But will it make fewer people barf? US FDA issues final food defense regulation

The U.S. Food and Drug Administration today finalized a new food safety rule under the FDA Food Safety Modernization Act (FSMA) that will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply. While such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply.

imagesUnder the new rule, both domestic and foreign food facilities, for the first time, are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to these areas receive appropriate training and maintain certain records.

“Today’s final rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply,” said Stephen Ostroff, M.D., incoming deputy commissioner for foods and veterinary medicine, FDA. “The rule will work in concert with other components of FSMA by preventing food safety problems before they occur.”

The rule was proposed in December 2013 and takes into consideration more than 200 comments submitted by the food industry, government regulatory partners, consumer advocates and others.

1900 sickened: DeCosters appeal jail time in Salmonella egg case

Austin “Jack” DeCoster and Peter DeCoster were sentenced April 13, 2015 to three months in prison for introducing adulterated food into interstate commerce after eggs from their Iowa farms were linked to a 2010 national salmonella outbreak which sickened at least 1,900 people.

decostersU.S. District Court Judge Mark Bennett required the father and son to complete a year of probation following prison and pay $100,000 each. The DeCosters’s former company, Quality Egg LLC, was fined nearly $6.8 million.

More than 1,900 people across the country reported getting sick from Salmonella enteritidis linked to tainted eggs supplied by Quality Egg. The companies recalled 550 million eggs nationwide.

Quality Egg pleaded guilty in June 2014 to bribing public officials and misbranding eggs to make them appear fresher.

The DeCosters’s sentences — especially the prison time — were viewed as a warning to other food producers.

Jack DeCoster, 82, of Turner, Maine, and Peter DeCoster, 52, of Clarion, are now trying to get out of their jail time. They filed an appeal April 27, 2015, asking the U.S. District Court of Appeals 8th Circuit to remove incarceration from their sentence.

“They’re arguing that, based upon the type of offense, any sentence of jail time is not appropriate,” Assistant U.S. Attorney Peter Deegan said last week.

Pro-business groups, including the Cato Institute and the National Association of Manufacturers, filed briefs in support of the DeCosters, arguing executives shouldn’t serve jail time for this type of crime.

“If executives can be imprisoned for criminal violations of strict liability laws by virtue of the position they hold within a company, the United States economy would suffer,” attorneys for Cato and the manufacturing association argued. “Executive business decisions would be motivated less by good business principles and more by fear of possible future prison sentences.”

The 8th Circuit heard oral arguments in the appeal March 17 in St. Paul, Minn., and the parties are now waiting for a decision.

All food can be contaminated: Huge recall of frozen fruits and vegetables after Listeria outbreak

The N.Y. Times has noticed the growing number of recalls linked to Listeria-positive frozen produce packed by CRF Frozen Foods in Pasco, Wash., but offers little perspective on why.

beaker.the.screamZero-tolerance is not discussed. Neither is the test-and-hold approach used by many frozen-produce packagers. And of particular note: During our tour of Ontario processing vegetable growers and processors 15 years ago, Chapman and I were told that almost all processing vegetables are blanched – not so much for food safety but for quality – except onions.

Back to the onions at the end.

Brittany Behm, a spokeswoman for the U.S. Centers for Disease Control and Prevention, told the Times the scale of the recall reflects the severity of the outbreak of the illness, Listeria, and of concerns about how the contaminated food might have “trickled down” into other products.

The processing plant, has voluntarily recalled more than 350 frozen foods — including carrots, onions, peaches and strawberries — that were sold in all 50 states and Canada and Mexico, and the EU. The recall began on April 23, with 11 frozen vegetables, but was significantly expanded on May 2.

Eight people sickened with the bacterium Listeria monocytogenes have been confirmed since 2013 — six in California and one each in Maryland and Washington, Ms. Behm said. All of the cases, involving patients 56 to 86 years old, resulted in hospitalizations.

The two people from Maryland and Washington died, but the authorities did not directly attribute their deaths to Listeria because they may have already had weakened immune systems or other illnesses, Ms. Behm said.

It was not clear how many packages were affected by the recall. A spokesman for the company, Gene Grabowski, did not respond to a phone call on Friday. He told The Associated Press that the CRF plant closed two weeks ago and that the company was trying to pinpoint the source of the contamination.

