Food Safety News
More than 100 people are sick in a Campylobacter outbreak in Denmark linked to a local dairy.
The Danish Veterinary and Food Administration (Fødevarestyrelsen), DTU Food Institute and Statens Serum Institut (SSI) are investigating illnesses that began in Bornholm in late May.
Patient interviews point toward milk from Bornholms Andelsmejeri (Bornholm Dairy) as the source of infection but product testing has been negative for Campylobacter. Bornholm Dairy is a cooperative owned by Bornholm milk producers.
From May 28 to June 5, 107 people living on Bornholm or who recently visited the island have tested positive for Campylobacter. The alarm was first raised by Bornholms hospital and at least 10 people needed hospital treatment after Pentecost, a Christian holiday.
SSI contacted patients and asked them what they ate and drank before becoming ill. The agency also interviewed a control group of healthy citizens. Answers on what 34 patients ate and drank were compared with responses from 68 healthy people living in Bornholm.
The outbreak peaked in late May. Authorities believe it is an isolated incident and that there are no products still on the market that could make people sick.
Campylobacter is the top cause of gastrointestinal infection in Denmark. In 2019, more than 5,300 cases were registered, which is the highest number ever recorded.
Negative product testing
The Danish Veterinary and Food Administration (DVFA) took samples from milk but no traces of Campylobacter have been found.
“It hasn’t been possible to find Campylobacter in the milk so we don’t have the physical proof. We took samples from four days of production, each day when they do a production they take out some reference samples and put them in the fridge and store them for a few days,” said a DVFA spokesman.
“So when we heard about the problem we tested the reference samples and there was no Campylobacter in them. It might be because it is a low concentration. Another possibility is a problem in production that has already taken place. In the coming weeks other channels will be examined, it could be in the water or in the milk producing animals.”
The spokesman said only milk and not cheese is affected but declined to answer a question on the distribution of potentially contaminated milk.
The dairy has stopped producing to do a technical review of production equipment and cleaning, according to the DVFA.
A statement from the company said no Campylobacter has been found in dairy products, the plant is clean and free of defects, and that all lawful procedures have been followed. It added there was no possibility that pasteurized milk could be mixed with the unpasteurized milk.
All consumer products analyzed from May 26 onward have not revealed any Campylobacter and site inspections by authorized external service engineers and DVFA did not find any issues.
People with Campylobacter infection usually get diarrhea, fever, and stomach cramps. They may also have nausea and vomiting. These symptoms usually start two to five days after the person ingests Campylobacter and last about one week.
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Demand for fresh meat and poultry has not diminished but, because of COVID-19 outbreaks in facilities across the U.S., meat processing plants are struggling to keep up.
In an effort to help stop the spread of COVID-19, keep plant employees, inspectors and consumers safe, a team from the University of Nebraska-Lincoln is sharing a new supply of hand sanitizers with the United States Department of Agriculture. The USDA, like many others, is experiencing difficulties because of the short supply of hand sanitizer.
The hand sanitizer will help prevent the spread of COVID-19 through the more than 6,500 meat-processing facilities across the country. Thanks to an innovative partnership between Nebraska’s ethanol industry and the University of Nebraska–Lincoln, the university has supplied the USDA with more than 6,800 gallons of hand sanitizer, with more hand sanitizer on its way to the USDA in the coming weeks.
The team has also distributed more than 60,000 gallons of the product to the state government and local public health officials, along with frontline health care providers and first responders.
“This project represents the true grit of Nebraskans and the innovative ways the agriculture community joins together to take care of one another,” said Nebraska Department of Agriculture Director Steve Wellman. “We appreciate the dedication and donations that the ethanol industry, hard hit by this virus themselves, has made to see this project through, as well as the perseverance of the Food Processing Center staff to create a product that will help slow the spread of COVID-19.”
Green Plains Inc. operates 13 biorefineries across the United States and has donated a significant amount to the project from its York, NE, facility. The alcohol is higher in purity and quality than traditional fuel-grade ethanol. Green Plains does not sell any fuel-grade alcohol for use in disinfectants or sanitizers.
“During this health emergency, Green Plains and its employees feel a deep responsibility to do our part to help address this crisis in communities nationwide,” said Todd Becker, president and CEO of Green Plains. “We are pleased to donate high-quality, FDA approved, FCC Grade alcohol for the USDA’s Food Safety and Inspection Service team.”
Other various supplies have been provided by BASF, Cargill, Syngenta, Phillips 66 and the State of Nebraska, among others.
“I cannot say enough about the incredible generosity of our partners in the ethanol industry during an economically challenging time,” Hunter Flodman, an engineering professor of practice at Nebraska who has helped spearhead the project, said. “In this case, Green Plains is helping ensure that consumers get a safe product, whether they buy meat at a supermarket or a meat locker in their community.”
“It’s been a privilege for the Food Processing Center and its faculty and staff to contribute to this important project,” Terry Howell, executive director of the Food Processing Center at Nebraska Innovation Campus, said. “It’s humbling to be able to make a difference during this health care crisis.”
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Federal officials say a three-year Listeria outbreak caused by mushrooms imported from the Republic of Korea appears to be over.
The implicated enoki mushrooms from H&C Food Inc., Guan’s Mushroom Co. and Sun Hong Foods Inc. are past their shelf life and should not be available for sale, according to an outbreak update the U.S. Centers for Disease Control and Prevention posted today.
Public health officials in Michigan, California and other states worked with the CDC to use DNA fingerprinting on samples from patients and mushrooms. The outbreak strain of Listeria monocytogenes was found in two samples of mushrooms collected from a grocery store by Michigan officials. An outbreak patient reported eating mushrooms from the store before becoming ill. The California Department of Public Health collected enoki mushrooms from grocery stores and identified the outbreak strain in one sample.
FDA collected samples of enoki mushrooms for testing at import from Green Co. LTD of the Republic of Korea. On April 6, 2020, results showed that two samples yielded the outbreak strain of Listeria monocytogenes. As a result, on April 7, 2020, FDA placed Green Co. LTD on an import alert, meaning their product can be stopped at the U.S. border.
Having been determined to have begun in November 2016, the CDC reports the outbreak lasted through December 2019.
“As of June 9, 2020, this outbreak appears to be over. Epidemiologic, traceback, and laboratory evidence showed that enoki mushrooms supplied by Green Co. LTD, located in the Republic of Korea, were the likely source of this outbreak,” according to the outbreak update. “. . . enoki mushrooms supplied by Green Co. LTD, located in the Republic of Korea, were the likely source of this outbreak.”
A total of 36 people have been identified so far as having been sickened in the outbreak. The patients are from 17 states. Almost all patients — 31 of the 33 with information available — were so sick they had to be admitted to hospitals. Four patients died. Six pregnancy-associated cases were reported, with two resulting in fetal loss.
Ill people ranged in age from less than 1 to 96 years old, with a median age of 67, according to the CDC. Fifty-eight percent of ill people were women.
On March 18, 2020, the Korean Ministry of Food and Drug Safety published its investigation findings and steps it will take to prevent future illnesses. It found Listeria monocytogenes in enoki mushrooms produced by two firms in the Republic of Korea.
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Just as it was looking like American agriculture was going to survive the pandemic and planting was turning out successful, rural areas learned they were losing the weedkiller dicamba to protect the soybeans they’ve put the ground.
Xtendimax, FeXapan, and Engenia the three dicamba herbicide brands or “labels” sold by Bayer, Corteva, and BASF, are no longer legal for use by farmers, according to the June 3 federal court ruling.
Dicamba is a broad-spectrum herbicide first registered in 1967. It is widely used in grain crops and grasslands and was long considered safe if used properly under label instruction.
The ruling by the U.S. Court of Appeals for the Ninth Circuit reportedly vacated the federal registrations of the three dicamba herbicide brands effective immediately. Issues of “drift damage” to nearby organic fields and whether it is “safe enough” landed dicamba in courts about four years ago.
