complaint, Lynn, MA-based Kettle Cuisine Midco LLC has recalled about  200 pounds of ready-to-eat (RTE) lentil and beef soup because of misbranding and undeclared allergens, according to the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS).

The products contain egg and wheat, known allergens, which are not declared on the product label.

The RTE lentil and beef soup items were produced on Dec. 12, 2019. The following product is subject to recall:

  • 7-oz. polypropylene cup with a film containing “little dish FRESH FOOD FOR KIDS Lentils & Beef with Vegetables for toddlers” with the best buy date of 1/10/20.

The recalled products  have the establishment number “EST.18468” printed inside the USDA mark of inspection. These items were shipped to customers in Connecticut, Maryland, New Jersey, New York, Pennsylvania, and Washington D.C. via internet sales.

The mistake was discovered when the company received a complaint from a consumer who reported finding noodles in their lentil and beef soup. 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 could be in consumers’ refrigerators. 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 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. When available, the retail distribution list(s) will be posted on the FSIS website.

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IAFP deadline for student travel scholarship applications closes soon; abstract deadline this month also

January 3, 2020 - 11:51am

The deadline for applications to the 2020 IAFP European Symposium Student Travel Scholarship is coming up next week. IAFP is offering the scholarship to support the travel of two students to attend the IAFP European Symposium on Food Safety in Munich, Germany, 7 to 9 April, 2020.

The International Association for Food Protection (IAFP) recognizes students are the future leaders in food safety.

The scholarship will be awarded to two students living in Europe and enrolled full-time in a college or university food safety degree program in the region. Previous recipients are not eligible to apply.

Applications will be accepted electronically through Jan. 7, 2020, from IAFP student members.

The selection committee’s decision will be communicated to all applicants by Feb. 5, 2020, and the scholarship recipients will be formally recognized during the IAFP European Symposium on Food Safety.

Maria Gkerekous from the Agricultural University of Athens in Greece and Yifan Zhang of ETH Zurich in Switzerland received the 2019 European Symposium Student Travel Scholarship.

The deadline for individuals to submit an abstract proposal for presentation during the IAFP European Symposium on Food Safety is Jan. 14 with an acceptance or rejection notification by Feb. 4, 2020.

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Coming in 2020: Europe and Asia

January 3, 2020 - 12:05am

While people reading this may not be able to agree whether 2020 is the start of a new decade or end of the last one like many on social media, I am sure we can agree to focus on food safety.

Whatever year it is we will have annual reports like the EU figures on zoonoses, Operation Opson run by Europol and Interpol, and the Rapid Alert System for Food and Feed (RASFF) analysis of recalls. As well as something that feels like it has been dragging on for a decade: Food safety in the United Kingdom with Brexit and potential new trade deals.

Who would have predicted Spain’s Listeria outbreak last year and multi-year Listeria outbreaks being solved in Germany and the Netherlands? Strap yourselves in and see what 2020 has in store for us. Plus, the bottom of this article lists events in Europe, Africa and Asia in date order to help fill in the diary for this year.

Second World Food Safety Day
There was plenty of noise to mark the first World Food Safety Day on June 7, 2019, and two international events in Addis Ababa and Geneva, but I would have liked to have seen or been told about more action.

We all know the figures published in 2015: Every year as many as 600 million, or almost 1 in 10 people in the world, fall ill after eating contaminated food. Of these, 420,000 die, including 125,000 children younger than 5 years. Will we see revised estimates in 2020?

Unofficially, the World Health Organization is working on updates this year. Officially, the plan is to update the report for 2025 but 2020 could see countries being encouraged to do national estimates, which will inform global figures. For now, just mark the diary date of June 7 for the second World Food Safety Day.

Food safety, trade deals and Brexit
The United Kingdom is still scheduled to leave the European Union following results of a referendum in 2016 and despite delays in 2019 this is almost certain to happen in early 2020.

The U.K. and Europe have an agreement in place until the end of this year to keep things as they are now. The plan is to strike a trade deal between the two parties by the end of 2020. British Prime Minister Boris Johnson has said this transition period will not be extended.

The government has repeated many times that food safety and standards will not be compromised but that has not made the concerns go away. International trade negotiations with the U.S., Australia, New Zealand and Japan are on the table.

The issue was emphasized in a New Year’s message from National Farmers Union president, Minette Batters. She said the country cannot allow food imports such as chlorinated chicken and hormone-fed beef that are produced in ways illegal in the U.K., onto the U.K.’s supermarket shelves.

EFSA BPA risk assessment
The European Food Safety Authority (EFSA) should come out with the reassessment of Bisphenol A (BPA) this year. BPA is a chemical used to manufacture polycarbonate plastics and epoxy resins which coat some metal food cans and bottle tops.

Safety in food contact materials has been assessed several times and most recently in 2015. This review concluded BPA poses no health risk to consumers of any age group at current exposure levels. Despite this, the EU strengthened the law around BPA in food contact plastics and food contact varnished or coated products in September 2018.

The U.S. National Institute of Environmental Health Sciences (NIEHS), National Toxicology Program (NTP), and Food and Drug Administration (FDA) are also looking at the chemical through the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). Results showed health effects at high BPA doses and some impact at low doses but it was not clear if the chemical was solely responsible. A final report was planned for the end of 2019 but has not yet been published.

Happy Birthday to the FSA
The Food Standards Agency will be marking its 20th anniversary in April this year. There is still plenty to be getting on with such as updating regulations, food crime and online food sales.

Heather Hancock, currently FSA chair, will be leaving the post in October. Emily Miles, CEO of the agency, has been in that role since July 2019.

A report from the National Audit Office in 2019 found the food regulation system is complex, has come under financial pressure and has elements that are outdated. The FSA first put plans forward about updated legislation in 2017 and developments have been made since, but Regulating Our Future (ROF) is due for completion in 2020.

Things are not about to get easier with the U.K.’s exit from the EU, a decline in sampling, local authority staffing levels and a lack of regulation around food sales on the Internet and via platforms such as Just Eat and Deliveroo.

