Sunday, January 22, 2012

Mosaic of life... bacteria 'R' us

Watching waves in the quiet of the morning hours, I find my peace.  The waves were clear and crisp; an icy blue-green.  Perfect surfing waves. Surfing a wave is learning to live with the world around you.  You are the ocean and yet you are not the ocean.  You are the ocean for one brief moment in time, all wet and salty.  Your senses take in the warmth of the sea, the taste of salt and seaweed.  You share your wave with a host of sea animals.  In the distance there may be dolphins playing in the waves, too.  Sometimes, you get a close encounter with a black-tipped shark plying the waters for food.  Hopefully, you are out of bite-range.  You may step on a little crab or step on the mighty manta ray.  Overhead the pelican soars and splashes hard, right near where you want to be to catch some waves.  The laughing gulls are making a mighty racket today.  I think they are laughing at me, the old woman thinking she can play at their beach.  You play in the ocean and you begin to respect the lives around you.  Live and let live, let's all enjoy our moments on this planet called earth.

Watching the ocean is never as good as being in it.  Although who hasn't been mesmerized by the sea.  Enchantment.  That enchantment never ends and is replayed and replayed on the faces of our children.  Watch a child play by the sea.  They bury themselves in the sand, and some even eat the sand. Then they run to the ocean to wash it off.  But the ocean does not so easily wash off.  It enters your pores and creates a memory that never dies.  You walk to the beach as an adult and that memory comes back to sooth your soul.

We are the ocean, we are the earth.  We are the bacteria of our environment.  We cannot escape our environment.  Life is out there but life is within us.  Scary but not so scary.  Our bodies know what to do, if our immune system is in working order.  We live in balance with the pathogens in our environment.  The problem is when our bodies cannot maintain that balance.  When our immune system is no longer able to cope with the pathogens in our environment.  

With the human infant the balance is preserved by breastfeeding.  Breastfeeding, is a river of life.  This river of life protects the infant from being overwhelmed by the pathogens in the environment.  Humanity cannot live in sterile settings, not possible.  We can try.  We can sterilize everything and anything but that does not protect us from the world.  We live with microbes, the good and the bad ones.  We can sterilize our foods, we can sterilize our environments, but that doesn't protect us from disease.  In fact it may make us more vulnerable to disease.  We now know that we need good bacteria in our bodies, that good bacteria works in our digestive tracts.  Sterilizing everything makes us more vulnerable, when the next pathogen emerges. 

Infant formula usage is predicated on the ability to sterilize the water, sterilize the equipment, and sterilize the food.  And for good reason.  A human infant that is not breastfeed is in a state of immune compromise.  They are not getting a substance that is alive with antibodies and protective factors against bacteria, viruses, fungi, and parasites.  Instead the formula-fed infant is being served a dead substance.  A substance that, if it has anything alive in it, is pathogenic to that infant.  If there is a bacteria in that food, the formula-fed infant may not be able to muster an adequate defense.  And the more vulnerable the infant (born by C-section, premature, hospitalized, medical issues), the more likely that infant may succumb or become damaged by a pathogen.  Infant formula has to be sterile but there is a recognition by industry that formula-fed infants need bacteria, the good bacteria, that breastfed infants acquire and keeps them healthy.  The question is how do you put a live substance in a food that needs to be sterile (devoid of life)?  I don't think it can be done.  Maybe its time to admit, that breastfeeding in this day and age (with antibiotic resistance and new virulent pathogens) is a matter of public safety.  

How should a nation spend its public resources?  We, humans, think we can circumvent nature, that liberation is about choice in infant feeding.  Yet this choice seems foolhardy.  Society will spend a fortune in trying to keep infant formula a safe product.  But if the premise of choice is based on an illusion of safety, then we will continue to invest in a product that cannot build a fully functioning immune system.  We risk the health of our children, our future.  We are our environment.  Our bodies are a mosaic of all the things we encounter while we go about our daily lives.  Babies who are breastfed have a live substance, that works to protect them on a daily basis.
 Copyright 2012 Valerie W. McClain

PS:  Cronobacter is a gram negative bacteria that seems prevalent in our environment.  They have cultured it in hospitals, powdered infant formula, feeding equipment, a wide variety of foods.  Enterobacter sakazakii (Cronobacter) has been found on air filters in a manufacturing plant for powdered milk protein.  This study makes for interesting reading for those who are interested in the problems of PIF (Powdered Infant Formula).

