Cronobacter sakazakii Isolated in Two Infants in New Mexico, 2008

In the October 30, 2009, edition of its weekly MMWR publication, the Centers for Disease Control and Prevention (CDC) reported on an investigation in November, 2008, when the Cronobacter sakazakii bacteria was isolated in two different infants. As recognized by the CDC, isolation of this organism from human specimens is rare and makes these cases notable. Cronobacter sakazakii (formerly Enterobacter sakazakii) are rare causes of infant septicemia and meningitis, resulting in death in approximately 40% of cases. Since 1958, 120 cases of Cronobacter sakazakii infection in infants have been reported, an average of fewer than three cases per year worldwide. Powdered infant formula (PIF), which is not sterile, has been implicated repeatedly as a vehicle of Cronobacter infection. This report provides important additional information regarding this elusive pathogen, and updates the CDC’s recommendations regarding safer PIF preparation, storage, and handling.

The Cronobacter sakazakii bacteria were isolated from two non-hospitalized, unrelated infants in November, 2008, in New Mexico. The CDC and FDA investigators determined that the female infant had been infected with Cronobacter sakazakii, and that the male infant had been colonized with Cronobacter sakazakii, without clear evidence of infection. Ingestion of PIF was the only identified risk factor for Cronobacter sakazakii exposure for the two infants. The two infants had consumed the same brand of PIF but had no other common exposures. The female infant had documented Cronobacter sakazakii infection that led to severe brain injury and hydrocephalus. Although a Cronobacter sakazakii organism was isolated from the male infant at autopsy, the role of that organism in the infant's apparent death from SIDS is unknown.

The two infants had consumed the same brand of formula, but their clinical Cronobacter sakazakii isolates had different Pulsed Field Gel Electrophoresis (PFGE) patterns. None of the samples obtained from the home of the female infant yielded Cronobacter sakazakii. Samples taken from the home of the male infant, however, provided positive results for Cronobacter sakazakii. An opened can of PIF yielded a Cronobacter sakazakii isolate with a PFGE pattern that was indistinguishable from the clinical Cronobacter sakazakii isolate from the male infant. Additionally, the vacuum cleaner filter from the home of the male infant also yielded Cronobacter sakazakii, but with a different PFGE pattern than the PFGE pattern isolated in both the male infant and the open PIF can.

The CDC reaffirmed in this report that prior investigations have found Cronobacter sakazakii cultured from prepared formula, unopened PIF containers, and the environment where PIF was reconstituted, clearly implicating PIF as the source of outbreaks. Other than an improperly prepared intravenous nutrition solution implicated in one outbreak, no other clear source of Cronobacter sakazakii infection has been identified to date. Accordingly, the report recommended that preparers should be aware that PIF is not sterile and can contain pathogenic organisms, such as Cronobacter sakazakii. The report also recommended that WHO guidelines for preparation of PIF, including reconstitution with water hot enough to inactivate Cronobacter sakazakii, be adopted, for safer PIF preparation, storage, and handling. In the United States and elsewhere, present recommendations are: to breastfeed infants when possible; to use sterile liquid infant formula in high-risk settings (e.g., neonatal intensive-care units and hospital nurseries); and to adhere to the safest available PIF preparation procedures. Interestingly, the CDC report noted that the manufacture of sterile powdered infant formula, perhaps by using irradiation in combination with other techniques, could prevent infant disease. Finally, the CDC stated that further precautions to prevent extrinsic contamination of PIF are needed, including the engineering of PIF packaging to prevent introduction of contaminated hands, scoops, or other items.

The complete report is accessible at MMWR. 2009:58;1179-1183.

South Korea's Maeil Dairy Baby Formula Contaminated With Enterobacter Sakazakii

From news services in Seoul comes world that a South Korean baby formula is contaminated with Enterobacter sakazakii, the baceria that can cause meningitis in infants.

South Korea's National Veterinary Research and Quarantine Service (NVRQS) said Enterobacter sakazakii bacteria was found in 695kg of powdered milk made by Maeil Dairies Co. June 17. The discovery was made during regular sample testing by the agency under the food and agriculture ministry.

The government agency said the 53,460 individual 13g packages were contaminated overall, although none had reached the retail market.

Enterobacter sakazakii or Cronobacter poses particular risks to babies under six months old or weighing under five and half pounds. However, it poses no threat if mixed with boiling water exceeding 158 decrees.

"Investigators are trying to find the cause of the contamination that may have been related to the manufacturing process or the ingredients used," an NVRQS official said.

