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FDA issues final draft guidance to help businesses find and eliminate tampering

February 14, 2020 - 12:02am

Acts of terrorism and other intentional tampering with food are the subjects of the third and final installment of industry regulatory guidance on how to deal with the intentional adulteration of the food supply.

With the release of the draft guidance, the Food and Drug Administration completed the agency’s mandate to develop regulations to prevent, react to, and investigate acts of intentional contamination of food as described in the Food Safety Modernization Act (FSMA) of 2011.

“Unlike the other FSMA rules that address specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration,” according to an update from the Center for Food Safety and Applied Nutrition (CFSAN). 

The final installment of draft guidance for the Intentional Adulteration (AI) includes chapters covering topics focusing on food defense corrective actions, food defense verification, reanalysis, and recordkeeping. It also discusses how companies can determine whether they are considered small or very small operations, which are exempt from many of the FSMA regulations.

Food “facilities” covered by the rule are required to develop and implement food defense plans that identify vulnerabilities and how to deal with them. The businesses are also required to document that the mitigation strategies are working. Inspections are set to begin in March this year. 

For additional information, please see:

Spanish officials suspend operations of cheese firm after inspection

February 14, 2020 - 12:01am

An inspection at a dairy company in Spain has found serious issues meaning items made there could pose a risk to the public, according to authorities.

Officials from the Ministry of Health in Galicia, a region of Spain, informed the Spanish Agency for Food Safety and Nutrition (AESAN) of a series of breaches they called serious that were detected during official controls at the company Lácteos Casa Macán S.L.

AESAN said the detected breaches mean the safety of products made there, which include butter and cheese, cannot be guaranteed.

The findings prompted authorities in Galicia to provisionally suspend activities at the firm, seize existing products at the company and order the withdrawal from distribution of all products sold.

All batches of the different Casa Macán products such as manteca cocida de vaca, queso D.O. Arzúa Ulloa, queso D.O. Tetilla, queso D.O. Arzúa Ulloa curado, queso barra Costeño and queso gallego en lonchas are affected by the alert.

Issues found included failures in the structural, hygienic and operational conditions of production processes, non-compliance in storage, and traceability deficiencies, according to the Organization of Consumers and Users (OCU) in Spain.

Authorities urged people who have the implicated products not to consume them and to return them to the point of purchase. No reports of illness associated with the alert have been confirmed in Spain.

Based on information available so far, the affected dairy products were distributed in Galicia, Catalonia and Castilla-La Mancha.

The information was sent by AESAN to all communities through the Coordinated System for the Rapid Exchange of Information (SCIRI), to continue the withdrawal of affected products from the market.

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DeLauro challenges USDA officials about JBS corruption in meat industry

February 13, 2020 - 12:05am

Before 2007, before Brazil’s JBS S.A. bought Swift & Co. for $1.5 billion in an all-cash deal, there was not any question about a U.S. meat company being caught up in a breath-taking South American bribery scandal.

But since that transaction made the newly consolidated JBS Swift Group into the largest beef processor in the world,  Brazil’s investigation of JBS, dating back to 2014, has raised a few eyebrows in the United States. The bribery scheme involved meat inspectors and other officials up to and including the president of Brazil.

Not until this week, did any U.S. elected official go public with their inquiry into the situation. U.S. Rep. Rosa DeLauro, D-CT,  had an exchange earlier this week before the  House Appropriations Subcommittee where she pressured the USDA Inspector General to investigate possible corruption involving JBS and again questioned why USDA is subsidizing the Brazilian concern.

Last November, DeLauro had called on USDA Secretary Sonny Perdue to direct the USDA IG to open a suspension and debarment investigation given the “well-documented”  history of JBS’s corrupt and illegal behavior. A copy of Secretary Perdue’s response letter declining to take up the matter can be found here.

A full video of her more recent exchange with the IG can be found here. Following is the  transcript:

DeLauro: Thanks so much Mr. Chairman and welcome to all.   Ms. Fong, it’s great to see you again. I am concerned about the continued and substantial payments to U.S. subsidiaries of the corrupt Brazilian-owned and controlled meatpacker, JBS.

Trade Package, JBS has received a little over $100 million dollars in payments – that money I might add was supposed to have been for struggling farmers, ranchers who have been hurt by the Administration’s failed trade policies.

Unlike farmers and ranchers, JBS also receives payments on an annual basis and that’s through a USDA’s Agricultural Marketing Service. In fact, U.S. taxpayer has subsidized JBS to the tune of tens of millions of dollars over the past several years.

It’s a problem because according to the Federal Acquisition Regulation and related USDA policies, government contractors must have, and I quote, “present responsibility.” I’m not going to go through the explanation of that, it’s too detailed, but you know it. And accordingly, ‘the present responsibility’ can be impacted by fraud, bribery, other violations of federal laws.

JBS is currently under investigation by the Department of Justice for potential violations of the Foreign Corrupt Practices Act. This is because the Batista Brothers, the leading shareholders, have admitted to criminal acts, numerous criminal acts, consisting of the bribery of thousands of Brazilian government officials to obtain illicit loans from Brazil’s National Bank. The ill-gotten loans were then used by JBS to illegally enter and consolidate the meatpacking industry in the United States. You talk to cattle producers, you find out what they think about JBS, you’re not going to get a favorable answer. 

November of last year, I wrote to Secretary Perdue urging him to open up a suspension and debarment investigation into JBS to determine whether the company meets the legal requirement of ‘present responsibility.’ Just very, very recently received a reply from the Secretary stating that he refuses to open such an investigation. And Mr. Chairman I would like to submit both my letter and his reply into the record.

So, no action. So, I make an assumption that the Secretary condones the use of taxpayer dollars in order to subsidize a corrupt, foreign-owned corporation engaged in illegal activity. So, Ms. Fong, I don’t know what kinds of conversations that you have had with the Secretary on this issue, the criminal allegations, do you take them seriously by this department? And I have two other questions, so I’d like a quick answer: How seriously are you taking these allegations?

Fong: We are aware of these allegations as reported by you and the media.

DeLauro: Right.

Fong: And we are doing what we believe to be appropriate at this time.

DeLauro: What are you doing?

Fong: I think it would be useful if our staff talked with your staff.

DeLauro: Happy to do it. Please do and we have been talking to your staff, over and over and over again. Let me just say, that the Secretary said USDA Suspension and Debarment Investigation into JBS would quote, “conflict with investigations by DOJ and SEC.” Is that the case?

Fong: I can’t comment on their position.

DeLauro: I am not asking you that, but is it a conflict?

Fong: I don’t know what the basis for his response is.

DeLauro: Fine. Because you by the Inspector General Act of 1978, amended in 2008, you have independent authority and responsibility to ensure that taxpayers dollars do not continue to flow to a company that is engaged in criminal behavior. Are you going to conduct an investigation?

Fong: We are also required by the IG Act to appropriately coordinate with the Department of Justice.

DeLauro: Are you with your independent authority going to conduct an investigation?

Fong: I can’t comment on that.

DeLauro: No comment. That means we don’t know. And whether or not your authority is being challenged in any way, it is. You are independent. That’s what makes the IG so critically important to all of us up here. I’ll make one final comment to you, because in your testimony you talk about workers’ safety and pride your selves on dealing with workers’ safety. JBS subsidiaries have engaged in the litany of practices leading to violations of labor, environmental, food safety laws, investigation by the Washington Post 2015-2018, JBS has the highest rate of serious worker injuries—those involving amputation, hospitalization, among all meat companies in the United States. And the second-highest rate of serious injuries among all companies in the United States. A subsidiary that’s getting over $100 million dollars, investigate. Use your authority. Thank you, Mr. Chairman.

