France has become the fifth country to report Listeria in enoki mushrooms from South Korea.

It was already known that 36 people fell sick and four died in the United States from November 2016 to December 2019. Six illnesses were recorded in Canada between 2017 and 2019 and five in Australia between October 2017 and March 2020. Indonesian authorities ordered a recall of affected mushrooms from Green Co. Ltd in May but did not report any patients.

French authorities confirmed five food isolates collected in 2017 but no illnesses from enoki mushrooms from the Republic of Korea, and distributed via the Netherlands, shared the same core genome multilocus sequence typing (cgMLST) as other countries.

Implicated enoki mushrooms were distributed by one exporter to Australia, Canada, Hong Kong SAR (China), Indonesia, Myanmar, Netherlands, the Philippines, Singapore, and the U.S.

Steps to mitigate risk were taken by authorities in the Republic of Korea, such as food safety education for farmers and including a note on the pack of enoki mushrooms to alert consumers of the need to cook products before consumption.

INFOSAN second-quarter highlights
The new information comes from the International Food Safety Authorities Network’s (INFOSAN) summary of food safety events from April to June.

The network, run by the Food and Agriculture Organization (FAO) and World Health Organization (WHO), was involved in 29 incidents in 2Q 2020 compared to 38 in the first quarter of the year.

Of the 29 incidents, 13 were biological involving Salmonella five times, Listeria monocytogenes on three occasions, Clostridium botulinum twice, Vibrio cholera once and two for an unspecified biological hazard.

The main food categories involved were fish and other seafood, alcoholic beverages, meat products, composite food, fruit products, milk and dairy products, and cereals and cereal-based products.

Food for infants and small children, herbs, spices and condiments, nuts and oilseeds, products for special nutritional use, snacks, desserts, and other products, vegetable and vegetable products, and legumes and pulses were also mentioned in alerts.

Six incidents involved a chemical hazard – methanol three times, histamine twice, and patulin once. Five were due to an undeclared allergen including cashew and pistachio, sesame, wheat, mustard, and peanuts. Three were because of glass as a physical hazard and the other two were unspecified hazards that looked to be related to food.

Methanol poisoning cases
In the second quarter of 2020, the INFOSAN Secretariat was made aware of three methanol poisoning outbreaks in Mexico, Dominican Republic, and Cambodia. It appears outbreaks were localized and not linked in terms of the adulterated products.

“They highlight a common issue whereby fraudsters may be taking advantage of opportunities where legal alcohol sales have been restricted in order to boost their own sales. Such opportunities appear to be occurring more frequently during the COVID-19 pandemic where alcohol sales have been reduced or restricted in some jurisdictions,” according to INFOSAN.

“COVID-19 and the measures taken to mitigate the global impact of the pandemic have disrupted food production and food supply chains worldwide.”

In May and June, more than 100 deaths in Mexico were linked to drinking fraudulent alcoholic beverages adulterated with methanol. In June, it was reported that 215 fatalities and 340 cases of methanol poisoning were registered in the Dominican Republic. Three people were arrested in clandestine factories and 2,864 bottles confiscated.

A total of 43 cases and seven deaths were reported in an outbreak of methanol poisoning in Cambodia, suspected to be caused by consumption of wine.

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A California company is recalling fresh mushrooms imported from Korea after state testing returned positive results for Listeria monocytogenes.

The company, Guan’s Mushroom Co. of Commerce, CA, is recalling all cases of its 200-gram/7.05-ounce packages of enoki mushrooms, according to a recall notice posted by the Food and Drug Administration. 

Guan’s sent the implicated mushrooms to retailers in California, New York, and Pennsylvania via produce distributors or wholesalers. The company’s recall notice does not indicate if the distributors and wholesalers may have sold the product to other customers. The distribution of the product has been suspended, according to the recall notice.

Consumers can identify the recalled mushrooms by looking for 200-gram/7.05-ounce clear plastic packages with the description “Enoki Mushroom” in English, Korean and French, and Guan’s logo in the front. At the back, there is the UPC number 859267007013 and a package code of 14-1 at the lower right corner. The product is being shipped in a white cardboard box with 25 pieces of 200 grams. The boxes have Guan’s logo in green and #02473 printed on each.

No illnesses have been reported to date in connection with the recalled Guan’s mushrooms. However, earlier this month federal officials reported a 3-year-long listeria outbreak traced to Sun Hong Foods enoki mushrooms. 

Consumers who have purchased 200-gram packages of Guan’s enoki are urged to return them to the place of purchase for a full refund. Consumers with a question may contact the company at 323-223-1188.

Established in 1996, Guan’s Mushroom has five distribution centers located in San Francisco, Los Angeles, New York, West Grove, and Toronto, according to the company’s website.

