The owners of a factory in the Netherlands linked to a Listeria outbreak have decided not to reopen part of it.

The Offerman plant in Aalsmeer was shut in October this past year while Dutch authorities investigated the outbreak.

Ter Beke considered renovating the factory but will close the large hall while a smaller one which employs around 40 people will remain open. Some production lines have been moved to different plants while others stayed in Aalsmeer. The company has not yet responded to a request for comment from Food Safety News.

Outbreak details
Twenty-one people were infected with Listeria monocytogenes in the Netherlands and Belgium. One person fell sick in October 2017, eight in 2018 and 12 in 2019.

Three people died. All patients were hospitalized and one woman had a miscarriage. Two Dutch patients were pregnant women in their 30s. The others ranged in age from 64 to 94 years old and 10 were men.

Sliced ready-to-eat (RTE) meat products from boiled and raw sausages from different suppliers produced between 2017 and 2019 by Offerman were contaminated with Listeria that matched the outbreak strain.

An assessment by the European Food Safety Authority (EFSA) and European Centre for Disease Prevention and Control (ECDC) could not identify the exact point of contamination but found it likely happened at Offerman, which was the only common manufacturing point of contaminated products.

Union action
The news was revealed by CNV, the second largest union in the Netherlands. It represents a number of workers at the Offerman Aalsmeer plant as well as other Offerman and Ter Beke sites.

Soraya Faez, from CNV, said 50 people have lost their jobs at the plant in Aalsmeer but some were offered roles at another Ter Beke site in Ridderkerk.

“The other half could stay in Aalsmeer or were offered a new position at another plant. During negotiations we agreed that the employer could offer workers positions in Ridderkerk but acceptance of that position was to be voluntary. This way a worker could choose not to accept the job in Ridderkerk and keep their severance package,” she told Food Safety News.

Faez added the union knew in October that the plant would not reopen and in the first week of January employees were told whether they could stay in Aalsmeer.

“We now have to wait and see how long the plant in Aalsmeer stays open. We did make sure that the severance package we agreed on would also apply to the workers who work in Aalsmeer at this moment. We did that because there were rumors of the second building also closing.”

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Spanish authorities have busted a suspected organized crime group selling horse meat that could have been unfit for human consumption.

The Spanish Civil Guard (Guardia Civil) was supported by Europol. The alleged criminal organization, based in the province of Barcelona, reportedly falsified equine documents and sold horse meat without the mandatory documentation to support their activities. Law enforcement officials also searched various horse stables in Catalonia.

Officers from the Spanish Environment Protection Service (SEPRONA) found the implicated horse meat on the market came from 300 horses killed in slaughterhouses. Documents of more than 10,000 horses were checked during enquiries.

Supply chain involvement
The operation led to the arrests of 15 suspects and investigation of 13 others for allegedly commercializing horse meat that did not have the necessary documentation for human consumption. It resulted in the seizure of 185 falsified horse passports and detection of 100 other horses uncompliant with food market regulations.

Members of the criminal network, active since 2015 according to officials, falsified horse passports in slaughterhouses and farms in Barcelona classifying meat as fit for human food. The slaughterhouse, several livestock farms, cattle dealers and veterinarians were involved in the criminal activities.

Meat has not been available for sale since 2018 when the Civil Guard started the investigation after issues were detected with traceability meaning it was withdrawn from the market.

Seized false documents showed the group could have been responsible for introducing meat from hundreds of slaughtered animals onto the market, which failed to comply with national and European regulations.

Previous incidents
It is not the first time authorities have acted in this sector. In 2017, 65 people were arrested in Spain after a Guardia Civil and Europol operation uncovered trading of horsemeat in Europe unfit for human consumption. Work was carried out with Belgium, France, Italy, Portugal, Romania, Switzerland and the United Kingdom.

Offenders were charged with animal abuse, document forgery, perverting the course of justice, crimes against public health, money laundering and being part of a criminal organization.

Operation Gazel detected horses in bad shape, too old or labelled as not suitable for consumption were slaughtered in two different slaughterhouses. The animals came from Portugal and northern Spain, their meat was processed in a facility and sent to Belgium.

In 2019, Spanish police arrested one of the alleged ringleaders of the 2013 horsemeat scandal.

Guardia Civil detained Dutchman Jan Fasen at the request of French authorities. Fasen was sentenced to two years in prison and banned from working in the French meat industry by a Paris court. He had been detained by Guardia Civil during Operation Gazel in July 2017 before being released pending trial.

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Officials have shut down operations at a raw milk dairy and are warning consumers against using unpasteurized milk from Pennings Farm because of positive tests for potentially deadly Listeria monocytogenes.

Initial and followup testing showed the contamination, according to the New York State Department of Agriculture and Markets. State officials first notified the dairy owners of positive initial test results on Jan. 15, but operations continued. Confirmation testing returned positive results for the pathogen on Jan. 21.

Pennings Farm, Warwick, NY, is now prohibited from selling raw milk until testing shows no contamination. No illnesses have been confirmed in relation to the raw, unpasteurized milk.

Any consumers who have any of the raw milk from Pennings Farm on hand should dispose of it immediately. Anyone who has consumed any of the raw milk should monitor themselves for symptoms of Listeria infection for the following 70 days.

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 consumed any implicated milk and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has consumed any of the Pennings Farm raw milk should monitor themselves — or children who consumed the milk — 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.

Researchers have estimated the prevalence of Listeria monocytogenes in beef from the Brazilian state of Mato Grosso, which is the largest producer and exporter of beef in the country.

From 50 samples analyzed, Listeria spp. was isolated in 18 and Listeria monocytogenes was confirmed in six of them, according to the study published in the journal Microorganisms.

Nine of 13 processing plants evaluated were positive for Listeria spp.

“These findings cause concern as they indicate that these positive plants are also suitable for Listeria monocytogenes growth,” said researchers.

Despite international regulations being followed by export-authorized plants, Brazilian internal rules only require the control of Listeria monocytogenes in ready-to-eat products.

More than 70 countries import fresh beef from Brazil including China, the Netherlands, Italy and Turkey. A ban is currently in place in the U.S. on fresh beef imports from Brazil.

Cleaning and disinfection
During a six-month period, 50 beef samples from 13 different export-authorized processing plants in Mato Grosso were obtained from regular material used in the pathogen monitoring program of the official inspection service.

Listeria isolates came from beef in nine different processing plants, but Listeria monocytogenes was confirmed in only four of them.

The serotype 4b, 4d or 4e was isolated in samples from processing plants in Várzea Grande exclusively. Serotypes 1/2b, 3b or 7 were isolated from samples in processing plants in Colíder and Matupá.

Listeria monocytogenes isolates were susceptible to most assessed antibiotics, although high rates of resistance were detected to sulfonamides, cefoxitin and cefepime.

All isolates presented minimal inhibitory concentrations (MICs) below the recommended concentrations of benzalkonium chloride, chlorhexidine, peracetic acid and quaternary ammonium.

However, two isolates exhibited MIC of sodium hypochlorite three times higher than its recommended concentration. The high availability and affordable price of sodium hypochlorite make it one of the most used disinfectants by industry and production farms.

Researchers said more intensive measures of cleaning and disinfection must be adopted by the beef processing industry of Mato Grosso.

“This situation puts at risk not only the Brazilian customer, but also the population of the countries that import beef from those processors.”

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A Centers for Disease Control and Prevention study has found that international trade of shellfish might be involved in the dispersal of Vibrio parahaemolyticus populations into the United States and Spain. The study found that severe weather, such as El Niño conditions in Peru, provide ideal conditions for the proliferation of Vibrio parahaemolyticus, Vibrio alginolyticus and Vibrio vulnificus.

The CDC reports that compared to other major foodborne illnesses, Vibrio parahaemolyticus infections have been steadily increasing. Vibrio parahaemolyticus is the leading cause of seafood-related bacterial infections globally. The CDC estimates that the average annual incidence of all Vibrio infections increased 54 percent during 2006–2017. Vibrio parahaemolyticus is believed to be responsible for about 35,000 human infections each year in the United States and has been the leading cause of foodborne infections in China since the 1990s.

The transition of V. parahaemolyticus disease from a regional to a global pathogen is connected to the emergence of isolates with epidemic potential.

Study Process and Findings:

• Transcontinental spread of Vibrio parahaemolyticus sequence type 36, North America, Peru, and Spain, 1985–2016. Timeline was estimated by using BEAST (Bayesian evolutionary analysis by sampling trees). Years on map indicate the inferred dates of arrival of V. parahaemolyticus sequence type 36 to that country. Old Pacific Northwest is the ancestral population (last strain identified in 2002) of the Pacific Northwest lineage complex, which also includes the modern (i.e., currently circulating) Pacific Northwest lineage, Pacific Northwest lineage 2, Atlantic Northeast lineage, and the South America–West Europe group. Click to enlarge.

  The CDC performed a genome-wide phylogenetic analysis of a global collection of 111 sequence type 36 isolates obtained during the past 30 years from the United States (west and east coasts), Canada, Spain, and Peru.

• Results indicated that the isolates from Peru were of 2 different genetic variants: 5 clustered with the modern (i.e., currently circulating) Pacific Northwest lineage, and 2 clustered in a distinctive group comprising isolates from the 2012 outbreak in Spain.
• The identification of sequence type 36 in Peru provides additional evidence of the extraordinary dynamics of Vibrio infections in this region.
• Since the emergence of cholera in 1991 and the subsequent implementation of an active surveillance system for Vibrio diseases in Peru, several instances of emergence of major epidemic clones of V. parahaemolyticus have been reported in the country.
• Although the sources and routes of introduction of these foreign clones remain yet undetermined, a growing body of evidence has linked the epidemic dynamics and spreading of disease in this particular region of South America to El Niño
• During the past 30 years, the emergence of cases in Peru associated with new clones of Vibrio has been sharply influenced by the onset of El Niño conditions, which has also shaped the extent and severity of epidemics.
• The arrival of extraordinary weather conditions brought on by El Niño (i.e., a combination of heavy rains and heat waves) provides the ideal conditions for the proliferation of Vibrio spp. in the environment.
• These circumstances, along with the disruption of sanitary infrastructure caused by floods and landslides, can help generate the perfect conditions for the explosive emergence of Vibrio diseases.
• Despite the evidence connecting the epidemiology of Vibrio in Peru to El Niño, little is known about the mechanisms of global dispersal and the introduction of foreign epidemic clones into the region. Ballast water from cargo ships and marine heatwaves have been associated with some instances of disease emergence elsewhere.
• Another mechanism that might be involved in the dispersal of V. parahaemolyticus populations is the international trade of shellfish, which was suggested to facilitate the introduction of sequence type 36 into the United States and Spain.

Click to enlarge.

Study Conclusions:

• The study reported the transcontinental expansion of sequence type 36 V. parahaemolyticus into South America.
• The presence of sequence type 36 in clinical and environmental settings in Peru emphasizes the exceptional epidemic potential of the Pacific Northwest complex and V. parahaemolyticus as a human pathogen.
• The long-term persistence and presence of environmental isolates suggest the successful establishment of sequence type 36 in environmental reservoirs.
• Sequence type 36’s ability for intercontinental dispersal, along with its highly pathogenic nature, makes this Vibrio population a major public health concern.
• Peru has shown that implementation of systematic surveillance for Vibrio species can facilitate the detection of emerging transnational epidemic strains.
• This strategy will play a crucial role under exceptional climatic conditions where the enhanced risk for outbreaks is likely.

