Screen Shot 2017-06-28 at 5.11.16 PMBeing in New Zealand, some 17 hours and a day ahead of the U.S. Midwest, should have given me a slight advantage of knowing what was happening in the U.S., but I missed a call from AP’s David Pitt for a comment on a court ruling that is making food executives take notice.

As David wrote, the U.S. Supreme Court declined in May to hear the appeals of Austin “Jack” DeCoster and his son, Peter DeCoster, without comment. Both have been sentenced by U.S. District Judge Mark Bennett to serve three months in prison. The sentences jarred the food and drug manufacturing industry because it’s rare that corporate officials are held personally responsible for an outbreak of foodborne illness.

Bennett in his 68-page sentencing opinion filed in April 2015 concluded that prison time was necessary to deter officials from marketing unsafe food.

“Given the defendants’ careless oversight and repeated violations of safety standards, there is an increased likelihood that these offenses, or offenses like these, could happen again,” he wrote. “The punishment will also serve to effectively deter against the marketing of unsafe foods and widespread harm to public health by similarly situated corporate officials and other executives in the industry.”

Last week Bennett ordered 53-year-old Peter DeCoster to report to the Federal Prison Camp in Yankton, South Dakota, a minimum security facility that is about 200 miles west of his home in Clarion, Iowa. DeCoster must surrender himself to authorities after July 30 when he is notified by the U.S. Bureau of Prisons the facility is ready to receive him.

His 83-year-old father Austin “Jack” DeCoster must serve his three-month term 30 days after Peter is released. He must report to the Federal Correctional Institution in Berlin, New Hampshire, a location Bennett approved at DeCoster’s request. DeCoster, who says he has several medical issues including prostate cancer, has moved from Iowa to Maine and the medium-security prison camp is about 70 miles from his home.

The DeCosters, who have already paid $100,000 each in criminal penalties, also owe $83,000 in restitution, according to court documents. Quality Egg paid a $6.8 million fine after pleading guilty to felony charges of shipping eggs with false processing and expiration dates and bribing a U.S. Department of Agriculture inspector to approve sales of poor-quality eggs.

PrisonI can hear a bit of silence in the board rooms of America.

Monday the U.S. Supreme Court declined to hear the appeals of Austin “Jack” DeCoster and his son, Peter DeCoster, without comment.  In April 2015 U.S. District Judge Mark Bennett sentenced the DeCosters to prison, saying they knew or should have known about the risks posed by the presence of Salmonella in and around millions of egg-laying hens. However, he allowed the DeCosters to stay free while they appealed the sentences, which they argued were unconstitutional and unreasonably harsh. The 8th Circuit Court of Appeals upheld the sentences last July and stayed any action until the U.S. Supreme Court appeal was resolved.

Now the DeCosters will now both face three month jail sentences stemming from a Salmonella outbreak caused by their Iowa egg farms in 2010.

The Salmonella outbreak ran from May 1 to Nov. 30, 2010, and prompted the recall of more than a half-billion shell eggs, the largest recall of its kind in history. And, while there were 1,939 confirmed infections, statistical models used to account for Salmonella illnesses in the U.S. suggest that the eggs may have sickened more than 62,000 people.

The family business, known as Quality Egg LLC, had already pleaded guilty to the federal felony count of bribing a USDA egg inspector and to two misdemeanors associated with the outbreak. It agreed that the LLC will pay a $6.8-million fine and the DeCosters would be fined $100,000 each, for a total of $7 million.

I am not sure if the Supreme Court read Bill Neuman’s New York Times article from September 2010 entitled, “An Iowa Egg Farmer and a History of Salmonella.” However, he should. Here are some of the highlights/lowlights:

  • DeCoster’s frequent run-ins with regulators over labor, environmental and immigrationviolations have been well cataloged. But the close connections between DeCoster’s egg empire and the spread of Salmonella in the United States have received far less scrutiny.
  • Farms tied to DeCoster were a primary source of Salmonella enteritidisin the U.S. in the 1980s, when some of the first major outbreaks of human illness from the bacteria in eggs occurred, according to health officials and public records. At one point, New York and Maryland regulators believed DeCoster eggs were such a threat that they banned sales of the eggs in their states. “When we were in the thick of it, the name that came up again and again was DeCoster Egg Farms,” said Paul A. Blake, who was head of the Enteric Diseases Division at the Centers for Disease Control and Prevention in the 1980s, when investigators began to tackle the emerging problem of Salmonella and eggs.
  • Records released by Congressional investigatorslast week suggest that tougher oversight of Mr. DeCoster’s Iowa operations might have prevented the outbreak, which federal officials say is the largest of its type in the nation’s history, with more than 1,600 reported illnesses and probably tens of thousands more that have gone unreported.
  • According to the records, Mr. DeCoster’s farms in Iowa conducted tests from 2008 to 2010 that repeatedly showed strong indicators of possible toxic salmonella contamination in his barns. Such environmental contamination does not always spread to the eggs, and it is unclear what actions Mr. DeCoster took in response. However, when the Food and Drug Administrationinspected the farms after the recalls, officials found unsanitary conditions and the presence of Salmonella enteritidis in barns and feed.
  • The first enteritidis outbreak recognized by public health officials came in July 1982, when about three dozen people fell ill and one person died at the Edgewood Manor nursing home in Portsmouth, N.H. Investigators concluded that runny scrambled eggs served at a Saturday breakfast were to blame. They traced the eggs to what the Centers for Disease Control reports referred to as a large producer in Maine; interviews with investigators confirmed that it was Mr. DeCoster’s former operation.  Eggs from the same farms were also suspected in a simultaneous outbreak that sickened some 400 people in Massachusetts.
  • In 1987, the deadly outbreak at Coler Memorial Hospital on Roosevelt Island occurred. Investigators determined that mayonnaise made from raw eggs had caused the outbreak. They traced the eggs to Mr. DeCoster’s Maryland farms. On a July night in 1987, scores of elderly and chronically ill patients at Bird S. Coler Memorial Hospital in New York City began to fall violently sick with food poisoningfrom eggs tainted with salmonella.  “It was like a war zone,” said Dr. Philippe Tassy, the doctor on call as the sickness started to rage through the hospital. By the time the outbreak ended more than two weeks later, nine people had died and about 500 people had become sick. It remains the deadliest outbreak in this country attributed to eggs infected with the bacteria known as Salmonella enteritidis.
  • After two more outbreaks were linked to DeCoster eggs the following year, New York banned Mr. DeCoster from selling eggs in the state. He was forced to agree to a rigorous program of salmonella testing on his farms in Maine and Maryland.  Michael Opitz, a poultry expert retired from the University of Maine, said that the testing found that a Maine breeder flock owned by Mr. DeCoster was infected, meaning that hens there could be passing the bacteria to their chicks, which might grow up to lay tainted eggs. Widespread contamination was also found in laying barns.
  • In 1991, tests revealed more salmonella contamination at one of Mr. DeCoster’s farms in Maryland. The state quarantined the eggs, allowing them to be sold only to a plant where they could be pasteurized to kill bacteria. Mr. DeCoster challenged the order and a federal judge ruled that Maryland could not block him from shipping eggs to other states. He was still barred from selling the eggs in Maryland, and in 1992, a state judge found that he had violated the quarantine by selling eggs to a local store; Mr. DeCoster was given a suspended sentence of probation and a token fine.
  • Soon after interstate shipments resumed in 1992, eggs from the Maryland farm caused a salmonella outbreak in Connecticut, according to a 1992 memo from the Maryland attorney general’s office. Federal regulators insisted that Mr. DeCoster decontaminate his barns.  Dr. Roger Olson, the former state veterinarian of Maryland, said that Mr. DeCoster complained about the cost of testing and the quarantine and insisted there was little risk associated with his eggs.

And, then there was 2010.  I think Jack and Peter need some time away to think about this.

The botulism outbreak was reported to have come from nacho cheese sauce sold at the Valley Oak Food and Fuel gas station in Walnut Grove.

37-year-old Martin Galindo from Antioch also died in a hospital in San Francisco on Thursday night after contracting what his family said is a rare case of botulism. ABC7 News reported on Friday that Martin Galindo contracted botulism from nacho cheese bought at the gas station and was being treated in San Francisco.

Inspection reports for the Valley Oaks Food and Fuel station show that on May 6 and 7, officers impounded bags of Montecito nacho cheese tortilla chips and closed the facility. On May 8, health officers from the state Department of Health impounded four bags of Gehls cheese sauce and reopened the store to sell prepackaged food items only.

Botulism is a rare but potentially life-threatening bacterial illness. Clostridium botulinum bacteria grows on food and produces toxins that, when ingested, cause paralysis. Botulism poisoning is extremely rare, but so dangerous that each case is considered a public health emergency. Studies have shown that there is a 35 to 65 percent chance of death for patients who are not treated immediately and effectively with botulism antitoxin.