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

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

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

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

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The final listeriosis outbreak of 2020 is in the books. It was officially declared over on Jan. 28, 2021, after a  five-month run. One person died.

Here are the details from the final outbreak report from the Centers for Disease Control and Prevention:

  • 12 people infected with the outbreak strain of Listeria monocytogenes were reported from Florida, Louisiana, Massachusetts and New York.  One additional confirmed case was added since the previous report.
    • All 12 people were hospitalized. One death was reported from Florida.
  • Epidemiologic evidence showed that deli meat was the likely source of this outbreak.
    • In interviews with 11 ill people, all reported eating Italian-style meats, such as salami, mortadella and prosciutto. They reported purchasing prepackaged deli meats and meats sliced at deli counters at various locations.
  • A specific type of deli meat or a common supplier was not identified.
  • Deli meats, also called lunch meat or cold cuts, can have Listeria bacteria. Always follow food safety steps to prevent getting sick from Listeria in deli meats, even when there are no ongoing outbreaks.

 October 22, 2020 report
The first report on the outbreak said a total of 10 people were infected with the same strain of Listeria monocytogenes and were from three states. A list of those original states and the number of cases in each can be found on the Map of Reported Cases page.

At that time the agency reported Listeria samples from ill people were collected from Aug. 6, 2020, to Oct. 3, 2020. Ill people ranged in age from 40 to 89 years, with a median age of 81 years. Eighty percent of ill people were female. All 10 ill people were hospitalized as of Oct. 22.

State and local public health officials interviewed ill people about the foods they ate in the month before they became ill. Of the nine people interviewed, all reported eating Italian-style deli meats, such as salami, mortadella, and prosciutto. They reported purchasing prepackaged deli meats and meats sliced at deli counters at various locations.

Listeria bacteria can spread easily to other foods and surfaces. The bacteria in a contaminated deli product may spread to other deli meats and cheeses in shared display cases or equipment at deli counters.  A traceback investigation is ongoing to determine if there is a specific type of deli meat or a common supplier linked to illness.

People who are higher risk of getting sick from Listeria were advised to avoid eating deli meats unless they are heated to an internal temperature of 165°F or until steaming hot just before serving.

December 4, 2020 report

Since the last update on October 23, 2020, one ill person was added to the investigation.

Epidemiologic evidence continued to show that deli meat is a likely source of this outbreak.

State and local public health officials interviewed ill people about the foods they ate in the month before they became ill. Of the 10 people interviewed, all reported eating Italian-style deli meats, such as salami, mortadella, and prosciutto. They reported purchasing prepackaged deli meats and meats sliced at deli counters at various locations.

Investigators are worked without success to identify a specific type of deli meat or a common supplier linked to the illnesses.

Last year’s only other listeriosis outbreak involved 36 confirmed cases in 17 states with 31 hospitalizations and four deaths.

The culprit in that outbreak was recalled enoki mushrooms that were past their shelf life and should have been removed from the marketplace.  That outbreak event was declared over in June.

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Any discussion of outbreaks in 2020 must be dominated by the coronavirus pandemic, even though it is not considered a foodborne outbreak. There is no solid evidence that the virus can be transmitted by foods or food packaging.

Experts say COVID-19 has roots in a live animal meat market in China. It was soon determined that it is transmitted person-to-person via microscopic droplets released when people speak, sing, cough and sneeze. Foodborne illnesses are rarely transmitted person-to-person.

Foodborne illnesses and injuries can be caused by bacteria, viruses, parasites, extraneous materials and intentional tampering, with no foods or beverages being immune to possible contamination.

Unfortunately, because of federal protections for corporate information and a snarl of red tape and businesses’ record keeping, the sources of foodborne outbreaks are sometimes impossible to determine, according to the Food and Drug Administration and the Centers for Disease Control and Prevention.

The CDC was able to log and investigate 10 multistate foodborne outbreaks in 2020, with three E. Coli O157:H7 outbreaks being labeled as “source unknown.” Federal officials declared two of them over on Dec. 18 with the other officially ending Dec. 22. 

Despite the “source unknown” determination, the CDC reported that two of the outbreaks were likely caused by leafy greens including but not limited to spinach and romaine and iceberg lettuce. As of the CDC’s most recent update on Dec. 22, the FDA is still analyzing samples collected from several leafy greens sources. 

The other seven foodborne outbreaks reported by the CDC involved a wide variety of foods ranging from deli meats to fresh peaches.

Here, in chronological order are the details of the 10 multistate foodborne outbreaks investigated by the CDC in 2020.