The National Food Crime Unit was established in 2015 following the horse meat scandal of 2013. It now has more funding and staff but has been criticized by some for a lack of public results. The Spanish Guardia Civil, French Douane and Italian NAS Carabinieri are not food focused but often publicize results of operations so hopefully 2020 will be the NFCU’s breakthrough year on that front.

New EU Health and Food Safety Commissioner
Stella Kyriakides is the new European Commissioner for Health and Food Safety and takes over from Vytenis Andriukaitis.

Kyriakides is from Cyprus and she has said priorities include the new farm-to-fork strategy to improve food safety and action against antimicrobial resistance.

She recently welcomed a decision not to renew the approvals of chlorpyrifos and chlorpyrifos-methyl, insecticides used to control insect pests on a range of crops. The first year of her role coincides with the International Year of Plant Health 2020.

Salmonella outbreak in eggs from Poland
Almost as regular as a visit from Santa and fireworks on New Year’s Eve is the annual update from the European Centre for Disease Prevention and Control (ECDC) and EFSA on a Salmonella outbreak in eggs from Poland.

Sometime in January we will have the next update to a multi-country outbreak of Salmonella Enteritidis linked to Polish eggs after one in November 2018, December 2017 and October 2016.

The last 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. Maybe our New Year resolution should be to wish for this outbreak to end?

Operation Opson: Europol and Interpol
Toward the middle of the year look out for the publication of the latest on Operation Opson. The annual operation is coordinated by Europol and Interpol and supported by customs, police and national food regulatory bodies as well as partners from the private sector.

In 2019 there were 16,000 tons and 33 million liters of potentially dangerous fake food and drinks seized and 672 people arrested. The operation in 2018 resulted in the seizure of around 3,600 tons and 9.7 million liters of counterfeit or substandard food and beverages and more than 700 people were arrested or detained.

 Food authority changes in 2020
Denmark has made food control more targeted at companies that cannot or will not comply with the rules beginning with the start of this year.

The Danish Veterinary and Food Administration (Fødevarestyrelsen) plans to focus efforts by using data and the experience of inspectors. All food businesses will continue to get inspection visits but how often will depend on what they have on the shelves and how good they are at following the rules. Assistance has been introduced so new entrepreneurs can get started properly. If a company does not live up to the rules they will have to pay for the two follow-up inspection visits.

The Swedish Government has tasked the Swedish Food Agency (Livsmedelsverket) with preparing criteria for monitoring and follow-up of municipal food controls.

The problem is there are difficulties in achieving an equal and effective food control as some municipal authorities do not perform the necessary checks. There are a large number of control authorities which limits the conditions for effective and equal food control with small authorities being particularly vulnerable.

The aim is increased cooperation between municipal control authorities to strengthen the equality of controls. The Swedish Food Agency has until the end of this year to report to the government.

One of the focus areas for the Dutch Food and Consumer Product Safety Authority (NVWA) this year is extra people to deal with reports in food safety quicker. There is additional capacity for work related to the new European Official Controls Regulation and Plant Health Regulation.

The rates that the NVWA charges companies for inspections, re-inspections, system supervision, certification, sampling and analysis have also changed from Jan. 1, 2020. A total of 70 percent of NVWA is paid by the Ministry of Agriculture, Nature and Food Quality (LNV) and Ministry of Health, Welfare and Sport (VWS). The remaining 30 percent is income from inspections and re-inspections at companies.

The Croatian Food Agency ceased work at the end of 2018 and continued activities beginning in January 2019 in the Croatian Agency for Agriculture and Food (HAPIH) as the Center for Food Safety, so happy second anniversary!

The Singapore Food Agency will introduce a new Food Hygiene Recognition Scheme (FHRS) in late 2020 for licensed food retailers to recognize consistent efforts in high hygiene standards. Food establishments will get a bronze, silver or gold award based on at least two, five or 10 years of good hygiene records respectively.

Existing grades of either ‘A’, ‘B’, ‘C’ or ‘D’ annually based on a snapshot assessment of the premises’ hygiene standards will be phased out.

Europe, Asia, Africa and Latin America events scheduled in 2020

  • International symposium on Andalusian Listeria outbreak Jan. 23-24 in Seville, Spain
  • BRC Food Safety Europe Feb. 12 in London, U.K.
  •  Asia-Pacific Symposium on Food Safety March 18-19 in Hong Kong
  •  Latin American Symposium on Food Safety March 30-31 in Santiago, Chile
  •  IFC 9th International Food Safety Forum March 31-April 1 in Nairobi, Kenya
  •  IAFP Europe symposium April 7-9 in Munich, Germany
  •  CIEH Safe Food Conference Oct. 22 in London, U.K.
  •  China International Food Safety and Quality Conference Nov. 4-5
  •  MoniQA Conference: The Future of Food Safety Nov. 9-11 in Rome, Italy
  • ESCAIDE in Warsaw, Poland with date TBC
  •  Global Harmonization Initiative Congress on Food Safety and Security. Date and Venue TBC

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CSPI seeks to expand efforts — apply now to join their food safety team

January 3, 2020 - 12:03am

Everyone who works in food safety is, in some way, working for the consumer. Public health officials, researchers, educators, and members of the food industry each have an important role to play in keeping our food safe. But there is something rare and powerful about being able to sit down at the table with other stakeholders who shape our food system and say “I am here to give consumers a voice.”

That is what we do at Center for Science in the Public Interest (CSPI). For almost 50 years, we’ve worked tirelessly to give consumers a compelling and outspoken voice in the food system. Our work is funded solely by members of the public and we take no government grants or corporate donations, leaving us free to bring bold ideas to the table and challenge the status quo.

Through the years, we have served as the inspiration and the engine behind many key policies that have laid out the rules under which our entire food system operates.