This article is entitled, "Dissemination of Cronobacter spp.(Enterbacter sakazakii) in a Powdered Milk Protein Manufacturing Facility," by N. Mullane et al (Appl Environ Microbiol. 2008 October; 74(19): 5913-5917.
"Air is a potential source of hazardous microoorganismsand one conclusion they draw, "Appropriate air filter maintenance along with surveillance for Cronobacter spp. would contribute to reducing the dissemination of these pathogens in the food chain."

Sunday, January 15, 2012

Little Miss Muffet rewrites history while sitting on her tuffet, eating her gmo curds and whey

Remember Little Miss Muffet who sat on her tuffet (eating her curds and whey)?  As a child, I wondered what was she sitting on?  What's a tuffet?  I thought it was another word for butt but just today I learned that tuffet is a low stool.  Yep, I am still learning new things at 60.  Was I a dumb little kid?  Or did I just not care because curds and whey wasn't a food I knew?  Sounded pretty awful to me.  And when I learned it was cow's milk...well that really grossed me out.   Of course, you have to understand I have an aversion to cow's milk (I now know it is an food allergy, among the many I am collecting).  My mom switched me to orange juice when I was a baby because I seemed to have a problem with evaporated milk and karo syrup. Never got mommy's milk.  Mom said she didn't breastfeed me cause it didn't work for my older brother.  Wonder if I would be different, if I was a breastfed baby?   How did I survive?  Great genes?  Maybe I had the gene for orange juice?  Maybe my body knew I would eventually live in Florida?  Maybe it's the reason I moved to Florida?  The mysteries of life will never be unraveled.  A person's history is so easily rewritten by forgetfulness, wishful thinking, and sometimes outright lies.  So much like how countries rewrite history to suit the current politics.  Or how the biotech/food industries are rewriting their history.

Shall we talk about how food industry/biotechnology rewrites history?  Only someone my age who has been looking at this information since the 1990's can see the rewriting of history regarding our food technology.  I have been trying for the past 2 weeks to find an article I saw some years ago which gave a history of genetic engineering.  In that article I distinctly remember them stating that 1985 was the year that genetic engineering of enzymes went commercial.  Do you think I can find that article now?  Nope.  Is my memory fading fast as I age?  Maybe, but I have a pretty good memory for odd bits of information.  Of course I cannot remember my kid's birthdays and one of my children reminds me of that fact from time to time.  Red with embarrassment for being such a terrible mother, I sometimes remind her that I breastfed her.  I am hoping that will compensate for my memory loss of birthdays.

So one can wonder whether or not I really saw that little fact about enzymes being genetically engineered commercially in 1985 or is history being rewritten?  What I am finding now across the internet is the information that the FDA approved the first enzyme that was genetically engineered in 1990.  That enzyme was chymosin (rennet) used in the production of cheese, manufactured by Pfizer.  Yes, I see ears perking up. Pfizer is not only a drug company, but also in the past few years bought out the infant formula division of Wyeth.  Later on I found information that Chr. Hansen marketed the enzyme for Pfizer in 1989.

Chr. Hansen is a global supplier of cultures and dairy enzymes, probiotics and natural colors.  They describe their ingredients as "natural."  Yet they did market chymosin genetically engineered for Pfizer and still seem to be developing and marketing this genetically engineered enzyme.  Their website shows a video of a baby being bottlefed with formula that has probiotics.

The Pfizer patent on the genetic engineering of calf rennin was filed in 1984, published in 1990.  It was entitled, "Expression plasmids for improved production of heterologous protein in bacteria," patent number 4935370, inventor Arthur E. Franke, owned by Pfizer.  The bacteria they were using was e.coli.  In the US, it is near impossible to obtain a cheese made with the real enzyme (comes from a calf's stomach).  Our food coop tried some years back to obtain cheese that was not processed using the genetically engineered enzyme.  We could only find cheeses from Europe that were so costly (importing adding to the cost) that we gave up. 