Clover Sprouts — E. coli O103
Reported over on April 22, this outbreak was traced to raw sprouts on sandwiches sold by Jimmy Johns restaurants. “Jimmy John’s LLC reported that all of their restaurants stopped serving clover sprouts on February 24, 2020. Clover sprouts are no longer available at Jimmy John’s restaurants,” according to the CDC’s final outbreak update.  

  • Reported Cases: 51
  • States: 10
  • Hospitalizations: 3
  • Deaths: 0
  • Recall: Yes — The FDA also identified the outbreak strain of E. coli O103 in samples of Chicago Indoor Garden products that contained sprouts. On March 16, 2020, Chicago Indoor Garden all products containing red clover sprouts.

The outbreak investigation also showed that a common seed lot was used to grow both the sprouts recalled by Chicago Indoor Garden and sprouts that were served at some Jimmy John’s locations. The same seed lot was also used to grow sprouts linked to an outbreak of the same strain of E. coli O103 infections in 2019.

Enoki Mushrooms – Listeria monocytogenes
Declared over on June 9, this outbreak was traced to enoki mushrooms from Korea and sold by H&C Food Inc., Guan’s Mushroom Co., and Sun Hong Foods Inc. Mushrooms were recalled after tests showed Listeria monocytogenes in product samples.

  • Reported Cases: 36
  • States: 17
  • Hospitalizations: 31
  • Deaths: 4
  • Recall: Yes

FDA collected samples of enoki mushrooms for testing at import from Green Co. LTD of the Republic of Korea. On April 6 results showed that two samples were contaminated with the outbreak strain of Listeria monocytogenes. On April 7 the FDA placed Green Co. LTD on Import Alert, meaning their product is stopped at U.S. ports of entry. On March 18 the Korean Ministry of Food and Drug Safety published its investigation findings and the steps it will take to prevent future illnesses. It found Listeria monocytogenes in enoki mushrooms produced by two firms in the Republic of Korea.

Bagged Salad Mix – Cyclospora
Declared over as of Sept. 23, this outbreak was traced to bagged salad mix containing iceberg lettuce, carrots, and red cabbage produced by Fresh Express. The company recalled certain Fresh Express brand and private label brand salad products produced at its Streamwood, IL facility.

  • Reported laboratory-confirmed cases: 701
  • States: 14
  • Deaths: 0
  • Hospitalizations: 38
  • Recall: Yes

Onions – Salmonella Newport
Declared over on Oct. 8, this outbreak was traced to onions from Thomson International Inc. The company was identified when the FDA and states reviewed records where ill people purchased or ate onions and foods containing onions. This traceback investigation identified Thomson International Inc. as the likely source. Red onions were implicated, but the company recalled its yellow and white onions also because they were processed using the same equipment.

  • Reported Cases: 1,127
  • States: 48
  • Hospitalizations: Of 705 patients for whom the information was available, 167 were admitted to hospitals
  • Deaths: 0
  • Recall: Yes

Peaches – Salmonella Enteritidis
Declared over on Oct. 16, this outbreak was traced to fresh, whole peaches from Prima Wawona or Wawona Packing Co. The FDA and regulatory officials in several states collected records from grocery stores where ill people reported buying peaches. These records showed that loose and bagged peaches distributed by Wawona Packing Co. were sold at multiple grocery stores where ill people bought peaches. On Aug. 22 Prima Wawona recalled bagged and bulk, or loose, peaches that they supplied to retailers nationwide.

  • Reported Cases: 101
  • States: 17
  • Hospitalizations: 28
  • Deaths: 0
  • Recall: Yes

Wood Ear Mushrooms – Salmonella Stanley
Declared over on Nov. 4, this outbreak was traced to wood ear mushrooms distributed by Wismettac Asian Foods Inc. On Sept. 23 Wismettac Asian Foods recalled dried fungus because of possible Salmonella contamination. The FDA and states conducted a traceback investigation from four restaurants with illness clusters to identify the source of the wood ear mushrooms eaten by ill people. On Oct. 1 the California Department of Public Health identified the outbreak strain of Salmonella Stanley in recalled dried fungus samples.

  • Reported Cases: 55
  • States: 12
  • Hospitalizations: 6
  • Deaths: 0
  • Recall: Yes

Deli Meats – Listeria monocytogenes
A Dec. 4 update from the CDC reports that “investigators are working to identify a specific type of deli meat or a common supplier linked to the illnesses.” Of the 10 people interviewed, all reported eating Italian-style deli meats, such as salami, mortadella, and prosciutto. They reported purchasing prepackaged deli meats and meats sliced at deli counters at various locations, according to the CDC update.