22xp-foodrecall_web2-master315“Unquestionably, this is a lot of product. … It reflects the severity of listeria as an illness, the long duration of illnesses and the outbreak and the long shelf life of the products,” said Matthew Wise, who leads the outbreak response team at the federal Centers for Disease Control and Prevention.

On May 14, 2016, Food Safety News reported that staff from the U.S. Food and Drug Administration inspected the CRF Frozen Foods LLC plant in Pasco, WA, from March 14-17.

The company stopped production at the plant April 25 after being notified by federal officials that frozen vegetables produced there had been linked by genetic testing to several people who had infections from Listeria monocytogenes.

The two-page FDA inspection report includes boilerplate citations of applicable sections of the federal Food, Drug and Cosmetic Act on its second page. The first page includes hand-written observations documenting:

a damaged plastic shovel used for food contact tasks;

chipping, cracking and missing pieces of plastic on food contact portions of equipment on the onion production line;

a plastic conveyor belt with missing plastic pieces on at least five legs that are in direct contact with onions;

utility knives used for trimming bad spots off onions that had initials etched on their blades; and

blue tape being used as a temporary repair on a cracked metal plate above a consumer pack line that was repacking product for export at the time of the inspection.

All of the examples cited by inspectors are cause of concern for the same reason — they mean it’s impossible to adequately clean the equipment that is in direct contact with food being produced.

“The materials and workmanship of equipment and utensils does not allow proper cleaning and maintenance,” according to the report.

“Investigations are ongoing to determine if food sources used to manufacture CRF Frozen Foods products could explain some of the illnesses,” FDA reported in its most recent update May 4.

One of those “food sources” could be onions from Oregon Potato Co., also located in Pasco, WA.

“March 2016 environmental samples collected by FDA from Oregon Potato Company, located in Pasco, WA, were found to be closely related genetically to seven of the isolates of ill people associated with this outbreak,” the FDA reported.

“Based on this information, Oregon Potato Company voluntarily recalled wholesale onion products, which led to subsequent downstream customer recalls, one of which publicly disclosed Oregon Potato Company as its product source.”

 

Stop kissing small turtles: 133 sick from four multistate outbreaks of human Salmonella

Since 2015, the U.S. Centers for Disease Control, multiple states, U.S Fish and Wildlife Service, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS), and the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine have investigated four separate multistate outbreaks of human Salmonella infections linked to contact with small turtles.

turtle.kissIn the four outbreaks, a total of 133 people infected with the outbreak strains of Salmonella were reported from 26 states between January 16, 2015 and April 8, 2016:

  • 38 ill people were hospitalized, and no deaths were reported;
  • 41% of ill people were children 5 years of age or younger; and,
  • epidemiologic and laboratory findings linked the four outbreaks of human Salmonella infections to contact with small turtles or their environments, such as water from a turtle habitat.

Since 1975, the FDA has banned the sale and distribution of turtles with a shell length of less than 4 inches in size as pets because they are often linked to Salmonella infections, especially in young children.

Small turtles should not be purchased as pets or given as gifts.

All turtles, regardless of size, can carry Salmonella bacteria even if they look healthy and clean. These outbreaks are a reminder to follow simple steps to enjoy pet reptiles and keep your family healthy.

It’s not simple or so many people wouldn’t get sick – so many little kids.

The outbreak is expected to continue at a low level for the next several months since consumers might be unaware of the risk of Salmonella infection from small turtles. If properly cared for, turtles have a long life expectancy.

Artificial sweetener, Xylitol, risk to dogs

According to the U.S. Food and Drug Administration, sugarless gum may contain xylitol, a class of sweetener known as sugar alcohol. Xylitol is present in many products and foods for human use, but can have devastating effects on your pet.

sadie.dog.powellOver the past several years, the Center for Veterinary Medicine at FDA has received several reports—many of which pertained to chewing gum—of dogs being poisoned by xylitol, according to Martine Hartogensis, a veterinarian at FDA.