You see our handiwork every day, in Nutrition Facts and allergen labeling on packaged foods and calorie counts on restaurant menus. And much of the work still being done behind the scenes to improve food safety in this country is framed by the Food Safety Modernization Act, a critical piece of legislation that we championed and are now working to see through implementation.

Working on food safety at CSPI is one of the most challenging and rewarding experiences I could possibly imagine as an advocate.

Now, I have the pleasure of inviting one of you to join me: CSPI is hiring a food safety campaign manager to strengthen our food safety team in Washington D.C. We are on the hunt for persuasive advocates, skilled scientists, and policy experts with a passion for turning scientific knowledge into concrete strategies that will transform our food system, helping make the food we eat safer for everyone.

You can read more about the position and how to apply here:

Editor’s note: Sarah Sorscher, deputy director for regulatory affairs at the Center for Science in the Public Interest provided this column on behalf of the organization. Founded in 1971, the Center for Science in the Public Interest is perhaps the oldest independent, science-based consumer advocacy organization with a record of accomplishments and a clear and ambitious agenda for improving the food system to support healthy eating, according to the CSPI website

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Raw milk risks, Salmonella and Listeria discussed in EU; high contamination levels revealed

January 3, 2020 - 12:01am

Pathogens in raw milk, Salmonella and Listeria monocytogenes were discussed at the annual meeting of a European microbial risk assessment network.

A total of 25 European Union countries as well as Switzerland and Norway are members of the network. The next meeting is in May 2020 in Parma.

Results from studies on raw milk quality from vending machines in Switzerland, Germany and Austria were presented. The Scientific Network on Microbiological Risk Assessment held its annual meeting in May 2019 in Parma.

Raw milk studies and findings
The German research involved 159 samples of raw cow milk from farm-gate vending machines collected between 2016 and 2018. Two samples were positive for Campylobacter, seven for Shiga toxin-producing E. coli (STEC), and six for Listeria monocytogenes.

The study in Austria included 74 samples of raw cow milk collected in July and August 2017. Twenty-two samples exceeded limits for total viable count (TVC) considering the Austrian national regulation for raw milk states the limit is 50,000 CFU/mL. Salmonella Dublin and Campylobacter jejuni were detected once and VTEC was isolated in two samples.

A Swiss study looked at microbiological quality of 73 samples of raw cow’s milk sold directly from farms to consumers. E. coli and coagulase-positive Staphylococci were each detected in 30.1 percent of samples. TVC results for raw milk from vending machines were higher than those from pre-filled bottles, showing the importance of correct cleaning and disinfection of vending machines.

Swedish officials presented a study on Campylobacter spp., Salmonella spp. and STEC in milk filters from dairy farms. A total of 302 milk tank filters were collected from three regions in Southern Sweden, each from a different farm that provided the filter after morning milking.

Forty-five isolates from 42 STEC-positive samples were investigated by WGS for virulence factors such as stx1, stx2 and eae. Serotyping on 29 isolates found the most common serotype was O145:H28. Two isolates belonged to O26:H11 and one to O157:H7. Only the latter was of high pathogenicity.

Thirty-eight samples were positive for Campylobacter of which 34 were jejuni and four were lari. Pathogen occurrence was higher in farms with more than 50 cows and an untethered milking system.

Microbial meat results
Results from the project Safemeat were presented by Belgian officials. A total of 105 pig carcasses were sampled and 64 percent were positive for Salmonella spp. Microbiological analysis showed the number of positives from rectum and mouth swabs increased after the dehairing process.

Research investigating the contamination rate and sources of Listeria monocytogenes in carcasses in Flemish slaughterhouses was also presented.

Listeria was isolated in three slaughterhouses and 42 of 90 carcasses were positive, from different areas of the carcass. To map contamination routes, samples from hides and carcasses from four slaughterhouses were collected showing 97 percent and 47 percent positive, respectively. This means direct transfer from hides to carcasses and persistent strains in the environment are important sources of contamination at the abattoir.

Croatia presented research on quality and microbiological safety of portioned raw meat on the last day of the expiry date. A total of 150 pre-portioned raw meat and 150 ground meat samples from different species were collected.

Salmonella spp. was detected in 10 samples and 22 poultry meat samples had Enterobacteriaceae concentration of more than 105 CFU/g. This indicates it is not possible to extend shelf life of these products.

Hepatitis E, Listeria growth and AMR in shellfish
Pork liver sausages and raw meat sausages from the Swiss retail market were tested for Hepatitis E virus (HEV). RNA of the virus was detected in 18 samples: 11 of 42 for liver sausages and seven of 190 for raw meat sausages.

Food businesses should apply strategies to minimize risks such as heat treatment of products and control of raw meat while consumers who want to minimize the risk of HEV infection should avoid eating raw meat products, especially those containing raw liver.

Ireland’s delegate covered foods that do not support the growth of Listeria monocytogenes. Fresh, uncut and unprocessed vegetables and fruits are legally considered unable to support growth of Listeria but evidence of survival and growth on whole fresh produce has been shown in some studies. It was agreed a questionnaire from Ireland would ask network members for their views and experiences on the topic.

Denmark shared research on the risk of introducing antimicrobial resistance (AMR) via shellfish and pangasius from Asia. Pangasius is imported as fillet for further cooking while prawns are brought in as raw and pre-cooked and the latter are often ready to eat.

There were 300 frozen samples collected. All pangasius fillets samples were contaminated with Enterococci and 52 percent with E. coli. While 89.7 percent of prawns samples had Enterococci and 25 percent E. coli. Ten multidrug resistant E. coli were isolated.

Most resistance genes in the study are already present in Danish products but mobile quinolones resistance genes were also identified. One isolate showed resistance to ESBL, macrolide, colistin and mobile fluoroquinolone resistance. The products may pose a risk to consumers by introducing AMR genes still rare in domestic food sources.

