Marler Blog - Providing commentary on food poisoning outbreaks & litigation

"People just don't really understand how horrible food-borne illness is," said William Marler, a prominent Seattle-based food-safety lawyer who is representing the Rivera family and 23 other victims in the cookie dough outbreak. "They think food-borne illness is a tummy ache and diarrhea."

I was much younger when Martin Luther King gave his famous speech – “I have a dream.”  But, if I could borrow that phase, I too “have a dream.”  I dream that Tuesday morning the President and House and Senate members and their staff would read Lyndsey Layton’s story – “This Woman Might Die From Eating Cookie Dough - Severe Case Gives Context to Issue of Food Safety” and get to work - really get to work.  In fact, I bet Mr. Rivera would love a call of support from the folks in Washington who could help fix this mess.  Call me and I will set it up.

I had a great talk with Tristan Baurick as he was writing “College Discourse Over Food Safety, Courtesy of Bainbridge Lawyer” – that would be me.  As I said, spending a few dollars to bring Michael Pollan to the WSU campus is worth it. It puts:

“Michael Pollan’s biting critique of industrial agriculture, “The Omnivore’s Dilemma” — into the hands of every freshman entering a university known for producing the best minds in agribusiness.”

“The book has become for food what ‘Silent Spring’ was for DDT, and what ‘An Inconvenient Truth’ was for global warming,” Marler said. “It’s helping people focus their attention on what’s happening to them, and how things need to change.”

“I may not agree with all of (Pollan’s) ideas, but I think they need to be talked about,” he said.

The main thrust of “The Omnivore’s Dilemma” — that large-scale food production and distribution are harming human and environmental health — fits with what Marler has learned though almost two decades of helping sick people sue corporations over tainted food.

“It’s a book perfectly suited for (WSU) to grapple with,” he said. “I can’t think of a better place to talk about this, and start dealing with these issues in a big way.”

Free speech is a good thing.

Myself, along with a number of others concerned about the safety of our food supply, were recently interviewed for Eating Well Magazine.  Here is my interview:

SPECIAL REPORTS - Food Safety Expert: Bill Marler

Bill Marler is a managing partner and personal injury lawyer at Marler Clark LLP, PS, and also a national expert in foodborne illness litigation and U.S. and international food safety policy. With his partners, he represents individuals in claims against food companies whose contaminated products cause serious injury and death.

Marler began litigating foodborne illness cases in 1993, when he represented Brianne Kiner, the most seriously injured survivor of the Jack in the Box E. coli O157:H7 outbreak, resulting in her landmark $15.6 million settlement. Marler has focused his practice on representing individuals in litigation resulting from E. coli, Salmonella, Shigella, hepatitis A and other food contamination cases. 

Under the umbrella of OutBreak, the nonprofit consulting arm of Marler Clark dedicated to food safety advocacy, Marler speaks to food industry groups, fair associations, and public health groups about the litigation of claims resulting from outbreaks of pathogenic bacteria and viruses and the issues surrounding it. He keeps a blog at www.marlerblog.com.

What is the single most important thing that can be done (by food growers, producers, government, consumers – any, or all of the above) to improve food safety in the United States?

B.M.: Prepare food, from farm to fork, like you were preparing it for your 4-year-old child. Do it safely. 

10 Commandments of Food Safety

Bill Marler tells us whether he abides by the following food safety recommendations.

1. I use a “refrigerator thermometer” to keep my food stored at a safe temperature (below 40°F).
B.M.: Yes.

2. I always defrost food in the refrigerator, the microwave or in cold water, never on the counter.
B.M.:Yes.

3. I always use separate cutting boards for raw meat/poultry/fish and produce/cooked foods.
B.M.: Yes.

4. I always cook meat to proper temperatures, using a calibrated instant-read thermometer to make sure.
B.M.: Yes.

5. I avoid unpasteurized (“raw”) milk and cheeses made from unpasteurized milk that are aged less than 60 days.
B.M.: Yes!