One of the things I have learned from looking at patents and their filing dates and publication dates that once a big company files a patent it usually becomes a product in the market place.  So I would suggest to readers that the filing date of Pfizer suggests that this became commercial in all probability in late 1984 (October) or 1985.  Can a food product go into the market place before FDA approval?  It looks that way to me. So 1990 is the date when the FDA approved the first genetically engineered food product for humans.
("Gene-altered Item Approved by F.D.A.," by Martin Tochin, The New York Times, March 25, 1990)

"When genetic engineering was developed in 1973, it was recognized as a more efficient method of replacing an array of industrial processes, from plant breeding to animal husbandry to the development of new pharmaceutical products and bulk foods."

Why am I fixated on dates?  Most websites, even those opposed to genetically engineered foods, state that genetically engineered foods entered the marketplace in 1995 with the genetic modification of soybeans, corn. etc (food crops).  Yet the real truth is that at least 5 years previously (if you believe that 1990 is the date, I believe 1985 is the true date), genetically engineered foods entered in to marketplace in the form of a new enzyme.  This enzyme was manufactured with the pathogen e.coli.  Genetic engineers originally used e.coli because at that time it was known as a benign pathogen, not harmful.  Strange how that has changed over the years and now we know of people who die from a vicious form of e.coli.  I find it stranger that many people do not connect the new virulence of pathogens (antibiotic resistant--genetic engineering uses antibiotic resistant genes) to our new technology.  We just believe that it is a natural mutation.

It seems to me that if the public is kept in the dark about when genetic engineering happened, then it is easy to dismiss the issues of antibiotic resistance, more virulent pathogens as just normal mutations.  It's easy to fool the people, when you change history.  It's just minor variations of the truth, right?  Or is it?  Take for instance the argument I got into with a food safety expert (employed by industry and government) regarding Enterobacter sakazakii.  She states categorically that J.J. Farmer did not discover Enterobacter sakazakii, he just renamed it.  Yet a paper written in the International Journal of Systematic Bacteriology of July 1980 is entitled, "Enterobacter sakazakii:  a New Species of 'Enterobacteriaceae' Isolated from Clinical Specimens."  In this article from 1980, Farmer et al. state, "The proposed change in the classification of this organism is based on differences between E. cloacae and E. sakazakii in deoxyribonucleic acid (DNA)-DNA hybridization, biochemical reactions, pigment production, and antibiotic susceptibility."  This is renaming a species, not discovery?  Why would someone in industry refuse to accept that a new pathogenic species has emerged?  Was it natural mutation or have our food technologists created this nightmare in their labs?  By rewriting the history of E. sakazakii (we are being lead to believe that this organism existed in 1959), who benefits?  And who do you believe?  

So how important is the genetic engineering of some little enzyme, called chymosin?  Well, chymosin is used in the production of cheese.  One of the by-products of cheese production is whey.  Whey goes into infant formula.  In fact one of Nestle's selling points regarding its infant formula is that is 100% whey protein, other companies use less.  Whey is suppose to be easy for babies to digest.  

"Enzymes used in the processing of foods do not have to be listed on product labels because they are not considered foods."  from Genetically Engineered Enzymes see

"Little Miss Muffet sat on her tuffet eating her curds and whey, along came a spider and sat down beside her and frightened Miss Muffet away."  Is there a moral to our childhood story?  Beware of hungry spiders? Let me see, I think I will rewrite that story...the genetically engineered spider, glowing in the dark saw Ms. Muffet because he had eaten his DHA for dinner last night....Ms. Muffet couldn't see the glowing spider....because she didn't eat last night....
Yeah, humor me....
Copyright 2012 Valerie W. McClain     

Sunday, January 8, 2012

Powdered Infant Formula (PIF), intrinsic contamination?

~photo by Mariah McClain~

I found myself browsing the internet, cruising around various papers to think about our standard belief that the only risk of powdered infant formula in developed countries is the risk of unsafe water in reconstituting the powder and/or unsafe hygiene practices in preparation of the formula.   We cannot fathom that the product itself might be unsafe, that we might have cases of intrinsic contamination.  We have such faith in our industry, in food manufacturing that we can only believe that the caregivers or hospital environment must be at fault, if a baby sickens from enterobacter sakazakii or salmonellaCertainly, that is a real possibility.  Parents may fix formula by methods that put their infant at risk for pathogens that sicken or kill their infants.  Hospital environments are known for their mix of virulent pathogens.  Yet, no one seems to get their heads around the idea that a food product itself could be the vehicle of pathogens.

Salmonella?  I didn't realize until I read a paper called, "Powderd Infant Formula as a Source of Salmonella Infection in Infants," by Sarah M. Cahill et al in Clinical Infectious Diseases medical journal 2008 that salmonella is another serious pathogen found in powdered infant formulas.