Infant botulism is the most common form of botulism. See below for symptoms specific to infant botulism.

Botulism neurotoxins prevent neurotransmitters from functioning properly. This means that they inhibit motor control. As botulism progresses, the patient experiences paralysis from top to bottom, starting with the eyes and face and moving to the throat, chest, and extremities. When paralysis reaches the chest, death from inability to breathe results unless the patient is ventilated. Symptoms of botulism generally appear 12 to 72 hours after eating contaminated food.  With treatment, illness lasts from 1 to 10 days.  Full recovery from botulism poisoning can take weeks to months.  Some people never fully recover.

In general, symptoms of botulism poisoning include the following:

  • Nausea
  • Vomiting
  • Fatigue
  • Dizziness
  • Double vision
  • Dry skin, mouth and throat
  • Drooping eyelids
  • Difficulty swallowing
  • Slurred speech
  • Muscle Weakness
  • Body Aches
  • Paralysis
  • Lack of fever

If found early, botulism can be treated with an antitoxin that blocks circulation of the toxin in the bloodstream. This prevents the patient’s case from worsening, but recovery still takes several weeks.

On victim, Lavinia Kelly, who is turning 33 today, was driving home from work as an inventory manager on April 21 when she pulled over at the gas station’s small market for a snack. She picked up a bag of Doritos chips and drizzled them with nacho-cheese sauce, said her partner, Ricky Torres.

Within hours, the usually upbeat mother of three felt fatigued, he said. The next morning she complained of double vision and went to Sutter Medical Center, but was sent home hours later. By that evening, she was vomiting and having difficulty breathing, Torres said. He drove her back to the emergency room.

The next day, doctors ventilated Kelly and admitted her to the intensive care unit, where she’s been since. The neurotoxins have affected her motor control to the point that she can’t open her eyes, Torres said. When Kelly wants to see who has entered the room, he and other loved ones lift her eyelids open, sometimes using tape to keep them up.

According to the lawsuit we filed yesterday, Lavinia Kelly remains partially paralyzed and on a ventilator as her family and friends wonder whether this will be her last birthday. She had no way of knowing when she stopped for a snack of chips and cheese sauce on the way home from work on April 21 that she would be admitted to an intensive care unit less than 48 hours later.

“She has remained in intensive care ever since, unable to move much, speak, breathe on her own, or open her eyes. Family members must pull her eyelids up to enable her to see at all,” according to the civil lawsuit filed in the Superior Court of California in Sacramento County.

“Lavinia Kelly experiences significant pain all over her body constantly. She is receiving methadone and Neurontin for pain control. (Her) medical condition is poor, and her prognosis uncertain.”

Botulism, which can be fatal can be caused by eating foods that have been contaminated with botulinum toxin, often homemade items that have been improperly canned, preserved, or fermented, according to the Centers for Disease Control and Prevention.  Symptoms can include double vision, slurred speech and muscle weakness. If left untreated, botulism can cause paralysis of the respiratory and other muscles.

Thirty-two people infected with the outbreak strains of STEC O157:H7 were reported from 12 states. Arizona 4, California 5, Florida 2, Illinois 1, Massachusetts 1, Maryland 1, Missouri 1, New Jersey 1, Oregon 11, Virginia 2, Washington 2 and Wisconsin 1. Twelve people were hospitalized. Nine people developed hemolytic uremic syndrome, a type of kidney failure. No deaths were reported. Twenty-six (81%) of the 32 ill people in this outbreak were younger than 18 years. Epidemiologic, laboratory, and traceback evidence indicated that I.M. Healthy brand SoyNut Butter was the likely source of this outbreak. Several soy nut products were recalled:

  • On March 7, 2017, The SoyNut Butter Company recalled all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products.
  • On March 10, 2017, The SoyNut Butter Company expanded its recall to include Dixie Diner’s Club brand Carb Not Beanit Butter.
  • On March 24, 2017, Pro Sports Club recalled 20/20 Lifestyle Yogurt Peanut Crunch Bars because they contain a recalled ingredient.
  • On March 28, 2017, the FDA issued a Suspension of Food Facility Registration Order to Dixie Dew of Erlanger, Ky., after an inspection revealed insanitary conditions at the firm that could affect the safety of finished products. Dixie Dew is the contract manufacturer for SoyNut Butter Company’s soy nut butter products. The close out of the outbreak investigation does not affect the suspension order.