6. I never eat “runny” eggs or foods, such as cookie dough, that contain raw eggs.
B.M.: Correct.

7. I always wash my hands in warm soapy water for at least 20 seconds before handling food and after touching raw meat, poultry or eggs.
B.M.: Yes.

8. I always heat leftover foods to 165ºF.
B.M.: Yes.

9. I never eat meat, poultry, eggs or sliced fresh fruits and vegetables that have been left out for more than 2 hours (1 hour in temperatures hotter than 90°F).
B.M.: Yes.

10. Whenever there’s a food recall, I check products stored at home to make sure they are safe.
B.M.: Yes.

As I wrote a year ago in a blog post, "Grass-Fed vs Grain-Fed Beef and the Holy Grail: A Literature Review," several people have commented that switching from grain to grass feeding could be one of the solutions to the problem with foodborne pathogens in cattle and other livestock. Quotes like these are becoming more common on the Internet and in recent media reports:

“Products from grass-fed animals are safer than food from conventionally-raised animals.” Eatwild, 2008.

“Research has shown that the strains of E. coli most devastating to humans are the product of feedlots, not cows. This is due to the animals being forced to eat an unnatural diet, and not their natural choice, grass.” Grass-Fed Beef: Safer and Healthier, Animal Welfare Approved, June 15, 2008.

I did an extensive literature review and simply did not find support for the belief that switching from grain to grass for cattle feed would make the world a bad place to be pathogenic E. coli. Now comes an article by S. Reinstein, J.T. Fox, X. Shi, M.J. Alam, D.G. Renter and T.G. Nagaraja. 2009, “Prevalence of Escherichia coli O157:H7 in organically and naturally raised beef cattle. Applied & Environmental Microbiology 75(16):5421-5423,” which states:

"The prevalences of E. coli O157:H7 that we observed in organically and naturally raised beef cattle were similar to the previously reported prevalence in conventionally raised cattle," the researchers said. "No major differences in antibiotic susceptibility patterns among the isolates were observed."

Now, before the internet erupts into a belief culture war between grain feeders and grass feeders, I am not saying that the cows themselves may not well be better off eating grass and roaming the range, and I am not saying that feedlots miles wide are not environmental hazards, but I think we need to face the fact that grain vs grass does not mean “E. coli.”

Kim Archer of the Tulsa World has done a great job of recalling the horrors of the United States’ largest E. coli O111 outbreak.

• 341 were sickened

• 70 people were hospitalized, including 22 children

• 17 people received kidney dialysis, including eight children

• 1 man died

Excerpts from the Article about just one of the victims:

His entire life, Kenneth Birkes has worked seven days a week from dawn to dark. Then he ate a meal in honor of his father's 85th birthday at Country Cottage in Locust Grove. It was Sunday, Aug. 17, 2008. Five days later, Birkes fell ill. The 61-year-old Grove man hasn't worked since.

"I was up in Kansas to get a drilling rig out in the country," he said. "It hit me so quick."  He had just put the rig on a trailer and driven to the town of Edna, all the while calling his wife to tell her he needed help.

"That's really the last thing I remember," Birkes said. His wife initially took him to a hospital in Coffeyville, Kan., but he continued to get worse. He didn't wake up until six weeks later at St. Francis Hospital.

Birkes said he went from making $12,000 a month to nothing.

"This pretty well wiped us out," he said. After three months in the hospital, he had to learn to walk again. Now, he has migraines four days a week and is only able to go three hours at a time before needing to rest.

"I'm still alive, and that's all that matters," Birkes said.

Birkes is among a group of clients of Seattle attorney Bill Marler asking for a settlement from the restaurant's insurance company.

"If they turn us down, we have no choice but to sue the restaurant and the owners for the policy and all personal assets," Marler said.

Denis Stearns and I will be speaking next week at the FSIS District Managers' Conference on "FSIS' Actions in the Judicial Branch" - here is the PowerPoint:

Three Family Members Sickened in Wisconsin, One Gravely.