The Lone Star State reacted by the next day with this statement by Texas Agriculture Commissioner Sid Miller: “For the farmers in Texas, I want to be clear: I’ve got your back. Dicamba is still available for use in Texas as currently labeled and will continue to be so until someone tells us to stop. In this difficult time, the last thing Texas farmers need is more uncertainty.
“The Ninth Circuit ruling on dicamba is already spurring very significant confusion and chaos among soybean and cotton growers and applicators here in Texas, who were intending to apply the herbicide today, tomorrow and over the coming weeks.”
Miller said the U.S. Environmental Protection Agency (EPA): can and should “provide clarity as soon as possible by announcing that it plans to take further administrative action, and then doing so.”
Miller said EPA must issue an existing stocks order to provide appropriate guidance to farmers and applicators and request a Section 18 Emergency Use for these products for Texas farmers.
By yesterday (June 8), the impacted farm states with the possible exception of South Dakota have joined with Texas in backing up their farmers, during this “spraying season.”
Nebraska Agriculture Director Steve Wellman anticipates the EPA will seek a review of the problematic ruling, perhaps as an emergency.
“The Nebraska Department of Agriculture has not issued a stop-sale order and will enforce the sales and applications of these products as they are currently registered in Nebraska,” said Wellman.
The EPA should immediately appeal the ruling, according to a disappointed National Corn Growers Association (NCGA).
“This decision to remove a weed control option, especially in the middle of the season, adds yet another challenge to an already difficult time and sets a concerning precedent,” NCGA said.
And the Nebraska Farm Bureau has asked the state’s attorney general to explore legal options that could help the state’s growers. Pesticide use and application programs require the states to name a lead agency.
The lead state agency is then responsible for licensing and training pesticide applicators, overseeing worker protection, registering pesticides for sale in the state and working to minimize unnecessary impacts to agriculture while enhancing the protection of endangered and threatened species
As an example, the Texas Department of Agriculture is the lead agency for the Lone Star State with more information available at visit the TDA Pesticides.
“The timing of this ruling couldn’t be worse,” said Nebraska Farm Bureau President Steve Nelson. “Dicamba products are stringently regulated and agricultural producers have a limited window to use these products. We are in that window of use time right now, but that window is rapidly closing.
“The timing of the court’s decision has needlessly created tremendous uncertainty for farmers. Worse yet, many farmers made planting decisions and herbicide purchases based on their understanding these dicamba products would be available for their weed control programs.”
Secretary of Agriculture Sonny Perdue called on the EPA to “use any available flexibilities to allow the continued use of already purchased dicamba products, which are a critical tool for American farmers to combat weeds resistant to many other herbicides, in fields that are already planted.”
He said the Ninth Circut ruling was taking away one of the tools farmers need to produce the world’s food, fuel, and fiber after they’ve purchased the herbicide they need to combat weeds in the fields they’ve already planted.
After Minnesota joined Texas and the other state at about 2 p.m. Monday, it appears that South Dakota is the only significantly impacted state to submit to the appellate court’s decision.
According to the Mount Rushmore State’s officials, the “sale and use of those impacted products must be discontinued immediately.”
Environmental groups are celebrating the ruling as a victory.
“Today’s decision is a massive win for farmers and the environment,” said attorney George Kimbrell of the Center for Food Safety (CFS), “It is good to be reminded that corporations like Monsanto and the Trump Administration cannot escape the rule of law, particularly at a time of crisis like this. Their day of reckoning has arrived.”
Kimbrell was lead counsel for the environmentalists. He said the Ninth Circuit ruled that the new over-the-top use registrations of dicamba formulations XtendiMax, FeXapan, and Engenia are null and void, effective immediately.
“The ruling was crystal clear: These pesticides can no longer be legally sold or sprayed on dicamba-resistant soybeans or cotton, he said.
“State officials have called on the EPA for clarification of the court’s ruling, some maintaining their states will allow continued use of dicamba unless or until directed otherwise. But the EPA has ignored their calls, just as it ignored the growers harmed by dicamba.”
In his statement on Monday, Kimbrell also said the EPA should “confirm to the states that these uses are illegal. EPA’s failure to do so to this point is a dereliction of the agency’s duty to farmers and the public. We represent farmers, including many who have suffered years of drift damage from these harmful dicamba products. They must not be subjected to the fourth year of rampant injury to their crops from dicamba drift.”
“And the (drift) damages are more than economic,” he says the issue is “tearing the fabric of farming communities.” Kimbrell makes several other points:
- The pesticide companies have already deceived farmers twice. They pressured the EPA for approval and then sold their dicamba products for four years in the face of substantial evidence that they would cause disastrous offsite drift damage.
- Worse, when unprecedented and disastrous drift injury did occur, these companies blamed their farmer customers rather than their harmful products.
- If Bayer/Monsanto, Corteva, and BASF want to help their customers, they should reimburse them for their unusable dicamba products, facilitate safe disposal, and make their farmer-customers whole.
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Rates of Campylobacter and Salmonella infections in Australia have almost halved since the lockdown because of the Coronavirus pandemic that began in March.
The Food Safety Information Council revealed that since the COVID-19 shutdown started, reported rates of these infections per 100,000 people have declined compared to the past two years.
This shows the effectiveness of good handwashing, and that there has been less bulk catering as fewer people have been eating out or entertaining, according to the health promotion charity.
In April, 839 Salmonella infections were recorded compared to 1,383 in 2019. For May, 818 cases were reported versus 1,172 in the same period the year before, according to the Australian Department of Health’s National Notifiable Diseases Surveillance System. These figures convert to a reporting rate of 3.4 in April compared to 5.5 in April 2019 and 3.3 in May versus 4.7 in May 2019.
For Campylobacter, 1,438 cases were recorded in April compared with 2,427 in 2019 and 1,830 for May compared with 2,687 in 2019. Rates were 8.5 in April 2020 compared with 14.3 the year before and 10.8 in May 2020 versus 15.8 in May the year before.
Shiga toxin-producing E. coli (STEC) reports were also down from 51 in April 2019 to 21 this year and from 56 in May 2019 to 30 in 2020.
Handwashing and social distancing impact
Cathy Moir, council chair, said in a normal year there are an estimated annual 4.1 million cases of food poisoning that result in 31,920 hospitalizations, 86 deaths and 1 million visits to doctors.
“There have been drops in other infectious diseases such as influenza and measles during this period which shows how effective good handwashing and social distancing can be in controlling infectious diseases. Also, food poisoning is more commonly identified when food is prepared in bulk and there has been less entertaining and eating out with larger groups of people during the lockdown,” she said.
“But we mustn’t become complacent – our 2019 handwashing study found 29 percent of Australians said they didn’t always wash their hands after going to the toilet and more than a third admit they don’t always wash their hands before touching food. Now we have better handwashing as a result of COVID-19 we urge people to continue to wash their hands often even after the pandemic ends.”
FSIC also announced the theme for Australian Food Safety Week Nov. 14 to 21 will be “Food Safety – it’s in your hands.”
The group will aim to build upon good behavior established during the COVID-19 pandemic to continue to reduce the amount of foodborne disease.
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New research underway seeks to determine how and where bacteria hide in food processing plants so that they can be eliminated, to the benefit of public health and the bottom line of food companies.
The project involves scientists at Texas A&M, Stanford University and the USDA’s Agricultural Research Service U.S. Meat Animal Research Center’s pilot meat processing facility in Clay Center, NE. Their work has the backing of a $479,000 grant from the U.S. Department of Agriculture (USDA).
While the project could ultimately benefit food facilities from fresh produce processing plants to candy makers, the reseachers will be taking an extra close look at the meat industry.