The full study can be found here.

This study was funded through the Natural Environment Research Council.

More about Vibriosis, its causes, prevention and symptoms can be found here.

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The Dirty Dog, a mobile food vendor in Seattle, was closed by a Public Health food inspector on Jan. 18, because of several violations.

The establishment will be reopened once an inspector confirms that these issues have been resolved:

• Lack of hot water at handwash sink
• Lack of handwashing
• Expired food worker card
• Inadequate equipment for temperature control

Public Health for Seattle-King County currently has seven food establishments shut-down for food safety violations.  The agency says the Dirty Dog,  1700 1st Ave South, will be reopened once the inspector confirms corrections have been made.

Reasons for closing a food establishment can vary and include such issues as failure to follow the permit process and unsafe food handling.

The six other food establishments that remain closed in the Seattle area based on Public Health orders were all shut-down during 2019 and have yet to take necessary actions to re-open.

The food establishments that remain closed from 2019 include:

• Clock Restaurant at 8319 Wabash Ave. S in Seattle. It was closed at 2 p.m. on Dec. 24 for failure to renew an operating permit and for operating a food establishment without a valid license.
• Unapproved food stand found operating in Enumclaw, WA, was closed at 12:15 p.m. Dec. 4 for operating with a permit, serving food from an unapproved source, and operating without handwashing facilities.
• Champion Grocery, 1175 NW Gilman Blvd., Suite 2, in Issaquah, WA. It was shut down at noon, Nov. 14, for operating without approved plans and permits.
• An unlicensed vendor was selling food out of a personal car with a valid permit at a construction site at 17211 15th Ave. N.E., in Shoreline, WA. The vendor was shut down at noon, Nov. 13.
• Boise Creek Grocery, 46918 244th Ave S.E., Enumclaw, WA, was closed on Nov. 13 at 10:10 a.m. for operating without a valid permit.
• A mobile food truck doing business as Tacos El Guero was closed down at 11:50 a.m. on May 31 for operating a mobile food unit without a valid permit. The truck put out of business is for the vehicle with license plate C39468D.

Tacos El Guero has another mobile food unit that is legally operating in King County.

Seattle-King County’s Public Health is one of the largest metropolitan health departments in the United States.  With 1,400 employees, 40 sites, and a biennial budget of $686 million, Public Health serves a resident population of 2.2 million people.  Over 100 languages are spoken in the area, which also welcomes 40 million visitors annually.

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Michigan’s Northern Fish Five Star Food Inc., located in Garden City, has recalled  100 cases of Excellent Tahina 800 g and 100 cases of Excellent Tahina 400 g in containers because it has the potential to be contaminated with Salmonella.

No illnesses are yet associated with the Sham Gardens Tahini recall. The Michigan Department of Agriculture and Rural Development discovered potential contamination by random sampling.  Final laboratory reports are pending, but  Five Star Foods opted to recall the following products as listed by product code.

Product Code Product Description UPC Expiration TAH806SG Excellent Tahina 800 g 6214002717420 Best By Nov 2020 TAH400SG Excellent Tahina 400 g 6214002717413 Best By Nov 2020

The recalled product was distributed in states of Michigan, Ohio, New York, Florida, North Dakota, Virginia, Pennsylvania, and Texas and is sold in 800 grams (1.76 lb) and in 400 grams (14.1 oz).

Expiration dates (Best By Nov 2020) are printed on the lid of the container.

Salmonella is an organism that can cause serious and sometimes fatal infections, especially in young children, frail or elderly people, and others with weakened immune systems.  Others infected with Salmonella often experience fever, diarrhea, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe and potentially deadly illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.

Consumers who have purchased Sham Gardens Tahini with these codes should discontinue use and return it to the store of purchase for a full refund. Retailers that may have further distributed the recalled codes should share this notice with their customers.

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A petition to USDA’s Food Safety and Inspection Service asking for the listing of 31 Salmonella strains as meat and poultry adulterants raises a question. How did FSIS respond the last time someone wanted to list Salmonella as an adulterant?

That someone was the Center for Science in the Public Interest, which spent much of the past decade trying to persuade FSIS to declare four Salmonella strains as adulterants because they are antibiotic-resistant (ABR) strains. The four ABRs are: Hadar, Heidelberg, Newport, and Typhimurium.

The new petition, filed Sunday by food safety attorney Bill Marler, asks FSIS to declare adulterant status for the four ABS strains and 27 others that he calls the “Salmonella Outbreak Serotypes.”

They are: Salmonella Agona, Anatum, Berta, Blockely, Braenderup, Derby, Dublin, Enteritidis, Hadar, Heidelberg, I 4,[5],12:i:-, Infantis, Javiana, Litchfield, Mbandaka, Mississippi, Montevideo, Muenchen, Newport, Oranienburg, Panama, Poona, Reading, Saintpaul, Sandiego, Schwarzengrund, Senftenberg, Stanley, Thompson, Typhi, and Typhimurium.

The CSPI wanted the four ABR strains declared adulterants. It also wanted FSIS to ensure adequate sampling and testing for the pathogens and then remove contaminated meat and ground poultry products from the human food supply.

“After thoroughly reviewing the available data, FSIS has concluded that the data do not support giving the four strains of ABR Salmonella identified in the petition a different status as an adulterant in raw ground meat and raw ground poultry than Salmonella strains that are susceptible to antibiotics,” FSIS said in response to the CSPI petition.

“Additional data on the characteristics of ABR Salmonella are needed to determine where certain ABR Salmonella could qualify as adulterants under the Federal Meat Inspection Act, ” it continued. “Therefore, FSIS denies your request without prejudice.”

ORDINARY COOKING

The ruling said most foodborne pathogens, including Salmonella, are not considered adulterants of raw meat or poultry because of ordinary cooking, which is usually sufficient to destroy the pathogens.

A 1994 ban of E. coli O157:H7 — and 2011’s addition of six other STEC serogroups (026, 045, 0103, 0111, 0121; and 0145) — in meat and poultry was enacted because they can survive home cooking.

The FSIS said the banned E. coli strains “contain a poisonous or deleterious substance and are adulterated with the meaning of (the Food and Drug Act).”

The agency does not consider raw meat and poultry products, including ground meat and poultry, to be adulterated when they contain Salmonella because ordinary methods of cooking and preparing food kill Salmonella.

The CSPI tried to make the argument that the ABR Salmonella strains had “distinguishing characteristics” that support its classification as an adulterant in raw ground meat and poultry. But to scientific studies, FSIS said more data would be needed for CSPI to make its case.

CSPI leaders thought the human involvement in antibiotic-resistant would help lift ABR Salmonella strains over the others, but FSIS found the petition lacked a definition of “antibiotic resistance.” It also said ABR can occur with or without human involvement.

“Further, most Salmonella species are pathogenic in that they can cause disease, ” the 9-page FSIS ruling continued. “Thus, the issue is whether ABR Salmonella strains are more virulent than susceptible strains. The level of virulence of a pathogen may vary and determine whether a pathogen carries virulence attributes that can be objectively determined.”

FSIS also found ABR Salmonella strains are no more heat resistant than other Salmonella strains. It also said there is a need for more data on what constitutes an infectious dose of ABR Salmonella.

Finally, FSIS said international Codex Guidelines do not require listing Salmonella as an adulterant, and there is no reason to believe that raw meat and raw poultry containing specific strains of ABR Salmonella is unfit for human consumption.

The FSIS is responsible for the safety of the nation’s commercial supply of meat, poultry and egg products. As part of this responsibility, FSIS issued the “Pathogen Reduction; Hazard Analysis and Critical Control Point (PR/HACCP) Systems, Final Rule” in 1996.

That rule sets Salmonella performance standards for establishments slaughtering selected classes of food animals or those producing selected classes of raw ground products to verify that industry systems are effective in controlling the contamination of raw meat and poultry products with disease-causing bacteria, like Salmonella.

FSIS inspectors make sure the establishments are meeting the standards by collecting randomly selected product samples and submitting them to an FSIS laboratory for Salmonella analysis.  FSIS requires all plants to reduce bacteria by means of the PR/HACCP system.

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Vietnamese authorities have identified eight forged health certificates related to one meat processing plant.

The Centre for Food Safety (CFS) in Hong Kong found discrepancies in serial numbers of health certificates issued by Vietnamese authorities when processing data during modifications to the import food information system.

Suspected forged health certificates were used by a Vietnam meat processing plant for application of an import license of frozen pork to Hong Kong.

Health certificates are issued by an authority at the place of origin for a consignment of food, showing it has been inspected and is safe for consumption. In Hong Kong, the document is a legal requirement for import of high risk food such as game, meat, poultry and eggs.

Involved importers and Vietnamese firm
A CFS spokesman said it was informed by Vietnamese authorities that after reviewing all health certificates submitted to CFS in 2019, there were eight forged ones.

“All forged health certificates were related to one meat processing plant in Vietnam. The Vietnamese authorities have suspended issuance of a health certificate to this plant. The investigation of CFS revealed that from May to October (2019), there were eight consignments of frozen pork weighing 176 tons exported by the concerned meat plant, using high-quality forged health certificates, to three local importers.”

CFS staff issued import licenses to the eight consignments of frozen pork before finding the problem.

“All the eight consignments of frozen pork were distributed to other food premises, such as food factories, and tracing work is ongoing. The concerned frozen pork was medium pigs and generally supplied to food factories for preparation of roasted meats,” said the spokesman.

CFS told the three importers, Wealth Fortune Trading Ltd., Golden Rainbow Trading Ltd. and Keung Kee Food Trading Co. Ltd., to stop sale and recall concerned products.

The agency has suspended import of frozen pork from the Vietnamese meat processing plant called Haiphong Trading Goods Export Joint Stock Co. It is the first time suspected forged health certificates have been discovered in Hong Kong involving this processing plant. Vietnamese authorities have inspected the implicated processing plant to ensure the environment is clean and processed meat is fit for human consumption.

CFS has collected more than 10,700 samples of pork, beef, poultry meat and such products from 2018 through November 2019 for chemical and biological testing including residual veterinary drugs, preservatives and pathogens, with a satisfactory rate of 99.8 percent. The 25 unsatisfactory samples did not involve frozen meat from Vietnam.

Paper or electronic?
CFS has enhanced inspection of all health certificates for imported frozen meat issued by Vietnam and will verify with Vietnamese authorities every certificate before issuing an import license. Hong Kong and Vietnam only have a meat import arrangement for frozen pork.

The agency has enhanced testing of related products imported from Vietnam and staff will take samples of frozen pork from Vietnam.

Paper health certificates have been effective for countries in ensuring the safety of imported food but the incident is a reminder there are potential loopholes, according to Lai Chi Tse and Edmond Ng, from CFS.

Food safety authorities in other countries advocate using electronic health certification. Requirements are the same as those for the paper version with information including a unique identification number. Electronic health certificates allow instant online verification by third parties and are difficult to forge, officials say.