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FDA testing finds pathogens in domestic, imported herbs and avocado products

February 13, 2020 - 12:04am

A quarterly report from the FDA shows contamination in some domestic and imported herbs and guacamole.

Such special testing programs by the FDA are ongoing for a variety of foods, including romaine lettuce.

No conclusions can be drawn at this time, according to the report from the Food and Drug Administration05. The document marks the end to the special testing program for processed avocado and guacamole products. A final report on the two-year study will be released at a future, unspecified time. 

Guacamole and avocado products
“The FDA initially planned to collect 1,600 processed avocado and guacamole samples — 800 domestic, and 800 of international origin — under this assignment. In July 2018, the FDA adjusted its collection target to 1,200 samples — 936 domestic, and 264 of international origin — after initial sampling confirmed that a relatively small number of firms produce and/or distribute processed avocado,” according to the report.

“In March 2019, the FDA further reduced its collection target to 1,056 samples — 824 domestic, and 232 of international origin — given the 35-day lapse in appropriations that began on December 22, 2018, and the associated impact on the workload of the agency’s field staff.

“The final collection total is 887 samples — 777 domestic, and 110 import.”

According to the Centers for Disease Control and Prevention, there were 12 outbreaks of foodborne illness related to avocado, avocado products or guacamole products from 2005 to 2015. Of those 12 outbreaks, nine involved Salmonella and three involved E. coli, resulting in 525 illnesses and 23 hospitalizations in all. Though no listeriosis outbreaks were reported in connection with avocados from 2005 to 2015, a recent sampling assignment by the FDA detected Listeria monocytogenes in samples collected from the fruit’s pulp and skin. The agency is seeking data on the prevalence of Salmonella and Listeria monocytogenes in processed avocado and processed avocado products.

As of the end of the testing period, Sept. 30, 2019, the FDA had found Salmonella in two domestic samples and none of the imported samples. For Listeria monocytogenes, 13 domestic samples were contaminated with the potentially deadly pathogen while two samples of imported product was contaminated.

Fresh herb testing
“From 1996 to 2015, the FDA reported nine outbreaks linked to basil, parsley and cilantro, which resulted in 2,699 illnesses and 84 hospitalizations,” according to the FDA quarterly report. “Four of the outbreaks were linked to basil, three to cilantro, and two to parsley. Of those same nine outbreaks, seven were attributed to Cyclospora cayetanensis; one was attributed to E. coli O157:H7; and one was attributed to Shigella sonnei. The FDA is seeking to obtain baseline estimates of the prevalence of Salmonella and Shiga toxin-producing E. coli (STEC) in cilantro, basil and parsley.”

For the fresh herbs, the FDA plans to collect 1,600 samples, 761 domestic and 839 of international origin. As of Sept. 30, 2019, the agency had collected and tested 746 domestic samples and 468 import samples. 

Of the samples, 13 tested positive for Salmonella, four domestic and nine imported. Nine tested positive for Shiga-toxin producing E. coli, four domestic and five imported. 

“Further study showed that the STEC were incapable of causing severe illness. The FDA did not detect E. coli O157:H7 in any of the fresh herb samples,” according to the report.

“The FDA also began testing its fresh herb samples for Cyclospora cayetanensis in July 2018, given that Cyclospora-related illnesses typically occur during the summer. The agency detected Cyclospora in 16 of the 666 fresh herbs samples tested, 4 domestic and 12 imported.” 

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Record low for Campylobacter presence in Swedish poultry

February 13, 2020 - 12:03am

The level of Campylobacter in Swedish poultry for meat production is at an all-time low, according to the Swedish Poultry Meat Association.

The group claims the presence of Campylobacter in poultry meat in 2019 declined from the year before with a calculated average from sampling of 4.6 percent of positive flocks.

Pia Gustavsson, a veterinarian at the Swedish Poultry Meat Association (Svensk Fagel), said it calculates an average of Campylobacter presence in Swedish poultry for meat production every year.

“The figures for 2019 showed a record low, and the yearly average ended up at only 4.6 percent – halving last year’s figures. This is a huge difference compared to the rest of Europe where there is a large spread in prevalence, and figures of 50 to 80 percent are not uncommon.

“Hygiene in the kitchen plays a vital role to reduce the risk of presence of Campylobacter when handling food. Washing hands, using separate cutting boards for chicken and vegetables as well as heating to at least 70 degrees C (158 degrees F) are simple and great guidelines to follow.”

Campylobacter monitoring program
In 2018, from 4,331 groups bred by members of the Swedish Poultry Meat Association sampled at slaughter, Campylobacter was detected in 8.7 percent of the flocks.

During 2018, 63 samples were also analyzed from chicken bred and slaughtered in slaughterhouses that are not members of the Swedish Bird Protection Infection Program or Animal Care Program. Campylobacter was detected in 24 (38.1 percent) of these flocks.

The Swedish Poultry Meat Association has been trying to reduce the

Flocks positive for Campylobacter by year

presence of Campylobacter in poultry flocks. The ambition of industry is to reach the same low levels as for Salmonella.

More than 30 years ago, the association, Swedish Board of Agriculture, Swedish National Food Agency (Livsmedelsverket), Swedish Veterinary Institute (SVA) and Swedish Institute of Infectious Diseases (now Folkhalsomyndigheten) started a monitoring program to reduce prevalence of Campylobacter in Swedish poultry.

Within this program, research and studies are conducted at farm level including sampling to further reduce the number of positive poultry flocks. The advice developed as part of this work mainly focuses on preventive hygiene practices. The number of positive flocks has declined from about 60 percent in 1989 to 4.6 percent in 2019.

Progress has not always been straightforward. An estimated 5,000 more Campylobacter cases than normal were reported in the country between August 2016 and May 2017. Some of these infections were linked to chilled chicken produced by Kronfågel.

The number of flocks carrying Campylobacter varies by season. Prevalence is highest during late summer and autumn.

“We find it gratifying that the industry’s work, mainly the preventive hygiene efforts within the poultry production, has yielded such good results and that the positive trend will continue,” said Karin Åhl, from the Swedish Board of Agriculture.

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Salmonella and Campylobacter levels stable in Scotland

February 13, 2020 - 12:01am

The number of Salmonella and Campylobacter infections remained stable this past year according to data from Health Protection Scotland.

During 2019, there were 756 isolates of human non-typhoidal Salmonella reported to Health Protection Scotland (HPS). This was in line with the 751 reports in 2018 but a decrease on the 840 cases in 2017.

Surveillance of Salmonella relies on reports from the Scottish Salmonella, Shigella and Clostridium difficile Reference Laboratory (SSSCDRL) who receive isolates from all diagnostic microbiology labs in Scotland. These are reported to HPS via Electronic Communication of Surveillance in Scotland (ECOSS).

Top serotypes
Most isolates were reported during the summer months. There was another peak later in October which coincides with the mid-term school break.

Salmonella reports in Scotland

The most common serotypes were Salmonella Enteritidis and Salmonella Typhimurium which accounted for 58 percent of all Salmonella isolates in 2019. Salmonella Enteritidis remains the most common with 297 (40 percent of) reports. This was a rise on the 275 in 2018.