Led by Sapna Chitlapilly Dass, a post-doctoral meat science research assistant professor in the Texas A&M’s College of Agricultural and Life Sciences Department of Animal Science, the team will be looking at “hotspots” that easily harbor biofilms, also known as slime. Dass and the other researchers are trying to figure out not only where bacteria like Salmonella, Listeria and E. coli O157:H7 are hiding, but what sanitizers they have become resistant to.
“In the processing industry,” Dass said, “they hide in areas such as the back of conveyor belts or drains, which have poor accessibility for sanitation and therefore result in biofilms with greater sanitizer tolerance and antimicrobial resistance. We want to control food contamination by investigating the biofilm hotspots.”
Drains are predisposed to develop biofilms be the nature of their function and have a natural pathogen distribution system — microscopic droplets and other fluids going down drains and standing liquids at drain sites can easily carry bacteria to foods and food contact surfaces. That kind of contamination is dangerous in more than one way.
“Reducing contamination of our meat supply by pathogens such as E. coli O157:H7 and Salmonella will reduce recalls that trigger significant financial losses, but more importantly will reduce the incidence of human illness and death associated with contaminated food,” said Cliff Lamb, Ph.D. and head of Texas A&M’s Department of Animal Science.
“The development of new strategies for controlling accidental contamination of food with these pathogens will have significant impacts on human health and reduce economic losses.”
While examining drains and production and packaging equipment the research team expects to confirm that multiple species of foodborne pathogens live in biofilms. That helps makes containment and removal of the pathogens complicated. For example, certain strains of Salmonella that are present in biofilm may be susceptible to sanitizers, but others can survive certain chemicals and other sanitizing substances.
“One segment of the study will compare and characterize diversity, stability and resilience of the food pathogens and meat processing drain mixed-species biofilm in response to commonly used meat processing sanitizers,” according to a statement from Texas A&M. “Another segment of the study will examine whether spatial organization and location of the food-pathogen within the multi-species biofilm impacts sanitizer tolerance.”
The project will also evaluate how foodborne pathogens are detached and transmitted through a food processing facility. Dass stresses the double pronged value of the project with positive outcomes expected for public health and reducing economic costs associated with foodborne illnesses.
“. . . designing low-cost sustainable materials for drainage systems with microscale surface patterns that can prevent dispersal of pathogens to food,” she said.
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Five people from two households in New Zealand became ill with ciguatera poisoning after eating fish imported from Fiji earlier this year.
The outbreak in Christchurch affected three males of 19 to 58 years old and two females – one aged in her 40s and the other in her 50s. One person was hospitalized and diagnosed with ciguatera poisoning but has since recovered.
In late May, Krazy Price Mart Ltd recalled a batch of frozen camouflage grouper (kawakawa) due to ciguatoxin. The item was sold as an individual whole gutted fish wrapped in clear plastic but was not labelled so had no date marking. It was available between March 10 and May 21, 2020 only at Krazy Price Mart Ltd in Christchurch.
Sample analysis and label issue
The first household purchased, cooked and consumed affected fish on April 18 and the second household bought the fish on May 3 but did not cook and eat it until one week later. In both houses, the cases had onset of symptoms within eight hours of having the product.
The link between the product and illness was identified by the local public health unit investigator who interviewed the notified cases. Both affected families had purchased the same product from the same retailer but on different days. A sample of the fish remaining in the freezer of one of the households has been sent for analysis but results are not yet available.
The Australia New Zealand Food Standards code sets out the legal labelling requirements for food sold in the two countries. Lot identification is required for food labels. The lack of this information on the labels is being followed up as part of an ongoing investigation. Enquiries with Fijian authorities and Krazy Price Mart Ltd, the importer and retailer of the affected fish, are continuing.
Ciguatera is an illness caused by eating fish containing certain toxins. The toxins come from a type of algae, and get into the fish either through it eating the algae, or eating fish that ate the algae. Fish that can cause poisoning include coral trout, barracuda, red snapper, donu, parrotfish, grouper, Spanish mackerel, red emperor, wrasse, reef cod, sturgeon fish, trevally, kingfish and moray eel.
Ciguatera in New Zealand
Ciguatera poisoning is relatively uncommon in New Zealand. The last outbreak in Canterbury was in December 2019 and there were two local outbreaks that year. The fish species implicated in this outbreak has been linked to previous cases and outbreaks.
During 2018, no cases or outbreaks of ciguatera fish poisoning were reported in EpiSurv, New Zealand’s database for notifiable disease surveillance. Using hospital data, four people were reported with ciguatera poisoning as the primary diagnosis. From 2009 to 2018, seven outbreaks were recorded, with no more than two in any year.
Ciguatera poisoning is not a notifiable disease in the country but acute gastroenteritis is under some circumstances such as where there is a suspected common source. It is generally associated with private imports of imported reef fish from the tropics and not usually from New Zealand caught fish.
Possible symptoms of poisoning include nausea, vomiting, diarrhea, muscle pain followed by neurological symptoms including headache, temperature reversal (hot things feel cold and cold things feel hot), dizziness, tingling, muscular weakness and irregular heartbeat. Onset of symptoms usually occur within six hours of eating the contaminated product and last a few days or weeks. Ciguatera toxin does not affect the appearance, odor or taste of fish. Freezing or cooking fish once it has been contaminated will not kill the toxin.
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Bill Marler is getting the last word on the petition he filed with USDA’s Food Safety and Inspection Service (FSIS) in January, which is on behalf of Rick Schiller, Steven Romes, the Porter Family, Food & Water Watch, Consumer Federation of America, and Consumer Reports.
He’s waited for the formal comment period to end. Major meat and poultry industry comments were not made until late in the comment period. Marler explains why the law is not a barrier to getting dangerous Salmonella out of the nation’s meat and poultry. He points to the success the meat and poultry industry had in removing Shiga toxin-producing E. coli from meat, which came after their extended initial opposition.
The Marler petition requests that the FSIS declare several “outbreak serotypes” as adulterants in meat and poultry products. Listing these specific Salmonella serotypes as adulterants would prevent their presence in meat and poultry just as certain E. coli serotypes are banned today.
Marler is the managing partner of Marler Clark, the Seattle-based food safety law firm. The FSIS received 377 comments on the Salmonella petition by the May 25 deadline. About 15 percent of those comments were made anonymously.
Marler is getting the “last word” in a June 5 letter to Mindy Brashears, USDA’s Under Secretary for Food Safety. In it, he provides a “supplement” to the original petition “with additional and updated” information.
The Salmonella serotypes the Marler petition wants to ban from meat and poultry are Salmonella Agona, Anatum, Berta, Blockley, Braenderup, Derby, Dublin, Enteritidis, Hadar, Heidelberg, I 4,,12: i:-, Infantis, Javiana, Litchfield, Mbandaka, Mississippi, Montevideo, Muenchen, Newport, Oranienburg, Panama, Poona, Reading, Saintpaul, Sandiego, Schwarzengrund, Senftenberg, and Stanley,
“Salmonella is the leading bacterial cause of foodborne illness in the United States, resulting in an estimated 1.35 million illnesses, 26,500 hospitalizations, 420 deaths, and 130 outbreaks each year.” Marler’s letter to the Brashears says.
Low doses of Salmonella can make people sick and most of these illnesses and deaths are attributed to eggs, poultry, beef, and pork with the resulting cots falling on the public and annually running from $2.7 billion to $6.5 billion, according to Marler.
He acknowledges “significant efforts” by USDA to stem the number of Salmonella infections, but without decline, instead the trend line in recent years shows “substantial” growth.
“Each of the above-referenced outbreak serotypes has a demonstrable history associated with either an illness outbreak or a product recall and has been proven to be injurious to human health,” Marler writes.