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FiveStar Gourmet Foods recalls MiniMeal2Go-ProteinPack and MiniMeal2Go- AvocadoToast

January 2, 2020 - 8:25pm

FiveStar Gourmet Foods is recalling two fresh produce snack products, MiniMeal2Go-ProteinPack and MiniMeal2Go- AvocadoToast due to possible Listeria monocytogenes contamination. The products were distributed Meijer supermarkets in Illinois, Indiana, Kentucky, Ohio, Michigan and Wisconsin.

The company recall says that it is initiating the recall because “Almark Foods may have supplied single-serve prepackaged Hard Boiled Eggs contaminated with Listeria monocytogenes.”

The Almark egg facility has been confirmed to be contaminated with the same strain of Listeria monocytogenes that public health officials have found in patients involved in a multi-state outbreak. One person has died.

Recalled Products:

Retailer Brand Item Name Package Weight Item SKU UPC # Lot No Best By Meijer MiniMeals
2Go Protein Pack 6/8.25oz FG10461 8-
79311-3 34619,
35719 12/26/19,
01/06/20 Meijer MiniMeals2Go Avocado Toast 6/6.75oz FG10463 8-
79315-1 34619,
35719 12/26/19,

The company has received no reports of illness associated with the recalled product.

Consumers who purchased products listed are urged not to consume them and to throw the products away. For any questions, consumers may contact FiveStar Gourmet Foods at 877-546-8763

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 product 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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State test results prompt company to recall string cheese for Listeria risk

January 2, 2020 - 6:03pm

A Florida company is recalling string cheese after state officials reported positive test results for contamination with Listeria monocytogenes.

Limena LLC of Palm Springs, FL, reported shipping the implicated cheese to retail stores and direct to consumers through mail orders, according to a recall notice posted by the Food and Drug Administration.

“The production of the product has been suspended while FDA and the company continue to investigate the source of the problem. Consumers who have purchased the 1-pound blocks of ‘Salvadorean String Cheese’ (Quesillo Cheese) are urged to discard the product,” according to the company’s recall notice.

The expiration date space on the product labels is blank. However, consumers can determine whether they have the recalled cheese by looking for the following identifying markings:

  • 16-ounce blocks of Salvadorean String Cheese, often referred to as quesillo cheese, semi-soft cheese in clear plastic packages with blue and white labels and the lot number 1041020

As of the posting of the recall notice today, no confirmed illnesses had been reported in relation to the recalled cheese.

Consumers with questions may contact the company at 561-541-5206.

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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Meijer recalls diced eggs used in salad bars

January 2, 2020 - 5:33pm

N Meijer is recalling frozen hard boiled egg products used on salad bars at two stores because of possible Listeria monocytogenes contamination. The stores with the salad bars are located in Grand Rapid, MI.

The company recall says that it is initiating the recall “in conjunction with Almark Foods.”

The Almark egg facility has been confirmed to be contaminated with the same strain of Listeria monocytogenes that public health officials have found in patients involved in a multi-state outbreak. One person has died.

Recalled Product:


Store location:

  • The Knapps Corner Meijer at 1997 East Beltline Road in Grand Rapids, Mich.
  • The Rockford Meijer at 2799 10 Mile Road NE in Rockford, Mich.

The company has received no reports of illness associated with the recalled product.

Consumers with further questions about the recall should contact Meijer at 800-543-3704.

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 recalledproduct 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 product 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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Victim count in outbreak linked to freshcut fruit rockets to almost 100

January 2, 2020 - 3:19pm

In less than a month, the patient count in a Salmonella outbreak linked to pre-cut fruit sold by Tailor Cut Produce has jumped from 11 people to 96 people across 11 states.

Some of the additional 85 illnesses were suspected when federal officials posted a notice on Dec. 11, 2019, but those had not been confirmed at that time, according to an update today from the Centers for Disease Control and Prevention.

The Food and Drug Administration also released an outbreak update today that renews its warning against the implicated fresh-cut fruit from the Tailor Cut Produce in New Brunswick, NJ. The company issued a recall Dec. 7, 2019, for its “Fruit Luau” cut fruit mix as well as cut honeydew melon, cut cantaloupe, and cut pineapple products.

In late December state officials reported the outbreak had sickened at least 33 people at four health care facilities in Pennsylvania and 26 in Delaware’s schools. Today in its update the CDC reported that 27 of the patients in the 11 affected states have been so sick they had to be admitted to hospitals. No deaths have been confirmed. Ages of outbreak patients range from less than 1 to 92 years old.

As of Dec. 30, 2019, according to the CDC’s update today, the confirmed victims became ill on dates ranging from Nov. 15-Dec. 10. Officials expect the patient count to continue to increase because of the lag time between when a person becomes sick and when federal officials received results of confirmation tests from state health departments. The lag time is running four weeks or more for this outbreak of Salmonella Javiana.

In the update today the FDA spoke directly to the entities that received the suspect fruit. The products were not sold directly to consumers in grocery stores.

“Foodservice and institutional food operators should not sell or serve the recalled products.

“Tailor Cut Produce reports that their products may be found in restaurants, banquet facilities, hotels, schools, long-term care facilities and institutional food service establishments in Delaware, New Jersey, New York, and Pennsylvania.

“Because the recalled products may have been distributed to nursing homes, schools, hospitals and other facilities that cater to vulnerable populations, it is important that these facilities do not sell or serve them. Please consult with your distributor to confirm the source of the fruit mix and cut fruit used in your operation.”

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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Are we there yet? Where are we going in 2020

January 2, 2020 - 12:05am

If hindsight’s 20/20, and if Barbara Walters co-hosted 20/20, what are the odds that 2020’s crystal ball will show a clear picture of the year ahead? Who knows. I just had to get the 20/20 jokes out of the way.

Now down to the stuff that’s no laughing matter — the direction food safety is likely to take this year.

Several of the usual suspects are back on the predictable list for 2020, and we’ve got a couple of suggestions on other things to watch for in the coming months. By no means a comprehensive list, the below is in no particular order.