He said all products suspected of being tainted with the bacteria are currently in a holding area and will be destroyed, with Maeil ordered to take steps to prevent a recurrence.

The products contaminated were all disposable packages of the company's Premium Goong 1 baby formula. Larger cans containing the formula were not tainted with the bacteria.

According to financial websites: Maeil Dairy Industry Co., Ltd. with annual sales in the $1 billion range produces baby foods, beverages, yogurts, and soybean milk products. It also offers milk, fermented milk, cheese, nutritional meals for the pregnant, and oil products. In addition, the company imports and supplies chocolates, olive oil, and grape seed oil. Its products are used in hotels, restaurants, bakeries, and coffee franchises. Maeil Dairy Industry Co., Ltd. offers its products through contracted distributors. The company exports its products to Saudi Arabia, Jordan, Syria, Sudan, Egypt, the United Arab Emirates, China, Japan, Hong Kong, Macao, Singapore, Vietnam, Bangladesh, Afghanistan, the United States, Guam, Canada, Mexico, and the Russian Federation.
 

Bad Whey Not the Route Into China's Infant Market.

 

 

Whey protein being exported from the United States and New Zealand has been stopped at the borders of the People's Republic of China, the Shanghai Daily reports.

The whey protein was, according to China, contaminated by enterobacter sakazakii, a potentially fatal bacteria for infants that can cause bacteraemia, meningitis and necrotising enterocolitis.

The whey protein was being shipped to the infant products manufacturer Beingmate Group Co Ltd and Hangzhou-based Wahaha Health Food Co Ltd.

A total of 37 tons of whey protein imported by Beingmate from the United States and 5.2 tons Wahaha imported from New Zealand were tainted with the bacteria.

All the whey protein was " rejected or destroyed." The Shanghai Daily did not name the companies importing the bad whey.  For more, go here.

Recent E. Sakazakii Death and Near-Death Prompts Commentary

The Star-Gazette in Elmira, NY carries a timely commentary by Norma Ritter (right) on behalf of the La Leche League on the danger of Enterobacter Sakazakii in a first world country like the United States.  Her comments come in response to these two terrible incidents:

  • On Dec. 2, the New Mexico Health Department reported that one baby died and another was hospitalized because of infections caused by different strains of the bacteria Enterobacter sakazakii. (We reported on the death here.) Both babies had been fed powdered formula, which the Centers for Disease Prevention and Control says has been associated with contaminated powdered formula products.
  • On Nov. 25, a 5-month-old baby, weighing only 8 pounds, 6 ounces, almost died from water intoxication and malnourishment. His mother had been using water to dilute the formula she got each month through the Women, Infants and Children program. She could not afford the $16 to $18 for each of the additional five to seven cans the baby needed.

She also ties in some pointed comment on the melamine scandal and our government's response to it.  Check out what she has to say here.

New Mexican Baby Death Blamed On E. Sakazakii

One baby is dead and another is in the hospital as a result of baby formula contaminated with Enterobacter sakazakii. Both infants are from New Mexico border counties.

Enterobacter sakazakii causes an infection to the bloodstream and central nervous system.

The illnes has killed a male baby from Otero County and has left a female baby from Lea County hospitalized.

The U.S. Centers for Disease Control and Prevention says the illness is associated with powdered baby formula.

Both New Mexico babies, who were unidentified, had been fed powdered formula and other foods. They had different strains of the bacteria.

The Health Department says it's working to determine what caused the babies to develop the infection.

Beacon News & CBS2 in Chicago Press For Answers - Hospitals Still Putting Premature Babies At Risk Of E. Sakazakii

Why six years after being advised NOT to use milk-based powdered formula for feeding premature babies are hospitals still doing it?

That's the question that a joint investigation of The Beacon News and Chicago's CBS2 affiliate raises as it looks into why premature babies were fed powdered formula that was contaminated with Enterobacter Sakazakii.

Five-month old Connor McGray died on May 3, 2008.  Connor McGray and his twin brother Logan were born prematurely on Nov. 16, 2007, at Rush-Copley Medical Center in Aurora, IL.  Originally, Connor was the stronger of the two premature babies.  But then, he became lethargic and refused to eat.

The cause of death listed on the baby's death certificate is hydrocephalus and bacterial meningitis. The bacterial infection, according to a memo from the Illinois Department of Public Health, "may be associated with the consumption of a powdered breast milk fortifier."