CFS has established e-health certificate systems with New Zealand and Australia since 2011 and the Netherlands since 2017. The agency has also launched the Food Trader Portal (FTP), an IT system.

Key online functions include trader registration, food import applications and enquiry on such related information. Food traders will be able to use the free online services instead of having to send staff to submit application forms in person at the CFS, with the agency shortening processing time for certain types of import license application from one working day to four hours.

The FTP will preliminarily check the application information and alert the importer if an abnormality is detected such as when a health certificate number duplicated with a preceding application has been input.

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Opinion

Dear Editor,

As a former CFIA ( Canadian Food Inspection Agency) inspector, I have been following this story regarding the change in inspections on the hog plants with great interest. Change is hard but it doesn’t mean the job is eliminated. For the hog program to have the plant do the inspections is a good business move and it can free up the inspectors to focus more on other areas in the plant.

Canada has approved MPIP ( Modernized Poultry Inspection Program) and a recent hog modernized program. The plants had to go through a graduated process in order to enable full inspection by plant line workers. It still entails full inspection but hands off. An inspector shadows the workers and ensures all defects are detected.

The plant must maintain regular statiscally accurate sampling inspections for carcass defects using a coordinated statistical sample plan and the CFIA inspectors perform mirror inspections to verify the line is still operating with minimal defects.

I do not know if the USDA is tasked with approval and training for the independent plant inspections, but this method may be the best for both sides. Presence in the plants is still maintained and the inspectors can focus on other compliance verifications through the operations. The CFIA has CVS and SIP which is a structured program to inspect various prerequisites and critical areas based on the plants’ HACCP plans.

I do not know how the U.S. structures their inspections, but line efficiencies are needed in all types of slaughter facilities to minimize animal stress at slaughter and keep pathogen growth in check after product is processed

— Toni Allardyce-Harris

Editor’s note: We want to hear from our readers. Letters to the Editor can be submitted via the Contact Us link on our website. 

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Opinion

If you haven’t heard, a Seattle attorney is petitioning the USDA to make it illegal to sell meat and poultry that is contaminated with Salmonella. 

Yep, as of right now — and who knows how much longer — it is perfectly legal to sell you hamburger, whole hogs, turkey legs, chicken strips, and any other meat or poultry product if it is contaminated with this infectious bacteria. Even if they know a product is contaminated with Salmonella, producers from single-family farms to the world’s largest meat manufacturers are allowed to sell it.

Today I will share some of the petition, a legal document, focusing on the human suffering it represents through the stories of five victims. You can read the full petition and all of the 62-pages of legalese, but if you want to zero in on what Salmonella infections do to people, keep reading through a bit of background here and you will find the faces behind the petition.

To borrow an expression from the previous century: 

If  you’re not outraged, you’re not paying attention. 

The bottom line is that the government hasn’t declared Salmonella to be an “adulterant” in meat and poultry, so it’s considered an OK ingredient. Tongue in cheek use of ingredient there, in case you missed the implied emoticon.

Full disclosure here, the Seattle attorney who is handling the USDA petition for three consumer groups and five victims of Salmonella poisoning is the publisher of Food Safety News. His name is Bill Marler and you can read about him in this profile the Washington Post published yesterday under the headline “He helped make burgers safer. Now he’s fighting food poisoning again.”

The plaintiffs on the petition are victims Rick Schiller, Steven Romes, and the Porter Family. The consumer advocacy groups petitioning for the change are Food & Water Watch, the Consumer Federation of America, and Consumer Reports. Specifically, the petition asks the USDA’s Food Safety and Inspection Service to declare the following outbreak serotypes of Salmonella as adulterants in meat and poultry products:

Salmonella Agona, Anatum, Berta, Blockely, Braenderup, Derby, Dublin, Enteritidis, Hadar, Heidelberg, I 4,[5],12: I :-, Infantis, Javiana, Litchfield, Mbandaka, Mississippi, Montevideo, Muenchen, Newport, Oranienburg, Panama, Poona, Reading, Saintpaul, Sandiego, Schwarzengrund, Senftenberg, Stanley, Thompson, Typhi, and Typhimurium

The faces behind the petition

Rick Schiller, Salmonella Heidelberg, 2013
Rick Schiller was one of the hundreds of people sickened in March 2013 in a Salmonella Heidelberg outbreak linked to poultry distributed by Foster Farms. The outbreak spanned more than a year and sickened 634 people in 29 states and Puerto Rico. At least 240 victims were hospitalized, according to the Centers for Disease Control and Prevention.

On Sept. 27, 2013, Rick was diagnosed with gastroenteritis, yet did not seek medical treatment as he was convinced that he was suffering from a mild case of food poisoning. Rick could not have been more wrong.

On Saturday night, Sept. 28, 2013, Rick went to bed early, hoping to feel better in the morning. When he woke up the next day, his right knee was painful, reddened, and warm to the touch. 

On Sunday night, Rick went to bed with his right leg propped up and an ice pack on his knee. In the middle of the night, he was awakened by a sharp pain. When he pulled back the covers, he was startled by the sight of his own body— his right leg was dark purple and swollen to about three times its normal size. Rick’s fiancé immediately dialed for an ambulance, but Rick thought it would be faster to have her drive him to the emergency room. However, this was no easy feat. Rick recalls the agonizing experience:

“I couldn’t get my leg into the car because it wouldn’t bend. I leaned over into the driver seat and (my fiancé) had to force my leg into the car. It was excruciating. At the hospital, it took five people to help get me out of the car and into the ER. As soon as I got in there, they pumped me full of morphine for the pain, then they put Novocaine in my leg and attempted to tap the knee.

The first needle they stuck in didn’t work, so they got out a bigger one. They pulled on the syringe and meat- like stuff came out. It was excruciating, even on the morphine.”

Rick was in so much pain that he felt like he might die. After being admitted to the hospital, Rick took out his cell phone, snapped a photograph of himself, and proceeded to draft a Last Will and Testament on his phone.

During his time at the Kaiser San Jose Medical Center, Rick developed a very high fever. He recalls an unpleasant memory of being covered head-to-toe with ice packs. He continued to have pain all over the right side of his body. Both his right leg and right arm were painful. His right eye would crust up and his right ear had intermittently muffled sound.

The following day, doctors ran blood work and performed an arthrocentesis, a duplex Doppler sonography, and an MRCP (magnetic resonance cholangiopancreatography) on Rick. 

On Oct. 2, he was diagnosed with colitis — localized Salmonella infection — and arthritis of the right knee, and he was discharged from the hospital.

On Oct. 15, Rick returned to the Kaiser Medical Center for a follow-up. He was seen by Orod Khaghani, MD, who informed him that his gastroenteritis and Salmonella colitis were resolved; however, Rick was diagnosed with reactive arthritis. 

A few days later, Pradipta Ghosh, MD, performed X-rays on Rick’s lower extremities and diagnosed him with bone spurring and mild joint space loss, consistent with mild osteoarthritis.

Four months after his Salmonella infection, Rick returned to Dr. Khaghani, unfortunately having relapsed with lower left quadrant abdominal pain. He also complained of decreased appetite and loose stools. Dr. Khaghani confirmed his initial diagnosis of reactive arthritis and informed Rick that he was suffering from diverticulitis of the colon. At this point, Rick’s medical bills and estimated wage loss totaled nearly $15,000.

Rick’s reactive arthritis remains symptomatic to this day. He feels as if his “entire right side is now weaker than (his]) left.” He constantly worries about his health and feels as if he never fully recovered from his systemic illness. He notices generalized fatigue and is no longer able to do the handyman work that he once enjoyed.

According to the Centers for Disease Control and Prevention, the multistate outbreak Rick was involved in lasted from March 1, 2013, to July 11, 2014. The USDA’s Food Safety and Inspection Service (FSIS) was first notified of the Salmonella outbreak as early as June 2013. 

By September 2013, FSIS officials had determined that Foster Farms’ chicken was behind the outbreak, yet they were powerless and unable to force a recall of the tainted poultry until July 2014. 

The FSIS did not request a recall because “despite its efforts to identify the product causing the illness, no data were available that enabled its investigators to pinpoint the types of contaminated chicken products — for example, chicken breasts, whole chickens, or ground chicken — or production dates or lots.” 

In September of 2013, during a USDA-FSIS in-facility testing for Salmonella at three Foster Farms production plants in California and Washington, FSIS determined that sanitary conditions at the facilities were so poor that they posed a “serious ongoing threat to public health.”

Steven Romes, Salmonella Newport, 2018
In 2018, Steven Romes, of Gilbert, AZ, was a healthy and athletic husband, father, and insurance underwriter. On Sept. 3 of that year, he consumed medium-to-well done hamburgers as part of a Labor Day family cookout. 

Two days later, Steven fell violently ill with painful diarrhea, fever, and stomach cramps. Over the next few days, Steven’s symptoms worsened. He was unable to consume any solids and was forced to lay on his bathroom floor because he did not have the strength to crawl back into bed after severe bouts of diarrhea and vomiting. 

On Sept. 8, 2018, after his diarrhea progressed to bloody stools, Steven was rushed to the emergency room where urine tests revealed he was suffering from acute kidney injury. He was admitted to the hospital and his illness was determined to be one of many illnesses in a nationwide outbreak of Salmonella Newport linked by public health officials to the various ground and non-intact beef products. The manufacturer was the U.S. unit of JBS, the world’s largest meatpacker. 

The outbreak spurred one of the largest-ever recalls of ground beef — more than 12 million pounds of ground beef, the meat of an estimated 13,000 animals, was recalled. The recall affected nearly 50 different JBS product lines. 

There were 255 cases of Salmonella confirmed across 32 states. Twenty-nine percent of patients for whom information was available were hospitalized; 6 percent were admitted to intensive care units, and two died, according to the CDC.

Fourteen months before the recall the decades-old JBS beef plant in Tolleson, AZ, which was at the center of the outbreak, had received numerous complaints of “egregious” livestock conditions. Despite the conditions, JBS was allowed to continue producing meat for human consumption.

After a colonoscopy and three-day in-patient stay at the Dignity Health Mercy Gilbert Medical Center, Steven was finally discharged from the hospital. Unfortunately, his normal bowel habits and appetite never returned, and he was diagnosed with Irritable Bowel Syndrome. Today, Steven can only tolerate bland foods and he still occasionally suffers from stomach cramps and diarrhea.

The Porter Family, Salmonella I 4,[5],12: I -, 2015
On the afternoon of June 28, 2015, Rose and Roger Porter hosted a going away party at their home in Rainier, WA. The Porters planned on moving to Costa Rica and wanted to celebrate with their family and friends one last time.

On June 27, Rose Porter picked up a whole hog from Stewart’s Meats in McKenna, WA. The next day, Rose cooked the pig just the way she was told to by Stewart’s. Hours later, the Porters’ home was filled with friends and family, many of whom were about to become seriously ill with Salmonella poisoning. It all seemed so easy and matter of fact in retrospect, as Rose recalls:

“When (the whole roasted hog)was done, I served it up. After everyone left, I cleaned everything up and threw out any food that was leftover. We packed everything up and went to bed. The next day, I woke up with explosive diarrhea. I had a very busy day because we were packing up to move to Costa Rica. I had to get out of our house because we had renters coming in. I had to find a hotel and I was dealing with my daughter not feeling well at all. She went with me for the day because she wanted to sleep in a bed at a hotel. I had to stop every half hour to use the bathroom. Diarrhea kept up.”

