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.  This after poisoning over 30 people – mostly kids – several that suffered from acute kidney failure.

The recall notice, drafted by I.M. Healthy, on the FDA website did not mention where the tainted product was sold.  Nearly six months later Food Safety News reported on September 5: “Earlier today, Amazon.com was still selling I.M. Healthy soy nut butter that was recalled in March when federal officials traced an E. coli outbreak to the product.”  Then on September 26 a friend of a client whose son nearly died from consuming the soy nut butter found the product on “Close Out” at Lucky’s Market on 200 Woodside Rd, Redwood City, CA 94061.

So, why does the FDA not release the names of retailers to retailers and consumers during a recall and/or an outbreak?

Caitlin Dewey of the Washington Post asked the same question in March of this year – “Why the FDA hides the names of grocery stores that sell contaminated food.”  I reread it today and it still makes my head hurt.

According to Caitlin: The FDA does not specify, however, which stores, centers or schools — because that would violate its interpretation of an obscure trade secret rule. 

This interpretation differs from that of other agencies in the federal food safety system, an overlapping and often illogical network of regulatory fiefdoms. The system, which is responsible for keeping food free of bacteria and other pathogens, frequently has to weigh the very real interests of private food companies against potential risks to the public. In the case of releasing retailer lists during major outbreaks, the FDA has historically sided with business, ruling that such lists constitute “confidential commercial information” and thus should not be available for public consumption. 

Critics say that the agency’s unwillingness to share this information poses a clear danger to public health, particularly in cases like the current E. coli outbreak, where parents may not know if their child consumed the recalled product.

 “Our mantra is that a more transparent food system is a safer food system,” said Thomas Gremillion, the director of food policy at the Consumer Federation of America. “And there are lots of instances where having that distribution list would help victims of food-borne illness.”

The FDA’s current recall process has been in effect for years, though the agency did gain more recall authority under the FDA Food Safety Modernization Act of 2011. It is, for the most part, a voluntary system — which means there’s some variance in how quickly recalls happen. While most companies are highly motivated to clean up any contamination, it takes time to evaluate and respond to possible threats. And that time can be multiplied several times over if a product has moved through the hands of several distributors, manufacturers or other middlemen, an issue that the FDA was faulted for in a June 2016 alert by the Inspector General’s Office.

When a company does issue a recall, it has wide latitude over the amount of information it shares; in some cases, a recall will never be made public. Recalls that are made public typically contain a description of the product and an explanation of the problem. But companies are not required to reveal where the product was sold — whether to a store, a school, a restaurant or another manufacturer that put it in other products.

The recall for SoyNut Butter, for instance, says that “products were distributed in multiple states and may have been purchased in stores or through mail order. They were also distributed to childcare centers and schools in multiple states.” Those states include Virginia and Maryland, where two people have fallen ill. I.M. Healthy did not respond to a phone call or email requesting comment, though a statement on its website called the contamination “deeply concerning” and said that the company had immediately issued a recall. A list compiled by the site eFoodAlert claims that the product was sold at a number of major grocery chains, including Kroger, Giant and Whole Foods.

“Industry argues that they don’t want to turn over who they sell to, because competition will know and try to undercut them,” said Bill Marler, a prominent food safety lawyer who is representing the parents of one of the children sickened in the SoyNut outbreak. “That’s all well and good under normal circumstances. But those rules should not and do not apply to a product that could cause people to become ill.”

In a statement to The Washington Post, the FDA affirmed that it believes its disclosure measures are sufficient and blamed the lack of downstream recall information on federal disclosure rules. Federal regulations do limit the sort of information that can be released to the public. Under the Freedom of Information Act and Title 21 of the Code of Regulations, government agencies — and specifically, the FDA — are told to exempt trade secrets and commercial information from any of their releases.

“Examples of [confidential consumer information] include raw material supplier lists, finished product customer lists, trace back information, etc.,” said Peter Cassell, a spokesman for the FDA. “CCI is exempt from Freedom of Information Act requests, but can be shared through certain information sharing agreements (including with other Federal agencies).”