Salmonella Typhimurium decreased slightly in 2019, with 135 (18 percent of) reported illnesses compared to 139 in 2018 and 183 in 2017. Salmonella Newport and Salmonella Infantis were the third and fourth most common serotypes with 26 and 23 cases respectively. Forty-three serotypes were recorded only once.

Rates of infection vary across the population with higher ones in children less than 5 years of age compared with older children. Overall rates were slightly higher in females than males.

Almost half of cases, for whom information was available, were believed to have acquired infection abroad.

Campylobacter rates in Scotland

In 2019, there were four outbreaks of Salmonella reported to ObSurv, the surveillance system for all general outbreaks of infectious intestinal disease in Scotland. This compares with six in 2018. All incidents were part of wider United Kingdom outbreaks.

Campylobacter data
During 2019, 5,975 lab reports of Campylobacter were received by HPS. This was a decrease compared with 6,096 reports in 2018 but and an increase on the 5,795 in 2017.

As seen in previous years, most lab reports were recorded in the spring and summer months with a peak in May and June.

The rate of infection was not uniform across the population. Amongst children and young adults, rates were higher in children less than 5 years of age and amongst adults, rates were highest in those aged 50 years and older.

Overall rates were higher in males but the reasons for that are not well understood, according to the report.

Most cases of Campylobacter infection are apparently sporadic. In 2019, no general outbreaks were reported to ObSurv. The last general outbreak reported was in 2014. Since the system was established in 1996 there have been 35 general outbreaks.

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Walmart, Aldi, others fail recall litmus test; Kroger, Target earn higher marks

February 12, 2020 - 3:00am

Independent researchers say 22 out of the country’s top 26 grocery chains fail when it comes to warning the public about food recalls. Among those on the fail list are Walmart and Aldi.

Consumers have to struggle to stay updated on food recalls with the lack of effort on the part of retailers proving to be a big reason the public is in the dark, according to a report released today by officials with the U.S. PIRG (Public Interest Research Group) Education Fund. The epic fail on the part of the grocery industry is particularly unacceptable because of all of the technology and data processing in place.

“Supermarkets should be our best recall notification system, but instead, we found that shoppers must go on a nearly impossible scavenger hunt to learn if they’ve purchased contaminated food,” according to a statement from Adam Garber of the said U.S. PIRG Education Fund. 

“Stores already use modern technology to track customers, place products, and target us with ads. There’s no reason why they can’t also keep us healthy.”

The non-profit, non-partisan research organization assessed supermarkets on publicly available information about whether they tell customers about recall policies, in-store notification, and direct customer notification. Findings in the 29-page report include:

  • 22 out of 26 stores failed to adequately inform the public about recall notification efforts, how to sign up for direct notifications, or where to find in-store postings. Only Harris Teeter, Kroger, Smith’s and Target received a passing grade.
  • 58 percent of stores reported some program to directly notify consumers about recalls through email or phone. Of those 15 stores, only eight made it clear how customers could participate, how the system works, or what information is included in warnings.
  • Not a single store provided information online about whether recall notices are posted at  customer service desks, checkout counters, or store shelves.

The researchers say they know there might be programs in place that are not described in the public arena, but they also say retailers would not respond to requests for information about food safety recall measures.

“. . . most declined to answer the survey — and the few that did only responded to a handful of questions,” according to the PIRG report. That lack of transparency was surprising given the potentially dangerous impacts on customers of stores that consider themselves integral parts of so many American communities.”

The report cites a Salmonella outbreak traced to beef that sickened people for months and involved a 12-million pound recall. A similar if not identical scenario has played out repeatedly, according to the PIRG researchers, even though public health agencies issue warnings that are publicized by media outlets. 

Grocery retailers are in a unique position — at the final point in the supply chain before the customer takes possession of food — and therefore have the opportunity to have a powerful impact on public health.

“They might not be responsible for the recall, but they can make a difference. We look forward to seeing improved transparency about recall notification efforts and improved programs,” according to a statement from the PIRG Education Fund’s Dylan Robb.

U.S. PIRG (Public Interest Research Group) Education Fund is an independent, non-partisan group that works for consumers and the public interest. Through research, public education and outreach, we serve as counterweights to the influence of powerful interests that threaten our health, safety, and wellbeing.

What if an ‘unripe’ civil trespass statute goes to a bench trial in Arkansas?

February 12, 2020 - 12:05am

Back in the day, the Humane Society of the United States (HSUS) warned states to avoid passing what the some people called “ag-gag” laws. HSUS said “ag-gag” laws involved three elements:

  1.  a ban on taking photos or video of a factory farm without permission,
  2.  making it a crime for an investigator to get work (by falsifying a job application) at a factory farm, and
  3.  requiring quick mandatory reporting without time to document the pattern of abuse.

As HSUS and allies like the Animal Legal Defense Fund (ALDF) waged legal warfare against states that opted to erect barriers to protect animal agriculture, the battles evolved. ALDF sued states, knocking down large segments of ag-gag laws as unconstitutional.

Some states responded with new twists. One of those was to take the protection animal agriculture wants outside of criminal statutes entirely. Arkansas made it a new civil cause of action.  A bench trial, starting as early as Nov. 9, 2020, will determine if this new civil approach works in federal court.

But the State of Arkansas is not named in the lawsuit. Instead, Jonathan and DeAnn Vaught, owners of Prayer Creek Farm and Peco Foods Inc., are the only ones being sued by the activists. The plaintiffs are four national groups led by the ALDF that the defense says are “dedicated to advancing their vision of how farms and meat processing plants should be operated.”

The four animal groups sued Tuscaloosa, AL-based Peco Foods Inc., after requesting access to its Pocahontas, AR, processing plant, and demanding the company waive its legal rights under the new Arkansas law.

When the deadline they imposed passed without Peco submitting, the animal groups last June 25 sued in federal district court for the Eastern District of Arkansas. Assigned to the case is Judge James “Jay” Maxwell Moody Jr.

“This lawsuit is not the result of any actual dispute between any of the plaintiffs and defendant Peco Foods Inc, resulting from anything Peco has done to any of the plaintiffs but because of what they think Peco might do,” Peco attorneys said in demanding the dismissal of the federal lawsuit.

“Plaintiffs seek an advisory opinion that if plaintiffs undertake certain action targeted at Peco, and if they succeed, and if Peco is damaged as a result, and if Peco elects to sue one or more plaintiffs according to the cause of action provided by (the Trespass Statute), then the First and Fourteenth Amendments will have been violated,” their motion to dismiss continues.

“However, a bunch of ‘ifs’ does not create a valid case or controversy that Article III would permit this court to resolve,” it adds.

But so far, the lawsuit has not been dismissed. Instead, the court is working with both sides on discovery deadlines,

The Vaught-owned Prayer Creek Farm was named as a defendant because Rep. DeAnn Vaugh was the lead sponsor of the civil Arkansas ag-gag law.  Much of the rhetoric in the complaint is directed at alleged evils of production agriculture.

“When corporations trap massive numbers of animals in factory farms and process them through high-speed, dangerous slaughterhouses, all to enrich themselves and their shareholders, they cause irreparable harm to workers, rural communities, the environment, and the animals. However, the industry has been able to propagate by hiding its production methods,” the plaintiffs’ complaint says.

” Employment-based undercover investigations of industrial, agricultural facilities, which provide the public information about this secretive industry, have proven some of-the only means to demonstrate the truth about how it functions and reform its practices.”