Once Rose and Mikayla arrived at the hotel, all Mikayla could do was lie down. She fell asleep at 6 p.m. By 2:30 a.m. she was up and vomiting. Mikayla woke her mom up and, at 4:30 a.m. on June 30, they both headed to Providence St. Peter Hospital in Olympia, WA. Joseph Pellicer, MD, was on duty in the emergency hospital and listed Mikayla’s chief complaints as “abdominal pain, emesis, diarrhea, and fever.” 

Rose explained that Mikayla had been sick since the morning before with severe diarrhea. By the evening, Rose stated that Mikayla “felt like she was on fire.” Mikayla also described having shaking chills with fever and Rose told Dr. Pellicer that she was having similar symptoms. Mikayla was miserable, wracked with body aches and pain that radiated up into both of her shoulders.

Dr. Pellicer did an exam and found Mikayla was tachycardic with a heart rate of 125 and a diffusely tender abdomen. The doctor also observed that Mikayla was dehydrated with turbid urine, ketonuria, proteinuria, and dry mucous membranes. 

Despite these clinical symptoms, no cultures were sent to the lab and no stool sample was collected. Dr. Pellicer diagnosed Mikayla with “acute gastroenteritis.” Just after 8 a.m., he discharged Mikayla from the ER with a prescription for an antiemetic drug and clearance to travel to Costa Rica.

On July 2, 2015, the Porters landed in Costa Rica. Mikayla was still suffering from frequent bouts of diarrhea. Upon logging in to a social media website, Rose discovered that a party attendee’s daughter was being hospitalized for Salmonella poisoning. Rose decided to take her daughter to the local ER — Beach Side Emergency Clinic in Santa Cruz Guanacaste. Andrea Messeguer, MD, the medical director of the clinic, evaluated Mikayla and noted that she was lethargic with persistent abdominal pain in the periumbilical area. Because Mikayla was currently afebrile and able to orally hydrate, Dr. Messeguer told Rose she could watch her daughter at home.

Over the next day, Mikayla did little but drink ice water, sleep, and go to the bathroom. Unfortunately, things soon took a turn for the worse. Rose recalls:

“She started crying in the bathroom that she could not bear the stomach pains anymore and needed to go back to the doctor. She told me that she had blood coming out of her butt, that it had been that way for a while, and that she didn’t know what to do. The amount of time between her going to the bathroom went from every 20 to 30 minutes to every five to 10 minutes. She was screaming in pain in the bathroom. She said that she felt like someone was stabbing her over and over again in the stomach.”

On July 3, Rose took Mikayla back to see Dr. Messeguer at the urgent clinic and told the doctor that there was now mucus and blood in her daughter’s stools. Dr. Messeguer examined Mikayla and performed a stool smear and culture. While at the clinic, Mikayla’s diarrhea decreased in frequency and she was still holding down fluids, so the doctor diagnosed her with “bacterial gastroenteritis” until proven otherwise and sent her home.

It was not long before it was clear that Mikayla’s condition was deteriorating. By the morning of July 4, her stools were entirely bloody. Rose, once again, rushed her back to the urgent care clinic. Upon their arrival, Dr. Messeguer asked to speak to Rose privately. She informed her that Mikayla was losing a lot of blood and may need a blood transfusion. However, the clinic did not have the equipment or resources necessary to perform the procedure. 

Dr. Messeguer told Rose that her daughter could die on the four to five-hour drive to Hospital CIMA San Jose, and therefore, Mikayla would need to be airlifted there.

Rose and Mikayla were both transported by helicopter to Hospital CIMA San Jose in Costa Rica. According to a memorandum written by Luis Picado, MD, Mikayla presented with a high-grade fever, bloody stools, general malaise, and moderate dehydration. He wrote: “On admission, she presented with clear signs of bacterial gastroenteritis and required intravenous rehydration and parenteral antibiotics to control the infection. Stool studies were positive for Salmonella.”

Rose does not require a formal medical record to recall how things went for her daughter over the next several days. The memory is still fresh in her mind:

“For the next three days, I sat back and watched as my daughter cried in pain. I changed her bloody sheets when she couldn’t make it to the bathroom. I didn’t sleep for the first couple of nights because I was so scared that she wouldn’t wake up. (She) couldn’t process food or water. The doctor told me that the bacteria had gotten into her system and shut it down completely. When she ate or drank, it would go straight through her. She wasn’t getting any nutrition or hydration.

“The good news is that she is out of the hospital now. We have cut all pork out of our diets and are fearful of chicken and eggs. I have dealt with a husband over in Afghanistan and this was still the scariest thing I have ever been through.

I can’t say that I know what it is like to have a child die, but I do know what it is like to see a child on their deathbed.

“I have spent the last couple of months going over every detail that has happened over those two weeks. I felt totally responsible when this happened. I had to question all of my decisions as a mother. I felt like I poisoned my own child and everyone else that ate at my house. I lost friends from all of this. It was weeks later that I found out that, in the end, it wasn’t my fault.”

During the time of Mikayla’s illness, Rose and Roger had their own Salmonella illnesses to contend with. On the helicopter ride to the hospital in San Jose, Rose’s blood pressure plummeted, and she lost consciousness. Roger had gastroenteritis with uncontrollable diarrhea for several days. Rose and Roger still suffer from periodic bouts of severe diarrhea.

The Porters were three of 152 diagnosed victims of a nationwide outbreak of multidrug-resistant Salmonella I 4,[5],12:i:-. Stewart Meats’ distributor of whole hogs was Kapowsin Meats. 

Laboratory testing of environmental samples at Kapowsin Meats by the Washington State Department of Health confirmed the presence of Salmonella I 4,[5],12:i:- in the facility. As a result of the investigation, Kapowsin Meats voluntarily recalled more than half a million pounds of pork products.

No wonder the petition requests an expedited hearing, calling the situation with Salmonella contamination “an imminent threat to public health necessitating prompt agency action.”

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Attorneys representing the Center for Science in the Public Interest sued USDA’s Food Safety and Inspection Service in 2014 because the agency would not declare the most dangerous Salmonella strains as adulterants.

But after only about 60 working days, the same attorneys cited Civil Procedure Rule 41 A to get the U.S. District Court for the District of Columbia to dismiss the lawsuit “without prejudice.”

The “41 A” dismissal motion must be used quickly before defendants file any responses or motions for dismissal. It is still a bit of mystery as to why CSPI dismissed its case. It did not get FSIS to declare strains of antibiotic-resistant (ABR) Salmonella as adulterants in meat and poultry.  Nor have others who have tried.

“Ample scientific and medical research demonstrates that ABR Salmonella in meat and poultry poses grave public health dangers,” said the CSPI complaint in 2014. “However, after more than three years after CSPI’s petition, FSIS has neither granted nor denied the petition, and it has taken no action to declare ABR Salmonella as an adulterant.”

CSPI wanted “certain strains.” of ABR Salmonella declared as adulterants, including ABR Salmonella Hadar, ABR Salmonella Heidelberg, ABR Salmonella Newport, and ABR Salmonella Typhimurium.  After dropping the 2014 court challenge, CSPI filed a petition to ban ABR Salmonella only to see it denied in 2018.

The antibiotic-resistant Salmonella strains were then causing the most illnesses and deaths among meat and poultry consumers, and that continues. All of the world’s 2,650 or so Salmonella strains continue to be allowed in U.S. meat and poultry.

The latest development in this long saga, as first reported in Sunday’s Washington Post, is that food safety attorney Bill Marler wants the federal government to ban dozens of Salmonella strains from meat and poultry. Along with some victims and activist groups, he’s petitioning FSIS to ban a much longer list of Salmonella strains than was at the heart of the 2014 case from the Center for Science in the Public Interest.

Marler was a key figure in getting E. coli O157:H7 made illegal after the Jack-in-the-Box tragedy 25 years ago. He later was successful in getting six other Shiga toxin-producing E. coli strains banned.

His new targets are “the following outbreak serovars (serotypes) to be per se adulterants in meat and poultry products: Salmonella Agona, Anatum, Berta, Blockely, Braenderup, Derby, Dublin, Enteritidis, Hadar, Heidelberg, I 4,[5],12:i:-, Infantis, Javiana, Litchfield, Mbandaka, Mississippi, Montevideo, Muenchen, Newport, Oranienburg, Panama, Poona, Reading, Saintpaul, Sandiego, Schwarzengrund, Senftenberg, Stanley, Thompson, Typhi, and Typhimurium.”

Marler calls his list “Salmonella Outbreak Serotypes.”

The meat industry has a messaging problem with Salmonella. It goes from depicting Salmonella as a problem that will eventually be solved by technology to its old stand by position of blaming consumers who don’t understand how to use thorough cooking techniques to kill naturally occurring bacteria.

Neither FSIS nor the meat industry have yet responded to Marler’s 62-page petition.

About 1.35 million infections, 26,500 hospital admissions, and 420 deaths occur annually due to Salmonella, according to the federal Centers for Disease Control and Prevention (CDC).

Richard Raymond, USDA’s Under Secretary for Food Safety for President George W.Bush, told the Washington Post that “the contamination rate with chickens is a particular embarrassment.”

The Marler petition says the 10 most prevalent Salmonella serotypes are responsible for 59 percent of all NTS-associated human illnesses. Forty-one percent of Salmonella-related human disease is caused by the top three serovars.

“Accordingly, the petitioners urge the administration of FSIS to issue an interpretive rule declaring Outbreak Serotypes of Salmonella adulterants within the meanings of the FMIA and PPIA, ” the petition says. “By banning recurring serotypes in meat and poultry products, FSIS will take a significant leap forward in ensuring the safety of American consumers. As the burden of Salmonella infection within the U.S. steadily increases, immediate action on this issue is critical.”

Rick Schiller, Steven Romes, the Porter Family, Food & Water Watch, Consumer Federation of America, and Consumer Reports are among the Marler petitioners.   Marler is managing partner of the Seattle-based food safety law firm of Marler Clark and publisher of Food Safety News.

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Christina Hastings, a relief consumer safety inspector (CSI) in the Raleigh district, exemplifies all of FSIS’ core values — Accountable, Collaborative, Empowered and Solutions-Oriented, and she puts them into practice each day she performs her duties. Hastings explains that CSIs must possess and practice all the values because they are the standards that the Agency sets for all its employees.

Hastings is acutely aware that, as an inspector in the field, she is the “face” of the Agency, especially when she must protect the nation’s food supply. “I am accountable to the millions of strangers that I will never meet but must make sure they stay safe when consuming FSIS-regulated products. Verifying that establishments’ meat and poultry Hazard Analysis and Critical Control Points (HACCP) plans and labeling requirements comply with regulatory statutes is key.”

Christina Hastings

She communicates with her colleagues as they determine the best way to explain and clarify regulatory requirements to plant management, especially when barriers, like different languages, exist. “I may be the only inspector physically assigned at an establishment, but my fellow inspectors are only a phone call or a text away. I just received some good advice a few weeks ago from another inspector on a great way to explain the three parts of HACCP verification — which consist of identifying potential hazards; implementing control measures at specific points in the process; and monitoring and verifying that the control measures are working as intended — to the owner at a new very small plant.” This collaboration among peers is critical to Hastings in her role as a CSI.