033feb5Here is the Vulto Creamery’s FDA 483 Inspection Report

OBSERVATION 1

Failure to manufacture and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.

Specifically:

  • A finished product sample of your firm’s Ouleout soft raw milk cheese product bearing lot #617 was analyzed by an FDA laboratory and found to be positive for Listeria monocytogenes, a foodbome pathogen.
  • A finished product sample of your firm’s Ouleout soft raw milk cheese product bearing lot #623, collected by the New York State Department of Agriculture and Markets in your facility on 2/28/2017 during the FDA inspection, was found to be positive for Listeria monocytogenes, a foodbome pathogen.

OBSERVATION 2

Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.

Specifically, a review of your environmental sampling test records noted the following:

  • You have conducted environmental sampling during 20 months from 7/28/2014 through 2/19/2017. Your records show 54 out of 198 results positive for Listeria spp. taken from various locations throughout your manufacturing facility, which include, but are not limited to: floor drains in the manufacturing room, wash room and cheese aging room; outside of brine tanks in the walk-in cooler; door handles to the cheese aging room, walk-in cooler and entry door; various areas of the floor in the cheese aging room; bottom of a squeegee in the cheese aging room; employee aprons; and wooden cheese rack dollies in the cheese aging room.  The most recent positive finding being a swab taken from the floor in the manufacturing room on 2/19/2017. You have not conducted an investigation to provide identification of the Listeria spp. to Genus and species and you have also failed to identify its source or point of entry/harborage in your facility.
  • A total of 10 of the 54 positive results were found on food contact surfaces between 10/30/2014 and 4/28/2015. You did not conduct microbial testing of finished products to confi1m that your finished products were not contaminated with the organism found by your environmental testing program. According to your sample records, the food contact surface locations were as follows:

o Wooden cheese aging board in cheese aging room; positive result from 10/30/2014.

o The cheese brush used to brush Ouleout and Miranda soft cheeses and two wooden

cheese aging boards in cheese aging room; positive results from 12/3/2014.

o The cheese brush used to brush Ouleout and Miranda soft cheeses and two wooden cheese aging boards in cheese aging room; positive results from 116/2015.

o Two cheese brushes used to brush the Andes and the Walton Umber hard cheeses;

positive results from 2/3/2015.

o Two cheese brushes used to brush the Andes and the Walton Umber hard cheeses;

positive results from 3/22/2015.

o A cheese brush (not specified to product); positive result from 4/28/2015.

  • You did not continue sampling food contact surfaces after 4/28/2015 to determine if Listeria spp. was still present on these surfaces representing a continued contamination risk to your cheese products.
  • Upon finding a Listeria spp. positive result on a surface, you re-cleaned and re-sanitized the area, but did not re-swab that location until a month or more later, after additional lots of cheese had been produced, to determine if your cleaning and sanitizing was effective and to dete1mine if the Listeria spp. was still present.

OBSERVATION 3

The procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment.

Specifically, review of your environmental sampling results across 20 months from 7/28/2014 through 2/19/2017 showed positive results for Listeria species on several food contact and non-food contact surfaces in your facility.  Per your documented corrective actions, upon getting a positive result you re- cleaned and re-sanitized the affected areas using your routine cleaning and sanitizing operations. However, when you re-sampled these locations a month or more later and tests showed repeated positive results, you did not investigate the use of a more effective method of cleaning and sanitizing.

OBSERVATION 4

Failure to store cleaned and sanitized portable equipment in a location and manner which protects food- contact surfaces from contamination.

Specifically, you were storing wood boards that have been cleaned and sanitized in your facility attic, where exposed insulation and other debris were observed.   Your ready-to-eat Hamden, Blais Blue, Andes and Walton Umber cheese products sit directly on these boards during the aging process.

Additionally, you stated that the attic gets ve1y hot during the summer months, and that it can take approximately _________ for the wood boards to completely dry.

OBSERVATION 5

Failure to take necessary precautions to protect against contamination of food and food contact surfaces with Microorganisms and foreign substances.