A Wisconsin family sickened in the JBS Swift Beef Company outbreak of E. coli O157:H7 will file suit against the company Wednesday. The lawsuit will be brought by the Seattle-based foodborne illness law firm Marler Clark in the Federal Court, Eastern District of Wisconsin. This is the third lawsuit filed by Marler Clark in the aftermath of the JBS Swift outbreak, which sickened at least 23 people in nine states, 12 of whom had to be hospitalized.

“This has been a very difficult summer for contaminated meat,” said the family’s attorney, Drew Falkenstein. “Not only have there been several E. coli recalls, but now there is also a large recall of beef contaminated with Salmonella by Beef Packers Inc. With the huge uptick of tainted meat in the last several years, it’s vital that we dedicate resources on every level to prevent more families from going through what the Rosplochs had to endure.”

Nicole and Gerard Rosploch purchased ground beef from a Pick N Save near their home in Brookfield; the meat was later determined to be part of the recall of 420,000 pounds of beef by the JBS Swift Company of Greeley, Colorado. The family (except for Nicole, a vegetarian) made and consumed hamburgers on Sunday, July 19. By Thursday, Gerard and their two sons began to have abdominal cramps and nausea. On Friday, the 7-year-old began to experience frequent episodes of vomiting and frequent diarrhea, some of it bloody. His parents took him to the ER, where he was checked and released, having submitted a stool sample. Meanwhile his older brother, 11, began to show increased signs of illness including vomiting and diarrhea. Gerard’s illness also continued, although not as severe as his sons’.

When the youngest child continued to worsen, he was returned to the ER, where it was learned that the stool sample he previously submitted was positive for E. coli O157:H7. He was admitted to the hospital, where he continued to be very ill. By July 28, tests revealed that he had developed hemolytic uremic syndrome, or HUS—a complication of E. coli infection. The child had to have dialysis for the next 10 days, as well as blood transfusions.

Meanwhile, Gerard began to improve, but his 11-year-old son was still sick at home. For several weeks, the parents split hospital and home care responsibilities.

Their younger son is now also at home, and continues to recover from his illness. He is still on medication to regulate his blood pressure. The genetic fingerprint of the E. coli in his stool sample was a match to that of the JBS Swift outbreak.

June Dunning, E. coli O146:H21, 2006, Death

Right up until the time of her death, Ms. Dunning remained an active, self-aware and outgoing woman. Her health had always been good too. For the last seven years of her life, June lived in Hagerstown, Maryland with her daughter, and her son-in-law. On August 28, 2006, June Dunning consumed some Dole baby spinach from a bag her daughter had purchased at the local grocery seven days earlier. The bag would later test positive for E. coli O146:H21.

June fell ill on September 2, 2006. Her illness quickly progressed, and she was taken to the hospital the following day. June was first seen by a triage nurse, who noted a history of a sudden onset of diarrhea the night before, which had progressed to bloody stools and severe abdominal pain in the morning. June rated her pain at “9" on a 1-10 scale. Further examination and blood tests soon revealed a number of disturbing problems. A CT scan showed revealed diffuse thickening and swelling of the colon, with severe, acute inflammatory colitis of the ascending and transverse colon. June’s blood pressure was elevated. Also, June’s blood work demonstrated the onset of renal insufficiency. She was admitted to the hospital, and started on IV fluids.

Admission to the hospital did not slow the deterioration of June’s condition. She began to lose her mental faculties. She spoke, but did not make sense. She spoke of going to see her husband, deceased since 1996. All the while, she continued to suffer from frequent, painful, bloody diarrhea. Her renal failure deepened. The doctors worried about her colitis leading to systemic toxemia, and opted for surgical removal of a portion of her colon.

June survived the surgery, but continued to deteriorate. She became anemic and was placed in ICU. She stopped producing urine, and progressed to a coma-like state. In the early morning hours of September 7, she suffered a grand mal seizure, and underwent an MRI of the brain. On September 9, she suffered another seizure, followed by a drop in her oxygen levels. She was placed on mechanical ventilation. Her medical bills while hospitalized were nearly $50,000.