“The FDA publicizes recall notices, including pictures of affected products, and uses social media accounts to reach consumers as swiftly as possible,” he later added. “In some cases, the FDA can release certain information that is otherwise exempt from disclosure if it is necessary to effectuate a recall. In many cases, it is most efficient for the company to directly notify its distributors so they can take appropriate action.”

Cassell declined to make an agency lawyer available for comment or explain how the FDA had arrived at its definitions. But it’s probably worth noting that when another agency considered similar precedents, it came to different conclusions.

In the early 2000s, the Food Safety and Inspection Service — the branch of the U.S. Department of Agriculture that regulates meat, poultry and egg products — decided to revisit its own interpretation of the trade secrets rule. During a lengthy comments period, industry groups concerned with protecting their distribution lists from competitors faced off against consumer advocates. In 2008, after several years of debate, FSIS’s final rule concluded that it would “not cause substantial harm to the competitive position of any business” to disclose retailer names.

“FSIS now routinely posts these lists,” said Deirdre Schlunegger, the chief executive of STOP Foodborne Illness, an advocacy group for patients that lobbied FSIS 10 years ago. “We obviously believe consumers should have as much information as possible to make safe food decisions.”

Today, when FSIS issues a Class I recall — those that seem “reasonably” likely to cause health problems — it also issues a list of all the retail locations that have, or have had, the product. During last month’s massive cheese recall, for instance, FSIS published a list of every Safeway, Albertsons and Pak ’n’ Save that sold Taylor Farms salads containing Sargento pepperjack. But because FDA regulates the cheese itself, there was no such list of stores that sold the cheese outside salads.

“It does makes me wonder why the FDA can’t do the same,” said Sandra Eskin, the director of the Safe Food Project at Pew Charitable Trusts. “The fundamental issue is — is this information important to consumers during a recall? I would argue yes.”

But the man who led the effort to reform FSIS’s traded secrets rule has his own suspicions as to why the FDA hasn’t followed his lead. Richard Raymond, who was the undersecretary of agriculture for food safety under President George W. Bush, says that the fiercest opposition to the change came from the food industry. Raymond, who had been the chief medical officer in his home state of Nebraska, came to Washington, D.C., determined to change the rules on confidential information. He found himself surprised by the level of resistance.

“They were scared to death it would hurt their business,” Raymond said. “The retail stores want to protect their brand. … When you ask why FDA hasn’t done it, I suspect they don’t want that fight themselves.”

The FDA did not respond to Raymond’s comment by press time. But Gremillion, of the Consumer Federation, would like to see the agency take action.

“Why do confidential business interests trump public health in some cases and not others?” he asked. “We need more transparency around this.

I think it is past time for the FDA and the industries it oversees to be transparent – willingly or not.

What OIG Found

FDA is on track to meet the domestic food facility inspection timeframes for the initial cycles mandated by FSMA; however, challenges remain as FSMA requires FDA to conduct future inspections in timeframes that are 2 years shorter than the timeframes for the initial cycles. Also, inaccuracies in FDA’s domestic food facility data result in FDA attempting to inspect numerous facilities that are either out of business or otherwise not in operation at the time of the visit.

Although FDA is on track to meet the FSMA inspection mandates during the initial cycles, theoverall number of food facilities that FDA inspected since the passage of FSMA has decreased from a high of about 19,000 facilities in 2011 to just 16,000 facilities in 2015.

In addition, FDA did not always take action when it uncovered significant inspection violations—those found during inspections classified as “Official Action Indicated” (OAI). When it did take action, it commonly relied on facilities to voluntarily correct the violations. Also, it rarely took advantage of the new administrative tools provided by FSMA.

Moreover, FDA’s actions were not always timely nor did they always result in the correction of these violations. FDA consistently failed to conduct timely followup inspections to ensure that facilities corrected significant inspection violations. For almost half of the significant inspection violations, FDA did not conduct a followup inspection within 1 year; for 17 percent of the significant inspection violations, FDA did not conduct a followup inspection of the facility at all.