  • Reported Cases: 11
  • States: 3
  • Hospitalizations: 11
  • Deaths: 1

Unknown Source 1 – E. coli O157:H7
Declared over on Dec. 18, this outbreak “ended before enough information was available for investigators to identify the likely source,” according to the CDC. Some patients reported eating at the same restaurant, but investigators could not identify a common food among them. Other patients had not eaten at the restaurant, but were sickened from the same strain of E. Coli.

  • Reported Cases: 32
  • States: 12
  • Hospitalizations: 15
  • Deaths: 1

Unknown Source 2 – E. coli O157:H7
Declared over as of Dec. 22, this outbreak’s investigation showed that leafy greens were the likely source. Investigators were unable to identify a specific type or brand because patients in this outbreak reported eating a variety of leafy greens and because different leafy greens are often grown, harvested, and processed together, according to the CDC and the FDA. Several farms of interest were identified, but no single ranch was a common source of the leafy greens, according to the FDA.

  • Reported Cases: 40
  • States: 19
  • Hospitalizations: 20
  • Deaths: 0
  • Recall: No

Unknown Source 3 – E. coli O157:H7
Declared over as of Dec. 18, in this outbreak 13 people were interviewed about food they had eaten before becoming ill and all of them reported eating or maybe eating various types of leafy greens, including romaine lettuce, spinach, and iceberg lettuce. Laboratory testing identified the outbreak strain in a sample of Tanimura & Antle romaine lettuce in a single-head package, which was recalled on Nov. 6. However, investigators were unable to determine if any ill people in this outbreak got sick from eating the recalled product. No one specifically reported eating Tanimura & Antle romaine lettuce. “This outbreak ended before enough information was available for investigators to identify the likely source,” according to the CDC.

  • Reported Cases: 18
  • States: 9
  • Hospitalizations: 6
  • Deaths: 0
  • Recall: Yes

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With just six weeks to go, 2020 continues to look like a light year for the major foodborne illnesses when measured by multistate outbreaks. The three recently identified outbreaks of E. coli O157: H7 without any known food source are mysteries that remain to be solved before the year ends.

Various theories may explain the light year. The coronavirus has undoubtedly caused the diversion of public health professionals to the pandemic and caused ill people not to seek medical attention and testing in possible food poisoning cases.

The three E. coli outbreaks where the food source is unknown are described as follows:

  • As of Oct. 28, 2020, a total of 23 people infected with the outbreak strain of E. coli O157: H7 have been reported from 12 states.
  • As of Oct. 28, 2020, a total of 21 people infected with the outbreak strain of E. coli O157: H7 have been reported from eight states.
  • As of Nov. 9, 2020, a total of 12 people infected with the outbreak strain of E. coli O157: H7 have been reported from six states. 

Across the three outbreaks, reports include one death and 23 hospitalizations. Recalled Tanimura & Antle romaine lettuce in single-head packages may be the cause of the third outbreak.

The federal Centers for Disease Control and Prevention (CDC) in Atlanta said that as of Nov. 6 there is not enough epidemiologic and traceback information available at this time to determine if ill people got sick from eating Tanimura & Antle romaine lettuce. 

While the investigation continues, CDC nonetheless urges consumers not to eat, sell, or serve Tanimura & Antle’s packaged single head romaine lettuce.

  • UPC Number: 0-27918-20314-9
  • Packed on date: 10/15/2020 or 10/16/2020
  • Produce Traceability Initiative (PTI) sticker for retailers and distributors: 571280289SRS1 or 571280290SRS1

A multistate outbreak of E. coli O103 linked to clover sprouts sickened 51 people in 10 states from February through April. There were no deaths among the three hospitalizations. The sprout outbreak is the only other E. coli outbreak so far this year.

Listeria outbreaks
There have been two Listeria outbreaks in 2020. One, involving deli meats, remains active. It involves 10 people infected with the outbreak strain of 
Listeria who have been reported from Florida, Massachusetts, and New York. All 10 ill people were hospitalized. Florida has reported one death.

The other Listeria outbreak, involving recalled enoki mushrooms, was declared over on June 9. It was also deadly, killing four people with the infections of 36 people in 17 states, with the hospitalization of 31. H&C Foods, Guan’s Mushroom Co., and Sun Hong Foods recalled enoki mushrooms were associated with the recall.

Salmonella outbreaks
There are currently no active food-related Salmonella outbreaks in the United States. Earlier this year, there were three.

 On Oct. 8, a Salmonella Newport outbreak linked to onions was declared over after 1,127 confirmed patients in 48 states were confirmed infected. There were no deaths among the 167 hospitalizations 

On Oct. 16, a Salmonella Enteritidis outbreak involving peaches was declared over after 101 illnesses in 17 states with 28 hospitalizations and no deaths.