The plaintiffs further claim specific and definite plans to investigate Prayer Creek Farm and Peco Foods, lnc.’s Arkansas facilities so they can “use that information to challenge the animal cruelty, harm to workers, and environmental catastrophes these operations are causing in the state.”

Prayer Creek Farm and Peco attorneys says the lawsuit “is contrived and cannot survive a motion to dismiss.”

“Plaintiffs claims against Peco fail . . . because they lack any statutory basis for their causes of action and in any event, cannot sue a private party for the alleged constitutional violations,” defense attorneys say.  They say the claims should be dismissed because they are “unripe.”

The plaintiffs’ lawsuit “does not arise from anything that has actually happened,”  Peco attorneys say.

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Norway tests dried fruits, berries, nuts after outbreak; packaging also eyed

February 12, 2020 - 12:03am

Sampling of dried fruits, berries and nuts in Norway after a Salmonella outbreak linked to the products has shown no positive results in follow testing.

Although some finished products were positive, analyses of single ingredients were negative so the exact source remains unclear. Contamination along the packaging line is a possibility, according to Norwegian authorities.

In 2019, there was an outbreak of Salmonella Agbeni infections and one person with Salmonella Gamaba. A total of 58 cases were detected with disease onset between Dec. 31, 2018, and March 16, 2019. There were 21 people hospitalized but no deaths were recorded. People of all ages were part of the outbreak and lived across the country.

One lot number of dried exotic fruits of the brand “Dryss på – husk! eksotisk miks,” was identified as a vehicle for Salmonella. The ready to eat fruit mix contained dried pineapple and papaya from Thailand, sultanas from Turkey, sliced coconut from Ghana and banana chips from the Philippines.

It was packed in Italy by Eurocompany srl. The product was sent to the Norwegian importer and distributor Bama Gruppen AS in Oslo. Packs with the same content were also sent to Romania.

Some of the same ingredients were used in 331 lots of 66 other types of products distributed to Norway, Italy, Austria, France, Romania and San Marino beginning in March 2018.

Italian authorities investigated the company. Sliced coconut from Ghana was still stored at the factory and five samples were negative for Salmonella. A total of 17 samples analyzed by Eurocompany were all negative. Samples from the raw material supplier of papaya, pineapple and banana chips were also negative.

Salmonella was found in eight opened and two intact packs of this exotic fruit mix. Strains detected were Salmonella Agbeni and/or Salmonella Gamaba. One patient who had eaten this brand of dried exotic fruit mix, had a dual infection with Salmonella Wagenia and Salmonella Agbeni. The Norwegian Food Safety Authority (Mattilsynet) said these findings suggest the mix could have been contaminated with all three serotypes.

It was the first time Salmonella Gamaba had been reported in a sick person in Norway. From 2010 to 2018 only five cases of Salmonella Agbeni were recorded in the country.

Follow-up sampling findings
The Norwegian Food Safety Authority started sampling of dried fruits, berries and nuts in the Salmonella surveillance program for 2019 as a post-outbreak control measure. All 165 samples were negative for the pathogen.

Samples were taken during and after the outbreak from grocery stores, specialty shops, importers, manufacturers and wholesalers throughout the country.

The dried fruits, berries and nut mixes contained dried berries such as goji berries, mulberries, cranberries and blueberries. Also included were dried fruits like papaya, pineapple, mango, guava, melon, dates and coconut and nuts including pecans, pistachios, macadamia nuts, walnuts, hazelnuts, cashews and almonds.

Officials said the number of tests was too low to say anything about the state of the entire Norwegian market but results gave a picture of the situation. This year, the Norwegian Food Safety Authority will also take samples of ready-to-eat dried products such as nuts, dried fruits and berries to get more data on the product category.

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Smoothie kits recalled after company finds Listeria during product testing

February 11, 2020 - 4:06pm

Blendtopia Products LLC is recalling 29,078 cases of frozen Blendtopia brand “Superfood Smoothie Kits” because of potential contamination with Listeria monocytogenes.

“The company discovered the issue through its quality control processes. The issue is believed to be isolated to a supplied ingredient,” according to the recall notice posted on the website of the Food and Drug Administration

Blendtopia Products reported the smoothies were distributed to retail stores in Michigan.

To determine whether they have any of the recalled products they should look for the following labeling information on 7-ounce packages. Blendtopia brand, Superfood Smoothie Kits,  labeled Best By July 2021, Best By Oct. 2021, and Best By Nov. 2021. Flavors implicated in the recall are:

  • “Glow” Superfood Smoothie Kit
  • “Detox” Superfood Smoothie Kit
  • “Energy” Superfood Smoothie Kit 
  • “Immunity” Superfood Smoothie Kit
  • “Strength” Superfood Smoothie Kit

The company says it hasn’t received any reports of illness associated with the recalled products.

Consumers who purchased the recalled products are urged to return them to their place of purchase or discard them immediately. For any questions, consumers may contact Blendtopia Products LLC at 844-260-8181. 

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

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

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

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

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His new elite appellate team says Stewart Parnell did not get a fair trial

February 11, 2020 - 12:05am

His calendar at the medium-security federal prison at Hazelton, WV, might well have March 9 circled. His move there last year puts 65-year old Steward Parnell just 200 miles away from his family in Lexington, VA, much closer than he was when held in South Carolina.

Marks on his calendar are not likely there to remind Parnell about family, but what is shaping up quietly in federal court in Georgia. Parnell has been in federal prison for five years because of what happened in Georgia 12 years ago.

Parnell, then the top executive for his family’s Peanut Corporation of America, was at the center of a multistate Salmonella outbreak, sickening an estimated 20,000 people in 46 states. Linked to the outbreak were nine deaths and 166 hospitalizations.

Peanut butter and paste were the sources of the outbreak, and the contaminated came from PCA’s plant in Blakely, GA.

After a four-year federal investigation, five former PCA executives, including Parnell, were indicted on federal criminal charges. Two pleaded guilty in exchange for consideration at sentencing, and a 2014 jury trial convicted the other three.

The stiffest sentence went to Parnell, 28 years. The U.S. Court of Appeals for the Eleventh Circuit in Atlanta took up the convictions and sentence on review.

Case closed?

Amy Levin Weil and Amy Lee Copeland, two elite Georgia appellate lawyers, are attorneys for Stewart Parnell. The two Amys share some background as former assistant U.S. Attorneys who also managed appeals involving the government in their districts.

Since fall 2019 they’ve been pursuing a new legal strategy on behalf of their client. If successful, it could result in a court vacating Parnell’s conviction and setting aside his sentence.

The Parnell attorneys filed a motion for an evidentiary hearing based on two claims. Their motion and supporting brief claim:

1. counsel rendered constitutionally ineffective assistance when it failed to seek a change of venue due to adverse and extensive pretrial publicity and widespread pretrial publicity, jurors preconceived notions and the amount of media exposure that the case received throughout the entire division of this court; and

2. counsel rendered ineffective assistance in failing to move to strike for cause jurors with knowledge of the allegations that a salmonella outbreak caused deaths, resulting in the failure to secure a fail and impartial jury.

The case claims he was denied his constitutional right to a fair and impartial jury. The two Amys say structural errors like the right to an impartial adjudicator are not subject to “harmless error review.”

Filed under a “Section 2255,” the attorneys say the district court must “grant a prompt hearing” to allow them to “flesh out” the extent of the adverse pretrial publicity and juror bias.

While PCA’s role in the deadly Salmonella outbreak received extensive national media coverage, the Parnell attorneys are focusing their concern on local media.