There seems to be the same problems regarding this pathogen as enterobacter sakazakii.  The low levels of the pathogen make it difficult to detect in powdered infant formula.  Vulnerable infants are the most likely to sicken and die.  Both pathogens in outbreaks have low levels in the product samples making it difficult to detect.  This contamination is sporadic and it is believed that there is an under-reporting of these infections.

The journal article on salmonella in PIF makes the following statement, "In the United States, the incidence of salmonellosis (from all sources) among infants (121.6 laboratory-confirmed infections per 100,000 infants) was ~8 times greater than the incidence among other age groups." and

"In terms of public health, it is worth noting that other pathogenic bacteria also contaminate PIF and may cause disease through consumption of PIF (table1)." and,

"A review of peer-reviewed literature revealed several large recent outbreaks of Salmonella infection among infants that were attributable to contaminated PIF, resulting in diarrhea and, in some infants, bacteremia and meningitis.  Such outbreaks occurred even when the consumed PIF appeared to be in compliance with current international standards."

In Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2006;9124):74-9. authors H. Toyofuku et al.

"Experts from two FAO/WHO Expert Consultations, held in 2004 and 2006, concluded that intrinsic contamination of PIF with Enterobacter sakazakii and Salmonella has been a cause of infection and illness in infants, including severe disease which can lead to serious developmental sequelae and death."

In an article in Pediatric Infectious Disease Journal in 2007 entitled, "Two consecutive large outbreaks of Salmonella enterica serotype Agona infections in infants linked to the consumption of powdered infant formula," with authors C. Brouard et al,

"Powdered infant formulas are not sterile products and may contain low levels of Salmonella.  Routine microbiologic controls are insufficient to detect a low-grade contamination, which may cause serious illness and outbreaks among infants."

One would suppose that some people might question their whole-hearted faith that the risks of infant formula are for those infants who reside in developing nations.  How easy it is to blame a parent for mixing the formula wrong.  I once read that even the well-educated (college degrees) measure powdered infant formula wrong, sometimes over scooping the powder and sometimes under scooping it.  The consequences can impact an infant's health and well-being.  

I think the main tragic thought that I mull over in these early hours of the morning is the statement in the paper from Clinical Infectious Diseases
under Risk Management, "Although the World Health Organization recommends that infants should be exclusively breast-fed for the first 6 months of life to achieve optimal growth, development, and health, there is recognition that this is not always feasible..."

I believe it could be feasible.  I have this hope, this faith that we can turn this around.  Society must make a 180 degree turn and decide to create birth environments that support breastfeeding.  Birth environments that empower women who are the ones giving birth. Birth environments that respect the infant and its need for skin-to-skin contact.  Birth environments that give mothers and babies and their families privacy.  Greater access for all women to midwifery care and breastfeeding assistance.  Mothers need to feel supported and comfortable nursing in public.  And society needs to give mother and babies more time together (financial support in the early days so that our future, our children have more human contact with people who are emotionally connected to them).  May this New Year bring more thought and action into supporting mothers and babies.
Copyright 2012 Valerie W. McClain

Wednesday, January 4, 2012

Testing, testing, testing for Cronobacter sakazakii in powdered infant milks

According to an article written by Punendu C. Vasavada, Ph.D., written in August of 2005, "A mere two years ago, the food industry did not have a method to test for E. sakazakii..." [what we now have renamed Cronobacter sakazakii courtesy of researchers employed by the University of Zurich, Switzerland, Nestle Research Center, and University College of Dublin, Ireland]
Dr. Vasavada writes about the difficulty of determining how E. sakazakii gets into infant formula.  He mentions how it has been isolated in very low concentrations, "and even at these low levels, exposed at-risk infants have suffered serious injury and death."  In this article, he describes 3 methods of isolating and enumerating E. sakzakii from powdered infant formula:  the European Method, Canadian Method and the FDA Method.  These methods are all slightly different.  Then he discusses newer methods using PCR (polymerase chain reaction) for rapid screening of infant formula samples.  He states, "In collaboration with Nestle Research Centers in Switzerland and the U.S., Dupont Qualicon developed and introduced in 2003 a PCR-based assay for rapid detection of E. sakazakii in infant formula, dry dairy and soy ingredients samples."