It’s a simple concept, but one of the biggest challenges facing regulators, public health officials and businesses. The elusive component of commerce known as traceability is expected to remain unnecessarily at arm’s length.

Industry hasn’t done it when it comes to adopting uniform labeling and recordkeeping. Regulators haven’t forced the issue. Public health officials are stuck in a tangle of red tape and a snarl of incomplete and inaccessible shipping and receiving records when they are trying to trace the sources of foodborne illness outbreaks.

Here’s hoping Frank Yiannas can do what he said he was going to do in 2019. Yiannas is the Food and Drug Administration’s deputy commissioner for food policy and response. In early 2019 he promised “smarter” food safety with a more digital, traceable footprint. The agency floundered along with the helping hand of the food industry as outbreak investigations continued to be hampered by a fuzzy and sometimes blind view of the food supply chain.

With outbreaks ongoing as the calendar closes out on 2019 and opens on 2020, it seems little if any progress has been made with the problem of E. coli contaminated romaine lettuce. Unfortunately romaine is making consecutive appearances in the annual likely list — and not in a good way. 

The proximity of feedlots, also referred to as “concentrated animal feeding operations” (CAFOs), to fresh produce fiends, including romaine fields, continues to appear to be a known missing link in the contamination chain.

See also “traceability” for a key factor in the ongoing threat from romaine lettuce. Part of the romaine game is timing. Harvest season rotates between the Yuma, AZ, area and the Salinas, CA, area. There are few weeks of overlap every time the harvest areas switch. Industry has successfully distracted consumers and government from the real issues by pointing the finger at the other region.

Turkey and Salmonella
An investigation into a 2018 outbreak linked to turkey saw investigators confirm “widespread” contamination in the industry with the outbreak strain found at multiple locations.

Poultry industry leaders immediately said they would begin researching how to mitigate the issue and report back ASAP. 

Government regulators said they would hold industry to its word.

As 2020 begins we are still waiting on both to make good. Hopefully this hasn’t fallen off the radar and will be locked in for this year’s agenda.

FSMA — tha mantra continues
Pronounced fizz-ma, the abbreviation FSMA stands for Food Safety Modernization Act. It has been tripping off the tongue since well before it was signed into law in January 2011. It gives the FDA a lot of responsibility and some power.

The federal legislation sets a particular focus on fresh produce. Some say if water testing standards planned under FSMA would have been implemented instead of delayed at the request of industry, problems like the romaine outbreaks would have been much less likely.

Although several key elements of FSMA have been delayed, some are coming into focus in 2020 and promise to make a few headlines. One of those areas involves tree fruit, according to Trevor Suslow, vice president of food safety at  the Produce Marketing Association. 

The tree fruit industry will experience a number of FDA-483 Inspectional Observation warning letters resulting from FSMA inspections related to Listeria and insufficient Listeria environmental-monitoring programs, Suslow told Healio in recent days. 

USDA’s Food Safety and Inspection Service
When it comes to government agencies, its sometimes best to listen and then monitor. That’s the approach for 2020 as far as the FSIS is concerned. 

The agency has provided its focus areas. All we have to do is wait and watch. The USDA’s sub-agency says:

  • FSIS will finalize rules proposed in 2019, including the Egg Products Inspection Regulations rule.
  • FSIS developed a plan in 2019 to expand testing for non-O157 STEC to all FSIS regulated beef products. FSIS will propose this expanded testing and request comments on the plans before finalizing them during FY 2020.
  • FSIS will also continue to focus on food safety modernization, including:
    • Exploring improvements to beef slaughter inspection;
    • Expanding the chemical residue surveillance program;
    • Revising performance standards for Campylobacter in comminuted chicken and turkey products based on a method change; and
    • Proposing performance standards for Salmonella in raw pork cuts and raw comminuted pork products.

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Poland tries to tackle Salmonella in poultry problem

January 2, 2020 - 12:03am

Poland is trying to tackle the high and increasing number of alerts linked to Salmonella in poultry products made in the country.

DG Sante, the European Commission’s unit for policy on food safety and health, looked to see if production and placing on the market of poultry was in compliance with EU legislation and reported mostly positive findings.

The audit in Poland in March and April 2019 included visits to a regional veterinary laboratory, six slaughterhouses and seven cutting plants. Low-risk establishments are subject to controls once every 12 months; medium-risk sites have them once every six months and high-risk plants once every three months.

Official sampling detects Salmonella more often
Between January 2016 and March 2019, 181 Rapid Alert System for Food and Feed (RASFF) notifications (44 in 2016; 50 in 2017; 65 in 2018 and 22 until March) concerned Poland and Salmonella in poultry meat products.

A staggering 170 RASFF notices involved Salmonella and poultry meat from Poland in 2019 with serovars including Enteritidis, Typhimurium, Infantis, Newport, Kentucky and Bredeney.

Based on information provided by authorities for the first half of 2018, if Salmonella is present, the probability to detect it in company sampling is three times smaller than during official sampling. These data indicate for the second half of 2018 a 2.5 times smaller probability.

Authorities have put in place special official sampling procedures at slaughterhouse level to verify the reliability of businesses own-check sampling, which gives much lower rates of Salmonella detection. They have also revised approved private labs to find the root-cause for the increase in RASFF notifications.

The National Veterinary Research Institute (PIWet Puławy) inspected seven private labs doing tests for poultry slaughterhouses. After these checks, five had approvals for testing for Salmonella spp. withdrawn.

Although actions for following up RASFF notifications and food incidents were prompt and comprehensive they were mostly not effective in preventing reintroduction of Salmonella in the poultry meat processing chain, according to the audit report.

A previous audit highlighted deficiencies in application of national measures in low volume production establishments; sanitary shortcomings at site level not detected during authority inspections; insufficient supervision and control in use of food additives and labelling of mechanically separated meat; and to actions taken by authorities in cases of positive results in official Salmonella testing.

In the latest visit, at one slaughterhouse for water fowl and broilers with a cutting plant and a meat products establishment, the audit team noted approved capacities did not permit adequate cleaning and disinfection or provide the required working space for hygienic performance of operations.