Finally, on Nov. 4, a Salmonella outbreak involving dried wood mushrooms sold in restaurants was declared over after 55 cases in 12 states. Six were hospitalized with no deaths.

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Salmonella dominated hazards dealt with by a global food safety network in the third quarter of 2020.

The International Food Safety Authorities Network (INFOSAN) was involved in 37 events from July to September compared to 29 incidents in 2Q 2020.

Ten of 18 biological hazard incidents involved Salmonella while the next highest was E. coli and Listeria monocytogenes with two each. Norovirus, Pseudomonas spp., Clostridium botulinum, Bacillus cereus, Campylobacter spp. and Enterococcus faecalis were linked to one event each.

Six events involved an undeclared allergen such as peanut, milk, egg, soy, walnuts, and hazelnuts. Five were due to a physical hazard like plastic, glass, and foreign matter.

Five involved a chemical hazard including histamine, clenbuterol, and phytohemagglutinin and three were caused by unidentified hazards.

The most commonly involved food categories were nuts and oilseeds; snacks, desserts, and other foods; fish and other seafood; meat products; vegetable products and milk and dairy products.

Herbs, spices, and condiments; legumes and pulses; composite food; fruit products; fruit and vegetable juice; food for infants and small children; egg products; and cereal-based products were also linked to food safety issues.

Salmonella peach outbreak
In the quarter, there was a multi-country outbreak of Salmonella Enteritidis in the United States and Canada linked to the consumption of fresh peaches produced in the U.S.

More than 100 people infected with the outbreak strain were reported from 17 states in the U.S. while 57 people were affected in two Canadian provinces.

Implicated products were distributed from the U.S. to Australia, China, Costa Rica, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Panama, Philippines, the United Arab Emirates, Singapore, and Taiwan. They were also sent to New Zealand and were re-exported to Cook Islands, French Polynesia, Samoa, and Tonga.

Whole Genome Sequencing details were shared to help identify possible matching cases in these countries but no more illnesses were reported.

The second and third meetings of the INFOSAN working groups were held online in August and September. For the second session, participants discussed food recalls in an international context. During the third event, the group discussed allergens in food and their experiences when dealing with such issues.

INFOSAN is managed by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations.

The network was involved in almost double the number of incidents in 2018 and 2019 compared to 2016 and 2017, according to its activity report. Biological hazards were behind the majority of events, the most common of which was Salmonella.

Results from a study of INFOSAN were also published in the Journal of Food Protection to describe experiences of network members. The third and final phase of the research is ongoing.

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

Ventura Terra Garden Inc.
Ventura, CA

An import company in California is on notice from the FDA for not having Foreign Supplier Verification Programs for a number of imported food products. The inspection was initiated because of imported enoki mushrooms being associated with a multinational Listeria monocytogenes outbreak.

In the July 29 warning letter the FDA described an April 15-17, 20-21, and 29, 2020, Foreign Supplier Verification Program (FSVP) inspection at Ventura Terra Garden Inc.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in issuance of an FDA Form 483a. The significant violations are as follows:

  1. The firm did not have a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a control. The firm may rely on the hazard analysis of your foreign supplier to meet their obligations under the FSVP regulation, however, they did not provide FDA with any evidence that they documented their review and assessment of their foreign supplier’s hazards analysis. They may meet their requirement to conduct a hazard analysis, by reviewing and assessing their supplier’s hazard analysis and documenting their review and assessment of that hazard analysis.
  2. An onsite audit of the firm’s foreign supplier, (redacted), did not consider an applicable food safety regulation. Specifically, their third-party “Audit Checklist Report” (redacted) dated April 4, 2019, for their enoki mushrooms imported from (redacted), did not include the Food Safety Modernization Act (FSMA) Produce Safety Rule as part of the criteria.
  3. The firm did not promptly document their review and assessment of the results of a verification activity that was conducted by another entity. Specifically, they did not have documentation that they reviewed and assessed the result of third-party (redacted) audit for their Enoki mushroom imported from, (redacted).

The full warning letter can be viewed here.