So we have gone from no methods to test for this organism in powdered infant formula prior to the year 2003 to the development of rapid screening methods using PCR.  Some of the same researchers (employed by Nestle) who renamed E. sakazakii to Cronobacter also wrote another paper called, "Development of a Novel Screening Method for the Isolation of "Cronobacter' spp. (Enterobacter sakazakii)," published in Applied and Environmental Microbiology in February of 2008 with one of the authors affiliated with Oxoid Ltd. (a company that sells rapid test kits for the food industry, government, for such pathogens as Cronobacter sakazakii).

Oxoid Ltd. developed a PCR assay for the DuPont Qualicon BAX system.  Dupont Qualicon "collaborated with the Nestle Research Centers in Switzerland and the United States to develop a PCR-based assay for rapid detection of Enterobacter sakazakii in food and environmental samples."

Oxoid Ltd is one of the many partners to the CDC Foundation.  Some of the many partners are Abbott Laboratories (Ross infant formulas), Bristol Myers Squibb Company (Mead Johnson formulas), Pfizer (which bought out Wyeth's infant formula division), Target (which sells its own brand formula), The Bristol Myers Squibb Foundation, many other drug and food companies like Cargill, Coca-Cola, GlazoSmithKline, Gilead. OraSure (hiv testing), Eli Lilly, Genentech, Merck).  These partners work with the CDC Foundation's projects. 

As someone looking at this situation from a perspective of research funding and influences, I am rather concerned.  You have a huge food corporation, Nestle, funding the research for testing of powdered infant formula and other powdered milk products. Or should I say you have researchers who are paid by Nestle to create testing kits for Enterobacter sakazakii, renamed to Cronobacter (renaming based on research done by some Nestle researchers). While I understand a food company's interest in the development of testing kits for food pathogens, I feel concerned about how in 2011 we cannot find this renamed organism in powdered infant formula.  Yet, babies are still dying and being maimed by this organism.  So should we believe that the infant formula industry has fixed the problem of contamination by this organism in powdered infant formula?  And should we now believe that that the problem is in the environment, somewhere in the environment, either the parent improperly fixing the product or the hospital personnel improperly fixing the product? Legally for the infant formula industry, not finding this pathogen in powdered infant formula this year is financially beneficial. No lawsuits because they can prove by tests (that industry created) that the organism no longer resides in powdered infant formula.  It leaves this situation in a terrifying muddle because parents cannot know exactly how to protect their infant, other than breastfeeding.  And we know from the various infant formula blogging mommies that that isn't going to happen anytime soon.  I would feel more comfortable about this situation, if the tests that were developed had no one from the food industry involved.  And I would feel more comfortable about this situation if the CDC was not getting its "projects" funded by the CDC Foundation that partners with most of the infant formula, food, and drug industry.   Why aren't we more concerned about the kind of influence and funding going on that impacts our health care system.  Testing kits are becoming the bread and butter of our medical care, and yet their accuracy seems to go unquestioned.  We use genetic engineering techniques for these tests based on the belief in the infallibility of the science.  Yet from my perspective, it is akin to believing in the infallibility of the Catholic Pope.  Medical science has become a faith-based system and all doubters  are excommunicated. 
Copyright 2012 Valerie W. McClain

Sunday, January 1, 2012

Emerging pathogen, enterobacter sakazakii in powdered infant formula

A Reuter's article dated December 30, 2011 states:  "U.S. health officials said they found no trace of potentially deadly bacteria that killed two infants in recent weeks in sealed cans of Enfamil baby formula, and a recall was unnecessary, providing relief for the product's manufacturer, Mead Johnson Nutrition Co."  Providing relief... we seem to be only concerned about the relief for the infant formula company.

Later the article states, "Mead Johnson's name may be cleared, but the company will likely take some time to fully heal..."  Fully heal from the falling of their stock shares by 10%.  

Then the even sadder news for Mead Johnson, "negative publicity has already damaged Enfamil's brand equity and could have cost the company one cycle of new parents."  One whole cycle of new parents.  I think we are a sick society,when our public concern is for an industry that loses its market shares over parents whose infants have died or been maimed by a product.  A product that is considered a safe "choice" in our developed countries.  Mead Johnson has become a person in the heart and minds of this PR campaign to protect an industry.  As a corporation in the USA, it is a person.  It must heal, it must be offered relief.  What about the parents of those dead and maimed infants?  Will they get relief?  Will they fully heal from their grief? 