From this point forward, it was plain what the outcome would be. An EEG on September 11 showed slowing of brain activity. June’s daughter and son-in-law stayed with her for the final hours. Late on September 11, the ventilator and all medical support save Morphine were disconnected. The doctors said they expected June to pass within the hour. Instead, June persevered without life-support. For most of the next 36 hours or so, she appeared to be resting comfortably. In one frightening episode in the wee hours of September 12, June experienced one more seizure. She gripped her daughter’s hand, eyes wide open, moaning and sighing. Thankfully, the seizure passed. June remained until just after dawn on September 13, passing away at 6.45 a.m.  Click HERE to see video.

Megan Richards, E. coli O121:H19, 2006

Megan Richards, of Millville, Utah, was a young wife, mother, and educational conference coordinator in 2006, when she consumed a take-out lunch from a Wendy’s restaurant in Ogden, Utah, on June 30, 2006. Her illness was later determined to be one of many illnesses in an outbreak of E. coli O121:H19 linked by public health officials to food served at Wendy’s. Megan fell ill with significant diarrhea on July 3, 2006. Despite treatment by her regular physician her condition did not improve, and on July 10, she developed persistent vomiting. She was seen that day in the emergency room in Logan, Utah.

Blood tests in the emergency room indicated that Megan’s kidneys were failing, and she was admitted to the hospital. Over the next day, her kidney functioned continued to slow, and then halted altogether. She was transferred to McKay-Dee hospital in Ogden, Utah, to receive more specialized care. There, the diagnosis of hemolytic uremic syndrome (HUS) was confirmed. On July 14, Megan endured a kidney biopsy. The results were frightening: “…necrosis of nearly the entire specimen [noted to be kidney cortex].” The renal cortex is where the kidney’s filtering units are located and cortical necrosis indicates permanent loss of those filters—a finding typically found only in the most severe cases of HUS. The finding carried dire prognostic significance.

That same day, the nurses found Megan unresponsive and exhibiting seizure-like activity. A code was called. Dr. Pittman responded and arrived on the unit to find Megan with a heart rate of 160 per minute and tonic clonic seizures, with rigid posturing activity. Also, her oxygen saturation level was shockingly low at 71%. The physicians were able to get Megan’s seizures under control, and her oxygen levels back up, but it was clear at this point that she was fighting for her life. On July 15, Megan began hemodialysis and plasmaphoresis to replace the functions her kidneys could no longer complete. Megan remained hospitalized through July 28. When she was discharged, she still had not recovered kidney function, and was started on a program of out-patient hemodialysis.

Megan returned to the hospital three days a week for hemodialysis through September 7, when she was reduced to two sessions a week. Her kidney function remained abnormally low throughout. Megan was finally freed from regular dialysis in early October. Medical bills were over $350,000. Still, the damage to her kidneys was permanent and irreversible. Her prognosis as of 2008 was reported as follows:

Based on the severity of her HUS, the evident extensive damage to her renal cortex, her markedly reduced estimated filtration rate of currently only 35 mls/min and the fact that Megan also now has evidence of significant proteinuria, it is my opinion, based on reasonable medical probability, that Megan will develop end stage renal disease (ESRD) and require renal replacement therapy in the form of chronic dialysis or kidney transplantation in the future.

It is estimated that Megan will require renal replacement therapy or transplant by age 40 to 45. These are some of the challenges that await Megan once she undergoes a kidney transplant:

Megan will need to take immunosuppressive medications for the rest of her life. Those medications are not only very costly, but they also have significant side effects including causing high blood pressure, diabetes, osteoporosis, altered appearance (such as moon faces due to steroids and hair loss or excessive hair growth with calcineurin inhibitors), memory problems, and others. Immunosuppressive medications also significantly increase the risk for life-threatening infection or cancer.

Shiloh Johnson, minor, E. coli O111, 2008

Shiloh Johnson was one of hundreds sickened in the E. coli O111 outbreak at the Country Cottage restaurant in Locust Grove, Oklahoma, in August 2008. Shiloh developed bloody diarrhea, and was hospitalized on August 24, 2008. She would not be discharged until October 3.