What OIG Recommends

We recommend that FDA (1) improve how it handles attempted inspections to ensure better use of resources, (2) take appropriate action against all facilities with significant inspection violations, (3) improve the timeliness of its actions so that facilities do not continue to operate under harmful conditions, and (4) conduct timely followup inspections to ensure that significant inspection violations are corrected. FDA concurred with all four recommendations.

HERE IS LINK TO FULL REPORT

When you still can buy recalled product, that sickened dozens and nearly killed children, at Lucky’s Market on 200 Woodside Rd, Redwood City, CA 94061

Legal note:  It is against federal law for anyone to sell or resell recalled products in any setting, including yard sales and thrift shops.

Of course, this follows on Food Safety News reporting on September 5: “Earlier today, Amazon.com was still selling I.M. Healthy soy nut butter that was recalled in March when federal officials traced an E. coli outbreak to the product.”

And, for anyone who forgot the outbreak , the CDC reported on May 4, 2017, that 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. Twenty-six (81%) of the 32 ill people in this outbreak were younger than 18 years.

Epidemiological, 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 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.

Dear readers, anyone else find this product for sale at grocery stores, online or other wise?

So, anyone else up at I.M. Healthy, FDA or the US Attorney’s office?

There are now 16 dead with 292 sickened with hepatitis A in San Diego – mostly in the ignored homeless population. And, the numbers of people with this preventable disease is spiking in Colorado (57 ill with 1 death), Michigan (319 ill with 14 deaths), New York (46 ill) and other states and cities (Los Angeles has at least 10 sick, Salt Lake City 21).  Lately, we have also seen the spread to food service workers, potentially exposing hundreds of unsuspecting consumers.

This is all preventable.

In 2006, health officials recommended routine hepatitis A vaccination for all children ages 12-23 months, that hepatitis A vaccination be integrated into the routine childhood vaccination schedule, and that children not vaccinated by two years of age be vaccinated subsequently. The vaccine is also recommended for the following persons:

  • Travelers to areas with increased rates of hepatitis A
  • Men who have sex with men
  • Injecting and non-injecting drug users
  • Persons with clotting factor disorders
  • Persons with chronic liver disease
  • Persons with occupational risk of infection
  • Children living in regions of the U.S. with increased rates of hepatitis A
  • Household members and other close personal contacts

The vaccine may also help protect household contacts of those persons infected with hepatitis A. Although generally not a legal requirement at this time, vaccination of food handlers would be expected to substantially diminish the incidence of hepatitis A outbreaks.

Although outbreaks continue to occur in the United States, no one should ever get infected if other preventive measures are taken. For example, food handlers must always wash their hands with soap and water after using the bathroom, changing a diaper, and certainly before preparing food. Food handlers should always wear gloves when handling or preparing ready-to-eat foods, although gloves are not a substitute for good hand washing. Ill food-handlers should be excluded from work.

Hepatitis A is a communicable (or contagious) disease that often spreads from person to person. Person-to-person transmission occurs via the “fecal-oral route,” while all other exposure is generally attributable to contaminated food or water. Food-related outbreaks are usually associated with contamination of food during preparation by a HAV-infected food handler. The food handler is generally not ill because the peak time of infectivity—that is, when the most virus is present in the stool of an infected individual—occurs two weeks before illness begins.

Fresh produce contaminated during cultivation, harvesting, processing, and distribution has also been a source of hepatitis A. In 1997, frozen strawberries were the source of a hepatitis A outbreak in five states. Six years later, in 2003, fresh green onions were identified as the source of a hepatitis A outbreak traced to consumption of food at a Pennsylvania restaurant. Other produce, such as blueberries and lettuce, has been associated with hepatitis A outbreaks in the U.S. as well as other developed countries.

HAV is relatively stable and can survive for several hours on fingertips and hands and up to two months on dry surfaces. The virus can be inactivated by heating to 185°F (85°C) or higher for one minute, or disinfecting surfaces with a 1:100 dilution of sodium hypochlorite (household bleach) in tap water. It must be noted, however, that HAV can still be spread from cooked food if it is contaminated after cooking.