Since it was filed, the Marler petition has picked up endorsements from nationally known food safety advocates, including Stop Foodborne Illness, the Center for Science in the Public Interest, and the Center for Foodborne Illness Research and Prevention. With the petitioning organizations including Food & Water Watch, Consumer Reports, and the Consumer Federation of American, the vast majority of foodborne illness victims and consumers who want food safety favor banning the listed Salmonella serotypes in meat and poultry.
Unlike many of the comments, Marler advised the Brashears that “just cook it” does not “cut it.” He says most people know there are germs in meat and poultry and undercooking adds to the problem. However, he says studies show ‘time and time again” that too many consumers, restaurant managers, and chefs do not know how to handle and cook meat safely.
The meat and poultry industries greatly advanced food safety after E. coli O157: H7 was banned from their products more than a quarter-century ago. Marler at that time supported declaring O157 as an adulterant in meat and poultry while the meat and poultry lobby vigorously opposed the listing.
Few in those industries today would go back to E. coli days, however. Keeping O157 and six other E. coli serotypes out of meat and poultry cost about one penny per pound. Costs associated with civil lawsuits and recalls for E. coli were drastically cut.
But before Marler’s “last word,” major meat and poultry industries’ voices let FSIS know they oppose banning Salmonella in the 21st century. Here’s some of what they said in extended excerpts from the comments they filed in May.
Mark Dopp, North American Meat Institue
“The petition wrongly contends Salmonella is an “added substance” in meat and poultry products.
The backbone of the petition is its misplaced assertion that meat is “sterile” and therefore Salmonella is an “added substance.” The definition of “adulterated” in the Federal Meat Inspection Act (FMIA) and Poultry Products Inspection Act (PPIA) (collectively the Acts) provides a meat or poultry product is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health.3 (Emphasis added)
This definition establishes different standards for whether a meat or poultry product is adulterated depending on whether the substance is “added.”4 If the substance is “added” the easier to satisfy “may render … injurious to health” standard applies. Conversely, if the substance is not added, or what many consider naturally occurring, the more difficult to meet “does not ordinarily render it injurious to health” standard applies.
The petition wrongly seizes upon this distinction and argues that, because muscle tissue is sterile, Salmonella is an added substance and the “may render injurious” standard is applicable.5 For example, the petition states
Salmonella’s presence on muscle tissue, whether by spoilage or pathogenic, is a result of contamination because these parts have been shown to be sterile prior to their exposure to processing and reprocessing methods.6
This theme is reiterated throughout the petition, but it is wrong…”
Nelson J. Gaydos, American Association of Meat Processors
“AAMP is North America’s largest meat trade association. Our members include meat and poultry processors, slaughterers, caterers, food service companies, wholesalers, retailers, suppliers, and consultants to the industry…
..testing is not a preventative measure for food safety. It is merely a tool used to assess the current system. Focusing efforts on increased testing is not the way to decrease foodborne illness, that can only be done through good antemortem, slaughtering and post-mortem practices, processors following and executing their HACCP plans and educating the public.
This petition spent a considerable amount of time highlighting the lack of knowledge that chefs, restaurant workers, and consumers have about foodborne illness and proper food handling and safety, yet does not feel the need to correct this problem since, according to them, it has not worked in the past. Time and resources would be better spent on education rather than on more stringent testing and regulations for processors. The already occurring preventative measures done by processors are being negated by poor handling and cooking of chefs, restaurant workers, and consumers further down the line. These new measures suggested in the petition will not change that. We suggest that as an alternative to this petition, more efforts be put into educating the public including those who cook and prepare food for others, consumers who cook at home, and especially children in school (middle school, high school, and college).
If FSIS approves this petition, it will be extremely difficult to answer this question from our members: “Does FSIS want to put us out of business?” When we look at this petition and think about the requirements it will be asking of meat processors and of the economic impact it could have on the meat industry, it is hard not to wonder the same thing ourselves. We realize the intention behind this is to protect the public from unintentional contamination of meat and poultry products and agree on its importance; however, we do not agree on how to go about carrying out the goal of the petition.
AAMP believes that FSIS should not approve this petition and take a step back and work with the industry to create sensible recommendations based on sound scientific studies so that they are the most realistic…
Dr. Ashley B. Peterson, National Chicken Council
“The Petition requests a procedurally improper change to longstanding and unequivocal Agency policy that would contradict court cases dating back decades.
FSIS has for years expressly and consistently articulated its policy that Salmonella is not an adulterant in raw meat or poultry. This policy has been articulated in numerous Agency actions on which FSIS sought and responded to public comment through dockets announced in the Federal Register.
A few recent examples underscore just how established FSIS’s position is: In a 2016 Federal Register Notice announcing it would begin assessing whether establishments met the pathogen reduction performance standards in raw chicken parts and not-ready-to-eat (NRTE) chicken and turkey products, FSIS stated, “Salmonella is not an adulterant in NRTE poultry products. Therefore, a positive test result for Salmonella in imported (not-ready to-eat) poultry products sampled by FSIS import inspection personnel would not result in regulatory control actions at port-of-entry (i.e., refused entry of the product).”14 In FSIS Notice 21-19 on actions to take in raw poultry establishments exceeding Salmonella performance standards, FSIS stated it “does not consider raw poultry containing Salmonella to be adulterated as defined by 21 USC 453(g)(1) unless other circumstances make the product adulterated. Establishments are not required to segregate or hold product when the establishment exceeds a Salmonella performance standard.”15 In a 2012 FSIS final policy statement on not applying the mark of inspection pending certain test results,
FSIS stated that “the policy would not cover raw meat or poultry products tested for Salmonella or other pathogens that FSIS has not designated as adulterants in those products.” In its response to comments on changes to the Salmonella verification sampling program, FSIS stated unequivocally that “Salmonella is not an adulterant in raw meat products.”17 And in FSIS Notice 46-19 on analysis for Salmonella of all imported beef, FSIS stated it “does not consider Salmonella an adulterant in raw meat products. Therefore, a positive test result for Salmonella in imported raw beef and veal products, sampled by FSIS inspection program personnel (IPP), does not require a regulatory control action to be taken…”
The Last Word
Marler apparently does not think the meat lobby is going to get far making its legal arguments against the petition. To be sure, he’s provided Brashears with a legal lesson.
“As nearly every knowledgeable person would readily concede, the decision to declare a substance an adulterant under 21 U.S.C. § 601(m)(1) and 21 U.S.C. § 453(g)(1) involves a need to decide whether, legally speaking, the substance in question is ‘added.’ The commenters that argued (or simply asserted) that Salmonella is not, and cannot be, an ‘added substance’ did so on two grounds: one supposedly factual and the other primarily legal. But the arguments offered are misinformed at best and intentionally misleading at worst.
“The factual argument rests entirely on the assertion that some Salmonella that ends up as a contaminant of meat and poultry originates in the lymph nodes and thus is not added. But even if this were true (and it is only partly), there is no support for the idea that a substance cannot be declared an adulterant unless one hundred percent of contamination is attributable to an additive process.
“Those making the lymph node argument concede that nearly all such contamination is a result of an additive process. It also remains indisputably a fact that process controls, regulatory interventions, and other mechanisms can eliminate the presence of Salmonella in poultry. In sum, if the lymph node argument was to be dispositive here, then there is no reason that the USDA was also incorrect in declaring E. coli O157: H7 as an adulterant.”
One More Thing
Marler says plenty more in the letter about the law, but he also points out that comments were soiled by one opponent with a copy machine.
“Upon inspection of the comments to the Petition, we quickly noticed a troubling pattern — certain phrases and sentences were used repeatedly in many of the comments. Using the ‘search’ tool, we determined that 197 of the 377 comments (52 percent) contained the phrase ‘USDA should reject this petition;’ 201 of 377 (53%) contained ‘consolidating our meat supply in the hands of large-scale operations;’ 179 of 377 (47 percent) contained the sentence ‘While salmonella [sic] is a serious problem, this very broad, zero-tolerance approach is not the answer;’ and 191 of 377 (51 percent) contained the sentence ‘Many of these strains pose only slight risks, yet the testing requirements that would result from classifying them as adulterants could put small-scale processors out of business.’