The Enfamil brand powdered formula was fed to the baby while he was being cared for in the Neo-Natal Intensive Care Unit at Rush-Copley.

The Beacon News story sums up the threat Enfamil and like formulas present to premature babies:

 

"The danger with powdered formula is that, unlike the liquid kind, it cannot be sterilized, making it vulnerable to bacteria growing in it, according to the Centers for Disease Control and Prevention.

The most severe cases involve babies exposed to a bacteria called Enterobacter sakazakii, or E-sak, which can lead to raging infections, severe brain damage and ultimately death, according to the CDC.

(His mother) Amanda Carlin said Connor died after the E-sak bacteria led to an infection which caused the deadly form of meningitis.

The baby suffered from seizures and brain abscess. And his blood and cerebral spinal fluid tested positive for the organism, the Health Department document says."

Health professionals were warned about this in 2002 by FDA in this memo after an E. sakazakii outbreak in Tennessee in 2001.   CBS2 tonight reported on another victim in Des Moines, Iowa.  In that case, the infant is still alive but suffering from severe brain damage.  

See tonight's CBS2 report by going here.

The Beacon's main story is here.

 

China Blocks Milk Imports At Its Borders: Australians Insist Their Products Are Safe

 China and Australia are trading partners, but are not seeing eye-to-eye when it comes to the safety of some milk products being imported to the PRC. As we reported earlier this month: China Finds Enterobacter Sakazakii In Australian Baby Milk

China turned away nine tons of Ausnutria products, manufactured by Australian dairy supplier Tatura and 14 tons of Pauls milk, produced by Parmalat Australia, a subsidiary of the Italian food giant. All, said the China Inspection and Quarantine (CIQ) , contained Enterobacter sakazakii which can cause fatal infections in infants.

For its part, Tatura said it was surprised by the CIQ findings, and that it would not change its own testing procedures and it wanted to make clear that Tatura's product was not linked to the recent scandal in which the industrial chemical melamine was discovered in milk made by 22 Chinese companies and then in eggs.

China's melamine scandal has made at least 53,000 children ill, and killed at least four.

After exporting 891 tons of product to China this year, Tatura officials were flustrated by being blocked at the Chinese border. We don't get the results. You can't negotiate, you can't fight it, it just gets turned around (at the border)."

Meanwhile, some European officials were even more blunt. "It's just something they use, I'm sure it's retaliation," a European Union official said.

For more, go here and here.

China Finds Enterobacter Sakazakii In Australian Baby Milk

Baby milk, manufactured by Australia's Ausnutria Dairy Co Ltd, was found to contain the Enterobacter sakazakii bacteria and rejected for import to China.

China Daily reported that batches of the Australian baby milk were among  2,719 consignments of imported food and cosmetics were rejected in the first seven months of this year, according to the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ).

 

Of the rejected goods, 191 consignments were discovered during inbound tests, the AQSIQ said.

The tainted baby milk, manufactured by Australia's Ausnutria Dairy Co Ltd, was discovered on June 10 by the Hunan provincial quality supervision and inspection bureau.

China Daily said there were no reports of illness from Enterobacter sakazakii related to the bad milk. For more on the rejected imports, go here.

 

Looking for Melamine, Enterobacter sakazakii Bacteria Found in Sanlu Powdered Milk Formula

As if Sanlu does not have enough to worry about - A pathogenic bacterium has been found in milk powder that was also contaminated with melamine, according to a report in the Lanzhou Daily.  The report said that the Administration of Quality and Technology Supervision in Gansu Province issued an emergency notice on September 21, saying that Sanlu’s older and younger infant formulas contained enterobacter sakazakii as well as the toxic melamine.  Enterobacter sakazakii (E. sakazakii) is a gram-negative, non-spore-forming bacterium belonging to the Enterobacteriaceae family. It has previously been found in powdered infant formula around the world.  A 2007 World Health Organisation report, Microbiological Risk Assessment Series, No. 6, concluded "Intrinsic contamination of powdered formula with E. sakazakii can cause infection and illness in infants, including severe disease ... and death."

Enterobacter sakazakii is an uncommon, but often fatal, invasive pathogen that causes bloodstream and central nervous system infections.  The gram-negative, non-spore-forming, rod-shaped bacterium is from the family Enterobacteriaceae – the same family that E. coli O157:H7 belongs to.

While E. sakazakii has caused disease in all age groups, it is likely that immunocompromised or medically debilitated infants are more susceptible to infections with E. sakazakii.  One contributing factor in infant cases could be that the stomach of newborns, especially of premature babies, is less acidic than that of adults.  Several outbreaks traced to contaminated infant formula have occurred in neonatal intensive care units worldwide.