Hastings often must determine whether or not something is a non-compliance. “My supervisor supports my decisions. However, if I’m off-base on something, he will explain things to me in a way that I don’t feel belittled or embarrassed. I have always felt that way with all my supervisors in FSIS. I have the freedom to ask questions and to ask, ‘But why?’ I don’t always agree with the answers I receive, but just the freedom to ask the question is so very empowering.”

On a daily basis, Hastings finds herself trying to find solutions to prevent potential future problems. She describes her solutions-oriented approach as, “More than once I’ve made recommendations about combating condensation in coolers to plant managers. I would say, ‘I’m not sure if this will work here, but here are some things I’ve seen at other establishments that have dealt with condensation in coolers.’ It is still up to the plant to come up with a solution that works for their situation, but sometimes I may be able to mention an idea they haven’t thought of yet,” she said.

Hastings will celebrate 18 years with FSIS in July 2019, and says she can’t think of another profession she would have chosen besides being an inspector at FSIS.

“My job is satisfying, fulfilling and mentally stimulating. I enjoy breaking down a HACCP plan or using the GAD process — Gather the facts and any previous supporting documentation, Assess and verify all information, and Define the associations between the noncompliance and specific relevant regulations and other documentation — as a foundation when drafting accurate and reliable reports, to determine if there is a food safety hazard or other non-compliance. And, it is especially rewarding to be able to work in partnership with the establishments to achieve food safety and to know that my efforts made a difference,” she said.

Hastings recalls a time many years ago that had a lasting impact on food safety. “Nine years ago, I noticed that a 180-degree hot water utensil sanitizer was needed closer to plant workers in a cutting area. I brought up my concerns with plant management stating that I hadn’t observed employees using contaminated knives, but it would only be a matter of time before one of them did not walk all the way across the room to use the sanitizer. Plant management must have thought it was a good idea that would likely prevent a potential hazard because they installed another sanitizer sink closer in proximity to the workers. I am amazed that my observation still affects food safety in a plant that I haven’t stepped foot in almost a decade.”

Hastings, in need of a job that paid enough money to cover the rent and offered health benefits for her growing family reluctantly applied for a job in a turkey plant on the evisceration line, drawing turkey viscera out by hand. She recalls how that job led her to FSIS.

“It was not a glamorous job, but my coworkers were great, and it turned out that I actually loved the company and what I was doing,” Hastings said. “I was promoted to the quality assurance department and had daily interactions with the FSIS consumer safety inspector who was assigned to our establishment. We would chat every day and the inspector encouraged me to apply to FSIS because ‘It would be great career.’” She’s glad she did.

Hastings earned her Bachelor of Science Degree in Food Science and Industry from Kansas State University in 2018 — a notable milestone after attending college part-time for years.

Hastings, a St. Charles, Missouri native, currently resides in Leesburg, Virginia. She has two adult children, 10 grandchildren, and is engaged to Eilana, her partner of eight years.

Hastings loves to hike, bike, play foosball and binge-watch scary, creepy TV shows on a cold Sunday afternoon. One of her favorites is AMC’s “The Walking Dead.” She is also an avid marathoner and was part of Team FSIS, which consists of Agency employees who compete in various marathons around the country.

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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.

Country Fresh Inc. — Spring, TX

The Food and Drug Administration sent a warning letter dated Dec. 12, 2019, to the CEO of Country Fresh Inc., William Anderson.

During an inspection at Country Fresh inc. ready-to-eat (RTE) food manufacturing facility, on July 9 to 17, 2019, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP and PC Rule), Title 21, Code of Federal Regulations (CFR), Part 117 (21 CFR Part 117). The warning letter says that, “FDA collected environmental samples from various areas in your facility, including areas that are near food processing operations. FDA laboratory analyses of the environmental samples (i.e., swabs) found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Based on FDA’s inspectional findings and the analytical results for the environmental samples, we determined that your RTE products are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health ”

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

The violations noted by the FDA:

1. “You are required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act (21 U.S.C. §§ 342 or 343(w)), to comply with 21 CFR 117.135(a)(1).”
2. “You did not identify and implement a preventive control adequate to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes from contaminating RTE produce in your facility, as required by 21 CFR 117.135(a)(1) and (c)(3). The failure to have an adequate preventive control that significantly minimizes or prevents the environmental hazard of L. monocytogenes is reflected in Seven (7) environmental swabs (sample # 1113254) collected by FDA during our most recent inspection at your Country Fresh location in Grand Prairie, TX that were positive for L. monocytogenes. These samples were collected from the rubber base of the cutting table located on the NE side, the floor drain located on the SE side of the feeding table, the right leg of the pallet jack in the cold storage area, the East side of the cracked floor between the Fruit Room (redacted) and cold storage, the middle of the cracked floor between the Fruit Room (redacted) and cold storage, the blue squeegee in Fruit Room (redacted), and the left back side of the orange cull waste basket in Fruit Room (redacted). Furthermore, a retail product sample of watermelon spears (sample # 1108315) collected at Wal-Mart on May 9, 2019, by FDA tested positive for L. monocytogenes. The watermelon spears were manufactured at your Country Fresh location in Grand Prairie, TX. WGS of the sample revealed that it matched an environmental sample collected by the State of Texas in 2013 at your Country Fresh location in Houston, TX and historical clinical isolates. You stated that the two Country Fresh locations (Grand Prairie and Houston) shared product, equipment, and suppliers.”

“These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes from contaminating RTE fresh cut produce in your facility. Once L. monocytogenes 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 areas of the food processing plant where this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.”

1. “You did not implement your preventive control to prevent cross-contamination during washing. Your firm identified holding fruit in (redacted) for (redacted) to (redacted) as a critical limit to control for pathogens such as Listeria monocytogenes and Salmonella. In addition, you stated that employees are required to (redacted). On July 9, 2019, the FDA investigator observed an employee on the cantaloupe line not allowing the fruit (redacted) for (redacted) as required in your food safety plan. In addition, you do not have monitoring records to document employees are allowing fruit (redacted) for (redacted) to (redacted).”
2. “You did not validate that your preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system, to comply with 21 CFR 117.160. Specifically, you did not properly validate your preventive control for the use of (redacted) to prevent cross-contamination. The study presented by your firm is titled “EPA Food Contact Sanitizer Test for Previously Cleaned Food Contact Surfaces (AOAC Germicidal and Detergent Sanitizing Action of Disinfectant) against Salmonella choleraesuis and Listeria monocytogenes.” That study pertains to food contact surfaces and was not designed to validate, nor is it adequate to validate, the antimicrobial efficacy of peracetic acid against pathogen cross-contamination during the produce washing process.”

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

Tugusto Foods, Inc.  — Bayamón, Puerto Rico

The Food and Drug Administration sent a warning letter dated Dec. 17, 2019, to the President and CEO of Tugusto Foods, Inc., Jaime Franco Salamanca.

During an inspection at Tugusto Foods, Inc.’s manufacturing facility on May 7-8, 2019, and June 7, 2019, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).

The warning letter says that the FDA “determined that the food products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)) in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive control’s provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)).”

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

The violations noted by the FDA:

1. “You did not prepare, or have prepared, and did not implement a food safety plan for the food products manufactured in your facility (including seasonings and spices), as required by 21 CFR § 117.126(a)(1). A food safety plan must include the following:”

    (1) “The written hazard analysis, as required by § 117.130(a)(2);”

    (2) “The written preventive controls, as required by § 117.135(b);”

    (3) “The written supply-chain program, as required by subpart G;”

    (4) “The written recall plan, as required by § 117.139(a);”

    (5) “The written procedures for monitoring the implementation of the preventive controls, as required by § 117.145(a);”

    (6) “The written corrective action procedures, as required by § 117.150(a)(1);”

    (7) “The written verification procedures, as required by § 117.165(b).”

2. “You did not conduct a hazard analysis for any of your products to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a).”
3. “You did not identify pathogens as a known or reasonably foreseeable hazard to determine whether pathogens are a hazard requiring a preventive control. Your facility manufactures various seasoning and spice products (redacted) Pathogen contamination has been associated with ingredients in seasonings and spice products that have not undergone lethal treatment and are used in manufacturing.”
4. “You did not identify mycotoxins as a known or reasonably foreseeable hazard to determine whether mycotoxins are a hazard requiring a preventive control. Your facility manufactures various products (redacted) These ingredients have been associated with mycotoxins.”
5. “You did not evaluate environmental pathogens, such as Salmonella, as known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control, to comply with 21 CFR § 117.130(c)(1)(ii). Specifically, your facility manufactures RTE food which is exposed to the environment prior to packaging. The packaged food does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen or control by the supply chain or downstream customer) that would significantly minimize the pathogen.”

“Your response indicates that you hired a consulting firm, (redacted) to develop your Food Safety Plan (FSP) by the end of August 2019. However, it is not clear if (redacted) will be developing an FSP for your firm because it is not outlined in the Service Agreement that was sent to FDA. It appears that (redacted) will only be conducting a mock food safety audit at your firm concerning your firm’s compliance with 21 CFR Part 117, subpart B (CGMPs), and will provide your firm with a written or oral report describing observations. The audit will not document your firm’s compliance with the Preventive Controls requirements. Furthermore, the agreement does not specify if a written hazard analysis will be conducted for your firm, including developing written preventive control programs and procedures. The adequacy of your food safety plan, including your hazard analysis and related procedures, will be verified during the next inspection.”

Current Good Manufacturing Practice (Subpart B)

3. “You did not take effective measures to exclude pests from your food plant and to protect against contamination of food, as required by 21 CFR Part 117.35(c). Specifically, on May 7, 2019, and May 8, 2019, your firm manufactured “Sazón con Culantro y Achiote” (Seasoning with (redacted)) (redacted4)oz. and (redacted)lbs. and also repacked “Agrandador de Sabor” ((redacted)) (redacted)oz.”
4. “At the entrance of the production and packing area, inside your facility, your firm had an (redacted) bait station with bait. Next to this rodent bait station our investigator observed what appeared to be four (4) rodent excreta pellets.”
5. “Our investigator observed two (2) dead cockroaches, dirt, and pieces of dead insects on the floor of the warehouse next to pallets of finished products for distribution such as “Sazón con Culantro y Achiote” (Seasoning (redacted)) (redacted)oz., “Agrandador de Sabor” ((redacted)) (redacted)oz., food ingredients, and packaging materials. Additionally, a dead cockroach was observed on the floor of the production area next to a sink used for cleaning equipment and a mop and bucket used to clean the facility.”
6. “Our investigator observed a live fly inside of a (redacted)lb. (redacted) jar that an employee stated is used during repacking and comes into contact with spices. In the same area, an employee was repacking by hand “Agrandador de Sabor” ((redacted)) (redacted)oz. for which there were open jars and exposed finished product.”
7. “In close proximity to the production and packing areas, our investigator observed an accumulation of waste, wooden pallets, old paperwork, materials, and equipment in disuse which could serve as harborage and breeding areas for pests. Additionally, accumulated dust and fine product particles which could attract rodents and insects were observed on surfaces throughout the facility.”
8. “There was poor or no illumination in the warehouse where pallets of finished products and packaging materials were stored. In addition, pallets were stored against the walls. These conditions prevent your firm from properly inspecting for rodent and pest activity.”