So, for Goodness Sake, Vaccinate Against Hepatitis A

The La Crosse County Health Department is conducting a disease investigation on reported cases of E. coli among La Crosse County residents.

Children under age 5 and the elderly are most susceptible to infection. To date, there have been 8 cases of E. coli O157, a particularly nasty form, which produces a toxin that can be harmful to the body organs such as the kidneys. This form of E. coli is also called STEC- Shiga Toxin-Producing Escherichia coli. Of the 8 cases, 6 children have been hospitalized for HUS – Hemolytic Uremic Syndrome.

The Health Department is working with the Wisconsin Division of Health to complete disease investigation to contain the outbreak. At this time, the investigation is ongoing, and a single source of infection or contamination has not be identified.

E. coli is a bacterial infection that is more common during the summer months. Cases can be linked or stand alone. It is transmitted by eating contaminated food or water and by contact with fecal material from infected persons or animals. Person to person spread of bacteria is possible and may occur in family settings, daycare centers and nursing homes.

Signs and symptom of E. coli O157 infection or STEC include severe abdominal cramps and loose and bloody diarrhea. Symptoms occur an average of 3-5 days after swallowing the germ. Some individuals become infected but do not develop symptoms. People do not develop immunity to E. coli.

Parents and caregivers whose children have persistent diarrhea (2-3 days) should consult their child’s doctor, keep the child out of daycare and school and follow extreme hand hygiene to prevent the spread of the bacteria. Testing for E- coli is done by sampling the stool and culturing the bacteria in a laboratory. Testing can take several days for results to be completed.

Precautions for the public at this time consist of:

  • Hand hygiene – hand washing with plenty of soap and water. Special attention should be given to hand washing after using the bathroom, when changing diapers, before preparing food and eating and after coming in from outside activities.
  • Parents need to supervise handwashing for their young children to ensure that hands have been appropriately washed.
  • Parents and caregivers should keep their ill children out of school and daycare until advised to return by their medical provider. The Health Department recommends children stay home until they have been symptom free for 48 hours (2 days).

Persons with E. coli infection usually feel better over a few days without specific treatment. Rest and fluids to prevent and treat dehydration are recommended. For more information on E. coli (O157), STEC or HUS and hand washing techniques, please visit the La Crosse County Health Dept. website at www.lacrossecounty.org/health/

The Times Union reported today that Death Wish Coffee is recalling its Nitro Cold Brew because there is a risk of Clostridium botulinum (C. botulinum) or botulism, a serious toxin that causes weakness of the muscles and difficulty breathing.

The coffee is being pulled from shelves at Price Chopper/Market 32, Healthy Living Market & Café, and independent retailers at the behest of Death Wish Coffee.

Nitrogen-infused coffee is a fairly new process with few federal standards and regulations through the Food and Drug Administration (FDA).

According to the Center for Disease Control, C. botulinum or botulism is a rare but serious illness caused by a toxin that attacks the body’s nerves. Symptoms of botulism usually start with weakness of the muscles that control the eyes, face, mouth, and throat. This weakness may spread to the neck, arms, torso, and legs. Botulism also can weaken the muscles involved in breathing, which can lead to difficulty breathing and even death.

CDC and Texas Health Officials Warn About Illness Linked to Raw Milk from Texas Dairy – Raw milk contained rare but dangerous germ, consumers should get antibiotics

People who consumed raw milk or raw milk products from one Texas dairy should contact their health care provider immediately, warn health investigators from the Centers for Disease Control and Prevention (CDC) and the Texas Department of State Health Services (DSHS). Raw milk from the K-Bar Dairy in Paradise, Texas (northwest of Fort Worth), tested positive for a rare but potentially serious bacteria known as Brucella RB51.