“We ultimately determined that these recurring phrases stemmed from a template posted online and sent around by the Weston A. Price Foundation. Thus, it is likely that many of the commenters using this template did not read the petition in its entirety, but instead, merely copied and pasted Weston Price’s template to comment in objection of our petition.”
Editor’s Note: Bill Marler is the publisher of Food Safety News.
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Editor’s note: Each Spring, attorneys Bill Marler and Denis Stearns teach a Food Safety Litigation course in the LL.M. Program in Agricultural and Food Law at the University of Arkansas School of Law. This specialized program for attorneys brings together those who are interested in our food system, from farm to table. As a final assignment, students are asked to write an op-ed or essay on food safety, with the best to be selected for publication in Food Safety News. The following is one of the essays for 2020.
By Alexia Kulwiec
As to that delicious steak or pork chop you are about to sink your teeth into, do you know where it came from? Will the grocery refrigerated cooler where you purchased that meat be empty tomorrow?
In the quest to produce beef and pork free of pathogens that could cause food borne illness, the United States has created a system that leaves the nation’s food supply vulnerable to a health crisis such as the country is now experiencing. At the same time, the U.S. system has decreased the ability of smaller local producers, often involved in humanely raising healthy animals, to provide healthy foods to the consumer. While strong health and safety measures are needed in the local food movement as elsewhere, smaller operations could be a large part of, if not the, solution to the current vulnerability in the U.S. food supply.
The world, but specifically North America, is beginning to experience the drastic impact of the ongoing consolidation of the meat processing industry, with concerns growing over the stability of the food supply. U.S. and local regulations must change to decrease this impact and can do so by supporting local independent growers. In the United States, USDA inspected meat processing plants have temporarily closed in South Dakota, Iowa, Minnesota, Pennsylvania, Colorado and Wisconsin. In Canada, a Covid-19 outbreak at a single Cargill plant in Alberta impacted close to one-half of Canada’s beef supply. Closed plants cannot process the beef and pork demanded by consumers. In turn, farmers and ranchers lack a market for their products. As an alternative and supplemental supply of meat products, consumers can obtain food locally sourced from producers they know and trust.
Until recently, the position of the USDA, and perhaps of consumers generally, was that to ensure a safe meat supply, meat must be slaughtered in USDA inspected plants. The federal Wholesome Meat Act requires processing of all beef and pork to be slaughtered and processed in USDA inspected facilities or state facilities that follow standards at least as stringent as federal rules.
In the abstract, this regulation has some merit – consumers rightfully demand beef and pork products free from pathogens, illness or other contaminants that could cause injury or illness. To date, while safety of meat produced has improved, the meat processing system itself, broadly speaking, is failing to meet the needs of American consumers. The past month in the United States has demonstrated that consolidation has led to a serious vulnerability in U.S. meat production as well as compromised safety and health of the meat processing workforce.
Also the food system as presently constituted, in part because of USDA regulations, fails to support local independent operations that help address the instability of the market.
Not healthy for the stability of the U.S. food supply
There has been tremendous consolidation in meat processing industries over the last several decades. The top 4 beef processors control approximately 80% of the U.S. meat supply. The top 4 pork processors account for approximately 63% of the U.S. market. The consolidation into just a few top processors has led to fewer and larger meat slaughter and processing facilities. As we have seen the past few weeks, the closure of one or more of these plants can have a serious impact on the nation’s supply of beef and pork. By one estimate, 10% of all beef production and 25 % of the U.S. pork production has closed after 13 packing and food processing workers died after contracting Covid-19. Because of the consolidation in the meat industry, one plant closing can have an enormous impact on the U.S. supply of fresh beef and pork.
Not healthy for workers
Workers in the meat and poultry industry on average earn less than $15 an hour and earn 44% less than workers in other manufacturing jobs. Yet this is dangerous work and has been prior to Covid-19. Eight plant workers died between 2013 – 17 from work related injuries, and a good number more lost body parts or were hospitalized for work injuries. Many suffer unreported injury and illness, particularly disabling musculoskeletal illness caused by high lines speeds and difficult repetitive work. Workers report long hours without breaks, lack of adequate access to sanitation facilities, and tremendous pressure to meet high productions quotas.
The regulatory system has supported growth of large-scale slaughterhouses and meat processing plants, where social distancing is impossible, line speeds have put workers’ safety at tremendous risk and conditions have already caused unnecessary injuries. Employees work shoulder to shoulder, processing up to 400 cattle per hour. During the Covid-19 crisis, workers have reported being encouraged to work even if they appeared sick. Many did not receive any PPE, Personal Protective Equipment, and at least 13 workers have died from exposure to the virus. As well as the toll on workers, this has led to the closure of a number of plants. This negatively impacts the nation’s supply of beef and pork.
Not healthy for local and smaller producers and their markets
The consolidation of the U.S. meat processing industry has been particularly difficult on smaller, local operations. Local processing plants that satisfy the USDA or state requirements are in short supply. Massive consolidation in the meat processing industry has led to the processing of most beef and pork in fewer but large processing facilities. As a practical matter, such facilities serve the industry. The often will not accept small quantities for processing, thus making it nearly impossible for smaller meat producers to ensure inspection of products for sale to consumers. At best, small producers are often told that plants cannot process their meat for six months. At worst, they are turned away. In addition, small producers have to transport their animals long distances for processing at these plants, often hundreds of miles. This transportation has an obvious environmental impact and causes unnecessary stress to the animals transported for slaughter. These delay and distance hurdles also create financial disincentives for small producers to raise animals for sale locally.
Meanwhile, reports suggest that consumer demand for local sustainably grown foods is increasing. Consumers want to know how their food is grown and processed, are interested in a shorter supply chain, and wish to support local producers.
These producers can certainly be part of any solution, yet they lack feasible access to approved processing facilities. In addition, while custom slaughter operations can process meat for an animal owner, these facilities are prohibited from processing meat for sale. This in turn continues to drive the consolidation of the industry that has made the nation’s food supply vulnerable during a crisis. Expanding the ability of these independent facilities, with appropriate safety regulations, to process meat for sale would help expand our nation’s safe meat supply.
Is the 400 an hour cattle processing really the best method to provide safe and healthy food?
So how do we keep this local food supply safe? Modifying regulations that allow for differences for smaller, local plants could increase the number of smaller plants. The current USDA meat processing regulations are numerous, difficult, and unduly burdensome on a smaller operation. Accounting for the differences in the size of processing plants while maintaining safety standards could go a long way towards decreasing reliance on a number of large plants. This would lessen the vulnerability to our food supply of the closure of one large facility. Allowing for a more diverse production system but with continued stringent safety standards would limit our reliance on the four corporations that control 80% of the American beef market and the few controlling pork production.
Modifying OSHA regulations protecting workers, such as providing for slower lines speeds and perhaps a plant design that allows workers more space, can impact the safety and health of employees as well maintain a healthier workforce. This in turn makes plant closure less likely in the event of a virus or other illness. Such a system can, and should, continue to impose rules to ensure the health of the meat supply. Certainly this may impact price. However, more competition from a more diverse supply chain would also positively impact price, as will transportation savings to independent producers
To this end, one option is the proposed change in federal law called the Processing Revival and Intrastate Meat Exemption Act (“the PRIME Act”), H.R. 2859. The Prime Act would repeal the ban on sale of meat processed by “custom slaughterhouses” that meet state regulations and basic federal requirements, but not those needed in larger facilities that are not as relevant in smaller operations. Currently, animal owners can have their own meat processed in these facilities but cannot sell products processed at custom facilities.