This article adds a little surprise.  "The death of a second baby, in Florida, was not known until an update from the US Food and Drug Administration and the Centers for Disease Control and Prevention late on Friday following the testing of samples taken from the infected babies' homes and company facilities."  What about the other baby girl, 25-day old Ivyionna Marie Pinnix of Grant City,  Missouri who died?  What is the explanation for her death?  She is not mentioned in most articles I have read.  And the Florida death, I live in Florida and I never heard about this.   Weird, its like there is a campaign of minimization of this tragedy.  Who does this protect?  Parents who might get upset that powdered infant formula is not necessarily a safe "choice."  Or are we protecting industry from lost profits?

I found an interesting article dated April 20, 2011 from the Ottawa Public Health, an alert on Cronobacter Sakazakii.  "Two infant cases of Cronobacter sakazakii meningitis were recently reported to the US Centers for Disease Control and Prevention (CDC) with onset dates March 25, 2011 and March 26, 2011.  These cases originate from Michigan and Ohio.  Typically, the CDC is aware of four cases annually."  Well, 2011, is beating this average, because  just by my count this brings it to 6 cases (not including the infant from Grant City), two deaths and 4 infants hospitalized.  Infants who survive meningitis from enterbacter sakazakii often are brain damaged with long term health issues. 

Today I found an article in Antara News (Jakarta, Indonesia) dated July 8, 2011 entitled, "All milk brands in RI found sakazakii-free."  

"Six months after mothers made a public fuss about formula milk tainted by Enterobacter Sakazakii, the Health Ministry has once again announced that all milk brands in circulation were free from the dangerous bacteria."  This article states how rare this pathogen is and that tests conducted in 2003 and 2006 found 20% percent of the samples were contaminated by Sakazakii bacteria..."the brands of the tainted milk have never been made public."  I am impressed that mothers made a public fuss in Indonesia.  Interesting that this organism cannot be found in powdered infant formula in 2011.  Yet it was found in 20% of the samples back in 2003 and 2006.  It's a miracle this organism that supposedly is everywhere in the environment can't be found in powdered infant formula anymore.  I guess they have figured out a way to sterilize the powder (although that is not possible).  So what's up with this?  Maybe its the range of difficulty of testing this organism in samples.  Maybe its the samples they get?  Maybe its reclassifying the organism--strange how industry itself (Nestle) can set the guidelines for classifying a pathogen implicated in the contamination of their product.  Rather interesting conundrum, the experts state that it is everywhere in the environment.  Yet it is no longer residing in powdered infant formula.  Can't be found.  So we are left in confusion other than telling parents that make the choice to use infant formula, that they should probably use either liquid or ready-to-feed formula for their newborns (much more expensive) or be more careful about boiling water when using the powder (and making up formula one feeding at a time, since long holding times are risky).  An article in a medical journal, Surgical Infections dated October 2008 entitled, "Enterobacter sakazakii:  An Emerging Pathogen in Infants and Neonates," by Catherin J. Hunter et al. comes to an interesting conclusion, "We recommend a focus on simple preventative strategies such as the promotion of breast milk feeding, inclusion of warnings on powdered infant formula packages that they may be contaminated with ES [Enterobacter Sakazakii], and abstinence from the practice of re-warming of reconstituted formula."   Hm...that's a problem. Promoting "breast milk feeding?"  How about promoting breastfeeding?  This organism that is in the environment, probably adheres to equipment used in feeding infants.  It would seem far better to promote breastfeeding (even with premature infants).   I am quite sure that no formula company will allow a label that states it's powdered formula may be contaminated with a pathogen.

I continue to read news articles that state that the risks of enterobacter sakazakii in powdered infant formula are small.  Yet are we looking at the tip of the iceberg?  We continue in the USA to promote "choice" because of a good PR system that makes the public believe that it is a balanced even choice between baby formula and breastfeeding.  But when you are the parent of a baby that died from powdered infant formula or was brain damaged or has life-long disabilities, your perceived risk was not small, it was 100%.  The parent lives with it for a life time.  And while a industry will whine about lost profits and brand equity, a parent will have a life-time of sorrow, regret, and unanswered questions.
Copyright 2012 Valerie W. McClain 

**12 known cases in the USA of enterobacter sakazakii in 2011