But gum isn’t the only product containing xylitol. Slightly lower in calories than sugar, this sugar substitute is also often used to sweeten sugar-free candy, such as mints and chocolate bars. Other products that may contain xylitol include:

  • breath mints
  • baked goods
  • cough syrup
  • children’s and adult chewable vitamins
  • mouthwash
  • toothpaste

In both people and dogs, the level of blood sugar is controlled by the release of insulin from the pancreas. In people, xylitol does not stimulate the release of insulin from the pancreas. However, it’s different in canines: When dogs eat something containing xylitol, the xylitol is more quickly absorbed into the bloodstream, and may result in a potent release of insulin from the pancreas.

This rapid release of insulin may result in a rapid and profound decrease in the level of blood sugar (hypoglycemia), an effect that can occur within 10 to 60 minutes of eating the xylitol. Untreated, this hypoglycemia can quickly be life-threatening, Hartogensis says.

Symptoms of xylitol poisoning in dogs include vomiting, followed by symptoms associated with the sudden lowering of your dog’s blood sugar, such as decreased activity, weakness, staggering, incoordination, collapse and seizures.

If you think your dog has eaten xylitol, take him to your vet or an emergency animal hospital immediately, Hartogensis advises. Because hypoglycemia and other serious adverse effects may not occur in some cases for up to 12 to 24 hours, your dog may need to be monitored.

(A note to cat owners: The toxicity of xylitol for cats has not been documented. They appear to be spared, at least in part, by their disdain for sweets.)

Change the law, name the supplier: Salmonella in seed transfers to sprouts in Kansas and sickens 26

They’re probably still eating sprout-laden sandwiches at science-based faculty meetings at Kansas State University.

jimmy.john's.sproutsFollowing an initial announcement of eight people sick with Salmonella from sprouts in Kansas and Missouri – followed by surveillance silence – the U.S. Centers for Disease Control now reports that 26 people were infected with the outbreak strains of Salmonella Muenchen (25 people), or Salmonella Kentucky (1 person), as reported from 12 states. Eight people were hospitalized and no deaths were reported.

In February 2016, state and local health and regulatory officials in several states traced back the source of the sprouts from multiple restaurant locations where ill people ate them, and identified Sweetwater Farms of Inman, Kansas, as a supplier of alfalfa sprouts to all of these locations. The FDA collected and tested irrigation water and alfalfa sprout samples from Sweetwater Farms LLC and found Salmonella Kentucky and Salmonella Cubana. Salmonella Muenchen was not isolated.

On February 19, 2016, FDA and other federal, state, and local agencies briefed Sweetwater Farms LLC on their findings, and the firm voluntarily recalled alfalfa sprouts grown from a specific seed lot.

On February 26, 2016, Sweetwater Farms informed the FDA that it would recall all of its sprout products from the market.

After the recalls by Sweetwater Farms were completed, Salmonella Muenchen illnesses were still reported by people who reported eating alfalfa sprouts before they got sick. FDA traceback investigations indicated that several sprouters other than Sweetwater Farms produced the alfalfa sprouts these ill people ate. All of these sprouters, as well as Sweetwater Farms, used the same seed lot.

FDA tested samples of seeds from this lot and isolated Salmonella Cubana with the same DNA fingerprint of the Salmonella Cubana isolated in irrigation water from Sweetwater Farms. FDA contacted the seed supplier, who then called for the return of the contaminated seed lot from growers. The seed supplier is not named here because FDA is prohibited by law from releasing certain information about supply chains, which may constitute confidential commercial information. However, FDA has been able to confirm that all domestic sprouters who received contaminated seeds either returned or destroyed the seeds, and the shelf life of all sprouts grown from this seed lot has expired. Therefore, no sprouts from the contaminated seed lot are expected to be on the market.

sprout.santa.barf.xmasOn May 13, 2016, CDC reports that this outbreak appears to be over. FDA has provided the sprouters with information on reducing microbial food safety hazards for sprouted seeds and complying with new standards for growing, harvesting, packing, and holding of produce for human consumption under the Produce Safety Rule, which beings to go into effect for sprouters in January 2017 with additional time for small and very small operations. In particular, covered sprouters will now be required to comply with sprout-specific requirements such as treating seeds to reduce the presence of microorganisms of public health significance, testing the growing environment for Listeria as well as testing each production batch of spent sprout irrigation water or sprouts for E. coli O157:H7, Salmonella species and, under certain conditions, other pathogens. In addition, sprouters would be expected to comply with all other applicable requirements of the Produce Safety Rule, such as requirements related to worker health and hygiene, agricultural water and buildings, tools and equipment.