Opponents argue against permitting farmers and ranchers to sell to consumers without the benefit of USDA inspection citing health and safety concerns. Yet under the PRIME Act, states are free to develop regulations of the industry to ensure safety while increasing access to wholesome food.
Opponents have also argued that there is a lack of accountability by the smaller producers under this system. Yet, smaller local producers are much more financially impacted by any problem in their food production. One illness is likely to drive them out of business, which in turn drives them to often utilize far greater protections in raising, slaughtering and processing their animals.
In the alternative to new federal legislation permitting local processing and sales directly to the consumer, the USDA and the states must increase the number of inspectors and provide for an increased number of smaller facilities. A greater number of smaller facilities would ensure that the impact of just one plant closing would not have a great impact on the U.S. food supply. It would also allow for greater physical space between employees, protecting them from contact during a health crisis such as Covid-19. It serves local producers, and the environment, in that they will spend less on transportation and be more likely to be able to profit from selling their meat locally. It helps meet consumer demand for locally grown organic food that meets animal welfare standards. Without more facilities, a local farmer or rancher who raises cattle in pasture without unnecessary antibiotics and houses the animal in clean facilities is often forced to then stress the animal by transporting them hundreds of miles for slaughter and processing, thus defeating many of the benefits of animals raised humanely.
The current USDA practices and procedures drives out small producers and processors at a critical time when our food supply demands more, not less, producers. This in turn has placed the U.S. market for meat, and consumers, in a vulnerable position. It has placed almost all of our beef and pork production in the hands of just a few giant corporations. As the Covid -19 virus has made us painfully aware, the corporations placed profit before the safety of our overall meat supply, not to mention their workers whose very lives have been put at risk. In light of the inadequate number of processing facilities and inspectors, regulations need to be modified to protect the industry, health and safety of workers, and the nation’s food supply.
1. See Dianne Gallagher, Meat Processing Plants Acorrs the US are Closing Due to the Pandemic. Will Consumers Fell the Impact?, CNN Business (April 27, 2020). See also Danielle Kaeding, JBS USA Announces Temporary Closure of Green Bay Meatpacking Plant, Wisconsin Public Radio (April 26, 2020). See also National Farmers Union, April 22, 2020 Media Release: Covid-19 Shuts Down Half of Canada’s Beef Supply, https://www.nfu.ca/. While not the subject of the post, the issue is beginning to surface in poultry as well: workers in Georgia and Alabama have contracted the covid-19 virus, with some plant mangers sending employees home. A Vancouver chicken plant closed after 28 workers tested positive for Covid -19.
2. 21 C.F.R. § 601 et. al.
3. Amelia Lucas, Meatpacking Union says 25% of US Pork Production hit by Coronavirus Closures, CNBC (April 23, 2020).
4.Taylor Telford and Kimberly Kindy, As they Rushed to Maintain U.S. Meat Supply, Big Processors saw Plants become Covid-19 Hot Spots, Worker Illnesses Spike, Washington Post, April 25, 2020.
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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.
Quality Dairy Company, Lansing, MI
Ken Martin, president
In a May 13 warning letter the FDA described a Jan. 8- 17, 2020 inspection at Quality Dairy Company’s ready-to-eat sandwich, salad, and bakery products manufacturing facility. Inspectors found that the company had serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.
FDA’s inspection resulted in the issuance of an FDA Form 483a.
The significant violations are as follows:
Hazard Analysis and Risk-Based Preventive Controls:
- The firm produces RTE foods exposed to the environment and thus apply sanitation controls to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergens. The firm’s sanitation control procedures did not ensure the cleanliness of food-contact surfaces and prevention of cross-contamination:
- The directions for the sanitizer they use, (redacted), state that “(redacted)” and “(redacted).” However, their cleaning procedures conflict with the directions as follows:
- The firm’s Commissary Cleaning of Stainless Tables procedure instructs employees to (redacted). Their commissary sanitation employee stated that after spraying the tabletops and other processing equipment with a sanitizer, he (redacted).
- The firm’s Commissary Cleaning of Blue Deli Coolers procedure instructs employees to (redacted). Note that although the procedure is specifically for their commissary area, the coolers were being washed in the pan washroom.
iii. The firm’s Commissary Cleaning of Meat Slicer procedure instructs employees to (redacted). Further, they failed to follow their procedure to use a (redacted) before sanitizing the meat slicer. On January 9, 2020, FDA Investigator observed a commissary sanitation employee sanitize the meat slicer without first cleaning it with a (redacted).
The firm’s response indicates that “All SSOP’s have been updated to reflect correct procedures and follow the chemical manufacturer’s direction for use. Each revised SSOP instructs (redacted) after sanitizer applied.” They did not indicate how they will ensure that employees follow their procedure to use a (redacted) before sanitizing the meat slicer. The FDA will verify the adequacy of the corrective actions and implementation during the next inspection.
- The firm’s Cleaning and Sanitation procedures (revision date 3/14/2015) state that “SSOPs for each item covered under the Master Cleaning Schedule” “will be documented and stored at the supervisor’s station and made available.” However, the firm only had three area-specific cleaning and sanitation procedures of the (redacted) listed in the Master Cleaning Schedule: stainless tables, blue deli coolers, and meat slicer.
The firm’s response indicates that “The Post-Op Daily Sanitation Sheet has been updated. The area-specific cleaning and sanitation procedures have been updated and expanded to show all procedures.” In their response, it appears that they are working to establish and implement additional written SSOPs for the items listed on their master sanitation list. We will verify the adequacy of the corrective actions and implementation during the next inspection
- The firm’s sanitation controls monitoring records were not reviewed within 7 working days after the records were created. Specifically, their sanitation preventive controls are monitored on a “Pre-Operation Check Sheet” and “Post Operation Schedule.” Review of these documents found as follows:
- The firm’s Pre-Operation Check Sheets were not reviewed for the following dates: 7/16/19, 8/23/19, 9/18/19, 11/1/19, 11/27/19, and 12/12/19.
- The firm’s Quality Dairy Commissary Post Operation Schedules were not reviewed for the following date ranges: 10/28/19-11/1/19, 11/25/19-11/27/19, and 12/09/19-12/13/19.
The firm’s response indicates that “all sanitation monitoring records will be reviewed daily and verified (redacted) by a PCQI (redacted) along with all documents associated with Preventative Controls.” However, their response did not include any documentation or completed records to show that this has been implemented. The FDA will verify the adequacy of the corrective actions and implementation during the next inspection.
- They did not implement their written sanitation control verification procedures for environmental monitoring.
Their Environmental Monitoring procedure dated September 19, 2019, states that “(redacted) environmental sampling is to be taken from the production area” and is to be tested for mold, Listeria, and Salmonella. However, they did not take samples as frequently as required by their procedures. A review of their records found that they did not collect environmental samples from the commissary area for Listeria spp. between September 5, 2019, and November 7, 2019. Additionally, they did not collect environmental samples for Salmonella analysis from any area in their facility, including the bakery, since September 5, 2019.
The firm’s response includes an updated Environmental Monitoring procedure dated February 6, 2020, which states, “(redacted) environmental sampling is to be taken from the production area” to be tested for Listeria and Salmonella. The procedure provides for a minimum of (redacted) samples to be collected and identifies multiple sampling areas, including zone (redacted) (“Direct food contact areas/surfaces”). Their response includes one set of environmental monitoring records with a laboratory analysis report dated February 17, 2020. The report indicates that no swabs were collected from the zone (redacted).
Procedures for environmental monitoring must, among other requirements:
- Identify the locations from which samples will be collected and the number of sites to be tested during routine environmental monitoring. The number and location of sampling sites must be adequate to determine whether preventive controls are effective.
- Identify the timing and frequency of collecting and testing samples. The timing and frequency for collecting and testing samples must be adequate to determine whether preventive controls are effective.