CDC advises that people who consumed raw milk or milk products from the K-Bar Dairy between June 1 and Aug. 7, 2017, should get antibiotic treatment to avoid the risk of lifelong, chronic infections. Initially, people with brucellosis experience fever, sweats, aches and fatigue. If not treated, Brucella RB51 infection can result in long-term complications, like arthritis; heart problems; enlargement of the spleen or liver; and, in rare cases, nervous system problems, like meningitis RB51 can cause severe illness in people with weakened immune systems and miscarriages in pregnant women.

“It’s very important for people who drank raw milk from this dairy to seek treatment to prevent infection with Brucella RB51,” said William Bower, M.D., team lead for the CDC group that investigates brucellosis. “Even if people don’t have any symptoms now, they can develop a chronic infection that can impact their health for years to come.”

Milk from K-Bar dairy is known to have caused Brucella infection in one Texas resident. One illness in a Texas woman has been linked to the dairy. Purchase records and illness reports indicate additional people in Texas and some as far away as California and North Dakota may need antibiotics to prevent or treat infection. In Texas, raw milk is only allowed to be sold on site at the dairy. According to Texas DHSH, K-Bar dairy has been operating in compliance with state dairy laws and rules and is cooperating fully with the investigation.

CDC and Texas health officials have been trying to reach people in more than 800 households known to have purchased K-Bar raw milk. Texas is following up with 170; CDC tried to contact the remaining 672 households but many did not provide contact information. Of the 485 households with contact information, CDC successfully reached 236 households. Among the 236 households, 83 percent of people were exposed to RB51 by drinking the milk.

Officials Worried People Not Aware of Risk

Due to incomplete contact information, CDC staff have been unable to reach about 200 households in which someone bought K-Bar milk. People who sampled the milk at the dairy or got the milk from friends or family also may not be aware of their risk.

So far, CDC and Texas health officials have received reports about people who drank K-Bar milk or have symptoms consistent with brucellosis caused by RB51 in Alabama, Arkansas, California, Ohio, North Dakota, Tennessee and Texas.

Those Exposed Need Antibiotics

CDC recommends that anyone who drank raw milk or consumed milk products from K-Bar dairy between June 1 and Aug. 7, 2017, see their doctor for antibiotics to prevent infection. Because Brucella can cause complications during pregnancy, including miscarriage, it is especially important for pregnant women who may have been exposed to seek medical care. RB51 is resistant to some antibiotics that would normally be used to prevent or treat brucellosis, so people who drank the milk should tell their doctor that they may have been exposed to RB51 and refer their healthcare provider to the CDC website (link below).

People who have consumed the milk should also check themselves for fever for four weeks after they last drank the milk and watch for other brucellosis symptoms for six months. These symptoms include but are not limited to: muscle pain, lasting fatigue, arthritis, depression, and swelling of the testicles.

Doctors can find more information about testing patients for RB51 and which antibiotics to use to prevent infection on the CDC website at: https://www.cdc.gov/brucellosis/clinicians/rb51-raw-milk.html.

About RB51

RB51 is a weakened strain of Brucella used to vaccinate young female cattle against infection with more serious strains of Brucella. Vaccinating cows with the RB51 vaccine helps prevent abortions in cows and reduces the risk of people coming into contact with cows infected with more severe strains of Brucella. However, in rare cases, vaccinated cows can shed RB51 in their milk.

Testing of milk from the individual cows in the dairy herd revealed two cows that were infected with Brucella RB51, supporting the conclusion that these cows are a source of RB51 contamination of the dairy’s raw milk. Testing is ongoing by Texas officials to assure that the remaining cows in the herd do not pose an ongoing risk of RB51contamination of the dairy’s raw milk. The only way to avoid this potential exposure is to drink milk that has been pasteurized to kill the germs.

Brucella is rare in the United States, largely due to our vaccination practices in cattle to prevent brucellosis. There are about 120 reported cases in people each year. Most cases of brucellosis in the U.S. occur in people who traveled to countries where Brucella is more common and drank contaminated cow, sheep or goat milk or had contact with infected animals. Among cases in the U.S. who acquired brucellosis here, infections occur from contact with feral swine or, more rarely, dogs, or because of accidental exposure in lab settings.