An updated table of raw sprout related outbreaks is available at: http://barfblog.com/wp-content/uploads/2016/04/Sprout-associated-outbreaks-4-27-16.xlsx

Listeria: Is zero tolerance consistent with risk-reduction

Tom Karst of The Packer writes it doesn’t seem quite right that many fresh produce processors aren’t testing for listeria on food contact surfaces in their facilities. Aren’t belts and other parts of a processing plant that touch product an important place to look for pathogens that might be present on food? 

listeria4Yet, that is the way it is, based on industry’s evaluation of Food and Drug Administration Guidance. Because any finding of listeria on food contact surfaces could result in an immediate recall situation, many in the industry believe the FDA’s zero-tolerance policy inhibits companies from testing food contact surfaces. 

The FDA is considering changing some of their guidance on listeria testing. Industry experts a new version of the guidance by late this year or early next year.  Perhaps the FDA will give more flexibility for companies to test for the listeria species – indicating the presence of the family of bacteria, but not necessarily the dangerous Listeria monocytogenes strain. Perhaps the FDA will establish a tolerance level for Listeria monocytogenes, though that doesn’t seem likely.

Karst got some standard answers from government spokesthingies, but got a more proactive answer from Martin Bucknavage, a Pennsylvania State University Department of Food Science food safety extension specialist, who said fresh produce and other food companies have to do a better job of understanding the presence of listeria within their operations and take stronger corrective actions. Most of the testing now being done for listeria is pre-operational and on nonfood contact areas, which he said has limited use.

“They have got to get more proactive and get rid of it,” he said. “I think it is time to batten down the hatches, get aggressive on sampling and put this thing to bed.”

Source poultry with lower loads of Salmonella: FDA NARMS retail meat report recites FightBac BS

The U.S. Food and Drug Administration has released a new interim report that measures antimicrobial resistance in Salmonella isolated from raw retail meat and poultry collected through the National Antimicrobial Resistance Monitoring System (NARMS).

AnimalHouse.satanThe 2014-2015 Retail Meat Interim Report contains data from January 2014 – June 2015. It focuses only on Salmonella, a major pathogen of concern in foodborne disease outbreaks. Information includes serotype distribution, prevalence by food source and state, selected resistance patterns, and a list of all the identified antimicrobial resistance genes. To provide data in a timelier manner, the FDA intends to issue retail meat interim reports twice per year. In this report FDA also includes, for the first time, whole-genome sequencing data for Salmonella as a new component of routine NARMS surveillance practices and has placed all the isolate-level data on its website.

NARMS was established in 1996 as a partnership between the FDA, the Centers for Disease Control and Prevention, and the U.S. Department of Agriculture to track antibiotic resistance in foodborne bacteria for drugs that are considered important in human medicine, including whether they are multidrug resistant (resistant to three or more classes of antibiotics). NARMS is critically important for monitoring trends in antimicrobial resistance among foodborne bacteria collected from humans, retail meats and food animals. In particular, it assists the FDA in making data-driven decisions on the approval of safe and effective antimicrobial drugs for animals.

The retail meat arm of the NARMS program collects samples of grocery store chicken, ground turkey, ground beef and pork chops, and tests for non-typhoidal Salmonella, Campylobacter, Escherichia coli and Enterococcus, to determine whether such bacteria are resistant to various antibiotics used in human and veterinary medicine. Enterococcus and most E. coli are not considered major foodborne pathogens but are included because they are helpful in understanding how resistance occurs and spreads.

Consumers can help protect themselves from foodborne bacteria, including antibiotic-resistant bacteria, by following four basic food safety tips: clean, separate, cook, chill. Learn more at http://www.foodsafety.gov/keep/basics/.

2014-2015 Retail Meat Interim Report

In many important categories, encouraging improvements found in 2011 continued to be evident in the latest data.

The prevalence of Salmonella in retail poultry is at its lowest level since testing began in 2002. In ground turkey, the prevalence of Salmonella has declined from a high of 19% in 2008 to 6% in 2014. In retail chicken over the same time period, it has dropped from 15% to 9%.