- Include the corrective action procedures.
In addition, the firm’s corrective action procedures do not address the evaluation of all affected food for safety. Corrective action procedures must ensure that:
- Appropriate action is taken to identify and correct a problem that has occurred with the implementation of preventive control.
- Appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur.
- All affected food is evaluated for safety.
- All affected food is prevented from entering into commerce if they cannot ensure that the affected food is not adulterated.
The FDA will verify the adequacy of their corrective actions during our next inspection.
Current Good Manufacturing Practice:
- They failed to exclude pests from their food plant to protect against contamination of food. Specifically. The FDA investigators observed the following:
- On January 8, 2020, FDA investigators observed five apparent dead German cockroaches: one in the “candy room,” three in the dry storage area approximately six feet away from blue and white sprinkles, and one in the bakery area; one apparent live German cockroach nymph on the wall in the bakery area adjacent to the yeast donut line approximately 12 feet away; apparent rodent excreta pellets in the boiler room; and an apparent dead mouse in the boiler room.
- On January 13, 2020, FDA investigators observed one apparent live German cockroach nymph crawling on the MDARD Inspector’s white inspection coat. The apparent German cockroach nymph was discovered on her inspection coat immediately after she examined the dry-cleaning process on the yeast donut line. Furthermore, their pest control contractor has historically documented problems with German cockroaches. During the FDA pest control records review FDA found that, between May 16, 2019, and December 20, 2019, their pest control contractor left reports detailing the observation of approximately 47 German cockroaches. The German cockroaches documented by their pest control contractor were found in their entry area, dry storage area, in the bakery area along the donut production lines, and near their mixers.
- Throughout the inspection, FDA investigators observed flying insects in their facility which were mostly concentrated along the donut lines. Since May 2019, their pest control contractor has documented multiple observations of aquatic flies, gnats, house flies, fruit flies, blow/bottle flies, and green bottle flies.
Pest observations were also documented during the FDA’s previous inspection conducted from April 22, 2019- May 14, 2019. The firm’s response indicates that they have increased the frequency of their pest control service monitoring and installed additional light traps. However, no documentation was provided to verify either of these actions. The FDA will verify the adequacy of these corrective actions during their next inspection.
- They did not monitor conditions and practices with sufficient frequency to ensure that effective measures are taken to protect finished food from contamination.
- On January 9, 2020, in the commissary, an employee used a pressurized hose to rinse/spray cleaned production equipment and floors. The FDA observed overspray from spraying the floors being deposited on exposed cleaned and sanitized production equipment and utensils.
- On January 8, 2020, an employee cleaning a donut icing flipper in the pan washroom broke down the icing flipper into three parts and cleaned and sanitized each one separately. After cleaning and sanitizing the main housing of the icing flipper, the employee uses a pressurized hose to spray the two removable pieces. The water from the pressurized hose was observed coming into contact with the floor and landing on the cleaned and sanitized icing flipper. The employee re-sanitized the icing flipper after installing the first removable piece, but the water was again observed hitting the floor and landing on the icing flipper when the second removable piece was sprayed with water. The employee did not re-sanitize the entire icing flipper after installing the last piece.
- On January 13, 2020, a sanitation employee scrubbed the donut cooling conveyor, a food contact surface, with a brush that was stored in a yellow bucket with water. This bucket is the same shape, color, and style with the same markings as the yellow buckets used to mop the floors around the facility.
The firm’s response indicates that its employees have been retrained and that sanitizing (redacted) is the last step in their updated cleaning procedures. Additionally, they have also obtained different color buckets for use when cleaning food contact surfaces and non-food contact surfaces. They have also clarified that the yellow buckets are for floor cleaning only. FDA will verify the adequacy of the implementation of these corrective actions during our next inspection.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at their facility. They are responsible for investigating and determining the cause of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is their responsibility to assure that they comply with all requirements of federal law and FDA regulations. They should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, and injunction.
In addition to the violations described above, the FDA offered the following comments:
During their inspection environmental swabs were collected from various locations throughout their processing areas. FDA laboratory analysis of the environmental sample INV1102223 collected on January 9, 2020, confirmed one swab positive for Listeria Seeliger, a non-pathogenic Listeria species. This positive swab was collected from a food contact surface area on a small hole on a stainless-steel table used to assemble sub sandwiches. The presence of Listeria species such as Listeria Seeliger suggests that conditions also are suitable for survival and/or growth of Listeria monocytogenes, which has been found in their facility in the past.
Specifically, during the agency’s previous inspection of their facility in 2019, FDA laboratory analysis of the environmental sample INV1046680 collected on April 23, 2019, confirmed two swabs positive for Listeria monocytogenes. Furthermore, during an inspection conducted by MDARD in 2019, they confirmed seven swabs positive for Listeria monocytogenes, and in 2016 they confirmed one swab positive for Listeria monocytogenes. Whole-genome sequencing of the Listeria monocytogenes isolates found that the 2 isolates from FDA 2019 sample and 1 isolate from MDARD 2019 sample are genetically identical. Additionally, the remaining 6 isolates from the MDARD 2019 sample and 1 isolate from the MDARD 2016 sample were determined to be genetically identical, indicating the presence of a resident pathogen in their facility from 2016 to 2019. FDA advised them of the WGS analysis during our Regulatory Meeting held on September 4, 2019.
When positive findings are confirmed it is critical that corrective actions are established and implemented to address any positive findings in order to eliminate the organism from their facility. The history of Listeria findings established by inspections conducted by the FDA and MDARD shows that ongoing attention needs to be paid to environmental monitoring and corrective actions to address Listeria’s findings and eliminate the organism from their environment.
The full warning letter can be viewed here.
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Today, June 7, is World Food Safety Day, and the Partnership for Food Safety Education is taking this time to recognize and celebrate the people who work tirelessly to provide healthy and safe meals.
Those recognized as food safety heroes in 2020, including write-ups and links to their work from the Partnership for Food Safety Education:
- Jollibee USA is recognized as food safety heroes. The jolly people of Jollibee USA have shown their care for customers and communities by serving great-tasting and safe food. They provided food to frontline medical workers in hospitals to help bring joy and support to nearby communities.
- Red Ribbon Bakeshop USA is recognized as food safety heroes. Team Red Ribbon Bakeshop USA keeps the stores clean and sanitary. They focus on food safety and love to donate food to the community. Red Ribbon makes moments sweeter for team members, customers and the community.
District of Columbia
- James McCarthy recognizes Linda Parisi of So Others Might Eat. Linda has been a tireless champion in feeding the homeless over the last 15 years. She ensures that the food the recipients receive is safe and wholesome.
- Patricia Buck recognizes Judith A. Cruz of Treasure Coast Food Bank. The Treasure Coast Food Bank in Fort Pierce Fla. provides clients with safe and wholesome food. During the COVID-19 pandemic, the food bank has distributed 3 million pounds of boxed fresh produce; 20,000 gallons of milk; 1,000 gallons of vegetable soup; and continues to provide meals to seniors, schools, food recovery and mobile pantries.
- The Idaho Falls Community Hospital‘s kitchen staff are recognized for being food safety heroes. Already dedicated to practicing food safety techniques, the kitchen staff began taking extra precautions to ensure meals for the doctors and nurses on the front lines were safe from additional pathogens during the COVID-19 pandemic. The kitchen staff have stepped up and worked as a team to deliver safe and quality food during a time of crisis!
- Lori Haroldsen recognizes Patience Allen of Idaho Falls Community Hospital. Six months after the Community Hospital opened, the COVID-19 pandemic hit. Patience has volunteered her time to come in early and stay late to ensure that the doctors, nurses, other staff, and patients have meals that are safe and healthy.
- Heather Whitehead recognizes Chris Martinez of St. Vincent de Paul Food Bank. Chris is the food bank manager. He dedicates many hours to keeping the pantry up and running, even continuing to work with an injury . During the pandemic, Chris has worked to line up volunteers to help two other area food banks stay open and serve people.