“Mr. Parnell’s claims are not patently frivolous, based on unsupported generalizations or affirmatively contradicted by the record,” his attorney brief says.

“First, Mr. Parnell’s brief sets forth portions of the media coverage during that time, the size of Blakely, Georgia (the location of the Peanut Corporation of America plant), and the dependency of the entire region on agribusiness generally and peanuts specifically.

But there are other facts from the record in this case that demonstrate the pervasiveness of the media coverage it occasioned.

During the selection process 47 of 77, or 60 percent, of the prospective jurors acknowledged hearing news or talking about the case. Hostility at PCA during jury selection was not usual. Parnell’s trial attorney has provided an affidavit with details about a juror excused for cause after saying he wanted to “exact my pound of flesh” and then waiting for Parnell in a parking garage.

The U.S. Department of Justice’s Consumer Protection Branch and the U.S. Attorney for the Middle District of Georgia oppose Parnell’s motion to “vacate, set aside, or correct” the sentence.

Parnell was responsible, they say, for a “chronic salmonella problem.” More than 70 lots of peanut products tested positive for salmonella GX 786 between February 2003 and January 2009. The peanut paste and peanut butter PCA was producing was not fit for human consumption, according to the Food and Drug Administration.

The “broader criminal scheme” involved withholding all those positive results from PCA’s customers.

“Worse still, PCA also knowingly shipped products that tested positive for salmonella or were outside microbiological specifications by repeatedly retesting peanut products until they received a negative result,” the government brief says. The fraud, it says, was perpetrated on PCA’s customers.

The government is again relying upon Parnell’s emails to his staff to make the case against him. In Aug 2007, he wrote, “these lab tests and COA’s are f___ing breaking me/us.”

“His desire to save money by knowingly shipping contaminated products led to his conviction.” prosecutors said.

March 9 is the deadline for all briefs and their responses.  Any word on a hearing will come after that.

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Scientists find cause for concern about hepatitis E in slaughterhouse pigs

February 11, 2020 - 12:03am

Contaminated blood from slaughterhouse pigs infected with hepatitis E could be reaching the human food supply chain, according to researchers.

“. . . 40 percent of U.S. slaughterhouse pigs (sampled) were seropositive for HEV (hepatitis E virus), indicating prior HEV infection of the pigs on the farms, which was consistent with prior estimates for farmed U.S. pigs,” according to a report just published by a team of scientists led by Harini Sooryanarain of Department of Biomedical Sciences and Pathobiology at Virginia Polytechnic Institute and State University.

The scientists went into the project knowing that in industrialized countries there are two of eight swine HEV zoonotic genotypes presenting an emerging foodborne illness threat to humans. The virus can be transmitted by consumption of raw or undercooked pork according to the research team and information from the federal Centers for Disease Control and Prevention.

It can take up to 60 days after exposure to the virus for symptoms to develop. Infected people can remain contagious for several weeks. The CDC reports that there is no vaccine for hepatitis E approved for use in the United States.

Researchers started with almost 23,000 samples from pigs from 25 slaughterhouses in 10 states. They used 5,033 samples randomly selected and representing all 25 slaughterhouses and all 10 states. The 23,000 samples were collected in 2017-2019 for a different study and archived for future analysis. The blood samples were collected on the kill floor at the slaughterhouses, and serum was separated and stored frozen at the U.S. Department of Agriculture’s Agricultural Research Service, Beltsville Agricultural Research Center.

“We previously showed that HEV-3 is present in U.S. swine herds and that a small proportion of commercial pork products, such as liver and chitterlings, from U.S. grocery stores contain infectious HEV,” according to the scientists’ report published in the February edition of Emerging Infectious Diseases

“However, the current HEV infection status of U.S. market-weight pigs at the time of slaughter, the entry point to the food supply chain, remains unknown.”

Although 40 percent of the samples were seropositive, only 6 percent of the pigs had detectable HEV viremia. That is still enough for concern, according t the research team. With that many slaughterhouse pigs viremic there is concern about pork safety because blood containing infectious HEV during slaughter may contaminate raw pork products.

The scientists reported that studies have shown almost 6 percent of the U.K.’s and 44.4 percent of Scotland’s slaughterhouse market-weight pigs were viremic. A growing number of reported cases of human infection have been attributed to consumption of raw or undercooked pork.

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NVWA changes poultry Salmonella control after EU pressure

February 11, 2020 - 12:01am

Dutch authorities have changed the method of controlling Salmonella in certain poultry farms after pressure from the European Commission.

Carola Schouten, minister for Agriculture, Nature and Food Quality, told the lower house of parliament (Tweede Kamer) about the move from the Dutch Food and Consumer Product Safety Authority (NVWA) in a letter in late January.

The EU threatened to stop co-financing the Dutch Salmonella program as the European Commission considered the standard retest process in the Netherlands to be contrary to regulations.

The change means animals from poultry breeding farms are immediately removed and slaughtered if the first control samples are contaminated with Salmonella. Meat from infected animals may be used as long as it is industrially heat treated.

Samples are taken by the farmer as part of the National Salmonella Control Plan that all countries are obliged to implement based on European regulations.

Until now, the NVWA has done a retest as confirmation in such cases. This retest will now only be done in exceptional cases when there is reasonable doubt about accuracy of the first test result.

Impact of change
The expected European co-financing for the Dutch Salmonella control program in 2020 is €2.4 million ($2.6 million) of which €400,000 ($437,000) is for the control of infected breeding companies.

Carola Schouten said it was a shame that European legislation leaves no room for the Dutch method.

“The Netherlands has repeatedly and extensively explained to the Commission that our approach guarantees food safety and at the same time tries to prevent wrongly identified contaminated flocks being unnecessarily prematurely slaughtered.”

Dutch authorities predicted control costs, including compensation for the poultry farmer, will increase on average by just under €700,000 ($765,000) per year but this figure will vary as the number of infections is also different every year.

In 2019, which was considered to be an average year, eight companies with 16 barns were found to be infected with Salmonella. Of these, seven were found to be negative after retesting by NVWA.

The Ministry for Agriculture, Nature and Food Quality (LNV) has asked Wageningen University and Research to see whether a different approach can offer comparable guarantees for food safety and reduce the chance that animals have to be removed prematurely.

The Netherlands Agricultural and Horticultural Association (LTO) said it was shocked such a measure had been implemented without consulting the sector.

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Corinthian Foods recalls fish nuggets mislabeled as chicken nuggets

February 10, 2020 - 6:45pm

Corinthian Foods is recalling “Uncooked Sweet Potato Crusted Alaska Pollack Nuggets” because the bags contain chicken nuggets instead of fish nuggets.

The products were distributed to retail stores in  Michigan.

The company recall says, “The problem was discovered when cases were opened to put out for retail sale, and the label on the retail package did not match the label and description of the master case. Subsequent investigation indicates the problem was caused during the packaging process. The incorrect labels were applied to the product causing the product to be mislabeled.”

Recalled Product:

  •  5-pound retail bags of Uncooked Sweet Potato Crusted Alaska Pollack Nuggets 1 oz. with date code CF35319. The product is packaged in clear 5-pound bags with a white label with black writing.

The company says that they have received no reports of illness associated with the recalled product.

Consumers who purchased products listed are urged to return them to their place of purchase. For any questions, consumers may contact Corinthian Trading, Inc./DBA Corinthian Foods at 912-634-0240.