FunkyChickenHiSalmonella resistance to ceftriaxone (an important antibiotic used to treat seriously ill patients) from chicken sources continued to decline steadily from a high of 38% in retail chicken meats in 2009 to 18% in 2014, and 5% during the first half of 2015. In ground turkey isolates, ceftriaxone resistance was detected in 7% of 2014 isolates and 4% of 2015 isolates collected through June, which represents an 80% decline since 2011 when resistance peaked at 22%.

Fluoroquinolones like ciprofloxacin are classified as critically important for the treatment of Salmonella infections. Ciprofloxacin resistance was absent in Salmonella from poultry and beef, although a single isolate was found in pork.

All Salmonella from retail meats were susceptible to azithromycin, another important antibiotic recommended for the treatment of Salmonella and other intestinal pathogens.

Multidrug resistance in Salmonella continued to show a downward drift in chicken and turkey from 2011 levels of 45% and 50%, respectively, to 20% and 36% in June 2015.

Findings of Concern

FDA identified the first instance of ciprofloxacin resistance in an isolate from retail pork, and identified the genes associated with this resistance for future tracking (see below).

One ceftriaxone-resistant retail chicken isolate from 2014 had the extended-spectrum β-lactamase (ESBL) gene blaCTX-M-65. This is the first time this important class of resistance gene was detected in the U.S. This ESBL gene causes resistance to β-lactam antibiotics, including third generation cephalosporins, resulting in fewer treatment options for infected patients.

While only three isolates of Salmonella serotype Dublin were recovered from meats (ground beef) in 2014, they exhibited extensive resistance patterns as in the past, showing resistance to 9-12 of 14 drugs tested.

Whole Genome Sequencing

Whole genome sequencing (WGS) has ushered in a new age in infectious disease science, with the power to greatly enhance diagnosis, tracking and treatment. Because WGS has become an inexpensive and rapid tool for characterizing bacteria, it has the potential to replace a number of long-standing laboratory methods such as biochemical tests to identify species, and the subtyping methods of serotyping and pulsed-field gel electrophoresis, each of which requires specialized training and separate lab processes. Whole genome sequence data are published for all 271 retail meat isolates from 2014 and 114 Salmonella isolated in the first half of 2015. All of the WGS data for NARMS isolates are now publicly available in GenBank bioproject PRJNA290865.

WGS data can be used to predict antimicrobial resistance for a number of bacteria, including the foodborne pathogens Salmonella, Campylobacter, and E. coli. In addition, WGS data reveal the range of genes causing resistance to a particular antibiotic. FDA has included comprehensive genetic data for the first time in a NARMS report, listing the antimicrobial resistance genes and resistance-associated mutations for Salmonella. Some notable findings from WGS in this report include:

WGS helped identify antibiotic resistant genes in the form of diverse quinolone resistance mechanisms. In addition to two isolates with well-known DNA gyrase mutations associated with quinolone resistance, two isolates possessed the plasmid-mediated qnr genes, one with qnrS and one with qnrB. This analysis revealed that the single ciprofloxacin-resistant isolate from pork carried the qnrS gene. The presence of such plasmid-associated resistance genes is of particular concern due to the potential for transmissibility to other strains of Salmonella. This appears to be the first report of qnr genes present in retail meat Salmonella isolated in the United States. Despite these findings, Salmonella largely remained susceptible to ciprofloxacin and other first line human clinical therapies, including azithromycin, during 2014 and the first half of 2015.

As noted above, 2014 was the first year FDA found a blaCTX-M-65 ESBL in Salmonella from a retail meat sample in the United States. This was identified by WGS and was seen in a single isolate. Studies are ongoing to see if this finding points to a broader distribution of this important trait in Salmonella from other sources.

The WGS data has allowed FDA, for the first time, to understand the mechanisms underlying each of the resistance phenotypes observed, and how they differ by source. For instance, the predominant β-lactamases in ground turkey and pork chop isolates were blaTEM enzymes, whereas in retail chicken and ground beef isolates, blaCMY were more prevalent.blaCMY genes are generally associated with more extended activity, and confer resistance to third-generation cephalosporins, important drugs in the treatment of Salmonella infections. The tetA gene predominated among tetracycline resistant isolates from retail chicken, ground turkey, and ground beef isolates, while in pork chop isolates tetB was most common. Additional genetic information over multiple years will be necessary to determine whether these differences are stable over time and may be used to help determine the source of resistant infections in isolates recovered from humans.