- Atalie Tompkins recognizes Ortus Café and Chef Edward Hammatt. Ortus Café, located in Abilene, was open just three months before the COVID-19 pandemic and the state of Kansas stay-at-home orders shut down all dine-in services in Dickinson County. The restaurant owners originally stayed open for curbside pickup, but as the pandemic progressed they made the difficult choice to close on March 2. The restaurant has been a model to the community for safety and encouraging people to stay at home and stay safe.
- Melissa Guillory recognizes Carol Neusetzer of the Louisiana Department of Health. Carol is a public health sanitarian consistently available to support inquiries, respond to concerns, provide education, and optimize food safety for citizens in Louisiana.
- Cheryl Bush recognizes Jenny Rhodes and Lee Bridgman of the University of Maryland Extension and Maryland Farm Bureau. Jenny, Lee and farm bureau members worked tirelessly to organize a safe and very successful bulk chicken sale on May 16, 2020. Queen Anne’s County Emergency Operations, Sheriff’s Office, Mountaire Farms staff and supportive volunteers rocked the sale!
- Brad Deacon of Michigan Department of Agriculture and Rural Development (MDARD) is recognized for working to ensure MDARD is prepared for any emergency. His vision and management has made MDARD a statewide resource for any response. He is a pioneer in ensuring Agriculture is represented and influences emergency responses.
- Suzanne Driessen recognizes Kathy Brandt of University of Minnesota Extension. During the COVID-19 pandemic, Kathy has coordinated our food safety team’s educational response, fielding hundreds of questions from Minnesota residences and correcting widely circulating misinformation.
- Cindy Brison recognizes the Nebraska Extension Food Safety Team of Nebraska Extension. The Nebraska Extension Food Safety Team has teamed up to increase consumer confidence in food safety during this COVID-19 outbreak. They have created timely social media posts, news articles and live videos. The team has encouraged consumers to stop using bleach and soap on their produce — a big concern to address.
- Carol Larvick recognizes Brenda Sale of the University of Nebraska in Dakota County. Several years ago, Brenda gathered community members to work on food insecurity. When the COVID-19 pandemic came, she moved them into overdrive by raising money and creating safe systems for distributing food to people in need.
- Sue Jackson of Sutton Community Home is recognized for coming to work every day with a smile on her face. She cooks meals with love and care. If someone wants something else to eat, Sue will whip it for them.
- Derrick Felder recognizes Nicolas Salas of Lutheran Social Services of Nevada. Nick provides food services to pantry shoppers each day during the COVID-19 pandemic shutdown. He is the first in the building and the last to leave for the day. Nick keeps the pantry organized and efficient for shoppers to have a joyful experience.
- Jenna Ricker recognizes Stiles Najac of Cornell Cooperative Extension Orange County. Stiles has been leading the Gleaning Program for more than a decade. She and her team have been able to quickly adapt to the impacts of the COVID-19 pandemic by safely making home deliveries to the individuals and agencies who rely most on this donated food.
- Gina Nicholson Kramer recognizes her son Reed. He works as a front line employee with Kroger. She said, “Reed is an essential employee who works so we can stay home.”
- Laura McClain of Wayne County Nursing Home is recognized for being a passionate advocate for proper handwashing before and during the COVID-19 pandemic. As a nurse at a county nursing home, she has been one of the only visitors her residents can see. Laura has made sure they are getting their food and care safely.
- Mark McClain of Gioninos is recognized for delivering pizzas to his community wearing a mask and following safe distancing throughout the COVID-19 pandemic. He especially takes great care, making sure that nursing homes’ pizza orders are received safely to keep those communities safe.
- Donna Timm recognizes Margaret Vattiat of Oregon Health Science University. Margaret trains all new hires in food safety practices. She works diligently to ensure that food prepared at the university is healthy and safe.
- Simone Cabaza, a mother, is recognized for washing her children’s hands and helping them be ready for a challenge.
- Ernie Julian of Rhode Island Department of Health is recognized for working in food safety for his entire career. Even though he could retire, Ernie continues leading food safety in Rhode Island with as much passion and effectiveness as the first day of his career. During the COVID-19 pandemic, he has spent late nights helping other jurisdictions with guidance.
- Stephanie Middleton recognizes Martha Robertson of Hardeman County School System. Martha is committed to making sure that the children of Hardeman County, TN receive healthy and nutritious meals on a consistent basis. She came out of retirement to accept the position of Nutrition Director for our school system.
- Kathy Means recognizes Christina Blick of Brighter Bites. Brighter Bites provides fresh produce to the under-served people in Texas, New York City, Washington D.C., and Southwest Florida (approximately 27 million pounds so far). With each delivery of fresh produce, they provide safe produce handling advice as well. Brighter Bites delivers healthy food and healthy handling information — skills that will serve them forever.
- Megan Levin recognizes Bill Schwartz of the Refrigerated Foods Association. Bill has diligently served on the RFA’s Technical Committee where he works to ensure food manufacturers understand all relevant food safety guidance, and that they are in compliance with regulations.
- Trudy Swain recognizes Mary Nagel of Washington State Office of Superintendent of Public Instruction. Mary is the supervisor for the Child & Adult Care Food Program in Washington State. In her instinctively fun and instructive way, she leads her team in providing food safety instruction and guidelines for adult and child care facilities throughout our state.
The Partnership for Food Safety Education delivers trusted, science-based behavioral health messaging and a network of resources that support consumers in their efforts to reduce risk of foodborne illness. They work with an active network of 13,000 health and food safety educators and support them by making their work more visible, collaborative, and effective.
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Up to 100 people could be affected by an ongoing Campylobacter outbreak on a Danish island.
The Danish Veterinary and Food Administration (Fødevarestyrelsen), DTU Food Institute and Statens Serum Institut (SSI) are investigating the outbreak that began in Bornholm in early June.
The alarm was first raised by Bornholms hospital and now there are reports of 100 people with symptoms similar to a Campylobacter infection with at least 10 of them needing hospital treatment.
So far, 54 people aged 9 months to 97 years old have tested positive for Campylobacter and other patient samples are being studied. Those sick live on Bornholm or visited the island recently.
While a specific source of the outbreak is still under investigation the cause is suspected to be a locally produced food, presumably a ready-to-eat product.
Campylobacter is the top cause of gastrointestinal infection in Denmark. In 2019, more than 5,300 cases were registered, which is the highest number ever recorded and up from 4,500 in 2018. Around a third of the cases were infected abroad.
Bornholms hospital received reports of fever, diarrhea, and general malaise after Pentecost, a Christian holiday and festival. More than 10 people were admitted to the hospital with symptoms and analysis showed they had Campylobacteriosis.
SSI is in the process of contacting patients and asking them what they ate and drank in the days before becoming ill. The agency is also doing interviews with a control group of healthy citizens and investigating if it is the same type of Campylobacter that has made people sick through the use of whole-genome sequencing.
The Danish Veterinary and Food Administration is visiting local producers on the island and taking samples of food for microbiological analysis to identify the source and stop the outbreak.
Nikolas Kühn Hove, from Fødevarestyrelsen, said several sources are being investigated.
“It is important that, as a consumer, you follow Fødevarestyrelsen’s general hygiene advice to wash fruit and vegetables, thoroughly cook chicken meat and keep raw meat separate from food, such as salad, bread, and cooked meat.”
Undercooked poultry is a common cause of infection with Campylobacter but other sources may include unpasteurized milk, contaminated fruits, and vegetables or drinking water, and contact with animals and pets.
People with Campylobacter infection usually have diarrhea, fever, and stomach cramps. They may also have nausea and vomiting. These symptoms usually start two to five days after the person ingests Campylobacter and lasts about one week.
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