Raw Milk: a Risk for Infections

Raw milk and raw milk products are those that have not undergone a process called pasteurization that kills disease-causing germs. CDC recommends that people only drink milk that has been pasteurized to kill germs. Even healthy animals may carry germs that can contaminate milk. There is no substitute for pasteurization to assure that milk is safe to drink.

The risk of getting sick from drinking raw milk is greater for infants and young children, the elderly, pregnant women, and people with weakened immune systems, such as people with cancer, an organ transplant, or HIV/AIDS. However, healthy people of any age can get very sick if they drink raw milk contaminated with harmful germs.

More info on raw milk: https://www.cdc.gov/foodsafety/rawmilk/raw-milk-index.htmland www.realrawmilkfacts.com

The CDPH Food and Drug Branch (FDB) and Sacramento County Environmental Management Department (SCEMD) recently investigated an outbreak of botulism linked to the consumption of ready to eat nacho cheese purchased at Valley Oak Food and Fuel in Walnut Grove, California. The nacho cheese was applied to chips by customers from a counter-top, self-service warming and dispensing unit supplied by the cheese manufacturer. These types of warming and dispensing units are typically designed to maintain the cheese at approximately 140 deg. F.

As of May 31, 2017, a total of 10 case-patients were laboratory-confirmed with C. botulinum toxin type A. All patients were hospitalized; nine were in an intensive care unit, seven required ventilator support, and one died. Leftover nacho cheese sauce collected from the gas station yielded C. botulinum toxin type A bacteria and toxin. Due to the extensive distribution of the same lot code of nacho cheese throughout the United States without additional botulism cases, internal testing conducted by the Wisconsin manufacturer of the nacho cheese, and only a single bag of cheese linked to human illness, FDB and SCEMD suspect the nacho cheese was likely contaminated at the retail location. A few items in particular were noted during the investigation that was concerning:

The 5 pound bag of nacho cheese collected at the retail location on May 5, 2017 was being used past the “Best By” date.

Records were not being maintained by the gas station employees indicating when the bag of nacho cheese was originally added to the warming unit.

The plastic tool designed to open the bags of cheese (provided with the nacho cheese warming and dispensing unit) was not being used by employees. 
FDB is aware that these types of nacho cheese warming and dispensing units are in use at many retail locations throughout California. These units generally provide safe, ready-to-eat foods without significant input from employees at each location. FDB would like to provide the following guidance regarding the use of nacho cheese warming and dispensing units in retail locations.

1.  Management and employees should follow the instructions for each type of machine and product they use. Instructions for use may be included on the packaging of the 
bagged nacho cheese or included on the interior panels of the warming and dispensing unit. These directions may include pre-heating and the length of time a product can remain at elevated holding temperatures. In some cases the product may only be held above 135 deg. F. for 4-6 days.

2.  Management should ensure that records are maintained indicating when bagged cheese was last changed. This may be accomplished by writing the date the product was added to the warmer on the bag itself.

3.  Management should ensure that the warming and dispensing units are not turned off at night or plugged into a timer. These types of machines need to remain “on” at all times. This will ensure that appropriate temperatures are maintained in this ready-to- eat food.

4.  Management and employees should ensure that any supplied tools for opening the bags of cheese are used per the product directions. These devices need to be washed, rinsed, and sanitized between uses. In some cases these opening tools are only supplied with warming and dispensing unit.

5.  Management and employees should verify on a regular basis that the internal temperature of the hot held cheese product is being held at the proper temperature. The internal temperature can be measured by placing the cheese product in a cup with a thermometer to verify the product is maintaining the minimum hot holding temperature of 135 deg. F as required under the California Retail Food Code Section 113996 or hot holding temperature as recommended by the manufacturer.

CDPH hopes this information can be shared widely to ensure retail food facilities have current information and are taking appropriate measures to keep our food supply safe. Thank you for your consideration and ongoing collaboration with our Department.