Kaymile Trading Inc.
South El Monte, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 28 warning letter the FDA described an April 24, 2020, Foreign Supplier Verification Program (FSVP) inspection at Kaymile Trading Inc.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in issuance of an FDA Form 483a. The significant violations are as follows:

  1. The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
  2. Roasted onion granules imported from (redacted) located in (redacted).
  3. Coarse black pepper imported from (redacted) located in (redacted).
  4. For the roasted garlic granules imported from (redacted), located in (redacted), they did not meet their requirements to conduct a hazard analysis. During the inspection, they provided a copy of their foreign supplier’s HACCP plan. They may meet their requirement to conduct a hazard analysis by reviewing and assessing their supplier’s hazard analysis and documenting their review and assessment of their supplier’s hazard. The firm did not provide documentation that they have reviewed and assessed their foreign supplier’s hazard analysis.
  5. The firm must approve their  foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food, and document their approval. They did not document their approval of their foreign supplier of roasted garlic granules imported from (redacted).
  6. The firm did not establish and follow written procedures to ensure that they import foods only from foreign suppliers they have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food.
  7. They did not establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the foods they import.
  8. The firm did not conduct and document (or obtain documentation of) one or more of the supplier verification activities listed for each foreign supplier before importing the food and periodically thereafter. For example, they did not conduct and document (or obtain documentation of) one or more of such supplier verification activities for their foreign supplier (redacted), before importing roasted garlic granules and periodically thereafter.

The full warning letter can be viewed here.

Pasha Food Distribution USA Inc.
Tarzana, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In a May 18 warning letter the FDA described a March 18, 2020, Foreign Supplier Verification Program (FSVP) inspection at Ventura Terra Garden Inc.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in issuance of an FDA Form 483a. The significant violations are as follows:

  • The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for roasted eggplant manufactured by (redacted), and dried sumac and tahini manufactured by (redacted).

If a firm is a very small importer and they choose to comply with the modified requirements, they must document that they meet the definition of very small importer as required. In addition, for each food they import, they must obtain written assurance, before importing the food and at least every two years thereafter, that their foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection. 

The full warning letter can be viewed here.

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Opinion

Now when I get a report on Salmonella infections in backyard flocks across 46 states or hundreds sickened by Salmonella Newport due to contaminated onions, I feel just a little bit of cheer.

Oh, it’s not that I am heartless about those suffering from Salmonella or unfeeling about just how icky almost 800 cases of cyclosporiasis can be. It’s just that at the moment, foodborne illness outbreaks and pathogens are signs that we might eventually be getting back to normal.

And that cheers me.

We’d started 2020 nicely enough with outbreaks of Listeria in 17 states for contaminated enoki mushrooms and of E. coli O103 infections in 10 states over clover sprouts.

President Trump activated the federal emergency over the COVID-19 coronavirus on Jan.31. For a while, after that, it seemed like foodborne illness dried up. Now it’s starting to feel like things might be getting back to good old normal.

We are into seven months of life being very different than it was before this emergency drill. We’ve all changed—some more than others.

As my routine involves news-gathering and writing, solo activities, I’ve been luckier than most. Still, I found myself listening to satellite radio’s Classics and Rural Radio instead of my bad old habits for talking heads on TV or radio.

There’s also more time for reading and reaching out without any noise.
Like most of us, I spend a half-hour or so each date updating myself on the various COVID-19 data sources–Worldmeter, John Hopkins, and CDC are all useful.

Is it good that we are at 5.1 million COID-19 cases when we had 60.8 million H1Ni cases during the 2009 pandemic? Or is it just bad that COVID-19 deaths in the U.S. had hit 165,000 when we got off with 12,469 during the 2009 pandemic?

Somebody this week wrote that we are closer to the end than the beginning. I think that is all a matter of one’s geographic perspective. I’ve been going back and forth between two areas with different experiences.

Weld County, CO, for example, has produced only a trickle of new COVED-19 cases this summer, and only one additional death. In the spring, it was a hotspot with more than 3600 cases and 90 deaths.

When I first arrived in Hays County, TX in the spring, fatalities since the onset was still in single digits, but grew to a total of at least 34 over the summer. Hays County did not escape the spike in cases Texas experienced over the summer, reaching 5,012 cases since the first diagnosis of the virus within the county on March 14.

There are currently 2,803 active coronavirus cases with 2,175 recoveries in Hays County, home to Texas State University in San Marcos.

Weld County is home to the University of Northern Colorado in Greeley.
Several convalescent homes and the JBS beef plant ran up the Weld County numbers in the spring. Texas put caution aside for a while, causing the spike, which came after TSU adjourned.

Living in either Greeley or San Marcos without fear is not difficult, although it can be tedious. It mainly involves staying away from other humans and masking up when some limited, short-time contact is required, like at the grocery store.

Dining is either take-out or outdoor seating, and some of the options are pretty good. Restaurants have done well with take-outs of dinner and drinks.

Traveling between the two locations is a two and one-half hour United non-stop from Austin to Denver. An MIT study out last week found there is a 1 in 4300 chance of contracting COVID-19 from a nearby passenger, or even better at 1 in 7,700 if the middle seat is vacant.

I’ve already “risked it” a couple of times, and plan to do so again in two weeks. Airports and airlines require masks, and its easy to avoid contact with people in the terminals. TSA wants to see your face but only requires removing your cover for a few seconds.