Also, the last amendment of an approval decision in March 2018 allowed the company to increase slaughter and processing capacity despite several RASFF notifications due to Salmonella and one due to Campylobacter in 2017 and 2018.

Authorized veterinarians pay problems
According to official sampling data from 2017, 1,119 batches of fresh poultry meat including carcasses were analyzed for Salmonella spp. of which 118 were non-compliant as 55 tested positive for Salmonella Enteritidis or Typhimurium.

The regional official lab analyzed 780 official poultry meat product samples for microbiological parameters in 2018 and 107 were non-compliant.

In two poultry meat product plants visited there were serious structural and hygiene requirements which had not been detected or corrected by any level of authority controls.

Decreasing numbers of official staff, their low salaries, and production related remuneration for authorized veterinarian’s impact on enforcement of EU legislation, according to the audit report.

The audit team were told the number of authorized veterinarians involved in official controls of meat establishments was 3,318 in 2018 and remained constant between 2016 and 2018. However, in the same period the number of permanent official veterinarians decreased by 141, most of them (90) in the districts, from 2,172 in 2016 to 2,031 in 2018.

One food safety official had to supervise 45 approved establishments with minimum frequency of controls from one to four times a year and one approved for export to the U.S. requiring one monthly audit/two days and 262 food entities. The official also has to participate in regional level audits of two days every three months and to supervise 30 AVs assigned in the district.

Authorized veterinarians are paid based on the number of animals inspected or the amount of meat introduced to the cutting plant they supervise. If the establishment is stopped for any reason, they are not paid for this period. This payment system undermines their independence in situations where the required enforcement measures to be taken on the spot would include stopping slaughter operations.

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FDA warnings involve raw pet food facility and seafood processing facility

January 2, 2020 - 12:01am

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.

G & C Raw, LLC — Versailles, OH
The Food and Drug Administration sent a warning letter dated Dec. 12, 2019, to the owner of G & C Raw LLC, Cathy Manning.

During an inspection at G & C Raw LLC, raw pet food manufacturing facility April 22-25, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507)).

The warning letter says that, “As a result of these violations, the raw pet foods manufactured in your facility are adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. The introduction or delivery for introduction into interstate commerce of an adulterated food is a prohibited act.”

In response to these deviations, the FDA issued an FDA 483 Inspectional Observations form that lists deviations observed at the facility.

Salmonella and Listeria monocytogenes can cause severe and potentially fatal infections in both animals and in humans. Children, the elderly, pregnant women, and people with weakened immune systems are especially at risk.

People are at risk if they handle the recalled pet foods. Also, surfaces such as freezers, refrigerators, counter tops and pet food bowls can become contaminated and easily infect people.

The violations noted by the FDA:

Current Good Manufacturing Practice (CGMP) Requirement Violations:

  1. “You did not handle work-in-process and rework in such a way that it is protected against contamination and the growth of undesirable microorganisms, as required by 21 CFR 507.25(c)(3). Specifically, our investigator observed:”
  • “An employee used (redacted). The (redacted) and containing raw Beef Veggie and Fruit Dog Food (redacted). Drops of water from (redacted). Employees were also observed stepping over this tote several times as drops of water from their boots fell into the (redacted). The raw dog food re-work in the (redacted) to be made into product. These practices could contribute to the contamination of your animal food with undesirable microorganisms or other contaminants, such as dirt or other foreign material, that may be present on the floor, employee footwear, the dustpan, or other non-food contact surfaces.”
  • “An employee lifted a barrel of ingredients from the floor and placed the barrel directly on (redacted), the remainder of the ingredients. The barrel was resting on its side, directly on top of raw meat and organ ingredients. This practice could contribute to the contamination of your animal food with undesirable microorganisms or other contaminants, such as dirt or other foreign material, that may be present on the outside of the barrel.”
  • “An employee placed a box of bone meal ingredient on top of a trash can that was being used to throw away containers that had fallen on the floor and raw ingredients, such as fat, that had not met quality standards. The employee scooped bone meal out of the box that was sitting on the trash can (redacted) raw meat and organ ingredients. This presents the potential to put contaminants into the box of bone meal instead of the trash can, or to accidentally take something out of the trash can to put into the animal food being manufactured.”
  1. “You did not conduct thawing of your frozen ingredients in manner that minimized the potential for the growth of undesirable microorganisms, as required by 21 CFR 507.25(b)(3). Specifically:”
  • “You stated that the frozen raw beef hearts that were used to make raw Beef Veggie and Fruit Dog Food were set out at ambient temperature on Monday, April 22, 2019, at approximately (redacted). On Wednesday, April 24, 2019, the investigator observed the beef hearts were used to make raw Beef Veggie and Fruit Dog Food and the final finished product went into the freezer at approximately (redacted). The beef hearts had been sitting at room temperature from (redacted) Monday, April 22, 2019, until approximately (redacted) Wednesday, April 24, 2019. Thawing raw meat product at (redacted) for (redacted), or portions of the ingredients, to reach a temperature that would support the growth of undesirable microorganisms in your animal food.”
  • “You reported that frozen raw meat, including beef, turkey, chicken, pork, and rabbit used to make your raw dog and cat food products, is (redacted). Thawing raw meat product (redacted), or portions of the ingredients, to reach a temperature that would support the growth of undesirable microorganisms in your animal food.”
  1. “You did not take reasonable measures and precautions to ensure that all persons working in direct contact with animal food, animal food-contact surfaces, and animal food-packaging materials conform to hygienic practices to the extent necessary to protect against the contamination of animal food, as required by 21 CFR 507.14. Specifically, on April 24, 2019, while watching the manufacturing of raw Beef Veggie and Fruit Dog Food, our investigator observed the following employee practices:”
  • (redacted) employees lifted a barrel to empty the remainder of the contents into (redacted). One employee grabbed the bottom of the barrel, which had been directly on the floor, with their gloved hand to dump it. The employee then used the same gloved hand that had been touching the bottom of the barrel to spread raw meat ingredients in the (redacted). The employee did not change gloves or wash their hands between touching the bottom of the barrel and the raw meat ingredients.”
  • “An employee was observed using their cell phone in the processing room while weighing open containers of raw Beef Veggie and Fruit Dog Food. The employee used their gloved hand to touch the raw dog food but did not change gloves or wash their hands after touching their cell phone.”
  1. “You did not take adequate precautions so that plant operations do not contribute to contamination of animal food, animal food-contact surfaces, and animal food-packaging materials as required by 21 CFR 507.25(a)(5). Specifically, our investigator observed the following operations:”
  • “An employee picked up empty containers that had fallen on the floor on their side and placed them on the cart with other empty containers. The containers that had fallen on the floor were then filled with finished raw dog food product. As employees pick-up the empty containers they could touch the floor and the inside of the containers, introducing undesirable microorganisms and foreign material to the inside of the containers.”
  • “An employee was (redacted) of raw beef heart being used to manufacture product. This can cause (redacted) to spread contamination around the processing area, including onto ingredients and animal food-contact surfaces.”
  • “An employee was seen washing a van in the parking lot of the facility with a hose that was connected to a sink in the processing room. The hose was pulled back into the processing room and used (redacted). This can introduce contaminants into the processing area from the parking lot, where they can be transferred to animal food, food-contact surfaces, and packaging materials.”