All the isolate-level data, including links to the WGS data, can be found at 
http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/ucm458213.htm  

4 dead, 33 ill from Listeria in lettuce: Of course Dole knew

Beginning August 2, 1998, over 80 Americans fell ill, 15 were killed, and at least six women miscarried due to listerosis. On Dec. 19, 1998, the outbreak strain was found in an open package of hot dogs partially consumed by a victim. The manufacturer of the hot dogs, Sara Lee subsidiary Bil Mar Foods, Inc., quickly issued a recall of what would become 35 million pounds of hot dogs and other packaged meats produced at the company’s only plant in Michigan. By Christmas, testing of unopened packages of hot dogs from Bil Mar detected the same genetically unique L. monocytegenes bacteria, and production at the plant was halted.

four.monkeysA decade later, the deaths of two Toronto nursing home residents in the summer of 2008 were attributed to listeriosis infections. These illnesses eventually prompted an August 17, 2008 advisory to consumers by the Canadian Food Inspection Agency (CFIA) and Maple Leaf Foods, Inc. to avoid serving or consuming certain brands of deli meat as the products could be contaminated with L. monocytogenes. When genetic testing determined a match between contaminated meat products and listeriosis patients, all products manufactured at a Toronto Maple Leaf Foods plant were recalled and the facility closed. An investigation by the company determined that organic material trapped deep inside the plant’s meat slicing equipment harbored L. monocytogenes, despite routine sanitization that met specifications of the equipment manufacturer. In total, 57 cases of listeriosis as well as 22 deaths were definitively connected to the consumption of the plant’s contaminated deli meats.

As far back as 2013, Blue Bell ice cream was finding Listeria in places like floors, catwalks and cleaning tubs. Blue Bell had positive listeria findings from at least 11 swabs of plant surfaces between March 2013 and November 2014. Each time, it vigorously cleaned the area, and moved on without testing the equipment that touches the ice cream. At the same time, Blue Bell had problems with the layout of its plants, with condensation dripping all over the place. After federal officials linked an illness outbreak to Blue Bell in 2015, they tested the company’s food processing equipment and found LM. Three people died and 10 were sickened.

In all three Listeria outbreaks, the companies had data that showed an increase in Listeria-positive samples.

But rather than pay attention, they ignored the safety.

Those who study engineering failures –the BP oil well in the Gulf, the space shuttle Challenger, Bhopal – say the same thing: human behavior can mess things up.

listeria4In most cases, an attitude prevails that is, “things didn’t go bad yesterday, so the chances are, things won’t go bad today.”

And those in charge begin to ignore the safety systems.

Or hope the problem will just go away.

Kellogg’s was taking Salmonella-contaminated peanut paste based on paperwork in 2009? Pay attention, Nestle did.

In 2009, the operator of a yakiniku barbecue restaurant chain linked to four deaths and 70 illnesses from E. coli O111 in raw beef in Japan admitted it had not tested raw meat served at its outlets for bacteria, as required by the health ministry.

“We’d never had a positive result [from a bacteria test], not once. So we assumed our meat would always be bacteria-free.”

Chipotle Mexican Grill was aware of a norovirus outbreak among people who had eaten in one of its restaurants in Simi Valley, Calif., but did not tell public health officials there until after it had closed and cleaned the restaurant. More than 200 people were sickened.

So it’s no surprise that officials at Dole’s Springfield, Ohio plant, which bags lettuce and other supposedly healthy meals, knew about Listeria in its facility for 18 months before shutting down and issuing a recall.

Four people have died and 33 sickened in Canada and the U.S. from Listeria in the Dole products.

Kudos to Bill Marler and his Food Safety News, as well as Food Poisoning Bulletin, for filing the Freedom of Information request on U.S. Food and Drug Administration inspections at the Dole plant and putting together a preliminary picture of who knew what when.

Inspection reports (483) obtained by Food Safety News revealed the timeline of positive Listeria results and inaction. Dole Fresh Vegetables Inc. finally suspended production at its salad plant in Springfield, OH, on Jan. 21 this year after a random test by state officials showed a bagged salad contained Listeria monocytogenes.