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

Raw Juicery Inc.
Los Angeles

A juice company in Los Angeles is on notice from the FDA for serious violation of the food code, notably, the firm did not identify patulin as a hazard likely to occur in their HACCP plan.

In a June 11 warning letter the FDA described a Nov. 6 and 12, 2019, inspection at Raw Juicery Inc.’s facility. The inspection revealed serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation. 

The significant violations are as follows:

The firm’s HACCP plan must list all food safety hazards that are reasonably likely to occur.  A “food hazard” is defined as “any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” However, the firm’s HACCP plan does not identify the food hazard of patulin. The FDA noted that the firm’s hazard analysis for Juice Blends, identified patulin as a hazard likely to occur. When an identified food hazard is determined to be reasonably likely to occur, the food hazard must be addressed in a HACCP plan.

The full warning letter can be viewed here.

Diamond Rock Food Imports Inc.
Copiague, NY

An import company in New York is on notice from the FDA for not having FSVPs for a number of imported food products.

In a June 8 warning letter the FDA described a March 9 Foreign Supplier Verification Program (FSVP) follow-up inspection at Diamond Rock Food Imports Inc.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for the following foods:

  • Tomato Sauce manufactured by (redacted)
  • Refried Red Beans manufactured by (redacted)
  • Grape Soft Drink manufactured by (redacted)

The full warning letter can be viewed here.

H & C Food Inc.
Brooklyn, NY
A food company in Brooklyn is on notice from the FDA for not having FSVPs for imported Enoki Mushroom and Teriyaki Kimnori Roasted seaweed from South Korea.

In a June 22 warning letter the FDA described an April 9 and 14 Foreign Supplier Verification Program (FSVP) follow-up inspection at H & C Food Inc.

The FDA’s inspection revealed that the firm was in compliance with FSVP regulations and resulted in issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for the following foods:

The firm did not meet their requirements to conduct a hazard analysis for their Enoki Mushroom imported from Green Co., Ltd., located in South Korea and their Teriyaki Kimnori Roasted seaweed Snack imported from (redacted) Specifically, the firm did not document their review and assessment of their foreign supplier’s hazard analysis. The FSVP regulation also generally requires that they evaluate their foreign supplier’s performance and conduct foreign supplier verification activities, among other requirements.

The full warning letter can be viewed here.

El Abuelito Cheese Inc.
Paterson, NJ
A cheese company in New Jersey is on notice from the FDA after inspectors found non-pathogenic Listeria species in its manufacturing facility.

In a June 4 warning letter the FDA described a Jan. 14 through Feb. 6, inspection at El Abuelito Cheese Inc.’s ready-to-eat cheese manufacturing facility. During the inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

The FDA’s inspection resulted in issuance of an FDA Form 483a. The significant violations are as follows:

Hazard Analysis and Risk-Based Preventive Controls:

  1. The firm did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at their facility to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control. Specifically, the firm did not identify and evaluate environmental pathogens, such as Listeria monocytogenes and Salmonella, to determine whether environmental pathogens are a hazard requiring a preventive control. Their facility manufactures RTE food which is exposed to the environment prior to packaging. The packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Listeria monocytogenes is an environmental pathogen that is a known or reasonably foreseeable hazard for cheeses, in particular soft cheeses such as queso fresco.
  2. The firm did not establish and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by their facility will not be adulterated. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan. For example, for the processing of RTE foods exposed to the environment, generally sanitation controls are needed to control environmental pathogens such as Listeria monocytogenes. Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system.
  3. They did not prepare or have prepared and did not implement a written food safety plan for any of the products manufactured in their facility. A food safety plan must include the following:
  4. The written hazard analysis;
  5. The written preventive controls;
  6. The written supply-chain program;
  7. The written recall plan;
  8. The written procedures for monitoring the implementation of the preventive controls;
  9. The written corrective action procedures;
  10. The written verification procedures.

The firm’s response indicates that they are working with a HACCP consultant to develop their food safety plan for their facility. The FDA will assess the adequacy and implementation of their food safety plan during the next FDA inspection.