“The following areas lacked protection against the entry of pests:”

1. “A screen gate leading from the outside of the plant to the interior of the warehouse and processing areas had gaps along the bottom and sides that ranged from (redacted) to (redacted) inches wide, providing ingress of insects and other pests into the processing area and other areas of the plant. Outside this gate was a dumpster, which can attract rodents and insects.”
2. “There was an opening approximately (redacted) inches wide on a wall of the production area, which led to the exterior of the facility. A window screen covering this opening was detached from the wall, leaving your production facility exposed to the entry of pests.”

“Your response indicates that your firm hired a third party to provide pests control services. However, your response does not address the other deficiencies cited, including the gaps and openings observed throughout the facility, which allow the entry of pests and the poor illumination observed at the warehouse. Further, you do not indicate whether any measures will be implemented to prevent recurrence of the deviation, such as routine inspections of the facility to detect the presence of pest activity.”

4. “You did not conduct operations under conditions and controls necessary to minimize the potential for growth of microorganisms, allergen cross-contact, contamination of food, and deterioration of food, as required by 21 CFR Part 117.80(c)(2). In addition, you did not maintain equipment and utensils and food containers in an adequate condition through appropriate cleaning and sanitizing, as required by 21 CFR Part 117.80(c)(1).”
5. “During production, employees (redacted) An employee identified (redacted) on all exterior surfaces of the mixer and other manufacturing equipment. The brushes were also used in the interior (food contact) surfaces of the mixer without being cleaned and sanitized before use. Your employee stated (redacted).”
6. “(redacted) production employees used dirty fabric mittens during (redacted) of “Sazón con Culantro y Achiote” (Seasoning with (redacted)) and repacking of “Agrandador de Sabor” ((redacted)). The mittens showed orange-colored stains that an employee identified (redacted) Your employee informed (redacted) Between uses, these mittens were exposed to the environment and in direct contact with dirty surfaces throughout the facility. Specifically, your employees used mittens for handling dirty surfaces, such as the corroded parts of the (redacted) drum used to collect ingredients, the forklift, dusty bags of ingredients, the brushes used to clean up the mixer, and plastic containers. These mittens were also used in the interior (food contact) surfaces of the mixer and capper machine without being cleaned and sanitized before use.”
7. “During the packaging activities of “Sazón con Culantro y Achiote” (Seasoning with (redacted)) an employee lubricated the machinery of a (redacted) machine wearing the fabric mittens and using a non-food grade lubricant oil. The same employee grabbed paper towels impregnated in oil and then handled the lids that were used to cap finished products. The employee did not remove the mittens and perform hand washing before touching the food contact surfaces of the lids. The employee wore the fabric mittens while touching dirty wooden pallets and a knife that was used to cut open carton boxes. In addition, the oil can was stored in the capper machine, along with the exposed products being packed.”
8. “Employees used filthy and deteriorated (redacted) containers (trash cans) lined with a dirty reused blue (redacted) bag for holding the finished blend of “Sazón con Culantro y Achiote” (Seasoning with (redacted)) until packaging took place. Our investigator observed your employees placing and dragging these containers throughout the dirty production area floor. An employee also stated (redacted) Our investigator also observed that the (redacted) bags were stored on dirty (redacted) pallets against a dirty and corroded (redacted) rack before being reused inside the containers with the seasoning.”
9. “An employee formulating “Sazón con Culantro y Achiote” (Seasoning with (redacted)) did not handle ingredients properly so as to prevent contamination during the addition of ingredients to the mixer. He did not clean the dust on the exterior of the bags of monosodium glutamate and salt before opening them. He also placed and dragged the bags of ingredients throughout the dirty production area floor. The employee then placed the bags inside of a (redacted) drum and tapped the bags with his hands to empty them. The (redacted) drum used to collect the ingredients was corroded and dusty; the lining was made of non-food grade plastic tape that was flaking. This tape could come off when ingredients are discharged from the drum, contaminating the finished product with plastic fragments. Our investigator observed dark particles that appeared to be rust fall from the corroded drum’s surface onto the ingredients in the mixer when the employee lifted the drum with a forklift and discharged its contents.”
10. “Dirty and deteriorated (redacted) containers showing scratches and discoloration were used to hold ingredients such as egg yellow shade colorant, coriander, garlic, black pepper, and cumin. Some of these containers were not labeled to identify their contents. Employees used shared dirty scoops to collect these ingredients. These practices could contribute to the contamination of treated spices with pathogenic microorganisms.”
11. “Employees used a deteriorated filthy razor to cut and open the packages of ingredients. The razor had a customized handle made with pieces of cardboard and tape. These practices expose your food to physical hazards (e.g. metal fragments and other potentially hazardous foreign matter) and microbial hazards.”
12. “A yellow apron used in the manufacturing operations was hanging against a dusty wall and a dirty working table with spider webs.”
13. “Throughout the processing area and warehouse, you had toxic compounds (e.g., paint, roof sealer, non-food grade lubricants and degreasers, gasoline, herbicides, pesticides, and rodenticides) gardening equipment and tools, garbage, empty dirty buckets, waste left by your employees (e.g., empty dirty coffee cups) and employees’ personal belongings (e.g., boots, bags, and lunchboxes). All these items were improperly stored next to or near where in-process and finished products were exposed.”
14. “You did not ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials maintain cleanliness by washing their hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, as required by 21 CFR Part 117.10(b)(3). Specifically, (redacted) employees were observed not washing their hands or changing their gloves after using their cell phones or returning to their working stations after changing tasks. An employee packaging “Sazón con Culantro y Achiote” (Seasoning with (redacted)) went to the bathroom with his gloves on, returned to his work station, and continued working wearing the same gloves. The employee changed his gloves when our investigator called his attention to the deficiency, but our investigator did not observe him re-washing his hands before donning new gloves. Our investigator observed that these employees had a box of disposable gloves available to change their gloves during manufacturing activities without having to go to the handwashing sink to re-wash their hands.”
15. “You did not provide hand-washing facilities designed to ensure that an employee’s hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature, as required by 21 CFR Part 117.37(e). Specifically, your firm’s hand-washing facilities lacked hot water, paper towels or another suitable drying device.”
16. “You did not provide shatter-resistant light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage, as required by 21 CFR Part 117.20(b)(5). Specifically, several light fixtures did not have covers and/or shatter proof bulbs so that their light bulbs remained exposed over the food and packaging materials stored below. These conditions expose your food products to potential glass contamination.”
17. “You did not ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices by wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR Part 117.10(b)(6). Specifically, (redacted) of your employees were observed not wearing beard nets during production and packaging. of the employees were working on the formulation of “Sazón con Culantro y Achiote” (Seasoning with (redacted)), and (redacted) was packaging the finished ready-to-eat product. Also, an employee was observed not wearing his hair restraint correctly, which left part of his hair exposed.”
18. “You did not ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials remove unsecured jewelry and other objects that might fall into food, equipment, or containers to protect against allergen cross-contact and against contamination of food, as required by 21 CFR Part 117.10(b)(4). Specifically, an employee was observed wearing three stud earrings on his left ear.”

“Your response indicates that preventive controls will be implemented according to the FSP developed by your consultant. You did not provide any documentation of measures that will be implemented to assure conformance with CGMPs and how your firm will prevent these violations from recurring while the FSP is developed. In addition, you did not provide documentation or a timeframe of when and how the corrections it will be implemented.”

Misbranding Violations

1. “Your Tugusto Bijaol Condimento Para Sabor y Color product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because it fails to bear a Nutrition Facts label, as required by 21 CFR Part 101.9.”
2. “Your Tugusto Chef Sazón con Culantro y Achiote and Tugusto Bijaol Condimento Para Sabor y Color products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but they do not bear labels that include a complete list of all the ingredients by common or usual name, as required by 21 CFR Part 101.4.”

a.” Your Tugusto Chef Sazón con Culantro y Achiote product is manufactured using (redacted) however, it fails to list the sub-ingredients “(redacted)” and (redacted). If the silicon dioxide ingredient serves as a chemical preservative and the term “anticompactante” (anticaking) refers to the ingredient’s function, it must be labeled in accordance with 21 CFR Part 101.22(j). Additionally, your Tugusto Chef Sazón con Culantro y Achiote product is manufactured using (redacted) however, it fails to list the sub-ingredient “(redacted)”.”

b. “Your Tugusto Bijaol Condimento Para Sabor y Color product is manufactured using (redacted) but fails to declare these ingredients. Furthermore, your Tugusto Bijaol Condimento Para Sabor y Color product fails to declare all sub-ingredients of the multicomponent ingredient (redacted) including (redacted) Additionally, your Tugusto Bijaol Condimento Para Sabor y Color product fails to declare the sub-ingredients of the multicomponent ingredient (redacted). If the (redacted) ingredient serves as a chemical preservative and the term “(redacted)” ((redacted)) refers to the ingredient’s function, it must be labeled in accordance with 21 CFR Part 101.22(j). You stated during the inspection that your Tugusto Bijaol Condimento Para Sabor y Color product (redacted) Your Tugusto Bijaol Condimento Para Sabor y Color product fails to declare the sub-ingredients (redacted) or (redacted) as appropriate.”

c. “Your Tugusto Chef Sazón con Culantro y Achiote and Sazón Tugusto Agrandador de Sabor products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] in that the product labels bear the nutrient content claims “40% Menos Sodio Que La Sal (40% Less Sodium Than Salt)” and “60% Less Sodium Than Salt,” respectively, but fail to declare clear and concise quantitative information comparing the amount of sodium per declared serving in the products to that of the reference food (salt) as required by 21 CFR Part 101.13(j)(2)(iv) and 21 CFR Part 101.61(b)(6)(ii)(B). This statement shall appear adjacent to the most prominent nutrient content claim on the information panel.”

d. “Your Tugusto Bijaol Condimento Para Sabor y Color product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. The product label declares “Harina de Maíz” (Cornmeal), “Pimentón” (Red Pepper), and “Glicol de Propileno” (Propylene Glicol) as ingredients although these ingredients are not part of the product’s formulation.”

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

 

Opinion

A recently announced interpretation of authority on mandatory recalls weakens food safety.

The Food and Drug Administration’s decision late last year not to order a mandatory recall of yellowfin tuna that sickened at least 50 people in 11 states threatens to undermine a crucial tool of last resort to protect consumers from hazardous food. FDA leaders should reverse course and require that the company responsible for these products remove them from the market.

In a Nov. 15 announcement, the agency said the illnesses were caused by imported tuna with high levels of scombrotoxin, a substance produced when certain fish species spoil. The company supplying most of the implicated tuna has not initiated a recall, despite an FDA request.

These products could still be on the market, according to the agency, and neither cooking nor freezing them will make them safe to eat. A Dec. 26 FDA update on the investigation said that additional illnesses had been reported and voluntary recalls by business customers of the fish supplier “have not effectively removed” the dangerous tuna from the market. Still, the agency stopped short of mandating a recall.