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Widow describes husband’s fight with Clostridium perfringens infection

February 10, 2020 - 12:05am

Munro Sefcik was a healthy and strong 50 year old when he went to lunch with a friend at a Subway in Charlotte, NC, Monday, March 9, 2015. Wednesday night he was in intensive care and by Thursday morning March 12, he had died.

Belva and Munro are engaged in the Summer of 1990.

When doctors told his wife Belva that Munro had died because of massive intravascular hemolysis and a liver abscess caused by a Clostridium perfringens infection, she couldn’t understand how it had happened. She couldn’t understand how he had gotten infected by Clostridium perfringens. Doctors explained that because of his diabetes Munro was the perfect host for the bacteria. They said the infection was from something he ate and they explained that the bacteria multiplied so quickly Munro did not have a chance.

“I think people who are diabetic or have an autoimmune disease or survived cancer should be able to eat in downtown Charlotte without fear of dying,” she told the doctors.

How Belva and Munro met

Munro and Belva’s Wedding in Charlotte, NC, Oct. 6, 1990.

Belva met Munro 30 years ago at a church Christmas party. Munro introduced himself and told Belva that he thought he knew her. “I found out he’d only been in Charlotte no time, so I thought, oh, he’s shooting me a lie, here, at a church Christmas party.”

Despite Belva’s reservations, the two exchanged names and numbers. Munro would end up dating someone else until March, but after that relationship ended Belva and Munro began talking on the phone.

“He would call me every night. And talk for 30 or 40 minutes. But he never asked me out.”

Finally, Munro did ask her out. He asked her to join him at a Fourth of July picnic party. Belva described Munro on the date, “He was shy and a hunk. An absolute hunk.”

The two won a Fourth of July costume contest at the picnic.

 From there Belva recalls things moving quickly. She said she knew by September that if things kept progressing, they would get married.

“He wanted to marry me and I told him that if he wanted to marry me now, he’d want to marry me in a few months and we could wait. And I told him, not to pray that we got married, pray for God’s will. And I didn’t trust him. So I told God, I said, if he’s over there praying for us to get married, don’t listen to him.”

Belva wanted a sign that she was supposed to marry Munro. Whether it was finding the perfect wedding dress by accident or being able to book the best wedding photographer in Charlotte, Belva got multiple signs. “There were so many things, it was uncanny. I just knew that it was what I was supposed to do.” Munro and Belva were married Oct. 6, 1990. 

Family life

Belva and Munro take their grandson to see Thomas the tank engine, 2010.

When marrying Belva, Munro became a stepdad to her two teenage daughters.

“They loved Munro as their own father. He loved them like they were his.”

Belva says that Munro was the role model her daughters needed. “They got to see what a good man was like.” “He was a great father. He was very loving to them and if they called, he would want me to put them on speakerphone so he could hear every word.”

Munro always supported Belva’s passions including her love for oil painting. He urged her to pursue art.  Belva explained that their relationship wasn’t always perfect.

“Don’t get me wrong, there were times when he would have paid someone to take me and vice versa, but it was a wonderful marriage. He always seemed to love me more. And all my girlfriends loved him because he was cute as a button. And was obviously in love with me, and that’s attractive to a woman, to see a man in love with his wife the way he was with me. He adored me. He loved me with all of his heart, and I loved him the same.”

Munro’s death

On Monday, March 9, 2015, at the age of 50, Munro went to Subway with a friend where he ordered and ate a meatball sandwich. He began feeling ill that night. Munro and Belva attended a midweek church service and friends told Munro that he wasn’t looking well. The next two days Munro felt ill — abdominal cramps, nausea and vomiting. Belva was gone all day Wednesday. When she returned home, she found Munro laying on the bed. He called his doctor to ask what kind of medication to get from the pharmacy because he felt so ill. 

Belva offered to accompany him to the store but he told her to stay and socialize with his sister and her husband. “The thing that kills me is I didn’t even hug and kiss him.”

Munro threw up at the pharmacy and came home in even worse condition.

“We were going to eat and he didn’t feel like eating, so we were eating and he’s lying on the couch and feeling worse.” Belva told him that he would be able to attend his Bible study in the morning. He told her that he knew he would and began to yell out in pain.

Belva took Munro to the emergency room. But as they exited the car, Munro laid on the parking lot ground. Belva ran and found a police officer. The office instructed medical attendants to get a gurney and followed Belva out to Munro. 

They rushed Munro into the emergency room and started tests. Belva remembers hearing them say, “That can’t be right,” as they rushed about. He was quickly transferred to the intensive care unit. Belva recalls a team of at least 17 devoted to her husband that night — surgeons, internists and nurses.

“I had no idea what was going on, and I told him to hang on. I told him to fight. And then a flash was maybe this is it? And I just pushed that right out of my mind. Because that’s ridiculous. I begged him to hang in there.”

Belva called Munro’s doctor and good friend and told him, “Munro is in the ER and he’s very sick.” He told Belva that he was trying to have some time off, but he listened to Belva and told her, it’s probably gallbladder. Belva said she would tell Munro. “I went in there and I said, Bobby just said it’s probably your gallbladder.” But he didn’t get better and early in the morning he had to be revived.

“I talked to him about holding hands. We would hold hands and watch TV and movies and eat popcorn. And I was begging him to stay, for that.” At 9 in the morning, Munro passed again, and this time was not revived, just 12 hours after entering the hospital.

Munro’s primary doctor and friend called crying. “He had gotten up and checked things, about an hour before Munro died. So he knew when he called that Munro probably wouldn’t live.”

When a stunned Belva asked the doctors what had happened, she was told they needed to perform an autopsy.

Clostridium Perfringens — How doctors traced it back to the meat sub

Belva and Munro pose with family and Santa, December 2014.

 The causes of death were noted to be the liver abscess caused by Clostridium perfringens infection, complicated by patchy pulmonary edema, cardiomegaly, bilateral pleural effusions, and diffuse cutaneous erythema.

The incubation period for Clostridium perfringens infections is 6 to 24 hours.

Such manifestations of C. perfringens infection are rare but well-documented in the medical literature. Munro’s C. perfringens infection was most likely the result of the consumption of the Subway meatball sub sandwich.

C. perfringens is the third most common cause of foodborne disease in the United States. It is estimated to cause almost 1 million illnesses per year. Munro’s illness began with gastrointestinal symptoms, which makes a food item the most likely source of the C. perfringens.

The time it takes C. perfringens from ingested until the first illness symptoms begin C. perfringens ranges from 6 to 24 hours. The time from when Munro consumed the meatball sub sandwich to when he first became ill fit within that time frame.

The types of food that most commonly serve as sources for C. perfringens infections for people are meat and poultry, and food items that are made from or incorporate meat and poultry.

“They told me what the germ was. Then they told me that it has a biological, it has a timestamp. And it doubles every seven minutes. So that’s exponential growth.”

Belva was told Munro, as a type 1 diabetic never stood a chance. 

“They said that he was the perfect host because he is diabetic. And they said people that are diabetic, or have an autoimmune disease, or have survived cancer are perfect hosts. And I said I think people who are diabetic or have an autoimmune disease or survive cancer should be able to eat in downtown charlotte without fear of dying.”

Aftermath

Munro and Belva on a cruise in the Spring of 2001.

“I pretended that he wasn’t dead. That he was at home or at work. I could not accept the fact. It was too devastating. I couldn’t take in the fact that he was really gone. It took me a long time before I could say or really admit that he was gone.”

Munro’s funeral was attended by the greatest number of people in the church’s history — a building that seats 720, had standing room only. Belva recounted a conversation with her and Munro’s young grandson at the service. 