Once admitted, Shiloh’s stool was cultured, returning positive for E. coli O111. At this time, she very quickly descended into hemolytic uremic syndrome (HUS): her kidney’s failed, and her red blood cell and platelet counts plummeted. With a complete loss of kidney function, Shiloh needed dialysis to survive. She was placed on continuous renal replacement therapy.

48 hours into her dialysis treatment, though, disaster struck. Shiloh developed a significant pericardial effusion (fluid around the heart) with tamponade (the stoppage of blood flow caused by fluid). Shiloh went into cardiorespiratory arrest. She was endotrachoeally intubated, and the pericardial fluid was drained. She was given a round of epinephrine, and the cardiorespiratory arrest was reversed. Shiloh remained on a ventilator through September 12. The fluid that was overwhelming Shiloh also filled the area around her lungs – bilateral pleural effusions. This required the placement of chest tubes.

Throughout this time, Shiloh remained in full renal failure. She received round the clock dialysis. The doctors placed a periotoneal catheter on September 10, and converted her to peritoneal dialysis. The dialysis continued through September 27. Her medical bills amounted to $450,000.

The severity of Shiloh Johnson’s HUS, and in particular the length of her renal failure puts her at serious risk of future complications including end stage renal disease. The extent of her long-term injury is still being assessed.

So, really why are these deadly pathogens not considered an adulterant by the USDA and FSIS when E. coli O157:H7 is?

Bill Marler is a national expert on foodborne illness. He has been deeply involved in issues related to food companies whose contaminated products have caused serious injury and death. His advocacy for better food regulation and his work as a lawyer has led to invitations to address local, national, and international gatherings on food safety, including recent testimony to the U.S. Congress' Committee on Energy and Commerce.

I blew it. I look at the FSIS site daily and I missed that they had posted the below list of retail outlets that received the Salmonella Newport Beef:

I am sorry.

The Sterling Pacific Meat products subject to recall include:

Fatburger Brand:

* 20-pound packages of "8 oz. PUCK (80/20) GROUND BEEF PATTIES."
* 10-pound "2.5 oz. BABY GROUND BEEF PATTIES."

Stock Yards Brand:

* 12-pound packages of "6 oz ROUND 80 % LEAN PURE GROUND BEEF PATTIES." Each package bears the identifying case code "13627."
* 12-pound packages of "(3/1) ROUND 80% LEAN PURE GROUND BEEF PATTY." Each package bears the identifying case code "13582."
* 12-pound packages of "(3/1) ROUND 80% LEAN GROUND BEEF PATTIES." Each package bears the identifying case code "10457" and the pack date "05/18/2009."
* 12-pound packages of "GROUND BEEF PATTY (8/1) SLIDER 80% LEAN." Each package bears the identifying case code "13657" and the pack date "05/18/2009."
* 12-pound packages of "(4/1) ROUND 85% LEAN PURE GROUND BEEF PATTY." Each package bears the identifying case code "13575" and the pack date "05/18/2009."
* 12-pound packages of "PURE GROUND BEEF PATTY 7oz WIDE PATTY 80% LEAN." Each package bears the identifying case code "13520" and the pack date "05/18/2009."
* 12-pound packages of "PURE GROUND BEEF PATTY (7/1) ROUND PATTY 80% LEAN." Each package bears the identifying case code "13577" and the pack date "05/18/2009."
* 11.80-pound packages of "PURE GROUND BEEF PATTIES 7 oz ROUND 80% LEAN." Each package bears the identifying case code "13520" or "13561" and the pack date "05/18/2009."

The packages also bear the establishment number "EST. 550" within the USDA Mark of Inspection and advise "KEEP REFRIGERATED" and/or "KEEP FROZEN." The ground beef products were produced on May 18, 2009, and were distributed at the wholesale level to food service companies, who further distributed the product to restaurants in Calif. and Ariz.