Congress armed the agency for exactly this kind of situation in 2011’s FDA Food Safety Modernization Act (FSMA). The law authorized mandatory recalls when companies do not conduct them voluntarily for products that may cause “serious adverse health consequences or death” to people or animals.

The agency’s initial announcement, however, argued that “because scombrotoxin fish poisoning causes temporary or medically reversible adverse health consequences this incident did not meet the threshold for the use of FDA’s mandatory recall authority.”

This interpretation of the law fails to protect Americans from preventable illnesses. Scombrotoxin poisoning can cause serious adverse health consequences. Among the symptoms are nausea, headache, faintness, abdominal cramps, and diarrhea. According to the FDA, “severe cases may blur vision, and cause respiratory stress and swelling of the tongue.” Patients may require medical treatment such as intravenous fluids, oxygen, and antihistamines, and people with particularly serious reactions to the toxin have experienced cardiac complications and low blood pressure.

FDA’s decision in this case could set a dangerous precedent, one that may encourage companies to disregard requests for voluntary recalls or to challenge agency-mandated recalls on the grounds that the harm likely done by their products is not serious enough.

The agency’s response also runs counter to pledges by its leaders to “make more robust use of mandatory recall authority”—a power used just three times since FSMA’s enactment nine years ago. In November 2018, the FDA released final guidance to clarify for businesses when and how it will exercise this authority for potentially contaminated food. Then-Commissioner Scott Gottlieb explained the goal: “Our aim is to expand the appropriate use of our mandatory recall authority in cases where we have to intervene quickly to help protect consumers from unsafe products.”

The ongoing outbreak of scombrotoxin poisoning presents a crucial test of this commitment. The agency’s overly restrictive interpretation of “serious adverse health consequences” undermines both the letter and the spirit of FSMA. FDA leaders should reconsider their response in this case and, going forward, should make greater use of mandatory recall authority to protect the public from preventable foodborne infections.

About the author: Sandra Eskin directs The Pew Charitable Trusts’ work on food safety. Pew is a global research and public policy organization operated as a non-partisan, non-governmental organization dedicated to serving the public.

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Whole genome sequencing offers new possibilities for foodborne outbreak detection and investigation, source attribution and hazard identification, according to an EFSA panel.

The scientific opinion by the panel on Biological Hazards covers use of whole genome sequencing (WGS) and metagenomics for outbreak investigation, source attribution and risk assessment of foodborne pathogens. Cost/benefit analyses and technical recommendations on use of WGS and metagenomics were not looked at.

A number of recommendations were made by European Food Safety Authority (EFSA) panel such as standardization and quality control parameters should be internationally agreed and validated to provide evidence that methods are repeatable, reproducible and accurate.

The panel also concluded that attention should be given to capacity building to apply WGS and metagenomics in European laboratories and worldwide to help the investigation of cross‐border outbreaks and development of international standardized risk assessments of foodborne microorganisms.

Linking food items to infections
Increased capability to match clinical strains to contaminated food products allows patients to be linked to an outbreak, even when different foods and geographies are involved or they are historic infections.

It is not prudent to define absolute thresholds of nucleotide differences for inclusion and exclusion of isolates within an outbreak, and epidemiological information should always be used to define outbreaks, according to the opinion.

EFSA and ECDC were previously asked by the European Commission to evaluate possible platforms for the set-up and running of a database to collect and analyze WGS data for Listeria monocytogenes, Salmonella and E. coli.

The discriminatory power of WGS for pathogen characterization is superior compared to molecular typing methods such as pulsed-field gel electrophoresis (PFGE) or multilocus variable-number tandem-repeat analysis (MLVA).

Single-nucleotide polymorphism (SNP) and multilocus sequence typing (MLST) are two approaches used to analyze WGS data for cluster detection and outbreak investigation but they are not directly comparable.

Results from SNP-based approaches are also not directly comparable between labs because of the number of sequences included for analysis, quality parameters used by the tool, high level of discrimination and selection of the reference genome.

MLST is referred to as the gene-by-gene approach and mostly considers genetic variations in the core genome MLST (cgMLST) or the whole genome MLST (wgMLST). There are interoperability problems related to the use of different schemes and the effect of different analytical steps on the accuracy and reproducibility of the allelic profiles is unclear.

Using metagenomics
Metagenomics has potential for detection and characterization of non-culturable, difficult-to-culture or slow-growing microorganisms. Use for outbreak investigation is still at an experimental stage.

Impact on future risk assessment of foodborne pathogens will depend on the ability to overcome constraints such as the lack of harmonized methods, low sensitivity in detecting certain taxa in the sample and limitations related to specificity of target pathogens or bacterial communities. Results depend on the choice of wet lab workflows like nucleic acid extraction protocols and library preparation strategies and choice of bioinformatics pipelines.

Shotgun metagenomics could provide information on genetic determinants harbored by pathogenic bacteria, making it a more informative technique for risk assessment.

In the transition period of WGS implementation, there could be difficulties in data exchange. Differences in the bioinformatic tools, databases used and nomenclature applied will affect comparability of results, according to the opinion.

Standardization and comparability
Experts recommended that international organizations for standardization provide guidelines covering the entire process from DNA extraction to final result. There is a need for standardization of analysis of WGS data with the goal being development of a universal scheme for strain nomenclatures and shared databases for uploading and comparing sequences.

The DNA extraction, library preparation and sequencing bit of WGS is part of ISO/CD standard 23418 that is under development. However, transparency on the bioinformatic approaches, reference sequences and software developments for the analysis of WGS data are also required.

A strengths, weaknesses, opportunities, threats (SWOT) analysis on the use of WGS and metagenomics for Salmonella and Shiga toxin‐producing E. coli (STEC) serotyping was done.

For STEC, isolates untypeable using classical serotyping and those showing unresolvable cross reactions can be assigned to a genome derived serotype using WGS data. WGS serotyping avoids resource intensive antisera production and quality control issues requiring specialist resources and expertise.

However, different tools/databases and local pipelines are in use for predicting serotypes of Salmonella and STEC and can lead to results not being comparable. WGS also offers a genotypic determination of the STEC serotype but virulence genes may not be expressed.

Limited funding could hinder the development, management and updates of web-based tools and databases for analyzing sequencing data. A transition phase of revisions to the White–Kauffmann–Le Minor scheme for Salmonella to be adapted to WGS is expected. This could hamper comparability of serotyping data exchanged due to the use of different approaches, according to the opinion.

Meanwhile, EFSA has opened a public comment period about recommendations for applicants on whole genome sequence analysis of microorganisms added to food and feed.

Use of microorganisms, such as bacteria, in food and feed needs authorization, which is based on EFSA’s risk assessment. In some areas, the use of WGS-based data is a requirement for risk assessment and parties need to use this tool to prepare applications. The deadline to submit comments is Feb. 28, 2020.

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Denmark and Sweden are the latest countries to report outbreaks of norovirus linked to shellfish from France.

At least 180 people in Denmark are sick since the start of the year and 70 are affected in Sweden, although some of these are thought to have fallen ill after eating Swedish oysters.

In France, 1,033 people have been sickened and 21 needed hospital treatment. Italy and the Netherlands have also reported outbreaks linked to live oysters from France.

Products have been recalled due to a risk of norovirus contamination in Belgium, Luxembourg, Switzerland, Hong Kong and Singapore. A total of 23 shellfish growing zones in seven regions have been closed with more than 400 companies affected, according to the French Ministry of Agriculture and Food.

Investigations continue in the Netherlands
Tjitte Mastenbroek, a press officer at the Netherlands Food and Consumer Product Safety Authority (NVWA), said illnesses in the country have not been definitely linked to oysters.

“There are some sick people in the Netherlands, who may have fallen ill from norovirus through oysters, but that has not yet been determined by analysis. It is therefore not yet established that there is a common source of these patients,” he told Food Safety News.

“However, we are aware of the recently increasing number of reports in a European context and the media coverage. We follow developments closely, and as soon as harmful parties are identified, we will monitor their withdrawal from the market.”

Standard advice of The Netherlands Nutrition Centre (Voedingscentrum) for consumers is: “Raw shellfish and crustaceans such as raw mussels or raw oysters can be infected with norovirus. You cannot see or smell this, but you may experience nausea, vomiting and diarrhea. To avoid this risk, it is better not to eat crustaceans and shellfish raw.”

Situation in Denmark and Sweden
The Danish Veterinary and Food Administration (Fødevarestyrelsen) started seeing reports of illness in the first few days of 2020.

Several outbreaks were reported and at least 180 people have been sick with vomiting and diarrhea after eating oysters from France in late December and on New Year’s Eve, according to Statens Serum Institut.

Affected products are sold at fishmongers, supermarkets and restaurants. The agency has informed importers they must avoid oysters from areas closed by French authorities. It is expected that oysters currently on the market come from open areas where no norovirus or other microbiological contamination has been found.

The Swedish Food Agency (Livsmedelsverket) reported that during December and January an unusually high number of people became ill after eating oysters. Outbreaks have occurred in several municipalities with 70 people contacting medical services and seeking help.

Symptoms have mostly been consistent with those for norovirus and in some cases it has been confirmed by microbiological analysis. Norovirus has also been detected in oysters in Sweden and other countries.

Swedish authorities have tracked where oysters that caused illness in the country came from. In some cases it is Swedish oysters that are suspected to have caused illness.

Symptoms of norovirus appear one to two days after being infected and typically last for two or three days. Norovirus is transmitted by having contaminated food or water or from person to person through contact with the skin, objects or inhaling airborne particles. The virus can live for long periods of time on surfaces such as counters and door knobs.

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During the first few days of the new year, the Canadian Food Inspection Agency (CFIA) has suspended the Safe Food for Canadians (SFC) licenses of three food companies, including a fish importer, multi-commodity processor, and a sausage producer.  While the actions carried into 2020, all three licenses were revoked as of Dec. 31, 2019.

The first license was taken from #9PHXCKMN for MAS Distribution Inc., a fish importer located in Laval, Quebec. While the suspension is in effect, the licence holder may not conduct any activity for which SFC licence #9PHXCKMN was issued.

There is no food recall associated with this suspension.

The CFIA suspended the license because the license holder did not develop a compliant preventive control plan in accordance with the relevant provisions of Part 4 of the Safe Food for Canadians Regulations (SFCR).

License holders are responsible for ensuring they comply with Canada’s food laws.  In a statement, the CFIA said it is committed to enforcing those laws.

Safe Food for Canadians licenses can be suspended:

• for failure to comply with the Safe Food for Canadians Act, the Food and Drugs Act and their related regulations
• for default of payment of any fee related to the license
• if the risk of injury to the public may result from  continuing to conduct the licensed activity

The licence suspension will be lifted if the CFIA determines that corrective measures have been taken. If corrective action is not taken within 90 days after suspension, the CFIA may cancel the license. The CFIA may also cancel the license on other grounds set out in section 39 of the SFCR. Cancellation can occur after the license holder has been notified of the grounds for cancellation and provided with an opportunity to be heard.

The CFIA also suspended the Safe Food for Canadians license #9XD46PCB of Fine Choice Foods Ltd., a multi-commodity processing establishment located in Richmond, British Columbia.

While the suspension is in effect, the license holder may not conduct any activity for which SFC license #9XD46PCB was issued.