Dole restarted production at the plant in Springfield, OH, on April 21. Company officials won’t say what was done to clean the plant or how they plan to prevent future contamination there.

powell_soli_AUG2Inspectors from FDA checked the production plant three times in January and twice in February after genetic fingerprinting showed the undeniable link between the sick people and salads from the facility. They collected swab samples, unfinished product samples, testing records and other documents and information.

According to the FDA’s inspection reports, in July 2014 Dole did swab tests of surfaces in the Springfield plant. The tests returned positive results for Listeria, but the facility kept producing salads, shipping them to dozens of states and at least five Canadian provinces.

At least five more times in 2014 and three times in late 2015 Dole’s internal tests showed Listeria contamination, but Dole kept the salad lines kept rolling until January this year.

The FDA inspection report states that Dole’s vice president for quality assurance and food safety, as well as the company’s quality assurance manager, were aware internal tests on Jan. 5 and 7 this year showed Listeria on equipment and other surfaces in the plant. But Dole continued to produce and ship salads.

The plant kept operating until Jan. 21. The following day Dole posted a recall notice with the FDA and the Canadian Food Inspection Agency (CFIA) for salads produced at the Springfield facility. Dole branded salads and house brands for Walmart, Kroger, Loblaws and Aldi were included in the recall.

Marler, a prominent food safety lawyer who represents one of the victims in a lawsuit against Dole told Stephanie Strom of the N.Y. Times, “If the government inspectors hadn’t showed up, who knows when or if they were going to tell anyone.”

“They’d been having positive tests for listeria for some time,” said William Goldfield, a spokesman for Dole. “We understand these recent news reports may raise questions among our consumers and customers. They should be assured, however, that we have worked in conjunction with the F.D.A. to address those observations and ensure that Dole products are safe.”

Lauren Sucher, a spokeswoman at the F.D.A., said that companies must notify the agency when they find a food has a “reasonable probability” of causing serious adverse health consequences.

But, Ms. Sucher said, not all strains of listeria cause disease. “When listeria is found in the manufacturing environment, rather than on the food itself, it is not uncommon for a company to immediately take corrective action rather than test further to see if the strain of listeria poses a threat,” she wrote in an email.

Food companies that find listeria during periodic testing are not required to run further tests to determine whether the pathogen is of a toxic variety.

In Dole’s case, it was swabbing various locations in its plant in Springfield, Ohio, not necessarily testing the finished products, according to the F.D.A. inspection. Rather, Canadian public health officials investigating an outbreak of listeriosis dating to summer 2015, tested bagged Dole salads and found four varieties that were contaminated.

Shit of the sea: Imported seafood shipments rejected by US FDA for ‘unsafe levels of filth and bacteria”

A new USDA analysis of the Food and Drug Administration’s import refusals report reveals that the FDA rejected tens of thousands of imported seafood shipments because they were unfit for human consumption.

shrimp.vietnamFrom 2005 to 2013, nearly 18,000 shipments were refused entry into the United States for containing unsafe levels of “filth,” veterinary drug residues and Salmonella, which is responsible for thousand hospitalizations per year and hundreds of deaths. “Filth” is a catchall term used to describe anything that shouldn’t be in food—like rat feces, parasites, illegal antibiotics and glass shards. 

The USDA summarized their findings by saying, “The safety of imported seafood clearly continues to be of significant concern, based on the number of shipments refused by FDA.”

Currently, the majority of all food refusals are seafood products; while the FDA is responsible for ensuring the safety of any food imported from foreign countries, they only have the manpower to inspect less than 1 percent of the 1.2 billion pounds of shrimp entering into the country each year.

The American Shrimp Processors Association (ASPA), a group representing the US Gulf and Southeast Atlantic Coast shrimp fishing industry, has expressed great concern over the findings. Dr. David Veal, the President of ASPA, was quoted as saying, “This issue goes beyond the FDA; I don’t think it’s unreasonable to expect food suppliers to take some responsibility for the health and safety of their products.” While there are a few more FDA inspectors now than a couple years ago, the ratio of shipments to inspectors is still impossibly high. Veal continued, “We hope shrimp exporters will take a more proactive role in assuring that suppliers adhere to laws designed to protect the people who buy their products.”