“Your firm manufactures raw pet food and many of the practices described above are ways in which the pet food you manufacture could become contaminated by undesirable microorganisms for which you have no control. Undesirable microorganisms include microorganisms that are pathogens, that subject animal food to decomposition, that indicate that animal food is contaminated with filth, or that otherwise may cause animal food to be adulterated. (See 21 CFR 507.3.)”

“The presence of undesirable microorganisms in your pet food and your processing environment is further evidence of the significance of your CGMP violations. On April 25, 2019, FDA collected sample number 1106962, which included (b)(4) unopened plastic containers, weighing 1 lb. each, of finished Raw Ground Turkey Dog Food. FDA analysis of the Raw Ground Turkey Dog Food product (#1106962) identified Listeria monocytogenes 3 in five of (b)(4) subsamples and in one of two composite samples analyzed for Listeria.”

“During the FDA inspection, we also performed swabbing for the presence of environmental pathogens. Sample number INV 1071173 consisted of (b)(4) environmental swabs. The FDA laboratory recovered Listeria innocua and Listeria grayi in one subsample. The presence of non-pathogenic Listeria species, such as Listeria innocua and Listeria grayi, is indicative of environmental conditions within your production facility that are suitable for the survival and/or growth of Listeria monocytogenes.”

Corrective Actions:
“We acknowledge that you performed recalls to remove specific lots of Ground Turkey Dog Food and Turkey Veggie Fruit Mix Dog Food from the market in response to our April 2019 sampling.”

“Further, we acknowledge receipt of your two e-mail messages on May 21, 2019, responding to the Form FDA 483. One e-mail contained a copy of an advertisement for a hand-washing sink you advised us you had ordered, without any indication of when it would be installed or how personnel would be instructed to use it. The other e-mail explained that one employee had been fired, listed some training you had conducted, mentioned that (redacted), that a paper towel dispenser had been installed, and that a separate hose had been purchased for use cleaning vehicles outside. Some photographs were included, as well, although aside from the paper towel dispenser, it is difficult to identify what these photographs are showing and their relevance.

“Although we appreciate this information, these responses do not provide enough detail for us to evaluate whether your response is sufficient to ensure long-term adoption of practices that will ensure your firm consistently meets the CGMP requirements. For example, your response included the statement “(redacted)” but you did not include any information explaining which food safety and handling procedures were discussed, or what your expectations for your employees now are. Likewise, although you (redacted), there was no explanation about how your processing practices are changing to adapt to the new equipment. How long will raw material (redacted), who will be monitoring this process and how will material be rotated, for example?”

Additional comments:
“Previous Instance of Undesirable Microorganisms in Your Facility’s Pet Food”

“Undesirable microorganisms have previously been found in your finished raw pet food products, indicating an on-going problem. In 2018, the Ohio Department of Agriculture (ODA) collected samples of finished pet foods stored in your freezer. The ODA laboratory identified Listeria monocytogenes in Ground Chicken Dog Food, Ground Lamb Dog Food, and Pat’s Cat Ground Turkey Cat Food. Salmonella spp.4 was recovered in Ground Chicken Dog Food and Chicken Veggie and Fruit Dog Food.”

“We acknowledge that you performed recalls to remove these products from the market when they were found in 2018.”

Preventive Controls Requirements:
“Although not covered during the April/May 2019 inspection, as of September 17, 2018, you are required comply with the hazard analysis and risk-based preventive controls requirements for animal food (21 CFR part 507, subparts C and E), unless an exemption applies (21 CFR 507.5). To comply with the preventive controls requirements, you must develop and implement a food safety plan. Specifically, a preventive controls qualified individual (PCQI) must prepare, or oversee the preparation of, a written hazard analysis to identify known or reasonably foreseeable hazards for each type of animal food produced at your facility. The PCQI, or designee, must then evaluate the known or reasonably foreseeable hazards to determine if your firm has any hazards requiring a preventive control, and you must implement preventive controls to significantly minimize or prevent those hazards. Preventive controls are subject to management components as appropriate to ensure their effectiveness. Salmonella and Listeria monocytogenes are known or reasonably foreseeable hazards in raw meat pet food.”

A complete list of the violations can be found in the FDA’s warning letter.

New 88 Japanese Food Trading Inc — Flushing, NY
The Food and Drug Administration sent a warning letter dated Nov. 22, 2019, to Mr. Shao Song (Kevin) Chen, president and co-owner of New Japanese Food Trading Inc.