Specifically, on 3/1/2017 the following was observed during the manufacturing of your Walton Umber hard cheese product:

  • You and your employee were observed placing your bare hands and arms, up to your elbows, directly into the cheese making vat in order to manually break up recently formed cheese curds. Although you washed your hands, neither of you washed your lower or upper arms. Additionally, your employee was observed to have multiple cuts and abrasions on his rums, which came in direct contact with cheese curds and whey.
  • A stainless-steel ladle, used to scoop milk for pH analysis, had buildup of a mold-like substance on its inner surface. You stated you use this same ladle in the same manner during the manufacturing of all cheese products.

OBSERVATION 6

The design and materials of equipment does not allow proper cleaning and maintenance.

Specifically, a large majority of the wooden boards used for aging in the cheese aging room are of a design that does not allow them to be appropriately cleaned and sanitized.  The boards, which you stated were made from __________ have uneven surfaces, were rough cut, and have knots, frays, and splinters, which allows for the collection of moisture and debris, representing a potential harborage area for filth and microorganisms. These wooden boards come in direct contact with your aging Hamden, Blais Blue, Walton Umber and Andes ready-to-eat cheese products.

OBSERVATION 7

The plant is not constructed in such a manner as to prevent drip and condensate from contaminating food and food-contact surfaces.

Specifically, on 3/1/2017, condensation was noted dripping from the horizontal stainless steel bar on the cheese press directly onto the food contact surface of the draining table below.  This table is used to allow molded cheese products to drain off whey.  Additionally, rust-like particles were noted in the condensation puddle on the table.

OBSERVATION 8

Employees did not sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated.

Specifically, during the inspection on 3/1/2017, it was observed that you and your employee did not sanitize your hands or arms prior to using them to stir and break up the in-process Walton Umber cheese curds.

OBSERVATION 9

Failure to maintain physical facilities in repair sufficient to prevent food from becoming adulterated. Specifically, the following was observed throughout the inspection:

  • Heavy buildup of apparent rust-like substance on the white painted ve1tical supp01t bars that hold the cheese presses in place. These bars are located directly over the draining table closest to the window in the manufacturing room; flakes of this rust-like substance were observed on the top surface of the drain table where molds of cheese are set to drain.
  • Heavy buildup of apparent rust-like substance on painted white metal storage shelf in wash room. This shelf is used to store cheese molds and other equipment and utensils.
  • A heavy buildup of apparent black and green rust-like substance was noted on the cement walls in the manufacturing room and wash room. Several cleaning brushes, storage racks and cheese molds were noted to come in direct contact with these walls.  Additionally, these walls were moist from condensation.
  • Heavy buildup of rust-like and black rust-like substance on stainless steel storage shelf in walk-in cooler. This shelf was being used to hold boxes of wrapped finished cheese products.
  • A large piece of ceiling tile was missing in the cheese aging room. Uncovered, ready-to-eat cheese was being stored directly below this area.
  • The exhaust fan on the ceiling in the manufacturing room has a buildup of dirt-like and rust-like substances. This fan is directly above a stainless-steel draining table where molded cheeses are placed to drain whey.

OBSERVTION 10

Failure to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food and food-contact surfaces.

Specifically, during the inspection, the following was observed:

  • On 3/2/2017, a fan in the attic that was in operation to my cleaned and sanitized wood boards regularly used for cheese aging was noted to have dirt and dust debris buildup on the spinning arms and face of the fan. These wood boards come in direct contact with Hamden, Blais Blue, Walton Umber and Andes ready-to-eat cheese products during the aging process in the cheese aging room.
  • On 2/28/2017, a fan in the manufacturing room was noted to have a ve1y heavy buildup of unknown debris on the spinning arms and face of the fan. You stated your firm uses this fan to help by the floor in the manufacturing room after cleaning.

OBSERVATION 11

Lack of an automatic temperature alarm system for each freezer and cold storage compartment used to store food capable of supp01ting the growth of microorganisms.

Specifically, your firms cheese aging room and walk-in cooler lack an automatic temperature alarm system that would provide indication that a significant temperature change occurred. Your finished cheese products are stored in the cheese aging room.

Additionally, you stated that you do not calibrate and never have calibrated the thermometers located in the cheese aging room and walk-in cooler.

Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition. Specifically, throughout the inspection the following was observed:

  • The concrete floors in the manufacturing room and cheese aging room were noted to be cracked and pitted; an accumulation of moisture was noted to be stuck in the cracks and pits of the floor.
  • A buildup of apparent black rust-like substance was noted on the window sill in the wash room.
  • There is an uneven layer of concrete mortar around the _________ in the manufacturing room. There are also cracks where the mortar meets the       .
  • The door to the manufacturing room does not have a door handle, but instead has plastic packing tape covering part of the hole.
  • The walk-in cooler door does not have a door handle, but instead has a duty cloth rag plugging up the hole.
  • A heavy buildup of rust-like debris was noted on the lower part of the manufacturing room door.
  • There was buildup of a black rust-like substance on the wall between the walk-in cooler and cheese aging room.
  • A hole was noted at the bottom of the wall near· the foot bath in the packaging room
  • A black rust-like substance was observed on the ceiling in the packaging room, near· the wash room entrance.

OBSERVATION 13

Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests.

Specifically, during the inspection on 2/28/2017, a long piece of sticky fly tape, heavily populated with dead insects, observed hanging directly over exposed, uncovered ready-to-eat cheese products in your cheese aging room was pointed out to you.  This fly tape was observed hanging in the cheese aging room in the same condition on 3/1/2017 and 3/7/2017.

OBSERVATION 14

Plumbing constitutes a source of contamination to equipment and utensils. Specifically, during the inspection the following was observed:

  • A hose with a nozzle on the end was directly connected to the potable water supply in the manufacturing room without a proper backflow prevention device installed. This hose is used during cleaning operations.
  • A hose with a nozzle on the end was directly connected to the potable water supply in the wash room without a proper backflow prevention device installed. This hose is used during cleaning operations.
  • The drain pipe from the 3-basin sink in the manufacturing room is approximately 2.5 inches wide. The air gap between the drain pipe and the waste funnel is only 1.5 inches, which does not provide an adequate air gap between your sink drain and waste pipe.
  • The wash room 3-basin sink does not have an air gap installed between the sink drain pipe and the waste pipe.

OBSERVATION 15

You did not submit a reportable food rep01t to FDA within 24 hours after you determined that a food was a reportable food.

Specifically, you were notified via telephone on 3/3/2017 that your firm’s Ouleout soft raw milk cheese product bearing lot #617 was found to be positive for Listeria monocytogenes, a foodbome pathogen, and that you would need to file a reportable food reported to the FDA within 24 hours.  At this present time, you still have not filed a reportable food report with the FDA.

2116b9af45f36c44e760b2bfe6139701See, Soy Nut Butter E. coli Outbreak

Twenty-nine people infected with the outbreak strains of E. coli O157:H7 have been reported from 12 states: Arizona 4, California 5, Florida 1, Illinois 1, Massachusetts 1, Maryland 1, Missouri 1, New Jersey 1, Oregon 9, Virginia, 2, Washington 2, and Wisconsin 1.

Illnesses started on dates ranging from January 4, 2017, to March 13, 2017. Ill people range in age from 1 to 57 years, with a median age of 8. Twenty-four of the 29 ill people are younger than 18 years. Among ill people, 59% are male. Twelve ill people have been hospitalized, and nine people developed hemolytic uremic syndrome.

Laboratory testing found the outbreak strains of E. coli O157:H7 in I.M. Healthy brand SoyNut Butter collected from the homes of ill people and from retail locations.

The FDA announced last week that on March 28, 2017, the FDA used authorities granted under the 2011 FDA Food Safety Modernization Act to suspend the food facility registration of Dixie Dew Products, Inc. (Dixie Dew) of Erlanger, Kentucky, because products manufactured in this facility may be contaminated.

Soy nut butter manufactured by Dixie Dew and sold under the brand name I.M, Healthy has been implicated in an outbreak of E. coli O157:H7.

On March 7, 2017, The SoyNut Butter Company recalled all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products. On March 10, 2017, The SoyNut Butter Company expanded its recall to include Dixie Diner’s Club brand Carb Not Beanit Butter. On March 23, 20/20 Lifestyle Yogurt Peanut Crunch Bars were recalled because they contain a recalled ingredient.

A manufacturer shuttered and product recalled, but the impact on consumers is still being felt.  Here is an email (somewhat redacted) that I received late Saturday night.

Our 11-year old son was diagnosed with E. coli. O157:H7 in January after he was admitted to the __________ Hospital on January 11, 2017.  He developed HUS and had multiple system organ failure.  He is still in the pediatric ICU on dialysis and a ventilator.  We believe that this was caused by I.M. Healthy soy nut butter and would like to discuss the possibility of a lawsuit against the manufacturer.

This outbreak will not really be over – for a lifetime – for some.