In March 2017, the Centers for Disease Control and Prevention (CDC) and several state health departments attributed a multistate outbreak of Shiga toxin-producing Escherichia coli O157:H7 to I.M. Healthy brand SoyNut Butter manufactured by Dixie Dew and sold at retail on online outlets.[1]

Outbreak investigators collected open containers of SoyNut Butter from the homes of sick people, and unopened containers from retail locations. Containers of SoyNut Butter from lots #243162 and 244161 tested positive for E. coli. Whole genome sequencing revealed that the same strain of E. coli was found in clinical isolates from sick people and containers of I.M. Healthy SoyNut Butter. Epidemiologic investigation determined that 32 people ill with this strain of E. coli had been infected by eating or attending a facility that served I.M. Healthy SoyNut Butter. This included residents of 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).

The damage caused by this outbreak has been considerable. Twelve people were hospitalized due to their infection, and nine developed hemolytic uremic syndrome (HUS). HUS is a debilitating condition caused by E. coli that is commonly characterized by kidney failure, but may also lead to brain damage, seizures, and diabetes. Children less than 10 years of age are particularly at risk for developing HUS.

I.M. Healthy brand SoyNut Butter has been recalled, but given its long shelf life, it may still be in some people’s homes. This product, therefore, may continue to pose a threat to people’s health.  Several online retailers continued to sell the recalled product at least well into August 2017.

It is not as if in 2017, contaminated nut butters should not have been an issue for manufacturers, suppliers and retailers.

In November 2006, public health officials detected a substantial increase in reports of Salmonella Tennessee isolates. In February 2007, a multistate, case-control study linked the consumption of either Peter Pan or Great Value Peanut Butter brands with infection[2]. 715 people were sickened with 129 hospitalized.  Subsequently the same strain of Salmonella Tennessee was isolated from unopened jars of peanut butter and from environmental samples collected from the processing plant. The product was recalled, and new illness reports declined. Unsanitary conditions at the Sylvester, Georgia, processing plant were known about since 2004. On April 5, 2007, ConAgra announced inadvertent moisture from a leaking roof and sprinkler system could have promoted bacteria growth in the plant. Great Value brand was sold at Walmart stores.[3]

Beginning in November 2008, CDC PulseNet staff noted a small and highly dispersed, multistate cluster of Salmonella Typhimurium isolates. The outbreak consisted of two pulsed field gel electrophoresis (PFGE) defined clusters of illness. The first cluster displayed a unique primary enzyme (XbaI) restriction pattern and an uncommon secondary enzyme (BlnI) pattern. The second cluster had two closely related XbaI patterns that were very similar to the first cluster and a BlnI pattern that was indistinguishable from the first cluster. Illnesses continued to be revealed through April 2009, when the last CDC report on the outbreak was published. A total of 714 were sickened, with 171 hospitalized and at least nine deaths. Peanut butter and peanut butter containing products produced by the Peanut Corporation of America plant in Blakely, Georgia, were implicated. King Nut brand peanut butter was sold to institutional settings. Peanut paste was sold to many food companies for use as an ingredient. Implicated peanut products were sold widely throughout the USA, 23 countries and non-U.S. territories.[4]

On September 22, 2012, the CDC announced a multistate outbreak of Salmonella serotype Bredeney linked to Trader Joe’s Valencia Creamy Salted Peanut Butter. Collaborative efforts by local, state and federal public health and regulatory officials traced the product to Sunland, Inc. a Portales, New Mexico company. Sunland issued a recall of multiple nut butters and products made with nut butters. When the outbreak was declared over, a total of 42 people infected with the outbreak strain of Salmonella serotype Bredeney had been reported by 20 states. Among persons for whom information was available, illness onset dates ranged from June 14, 2012 to September 21, 2012. Ill persons ranged in age from less than 1 year to 79 years, with a median age of 7 years. Sixty-one percent of ill persons were children less than 10 years old. Among 36 persons with available information, 10(28%) patients had been hospitalized. The FDA confirmed that environmental samples collected at the Sunland facility had an DNA fingerprint that was indistinguishable to the DNA fingerprint found in outbreak associated patients.[5]