“I said to my little grandson, ‘Your grandfather was very, very handsome. Do you think all these people came because he was handsome?’ 

“And he said, ‘No.’ 

“I said, ‘Like your grandfather, you’re very handsome. Like your grandfather, you’re very intelligent. Do you think they came here because he was intelligent?’

“He said, ‘No.’

“I said, ‘Like your grandfather, you have a wonderful heart. So do you think they came because of his heart?’

“And he said, ‘Yes.’

“And I said, ‘Yes, so go out and make a mark with your heart.’”

Munro will be remembered forever by his wife, daughters and grandkids, as well as those in the Charlotte community.

“I’ll love him forever,” Belva said. “He was a wonderful man. People saw the love he gave me.” 

After his death, art helped Belva get through difficult times. Belva’s work can be seen here.

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13 sick from Salmonella in France linked to eating raw milk cheese

February 10, 2020 - 12:03am

Salmonella has affected 13 people in France with a link to consuming a brand of raw milk cheese.

They have been infected with the same strain of Salmonella Dublin, according to the National Reference Center for Salmonella at the Institut Pasteur.

Santé publique France and the General Directorate of Food (DGAL) have identified a link between eating raw milk Morbier cheese made by the company Jean Perrin, based in the Cléron commune of Doubs in the Bourgogne-Franche-Comté region and those sick. Investigations with the producer are underway to identify the cause of contamination and take corrective actions.

SA Perrin has withdrawn from sale and recalled several lots and dates of Morbier cheese.

Products are sold in the traditional and self-service departments of supermarkets throughout France and can be identified by the approval number FR 25-155-001 CE on the cheese or packaging.

Authorities advised people that have the potentially affected products not to consume them and to take them back to the place of purchase.

Nine hospitalized and three deaths
Eight men and five women with a median age of 72 have fallen ill from late November 2019 up to early January this year. Cases are spread across seven regions of France and nine people needed hospital treatment.

Three people have died but it is not clear what role salmonellosis played in the deaths, according to Santé publique France.

Most cases reported having eaten raw milk Morbier cheese bought in different stores before their symptoms began. Analysis by DGAL of cheese purchases from loyalty cards of the cases made it possible to identify that the Morbier came from the same supplier.

French authorities are also investigating a foodborne outbreak suspected to be caused by Salmonella Enteritidis in organic eggs from Italy.

Around the same time the alert was posted on the Rapid Alert System for Food and Feed (RASFF), Olivero Claudio recalled organic eggs in Italy due to potential Salmonella Enteritidis contamination.

Santé publique France, Olivero Claudio and the Italian Ministry of Health have as yet not responded to questions about the outbreak from Food Safety News.

Symptoms of Salmonella infection can include diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating contaminated food. Healthy adults are usually sick for four to seven days. Older adults, children, pregnant women, and people with weakened immune systems, such as cancer patients, are more likely to develop a severe illness and serious, sometimes life-threatening conditions.

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Import alert changes involve undeclared allergens, illegal colors, seafood

February 10, 2020 - 12:01am

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.

Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Click on the links to view the full alerts.

Import Alert

Desc Text

URL

IA-16-04

DWPE Misbranded Seafood – Species Substitution -Rev 3/24/95

https://www.accessdata.fda.gov/
cms_ia/importalert_13.html

IA-16-120

Detention Without Physical Examination of Fish/Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP

https://www.accessdata.fda.gov/
cms_ia/importalert_25.html

IA-16-81

Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella

https://www.accessdata.fda.gov
/cms_ia/importalert_49.html

IA-45-02

Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors

https://www.accessdata.fda.gov/
cms_ia/importalert_118.html

IA-52-08

Detention Without Physical Examination of Ceramicware Due to Excessive Lead and/or Cadmium

https://www.accessdata.fda.gov/
cms_ia/importalert_122.html

IA-66-40

Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs

https://www.accessdata.fda.gov/
cms_ia/importalert_189.html

IA-66-41

Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.

http://www.accessdata.fda.gov/
cms_ia/importalert_190.html

IA-66-66

APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122

https://www.accessdata.fda.gov/
cms_ia/importalert_202.html

IA-68-19

DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED NEW ANIMAL DRUGS

https://www.accessdata.fda.gov/
cms_ia/importalert_1147.html

IA-89-08

Detention Without Physical Examination of Devices Without Approved PMAs or IDEs and Other Devices Not Substantially Equivalent or Without a 510(k)

https://www.accessdata.fda.gov/
cms_ia/importalert_244.html

IA-99-05

Detention Without Physical Examination of Raw Agricultural Products for Pesticides

http://www.accessdata.fda.gov/
cms_ia/importalert_258.html

IA-99-08

Detention Without Physical Examination Of Processed Human and Animal Foods for Pesticides

https://www.accessdata.fda.gov/
cms_ia/importalert_259.html

IA-99-19

Detention Without Physical Examination Of Food Products Due To The Presence Of Salmonella

https://www.accessdata.fda.gov/
cms_ia/importalert_263.html

IA-99-22

Detention Without Physical Examination Of Foods Containing Undeclared Major Food Allergens Or Foods That Fail To Properly Label Major Food Allergens

https://www.accessdata.fda.gov/
cms_ia/importalert_561.html

IA-99-30

Detention Without Physical Examination of All Milk Products, Milk Derived Ingredients and Finished Food Products Containing Milk from China Due to the Presence of Melamine and/or Melamine Analogs

https://www.accessdata.fda.gov/
cms_ia/importalert_401.html

IA-99-32

DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS FROM FIRMS REFUSING FDA FOREIGN ESTABLISHMENT INSPECTION

https://www.accessdata.fda.gov/
cms_ia/importalert_521.html

IA-99-39

DETENTION WITHOUT PHYSICAL EXAMINATION OF IMPORTED FOOD PRODUCTS THAT APPEAR TO BE MISBRANDED

https://www.accessdata.fda.gov/
cms_ia/importalert_1144.html

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Ill-fated quality control officer for Peanut Corp of America freed from federal custody

February 9, 2020 - 12:05am

Mary Wilkerson, quality control officer for the defunct Peanut Corporation of America, is free atter serving a 5-year federal prison sentence for obstruction of justice.

Wilkerson, 46 of Edison, GA., was released from a re-entry center, or half-way house, in Atlanta earlier this week. Her full release date was moved up by one month to Feb 2 by the U.S. Probation Office in Albany, GA. The mother of two has been separated from her husband and family for the past five years.

She was found guilty in 2014 by an Albany, GA, jury of one count of obstruction of justice while being acquited on another. The trial judge imposed the 5-year sentence in 2015.

Wilkerson was indicted and tried with the company CEO and his brother, Stewart and Michael Parnell. Stewart Parnell was the chief executive of PCA, while Michael Parnell was its peanut broker. In 2008-09, PCA’s Albany plant was linked to peanut butter and peanut paste that federal prosecutors charged was sold knowingly contaminated with Salmonella because the Parnells ignored testing results.

A four-year investigation by the FBI led to February 2013 indictments of Wilkerson, the Parnell brothers, and two other former PCA managers.

Wilkerson’s offense was a “process crime” over misleading federal agents during the investigation. The government acknowledged she was not part of the conspiracy that led to the Salmonella poisonings that sickened thousands and killed nine. She was not responsible for making restitution to any of the victims.