There are a lot of things I love about my job, but one is the science behind linking people in dozens of states to food that they consumed that poisoned them. Once that link is scientifically determined, and the outbreak stopped, then the time comes to learn from the mistakes so the next outbreak can be avoided. Frankly, we all need to appreciate (can you say increase funding) those public servants who toil in local, state and federal health agencies tracking food borne diseases. Without the work of dedicated people interviewing victims, testing stool and analyzing data, most outbreaks would never be determined, most victims would never be fairly treated, and most outbreaks would repeated without learning from past manufacturing mistakes. The science behind all the hard work is fascinating - especially, the "CSI" part.

The process of obtaining the DNA fingerprint is called PFGE (Pulse Field Gel Electrophoresis). This technique is used to separate the DNA of the bacterial isolate into its component parts. It operates by causing alternating electric fields to run the DNA through a flat gel matrix of agarose, a polysaccharide obtained from agar. The pattern of bands of the DNA fragments — or “fingerprints” — in the gel after exposure to the electrical current is unique for each strain and sub-type of bacteria. By performing this procedure, scientists can identify hundreds of strains of E. coli O157:H7 as well as strains of Listeria and campylobacter, and other pathogenic bacteria. The PFGE pattern of the bacteria can then be compared and matched up to the PFGE pattern of the strain of infected persons who consumed the contaminated product.

MLVA (Multiple Loci VNTR Analysis) is a method employed for the genetic analysis of particular microorganisms, such as pathogenic bacteria, that takes advantage of the polymorphism of tandemly repeated DNA sequences. "VNTR" means "Variable Number of Tandem Repeats". This method is well known in forensic science since it is the basis of DNA fingerprinting in humans. When applied to bacteria, it contributes to forensic microbiology through which the source of a particular strain might eventually be traced back. In a typical MLVA assay, a number of well-selected and characterized (in terms of mutation rate and diversity) loci are amplified by polymerase chain reaction (PCR) so that the size of each locus can be measured. From this size, the number of repeat units at each locus can be deduced. The resulting information is a code that can be easily compared to reference databases.

When PFGE and MLVA patterns match, they, along with solid epidemiological work (e.g., was the person exposed to the suspect food item), are proof that the contaminated product was the source of a person's illness.

In the Nestle Toll House Cookie Dough E. coli O157:H7 outbreak the science and epidemiological work produces the below partial “line list.” This list (as of June 25, 2009) lists 76 persons (that number is now 80) who are linked together by a common PFGE of E. coli O157:H7. Most have MLVA patterns reported - some were still pending. The bottom line is that this list, along with solid epidemiological work, show the “CSI” link between these 76 people and the Cookie Dough they consumed.

Another lawsuit on behalf of a customer sickened in the Milan McDonald’s outbreak was filed today in the Circuit Court of the Fourteenth Judicial Circuit of Rock Island County. The lawsuit was filed against McDonald’s Inc., and Kevin Murphy, the owner of the McDonald’s restaurant at 400 West First Street in Milan, IL, by Marler Clark, the Seattle-based foodborne illness law firm, and Craig Mielke of the Illinois firm of Foote, Meyers, Mielke & Flowers LLC. This is the second illness lawsuit; a class action lawsuit was also filed on behalf of restaurant patrons who had to get a shot to avoid illness.

The lawsuit is being brought by Karie Fiegel and her 14-year-old daughter, both of whom ate at the Milan McDonald’s in early June, 2009. Hepatitis A Virus (HAV) has an incubation period of 15-50 days, and it was not until early July that Ms. Fiegel fell ill with nausea, vomiting, fever, and jaundice. She sought medical care, but her symptoms only intensified, and she was admitted to the hospital where she remained for three days. In the hospital, tests revealed that she had been infected with HAV. Hepatitis infects the liver, and Ms. Fiegel’s liver enzymes were found to be elevated during her hospitalization. Although she has been released, her liver enzymes remain elevated.

Meanwhile, her daughter also began experiencing symptoms of HAV infection. The teenager was tested and also diagnosed with Hepatitis A.