In addition to the violations described above, the FDA offered the following comments:

  • During their inspection, the FDA collected environmental swabs from various locations throughout their processing areas. FDA laboratory analysis of the environmental sample INV1123037 collected on January 15, 2020 confirmed two (2) swabs positive for Listeria grayi and Listeria innocua; both are non-pathogenic Listeria species (Listeria spp.). One of the positive swabs was collected from a surface adjacent to a food-contact surface on the (redacted) edges of the (redacted) conveyor belt. Additionally, FDA laboratory analysis of the environmental sample INV1123040 collected on January 29, 2020 confirmed one (1) swab positive for Listeria innocua. The presence of Listeria spp. indicates that the conditions are conducive for pathogenic Listeria monocytogenes to be present in their facility. The firm only tests their environment for ATP and coliforms; they do not conduct swabbing for Listeria spp., which is an appropriate indicator organism for Listeria monocytogenes. As noted above, Listeria monocytogenes is a known or reasonably foreseeable hazard for cheese; sanitation controls are generally applied to prevent contamination of RTE food such as cheese from the environment, and environmental monitoring for Listeria spp. is usually used to verify these controls.
  • During FDA inspection, investigators made observations regarding the potential need for the monitoring of certain aspects of their operation, which would need to be assessed when their firm evaluates the need to establish and implement preventive control programs. Specifically, they do not monitor their sanitizer solution to ensure concentration levels are effective for their (redacted) sanitizer at the production entry door, their (redacted) of sanitizer containing white rags used to wipe down equipment, or their buckets of sanitizer used to soak utensils.
  • The FDA notes that part 117 includes requirements for training employees and keeping records of certain training. The firm’s response states that they (redacted). However, their response does not include details on when this (redacted) will occur or the records documenting that this (redacted) was conducted. The FDA will verify the adequacy during their next inspection.

The full warning letter can be viewed here.

Global Commodities Corp.
Hayward, CA
A food company in California is on notice from the FDA for not having FSVPs for imported Boy Bawang Mixed Nuts Snacks-Garlic, Buenas Kaong Red Sugar Palm Fruit in syrup, and Macapuno String in Syrup Preserves.

In a June 3 warning letter the FDA described a Feb.27 Foreign Supplier Verification Program (FSVP) follow-up inspection at Global Commodities Corp.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in issuance of an FDA Form 483a. The significant violations are as follows:

Significant violations of the FSVP regulation are as follows:

  1. The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for Boy Bawang Mixed Nuts Snacks-Garlic manufactured by KSK Food Products, Philippines.
  2. For a low-acid canned food not subject to further processing, the firm did not verify and document the food was produced accordance with the low-acid canned food regulations, or with respect to all matters not controlled by part 113, they did not have an FSVP. Specifically, the firm did not document compliance with 21 CFR part 113 or otherwise develop an FSVP for Buenas Kaong Red Sugar Palm Fruit in syrup and Macapuno String in Syrup Preserves manufactured by (redacted), Philippines.

The full warning letter can be viewed here.

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Federal officials say a three-year Listeria outbreak caused by mushrooms imported from the Republic of Korea appears to be over.

The implicated enoki mushrooms from H&C Food Inc., Guan’s Mushroom Co. and Sun Hong Foods Inc. are past their shelf life and should not be available for sale, according to an outbreak update the U.S. Centers for Disease Control and Prevention posted today.

Public health officials in Michigan, California and other states worked with the CDC to use DNA fingerprinting on samples from patients and mushrooms. The outbreak strain of Listeria monocytogenes was found in two samples of mushrooms collected from a grocery store by Michigan officials. An outbreak patient reported eating mushrooms from the store before becoming ill. The California Department of Public Health collected enoki mushrooms from grocery stores and identified the outbreak strain in one sample.

FDA collected samples of enoki mushrooms for testing at import from Green Co. LTD of the Republic of Korea. On April 6, 2020, results showed that two samples yielded the outbreak strain of Listeria monocytogenes. As a result, on April 7, 2020, FDA placed Green Co. LTD on an import alert, meaning their product can be stopped at the U.S. border.

Having been determined to have begun in November 2016, the CDC reports the outbreak lasted through December 2019.

“As of June 9, 2020, this outbreak appears to be over. Epidemiologic, traceback, and laboratory evidence showed that enoki mushrooms supplied by Green Co. LTD, located in the Republic of Korea, were the likely source of this outbreak,” according to the outbreak update. “. . . enoki mushrooms supplied by Green Co. LTD, located in the Republic of Korea, were the likely source of this outbreak.”

A total of 36 people have been identified so far as having been sickened in the outbreak. The patients are from 17 states. Almost all patients — 31 of the 33 with information available — were so sick they had to be admitted to hospitals. Four patients died. Six pregnancy-associated cases were reported, with two resulting in fetal loss.

Ill people ranged in age from less than 1 to 96 years old, with a median age of 67, according to the CDC. Fifty-eight percent of ill people were women.

On March 18, 2020, the Korean Ministry of Food and Drug Safety published its investigation findings and steps it will take to prevent future illnesses. It found Listeria monocytogenes in enoki mushrooms produced by two firms in the Republic of Korea.

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