And the victims were numerous, from the Salmonella outbreak illnesses and deaths to an estimated $1 billion in property damages suffered by other companies that were unwittingly being supplied with PCA contaminated products.
Almost 4,000 companies recalled more than 3,900 products. It was the most massive food ingredient recall in U.S. history.

Wilkerson is the first PCA defendant who went to trial to finish with federal prison. She served most of her time at the federal lock-up in Tallahassee, FL. During her last few months in federal custody, she transfered to Residential Re-entry Management (RRM), which manages half-way houses for about 8,000 inmates as they near their release dates.

Her supervised federal probation will continue for two years.

Samuel Lightsey, who managed the PCA plant in Blakely, GA, at the time of the deadly outbreak, was the government’s star witness at trial and served less than three years.

Another former PCA plant manager, Daniel Kilgore, also made a deal with the government for his testimony for a six-year sentence. He’s next up for release, now set for Jan 30, 2021. He is at a minimum-security federal prison in Oakdale, LA.

Doing the most time for the PCA-related convictions, however, are the Parnell brothers. The Albany, GA, federal jury found Stewart guilty on 67 federal felony counts and Michael guilty on 30. The second generation of his family to run PCA, which spanned three southern states, Stewart was sentenced to 28 years in prison, and his brother to 20.

Felony charges of introducing adulterated food into interstate commerce “with the intent to defraud or mislead” were among the most serious of the convictions.

Federal minimum security prisons hold the Parnell brothers. Stewart, 65, is at the Hazelton Federal Correctional Institute in West Virginia and Michael 61, is at Fort Dix, NJ.

Wilkerson began serving her sentence about one year after being found guilty of one count of obstruction of justice while being acquitted on another in the same jury trial that brothers Stewart and Michael Parnell were found guilty on multiple federal felony counts.

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FSANZ wants comments on planned produce rules

February 9, 2020 - 12:03am

Authorities in Australia are calling for comments on a plan to develop a primary production and processing standard for high-risk horticulture.

Food Standards Australia New Zealand (FSANZ)’s proposal will consider the development of a primary production and processing (PPP) standard for high-risk horticulture as part of a broader review of Chapter 3 and 4 of the Food Standards Code.

The agency will assess if sprouts and ready-to-eat minimally processed fruits and vegetables, which are covered by existing standards in the code, need more consideration as part of review work. Whether a food is determined to be high risk depends on its nature, whether pathogens can grow in it, and how the food is produced and consumed.

FSANZ has developed PPP standards for the seafood, dairy, egg, meat, poultry and seed sprouts sectors.

Two part process
Mark Booth, FSANZ chief executive officer, said it is looking at primary production and processing activities in leafy vegetables, melons, and berries as there are no consistent, national regulatory food safety requirements applied to these sectors.

“The vast majority of horticultural produce in Australia is safe and healthy, however outbreaks linked to particular produce sectors continue to occur. At the request of ministers responsible for food regulation, FSANZ is reassessing the need to amend the Australia New Zealand Food Standards Code to enact a primary production and processing standard to manage food safety for high-risk horticulture.”

Booth said the move is the first of two public rounds of consultation.

“This initial round of consultation is seeking information from stakeholders to help us better understand these high-risk sectors and whether a regulatory approach is required – including what that regulation might look like. We are also establishing a standard development advisory group consisting of representatives from industry peak bodies and government regulators to assist with and advise on the current work.”

The period for comment closes on March 18, 2020. There will be another opportunity to comment in a consultation expected in late 2020.

Need to address the issue
In June 2018, the Australia and New Zealand Ministerial Forum on Food Regulation noted an increase of foodborne illness outbreaks in Australia and agreed there was a need to reassess the food safety risk management of five high risk horticulture sectors: ready to eat, minimally processed fruits and vegetables, fresh leafy green vegetables, melons, berries, and sprouts.

Feedback on an information paper on reviewing the code published in May 2019 showed general support for FSANZ to consider high-risk horticulture and to develop a standard and traceability provisions.

An assessment of foodborne illness backed the assumption that fresh leafy vegetables and herbs, rockmelons (cantaloupes), fresh and semi-dried tomatoes and raspberries were commonly associated with illness. Key contributing risk factors involved in produce contamination included use of pre- and post-harvest water, environmental factors and poor hygienic practices.

An FSANZ preliminary assessment of Australian and international outbreaks between 2011 and 2019 indicated deaths and serious illnesses associated with high-risk horticultural produce continue to occur.

In this period, several foodborne outbreaks in Australia were associated with fresh horticultural produce involving more than 400 cases and nine deaths. Two rockmelon outbreaks in 2016 and 2018 were responsible for 166 illnesses and eight deaths. The 2018 outbreak of Listeria associated with rockmelons resulted in 22 illnesses, eight deaths, temporarily closed an export market and impacted the domestic market with losses to growers estimated to be around AU$15 million (U.S.$10 million).

FSANZ examined food safety management in the horticulture sector in 2011 but decided in 2014 not to change the rules. This was partly based on an estimated 70 to 80 percent of the Australian horticultural produce being grown under a food safety scheme. Investigations into some recent outbreaks show businesses had these system in place but they were not effective in avoiding an outbreak.

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Nearly 200 ill in UK after eating oysters

February 8, 2020 - 12:05am

Almost 200 people have fallen ill after eating oysters in the United Kingdom in recent months.

Since November 2019 there have been at least 180 reported cases of gastroenteritis associated with oyster consumption linked to multiple food outlets and oyster producers.

A Public Health England spokeswoman told Food Safety News that norovirus had been identified as the cause of a number of these outbreaks.

“Public Health England is working with the Food Standards Agency and Food Standards Scotland, and affected local authorities, to investigate outbreaks of gastrointestinal illness reported since November 2019 associated with consumption of oysters.”

Officials say there is no connection to the norovirus outbreaks from oysters in Europe. In Sweden, 70 people fell sick after eating oysters, some of which came from domestic production and others from France.

In Denmark, 180 people were ill after eating oysters from France. In France, 1,033 people have been sickened and 21 needed hospital treatment. Italy and Netherlands also reported outbreaks linked to live oysters from France. Products were also recalled due to potential norovirus contamination in Belgium, Luxembourg, Switzerland, Hong Kong and Singapore.

Various oyster sites implicated
A spokeswoman for the Food Standards Agency told Food Safety News that it has identified that the outbreaks appear to be linked to consumption of oysters from several different harvesters.

“We have identified from our investigations that there are numerous sites around the U.K. where oysters are produced and harvested. We have identified producers in East and South West of England and in Scotland that have supplied oysters that were eaten by a number of people reporting illness.”

Two harvesters in the South and West of England voluntarily ceased production in mid-November and a harvester in the East of England decided to stop harvesting in early January this year.

When asked why there haven’t been any product recalls when illnesses have been reported from November, the spokeswoman said: “Oysters have a short shelf-life and by the time cases of illness are reported, the affected oysters have normally been consumed.

“The official advice to consumers remains the same as usual: people should be aware of the risks of eating raw oysters. Elderly people, pregnant women, very young children and people who have a weakened immune system should avoid eating raw or lightly cooked shellfish to reduce their risk of getting food poisoning. To prevent passing norovirus on to family and friends, it’s vital to follow good personal hygiene practices.”

The main symptoms of norovirus illness are diarrhea, vomiting, nausea and stomach cramps. Symptoms can also include low-grade fever, headache, chills, muscle aches and fatigue. People who are ill should drink plenty of liquids to replace lost body fluids and prevent dehydration.

Symptoms 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.

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