There is no food recall associated with this suspension.

The CFIA suspended the license because the operator did not implement a preventive control plan in accordance with the relevant provisions of Part 4 of the Safe Food for Canadians Regulations (SFCR).

License holders are responsible for ensuring that they comply with Canada’s food laws. The CFIA is committed to enforcing those laws.

This license suspension will also be lifted if the CFIA determines that corrective measures have been taken. If corrective action is not taken within 90 days after suspension, the CFIA may cancel the license. The CFIA may also cancel the license on other grounds set out in section 39 of the SFCR. Cancellation can occur after the license holder has been notified of the grounds for cancellation and provided with an opportunity to be heard.

The CFIA’s also canceled the Safe Food for Canadians license #9K9WDGDF of Usine Amsellem inc, a ready-to-eat meat products (dried sausages) producer located in Laval, Quebec.

The license was canceled in accordance with the Safe Food for Canadians Regulations (SFCR) because the license holder failed to comply with Section 15 of the Safe Food for Canadians Act (SFCA) relating to one test result for Salmonella bacteria in one of their products. Section 15 of the SFCA states that it is prohibited for any person to make a false or misleading statement or to provide false or misleading information to a person exercising duties under the Act in connection with any matter under any provision of the SFCA or the SFCR.

A recall of dry beef sausage produced by this license holder was published on December 4, 2019, due to possible Salmonella contamination. Although no cases of illness associated with the consumption of this product have been reported, the CFIA took the necessary measures to protect consumers as soon as it was determined that a product was potentially contaminated.

CFIA has now concluded the food safety investigation, and no additional recalls are expected with respect to this investigation.

The sausage producer . was notified on December 5, 2019, of the grounds being considered for license cancellation and provided an opportunity to be heard. After meeting with the license holder and based on a review of the facts and submissions made, CFIA determined that the license holder failed to comply with Section 15 of the SFCA and their license was canceled.

The CFIA publishes a list of suspensions and cancellations on its website.

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It’s a rare day when two multistate and one single state outbreaks of E. coli O157:H7 are declared over.

It’s likely even a first-time event, just another in the odyssey that’s played out since late 2017 when romaine lettuce began spreading the dangerous adulterant that originates in bovine intestines.

The Food and Drug Administration, Centers for Disease Control and Prevention, Public Health Agency of Canada, and Public Health for Seattle-King County said the outbreaks are over and romaine is safe to eat again. Even romaine from the Salinas, CA, growing area.

But while the outbreaks or outbreak are over for the moment, the romaine problem is not solved. Neither a definitive source nor a root cause has been found. The growers of leafy greens are doing a ground-up review of their food safety protocols. California has stepped up with some leadership.

The industry was out with a swift stream of statements shortly after the governments made their announcements this week. Steve Church of Church Brothers is a leading romaine grower who serves on the Board of the California Leafy Greens Marketing Agreement. (LGMA).

“These outbreaks,” he says, “are devastating to our industry as well as to consumers, and they must stop.”

The LGMAs, in California and Arizona, are voluntary industry groups that focus on a variety of topics including food safety programs that impose more stringent standards on growers through state auditing programs. LGMA programs began in 2007, a year after E. coli contaminated spinach.

“We have to take control of our destiny,” California LGMA Chairman Dan Sutton said. “The LGMA exists to establish food safety standards for farming leafy greens. We need a focused industry-wide effort to figure out what’s happening in the environment where we farm.”

Sutton, himself a leafy green grower, says the LGMAs are “committed to making real changes” to improve the safety of their product. Both organizations tweaked their 2007-era standards since the romaine outbreaks began.

FDA reported it has not yet determined the source of the outbreaks. The agency has focused on a single farm in recent weeks, but it has not yet named anyone or any entity. To its previous find of E. coli in irrigation water, FDA has also made a find in the soil. It is not the outbreak strain or even one that is virulent, though.

A big part of the problem is that it is complicated. The industry’s root cause analysis includes three kinds of water — environmental runoff, irrigation or agricultural water, and harvest-use water — and about a dozen other non-water factors from farm labor contact to cross-contamination at harvest platforms.

“The leafy greens community is extremely motivated to get to the bottom of this, and we want to be more involved, said San Miguel Produce’s Jan Berk, who is also LGMA’s vice-chairman.

Berk suggests FDA investigators would benefit from including growers in the government’s probe. “They don’t know what’s going on in our fields the way we do, Berk says. “We are the ones who need to fix this.”

While waiting to be invited to help FDA, the LGMA growers and an influential industry association are not standing still. “The LGMA is currently conducting a systematic overhaul of the food safety practices included in our program, ” said Scott Horsfall, CEO of the California LGMA.

Horsfall says his group is working with Western Growers on “an open, transparent review of the required food safety practices under the LGMA.” The study will include outside expertise with new knowledge and research.

The California Department of Food and Agriculture has invited growers to a meeting on Feb. 4 in Salinas. The session is for growers to discuss research opportunities in “a broad study that will monitor environmental conditions in California that may be contributing to outbreaks.”

“Our goal is to work in conjunction with leafy green growers and with the U.S. FDA to resolve the problems that continue to impact romaine, ” said CDFA Secretary Karen Ross. “The LGMA and the entire leafy green industry has been extremely cooperative in these efforts. We all want to see an end to these outbreaks so that consumers can have confidence in eating leafy greens. We owe this to our consumers and to our growers.:

Changes the LGMAs make to their standards and procedures are requirements for thousands of farms, which together produce more than 90 percent of the leafy greens grown in the U.S. Government auditors verify that the growers are following new requirements though mandatory audits.

The total cases confirmed in the outbreaks declared over Jan. 15 is 221 in both the U.S. and Canada. About half required hospitalization, but in this round of E. coli illness, no one died.   The romaine-related multistate outbreaks of O157:H7 since late 2017were:

2017

• Leafy Greens – E. coli O157: H7

2018

• Romaine Lettuce – E. coli O157: H7
• Romaine Lettuce – E. coli O157: H7

2019

• Fresh Express Sunflower Crisp Chopped Salad Kits – E. coli O157: H7
• Romaine Lettuce – E. coli O157: H7

Together those outbreaks are responsible for six deaths and have sickened a total of at least 474 people in the United States with 219 or almost 50 percent requiring hospitalization. At any one time, the spat of romaine outbreaks has impacted consumers in 35 states.

Outbreaks that do not cross the boundaries of any one state are not included in the tally above. Also apparently not listed is the romaine-related E. coli outbreak that FDA and CDC kept from the public from Sept. 17 to Nov. 1.  It sickened 23 people in 12 states. Of those patients with complete information available, 11 were so sick they had to be hospitalized. Illnesses started on dates ranging from July 12 to Sept. 8.

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Salmonella has been knocked off the top spot by Listeria monocytogenes as the main hazard dealt with by an international food safety network.

During the fourth quarter of 2019, the International Food Safety Authorities Network (INFOSAN) was involved in four incidents involving Listeria out of 15 concerning 44 countries, according to a recent report.

Salmonella was tied for second with E. coli while other outbreaks from October to December 2019 featured norovirus and Clostridium botulinum. One issue each concerned glass and plastic fragments. INFOSAN was part of 83 events this past year which is the same as 2018. The 83 food safety incidents is one less than the network had to deal with during 2016 and 2017 combined.

Salmonella had been the top hazard since INFOSAN first started producing quarterly summaries in January to March 2018 when Listeria was the main problem.

Food categories most commonly involved in 4Q 2019 were meat and meat products, fish and other seafood, herbs, spices and condiments, milk and dairy products, alcoholic beverages, composite foods, fruit and fruit products, nuts and oilseeds, and vegetables and vegetable products.

Focus on E. coli O157 and romaine lettuce
The network is managed by the Food and Agriculture Organization (FAO) of the United Nations and World Health Organization (WHO).

In 4Q 2019, an outbreak of E. coli O157:H7 infections in the United States linked to romaine lettuce grown in Salinas, California, was reported to INFOSAN. Federal officials recently declared the outbreak over with 167 people infected from 27 states.

Following suspension in Hong Kong of import and sale of romaine lettuce from the U.S., INFOSAN worked with its Emergency Contact Points (ECP) to see if there were any illnesses in the country linked to romaine products.

Speaking in November, a spokesman for the Centre for Food Safety in Hong Kong, said the agency had instructed the importer, Wing Kee Produce Ltd., to stop sales and recall the affected product.

“The CFS’ follow-up investigations found that the importer had also sold several other kinds of the affected products produced in the area concerned. In addition, the center found that another importer, City Super Limited, had also imported several kinds of the affected products.”

Colleagues in the U.S. shared whole genome sequence information to assist with identification of international cases. It was later confirmed that no E. coli O157:H7 infections were documented in Hong Kong and no other reports of illnesses outside the U.S. were forwarded to INFOSAN.

In November 2019, media in Taiwan reported the Food and Drug Administration would require a safety certificate for all imports of romaine lettuce from the U.S. for one month due to the outbreak linked to some California romaine.

The Ministry of Health in Trinidad and Tobago, Department of Commerce and Consumer Affairs in Barbados and National Agricultural Research and Extension Institute in Guyana all advised consumers not to use romaine lettuce from Salinas, CA.

In Jamaica, a ban was imposed on imports of romaine lettuce in November 2018 which was still in place at the end of November 2019, according to the Plant Quarantine and Produce Inspection Branch of the Ministry of Industry, Commerce, Agriculture, and Fisheries.

Second meeting of network
In December, the WHO, FAO and Abu Dhabi Agriculture and Food Safety Authority, organized the second INFOSAN meeting, in Abu Dhabi, United Arab Emirates.

Picture courtesy of Abu Dhabi Agriculture and Food Safety Authority

The meeting brought together 250 representatives from more than 130 countries to discuss the progress and challenges faced by the network over the past 15 years.

Alan Reilly, INFOSAN advisory group member and Professor at University College Dublin, Ireland, said the network has had success in bringing some outbreaks of global foodborne illness to a conclusion.

“Regions and countries can work together, share information and protect consumer health by using the platform of INFOSAN.”

On the first day, attendees heard how INFOSAN has become global with a membership of 190 countries and 600 members.

The second day covered other regional networks such as the European Commission’s Rapid Alert System for Food and Feed (RASFF), the Gulf Cooperation Council RASFF, the Arab RASFF, the Association for South-East Asian Nations (ASEAN) RASFF, and European Food Safety Authority’s Emerging Risks Exchange Network (EREN).

“Artificial intelligence, machine learning and the use of big data will have a profound impact on food production, food control and outbreak investigation in the future and food safety managers need to prepare themselves,” said Peter Ben Embarek, INFOSAN Secretariat, WHO.

Cristina Baptista Rodrigues, INFOSAN ECP in Portugal, said the group was important to connect members with common interests from different countries.

“INFOSAN became a really important part of our work as we want to develop a connection between the food safety agencies in the Portuguese-speaking countries.”

Caroline Merten, INFOSAN advisory group member and scientific officer at the European Food Safety Authority (EFSA), said suggestions were made for future development of the network.

“There is a huge potential for INFOSAN to develop further in the future…such as providing training and building closer collaboration and communication on non-emergency activities, such as surveillance activities and risk assessment activities at national levels.”

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