During an inspection at New Japanese Food Trading Inc’s seafood processing facility and importer establishment on Aug. 13, 15, 19, 27, and Sept. 6, 2019, FDA investigators collected environmental samples from various areas in the processing facility, including areas that are near food and food-contact surfaces. The warning letter says that, “FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation [Title 21, Code of Federal Regulations, Part 123 (21 CFR 123)].”

In response to these deviations, the FDA issued an FDA 483 Inspectional Observations form that lists deviations observed at the facility.

The violations noted by the FDA

Presence of L. monocytogenes:
“L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls it can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to apply controls or take corrective actions as necessary to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.

“FDA laboratory analysis of the environmental sample INV1117726 collected on August 13, 2019, from various areas in your processing facility, including areas that are near food and food-contact surfaces, confirmed that ten (10) of the eighty (80) environmental swabs collected were positive for Listeria monocytogenes and one (1) additional swab was positive for non-pathogenic L. innocua.

“Three (3) of the swabs that were positive for L. monocytogenes were collected from the following food-contact surfaces:”

  • “The edge of the upper level of a table (swab # 17) that your firm was using to store unpackaged RTE tuna loins that were exposed to the processing environment;”
  • “The black rubber strips (swab # 26) mounted in the middle of the swinging doors that lead from your processing cooler to your storage cooler. Your firm was observed to push a table with unpackaged, RTE tuna loins exposed to the processing environment through these doors. The RTE tuna loins were observed to make direct contact with the black rubber strips; and”
  • “The top surface of a cutting board (swab # 38) that your firm reported was used to cut RTE tuna loins prior to sampling.’

“Whole genome sequencing (WGS) analysis was conducted on the ten (10) swabs obtained from INV1117726 that were positive for L. monocytogenes. WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome. This analysis found two (2) different strains of L. monocytogenes in your facility. Both strains were found on food-contact surfaces (Zone 1), and one (1) of the strains was also found in Zones 2, 3, and 4, indicating cross-contamination in your facility.”

“Our findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism.”

“Your September 27, 2019 response describes intensified environmental sampling being conducted, updating your sanitation procedures, and revising an environmental monitoring program. We will verify the adequacy of your corrective actions during a future inspection.’

Seafood HACCP:
“Your significant deviations are as follows:”

  1. “You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 117, Subpart B, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B:”
  2. “Design, material, and workmanship of equipment and utensils makes them adequately cleanable (21 CFR 117.40(a)). FDA investigators observed grooves on a plastic cutting board that did not allow for adequate cleaning and sanitizing. Your firm stated during our inspection that this cutting board was used earlier in the day to cut RTE tuna loins.”
  3. “Conducting food manufacturing, processing, packing, and holding under conditions and controls to minimize the potential for the contamination of food (21 CFR 117.80(c)(2)). FDA investigators observed:”
  • “Apparent moldy stains on various surfaces in the processing cooler, including on a folding table, the swinging doors that lead from your processing cooler into the storage cooler, and various other locations in your processing cooler. RTE tuna loins, staged on a table, were observed to make direct contact with these black rubber strips when the employees of your firm pushed the table through the these swinging doors and into your storage cooler.”
  • “Apparent grease on the handle of hoses used for cleaning your processing cooler.”
  1. “Taking effective measures to protect finished food from contamination (21 CFR 117.80(c)(6)). FDA investigators observed:”
  • “Condensation from an air-conditioner dripping onto RTE tuna loins that were being stored on a table.”
  • “Detergent and water sprayed from a high-pressure hose splashing from the floor to a bucket of uncovered ice and two boxes of uncovered striped bass.”
  1. “Excluding pests (21 CFR 117.35(c)). FDA investigators observed:”
  • “One mouse in the ambient storage area, approximately 3-5 houseflies in the processing cooler, and a spider web near the entrance to the processing cooler.”
  • “The gate door of your facility being left open and the plastic curtain leading to the processing cooler missing one strip.”

“Additionally, you must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records required for the processing of RTE tuna loins that we observed on August 19, 2019.”

“We have reviewed the corrections identified in your responses and determined that not all of them appear to be adequate. Specifically, your root cause analysis and corrective action described in your response to address the condensation from the air conditioning system that was observed to drip onto tuna loins does not appear appropriate. Your root cause analysis determined that “condensation was not wiped off immediately,” and your corrective action is to hang a squeegee in the designated location and to use a disposable paper towel to wipe off condensation. This correction does not address protecting food contact surfaces and product from dripping condensation. It was noted during the close-out of the inspection that your firm moved the staging table to the middle of the production room, so it is no longer below the AC unit, and your solution to the condensation problem was to turn on both units. Please clarify regarding how you are addressing condensation and provide an update on the status of this correction.”

“Additionally, your response to the detergent and water that was observed splashing from the floor to the uncovered ice and uncovered striped bass was to replace all hose nozzles. It is not clear how replacing the nozzle will address the observation. Also, continued use of high-pressure hoses does not appear to be consistent with your “Sanitation Handling Techniques, Personal Hygiene Practice and Color Coding Program” procedure which indicates that “(redacted)” and “(redacted).” To prevent aerosols from contacting RTE food, food contact surfaces, and food packaging materials, FDA recommends avoiding the use of high-pressure water hoses during production in areas where RTE foods are exposed or after equipment has been cleaned and sanitized.”

“Your response includes a new sanitation monitoring form; however, it lacks actual monitoring records.”

  1. “You must implement an affirmative step which ensures that the fish or fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not implement an affirmative step for the refrigerated tuna that you imported from (redacted).”

“Your response includes a certificate from the (redacted) Department of Agriculture certifying that the fresh chilled tuna manufactured by (redacted) is “manufactured under the HACCP system for assuring food safety.” However, to comply with 21 CFR 123.12(a)(2)(ii)(B), the certificate must specifically certify the fish or fishery product was processed in accordance with the requirements in 21 CFR Part 123.”

A complete list of the violations can be found on the FDA’s warning letter page.

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