Screen Shot 2017-03-30 at 4.51.03 PMThe FDA announced this evening that on March 28, 2017, the FDA used authorities granted under the 2011 FDA Food Safety Modernization Act to suspend the food facility registration of Dixie Dew Products, Inc. (Dixie Dew) of Erlanger, Kentucky, because products manufactured in this facility may be contaminated.

Soy nut butter manufactured by Dixie Dew and sold under the brand name I.M, Healthy has been implicated in an outbreak of E. coli O157:H7.

Twenty-nine people infected with the outbreak strains of STEC O157:H7 have been reported from 12 states. Arizona 4, California 5, Florida 1, Illinois 1, Massachusetts 1, Maryland 1, Missouri 1, New Jersey 1, Oregon 9, Virginia, 2, Washington 2, and Wisconsin 1.

Illnesses started on dates ranging from January 4, 2017, to March 13, 2017. Ill people range in age from 1 to 57 years, with a median age of 8. Twenty-four (83%) of the 29 ill people are younger than 18 years. Among ill people, 59% are male. Twelve ill people have been hospitalized, and nine people developed hemolytic uremic syndrome.

The FDA’s decision to suspend the registration of Dixie Dew Products was prompted by the E. coli O157:H7 outbreak and the findings of FDA’s March 2017 inspection of Dixie Dew, which identified insanitary conditions that could lead to contamination with E. coli O157:H7 in finished products.

No food can leave the Dixie Dew facility for sale or distribution while the food facility registration is suspended.

Screen Shot 2017-03-30 at 4.50.32 PMOn March 28, 2017, the FDA issued a Suspension of Food Facility Registration Order to Dixie Dew of Erlanger, Kentucky, after an inspection revealed insanitary conditions at the firm that could affect the safety of finished products.

The FDA inspected the facility between March 3 and 15, 2017.  On March 3, 2017, Dixie Dew refused to allow FDA investigators access to the facility’s environmental sampling and production records; the FDA subsequently issued a Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act. After receiving the Demand for Records, Dixie Dew provided FDA investigators with the necessary records. At the close of the inspection, the FDA provided Dixie Dew with a list of the investigators’ inspectional observations (Form FDA 483), noting objectionable conditions seen during the inspection. Dixie Dew responded to the report in writing with a list of actions the firm has taken to correct the conditions; however, FDA found the corrective actions were not adequate to fully address the risks that were identified, and issued the Suspension Order to prevent further illnesses from occurring.

The Suspension Order applies to the entire facility. While the order is in effect, no food product may leave the facility for sale or distribution.

Specific problems noted in the suspension order and Form 483 included (blanks reflect redacted information):

  • investigators observed grossly insanitary conditions that cause your firm’s soy nut butter products to be adulterated;
  • food contact surfaces, floors, walls, and ceilings in the soy nut butter processing and packaging rooms were heavily coated with soy nut butter build-up from previous production runs.
  • firm does not routinely wash and sanitize smaller pipes, pipe fittings, gaskets, seals, “or the rubber _____ plug” when broken down following a production run;
  • firm does not conduct a kill step for SoyNut Butter product remaining  in your firm’s mixing kettle leftover from a production run;
  • plant Manager stated, up to _____ may remain in the kettle overnight or weekend prior to resuming production. You and your Plant Manager stated the kettle is shut off when product remains in the kettle overnight and/or over the weekend;
  • plant manager and maintenance supervisor reported your _____ machine, used for fine mixing of the SoyNut Butter and ________, routinely shuts off during processing. Your Plant Manager stated this occurs one to two times per day and, this problem has persisted for approximately 15 years despite repeated maintenance intended to correct the problem;
  • firm monitors the SoyNut ______ with a ______ thermometer, but plant manager stated he has never verified the accuracy of this instrument;
  • you and your plant manager report,your temperature probe and chart recorder, initially engineered to verify and record _____ of product in the large mixing kettle, is not functioning properly and has not been used for well over a year.

FDA inspectors also noted problems with Dixie Dew’s food safety testing program, noting the company’s “failure to perform microbial testing where necessary to identify possible food contamination.” Inspectors found the testing materials on hand at Dixie Dew had expired in July 2016 and October 2015.

Problems in the Dixie Dew quality control lab were described in detail by FDA inspectors.

“An apparent fly infestation in your firm’s Quality Control and Product Development Laboratory was observed on 3/13/2017. Small apparent flies and fly larvae, too numerous to count, were inside an unplugged chest freezer,” according to the 483 report.