International Conference on Cronobacter (Enterobacter sakazakii)

UCD Centre for Food Safety presents a conference to be held at University College Dublin, Ireland over two days from Thursday January 22nd to Friday January 23rd in 2009.

The conference is intended as a forum to disseminate information between industry, clinicians, government bodies and academic research. This will be the first conference of its kind where representatives from all these disciplines with an interest in this area are gathered together to exchange ideas.

The conference will include sessions on taxonomy, identification, surveillance, occurrence, public health and risk assessment. Workshops will be held after each series of talks to provide an opportunity for questions and open discussion.

The conference will include poster as well as oral presentations and abstracts are invited.

UCD Centre for Food Safety Conference on E. sakazakii on January 22nd and 23rd in Dublin, Ireland.

For those interested in E. sakazakii, the place to be in the middle of January in Dublin, Ireland. See attached brochure.



The UCD Centre for Food Safety is engaged in the following research:

a. Development of an efficient capture-detection strategy for E. sakazakii in desiccated milk product and other base powders. This will be evaluated against the standardized US-FDA method requiring a 5-day test.

b. Determine the genetic relationship(s) by Pulsed-Field Gel Electrophoresis (PFGE), among a large collection of Enterobacter sakazakii from desiccated product, the processing plant environment and fatal cases of infection. Define isolate biotypes among these groups based on computational evaluation of macrorestriction DNA profiles.

c. Evaluate the thermotolerance characteristics among representatives of the biotypes as identified by PFGE.

d. Describe the molecular mechanisms contributing to the organism’s ability to survive under extreme dry-stress conditions.

Enterobacter sakazakii is a Gram-negative bacillus and a member of the family Enterobacteriaceae, genus Enterobacter. E. sakazakii is an emerging pathogen associated with meningitis and necrotisingenterocolitis in immunocompromised infants. Case mortality rates vary from 40-80%; with the majority of those who survive Enterobacter associated meningitis (94%) developing an irreversible neurological sequalae.

Jakarta Mothers Pressure Government on E. sakazakii

Mothers in Jakarta are pressuring the government to disclose which brands of formula milk have been found to be contaminated with the Enterobacter sakazakii bacteria.

The Jakarta Post reports the issue flared up after the Bogor Institute of Agriculture (IPB) announced findings that 22 percent of formula milk for infants on the market was infected with the bacteria Enterobacter sakazakii.

The newspaper quoted some of the worried mothers,  who want the government to disclose the brands:

"Since the issue of contaminated formula milk spread last week, I've been worried about my son's health," said Mona, a resident of Cilincing, East Jakarta.

"I hope the government discloses the brand names as soon as possible so the public, especially mothers, do not panic," she added.

Rini, a 36-year-old mother, said the government should also inform the public of the effects of contaminated formula on children.

"It is so confusing. As a mother of a 2-year-old girl, I urge the government to tell us the brand names and the effects of long-term consumption of the contaminated formula. Does it cause autism? Does it cause brain inflammation?" said Rini, who lives in Bekasi.

The Drug & Food Monitoring Agency, according to the Jakarta Post, is studying an additional 96 samples and will have results in about two weeks.  The complete story about the mothers can be found here.

Enterobacter sakazakii in infant formula

The Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) regulates infant formula manufacturers to ensure that all infant formula sold in the United States is safe for babies to consume.  FDA conducts yearly inspections at infant formula manufacturing plants, and collects and analyzes product samples. 

Baby formula can be purchased in either powder, liquid concentrate, or ready-to-feed form.  Powdered infant formula has been identified as the source of E. Sakazakii outbreaks, and adherence to proper formula preparation is important to prevent the growth of any bacteria that could be present in the formula.  According to FDA:
In most cases, it's safe to mix formula using ordinary cold tap water that's brought to a boil and then boiled for one minute and cooled. According to the World Health Organization, recent studies suggest that mixing powdered formula with water at a temperature of at least 70 degree C—158 degrees F—creates a high probability that the formula will not contain the bacterium Enterobacter sakazakii—a rare cause of bloodstream and central nervous system infections. Remember that formula made with hot water needs to be cooled quickly to body temperature—about 98 degrees F—if it is being fed to the baby immediately. If the formula is not being fed immediately, refrigerate it right away and keep refrigerated until feeding.
The FDA fact sheet on infant formula can be found here.