On August 21, 2014, the CDC announced a multistate outbreak of Salmonella Braenderup involving 6 people residing in Connecticut (1), Iowa (1), New Mexico (1), Tennessee (1), and Texas (2). Almond and peanut butter manufactured by nSpired Natural Foods, Inc. was named as the likely source of this outbreak. The outbreak was declared over on October 16, 2014. Illness onset dates range from January 22, 2014 to May 16, 2014. Among 5 ill persons with available information, one person reported being hospitalized. During inspections at the nSpired Natural Food facility in Ashland, Oregon, between January 2014 and August 2014, the FDA isolated Salmonella Braenderup from environmental samples. A search of the PulseNet database linked ill patients to the environmental isolates taken from the nSpired production plant. On August 19, 2014 nSpired Natural Foods issued a voluntary recall of certain lots of almond and peanut butters because of potential contamination with Salmonella. The recalled brands include Arrowhead Mills, MaraNatha, and specific private label almond and peanut butters.[6]

On December 2, 2015 JEM Raw Chocolate LLC (JEM Raw) of Bend, Oregon announced a recall of its full line of all nut butter spreads due to possible contamination with Salmonella. Health authorities at the FDA, Oregon Health Authority, Oregon Department of Agriculture and the CDC had linked illnesses in 13 persons who consumed nut spreads. Dates of onset ranged from July 18, 2015 to November 22, 2015. Cases were reported from California, Colorado, Georgia, Hawaii, Idaho, Illinois, Maine, North Carolina, New Jersey and Oregon.[7]

Dixie Dew and I.M. Healthly, and the entire supply chain, should have been aware of these outbreaks and taken precautions.

[1]           https://www.cdc.gov/ecoli/2017/o157h7-03-17/index.html

[2]           A 1996 Salmonella Mbandaka outbreak linked to peanut butter sickened at least 15 in Australia – Aust N Z J Public Health 1998 Scheil

[3]           https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5621a1.htm

[4]           https://www.cdc.gov/mmwr/preview/mmwrhtml/mm58e0129a1.htm

[5]           https://www.cdc.gov/salmonella/bredeney-09-12/

[6]           https://www.cdc.gov/salmonella/braenderup-08-14/

[7]           https://www.cdc.gov/salmonella/paratyphi-b-12-15/

The Ohio Department of Health, several other states, the Centers for Disease Control and Prevention (CDC), and the United States Department of Agriculture Animal and Plant Health Inspection Service (USDA-APHIS) are investigating a multistate outbreak of human Campylobacter infections linked to puppies sold through Petland, a national pet store chain.

The outbreak includes 39 people with laboratory-confirmed Campylobacter infections or symptoms consistent with Campylobacter infection who live in 7 states (Florida, Kansas, Missouri, Ohio, Pennsylvania, Tennessee, and Wisconsin) and were exposed to puppies sold through Petland stores; 12 are Petland employees from four states and 27 either recently purchased a puppy at Petland, visited a Petland, or visited or live in a home with a puppy sold through Petland before illness began.

Epidemiologic and laboratory evidence indicates that puppies sold through Petland stores are a likely source of this outbreak. Petland is cooperating with public health and animal health officials to address this outbreak.

Campylobacter can spread through contact with dog feces. It usually does not spread from one person to another.

Illnesses began on dates ranging from Sept. 15, 2016 through Aug. 12, 2017. The most recent illness was reported on September 1, 2017.

Ill people range in age from <1 year to 64 years, with a median age of 22 years; 28 (72%) are female; and 9 (23%) report being hospitalized. No deaths have been reported.

Epidemiologic and laboratory findings have linked the outbreak to contact with puppies sold through Petland stores. Among the 39 ill people, 12 are Petland employees from 4 states and 27 either recently purchased a puppy at Petland, visited a Petland, or visited or live in a home with a puppy sold through Petland before illness began.

Whole genome sequencing showed samples of Campylobacter isolated from the stool of puppies sold through Petland in Florida were closely related to Campylobacter isolated from the stool of an ill person in Ohio. Additional laboratory results from people and dogs are pending.