“A sealed blue plastic bag was inside the freezer and according to your plant manager, contained an egg product that became rotten when power was disconnected. The small apparent flies were observed along the laboratory counters and flying throughout the laboratory.”

FDA Form 483 (Inspectional Observations) for Dixie Dew Products, Inc.

Suspension of Food Facility Registration Order

big-map-3-28-17_1Since the last update on March 21, 2017, six more ill people have been reported from four states.

Twenty-nine people infected with the outbreak strains of STEC O157:H7 have been reported from 12 states. Arizona 4, California 5, Florida 1, Illinois 1, Massachusetts 1, Maryland 1, Missouri 1, New Jersey 1, Oregon 9, Virginia, 2, Washington 2, and Wisconsin 1.

Illnesses started on dates ranging from January 4, 2017, to March 13, 2017. Ill people range in age from 1 to 57 years, with a median age of 8. Twenty-four (83%) of the 29 ill people are younger than 18 years. Among ill people, 59% are male. Twelve ill people have been hospitalized, and nine people developed hemolytic uremic syndrome, a type of kidney failure. No deaths have been reported.

Laboratory testing found the outbreak strains of STEC O157:H7 in I.M. Healthy brand SoyNut Butter collected from the homes of ill people and from retail locations.

soynut-butter-productOn March 7, 2017, The SoyNut Butter Company recalled all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products. On March 10, 2017, The SoyNut Butter Company expanded its recall to include Dixie Diner’s Club brand Carb Not Beanit Butter. On March 23, 20/20 Lifestyle Yogurt Peanut Crunch Bars were recalled because they contain a recalled ingredient.

CDC recommends that consumers do not eat, and childcare centers, schools, and other institutions do not serve, any variety or size of I.M. Healthy brand SoyNut Butter, I.M. Healthy brand granola, Dixie Diner’s Club brand Carb Not Beanit Butter, or 20/20 Lifestyle Yogurt Peanut Crunch Bars, regardless of the date of purchase or the date listed on the container. Even if some of the product was eaten or served and no one got sick, throw the rest of it away. Put it in a sealed bag in the trash so that children, pets, or other animals can’t eat it.

big-map-3-17-177 with hemolytic uremic syndrome – 23 with E. coli O157:H7 in Arizona 4, California 5, Maryland 1, Missouri 1, New Jersey 1, Oregon 6, Virginia 2,  Washington 2, Wisconsin 1.

The CDC this morning updated the E. coli O157:H7 outbreak linked to I.M. Healthy and Dixie Dew Soy Nut Butter to twenty-three people infected with the outbreak strains of E. coli O157:H7 from nine states. Arizona 4, California 5, Maryland 1, Missouri 1, New Jersey 1, Oregon 6, Virginia 2,  Washington 2, Wisconsin 1.

Illnesses started on dates ranging from January 4, 2017, to March 5, 2017. Ill people range in age from 1 to 48 years, with a median age of 8. Twenty (87%) of the 23 ill people are younger than 18 years. Among ill people, 61% are male. Ten ill people have been hospitalized and seven people developed hemolytic uremic syndrome (HUS), a type of kidney failure. No deaths have been reported. Illnesses that occurred after February 24, 2017, might not yet be reported due to the time it takes between when a person becomes ill and when the illness is reported.

In interviews, ill people or their family members answered questions about the foods they ate and other exposures in the week before they became ill. Twenty (87%) of the 23 people reached for interview reported either eating I.M. Healthy brand SoyNut Butter at home (14 people) in the week before they became ill, attending a facility that served I.M. Healthy brand SoyNut Butter (2 people), or attending childcare centers that served I.M. Healthy brand SoyNut Butter and I.M. Healthy brand granola coated with SoyNut Butter (4 people). SoyNut Butter is a nut-free substitute for peanut butter. Investigators have reported to CDC two more ill people who either developed HUS or had test showing they were infected with the E. coli O157:H7 bacteria.

Laboratory testing identified E. coli O157:H7 in opened containers of I.M. Healthy brand SoyNut Butter collected from the homes of ill people in California, Oregon, and Washington. Officials in California also isolated E. coli O157:H7 in unopened containers of I.M. Healthy brand SoyNut Butter collected from retail locations. Further testing using pulsed-field gel electrophoresis (PFGE) showed that the E. coli O157:H7 in all of these containers of SoyNut Butter had the same DNA fingerprints as the E. coli O157:H7 isolates from ill people.