“There are 30 confirmed cases of HAV,” said William Marler, the family’s attorney. “Given the incubation period of hepatitis A, it’s possible that the outbreak is not over, and we may see additional illnesses. It is very important for anyone who ate at the Milan McDonalds in June to monitor their health—and their family’s heath—very carefully.”

A food worker at the Milan McDonald’s had Hepatitis A, and a series of mistakes exposed as many as 10,000 restaurant patrons to the virus before the restaurant was closed and cleaned (it has since re-opened). A separate class action lawsuit was filed July 21 on behalf of those who had to get Immune Globulin (IG) shots after exposure to HAV at the Milan McDonald’s restaurant. Almost five thousand people have already received shots in mass clinics coordinated by the Rock Island County Health Department. Eligible individuals are still joining the class action suit.

CDC Published this Morning:

CDC is collaborating with public health officials in many states, the United States Food and Drug Administration (FDA), and the United States Department of Agriculture Food Safety and Inspection Service (FSIS) to investigate an outbreak of E. coli O157:H7 infections.

As of Friday, July 31, 2009, 80 persons infected with a strain of E. coli O157:H7 with a particular DNA fingerprint have been reported from 31 states. Of these, 70 have been confirmed by an advanced DNA test as having the outbreak strain; these confirmatory test results are pending on the others. The number of ill persons identified in each state is as follows: Arizona (2), California (5), Colorado (6), Connecticut (1), Delaware (1), Georgia (2), Iowa (2), Idaho (1), Illinois (7), Kentucky (2), Massachusetts (4), Maryland (2), Maine (3), Minnesota (8), Missouri (1), Montana (1), North Carolina (2), New Hampshire (2), New Jersey (1), Nevada (2), New York (1), Ohio (3), Oklahoma (1), Oregon (1), Pennsylvania (2), South Carolina (1), Texas (3), Utah (4), Virginia (2), Washington (6), and Wisconsin (1).

Most persons became ill during May and June. Ill persons range in age from 2 to 65 years; however, 66% are less than 19 years old; 69% are female. Thirty-five persons have been hospitalized, 10 developed hemolytic uremic syndrome (HUS).  We represent 24 people sickened - most of them were hospitalized (one still is) - 6 developed HUS.  Three lawsuits have been filed - Colorado, California and Washington.

Personally, as I said to the Los Angeles Times a few days ago, “I think that anything that can poison or kill a person should be listed as an adulterant” [in food].

According to the CDC, E. coli O157:H7 is the source of an estimated 73,000 illnesses, 2,000 hospitalizations, and 60 deaths in the United States every year.  Correctly so, USDA/FSIS has considered this nasty pathogen an adulterant on and in beef (at least hamburger) since 1994.

However, despite causing serious injury and death, other shiga-toxin producing E. coli, such as E. coli O111 and E. coli O21:H19 have not been considered an adulterant by the USDA/FSIS.  In fact, we have found pathogenic E. coli in retail hamburger in private lab tests.  So, we know it is there and USDA/FSIS does too.  Ignoring this makes no sense.

Ignoring Salmonella in meat also makes little, if any, sense.   Even after a Court’s twisted opinion in Supreme Beef v. USDA, where it found Salmonella to be “not an adulterant per se, meaning its presence does not require the USDA to refuse to stamp such meat 'inspected and passed," our government’s failure to confront the reality of Salmonella, especially, antibiotic-resistant Salmonella, is inexcusable.  See, www.foodpoisonjournal.com for a bit(e) of history.  The Wisconsin Supreme Court in Kriefall v Excel called it as it saw it:

“The E. coli strain that killed Brianna and made the others sick is a “deleterious substance which may render [meat] injurious to health.” There is no dispute about this. Thus, under the first part of 21 U.S.C. § 601(m)(1), meat that either “bears or contains” E. coli O157:H7 (the “deleterious substance”) is “adulterated.” That E. coli O157:H7 contamination can be rendered non-“injurious to health” by cooking thoroughly, as discussed below, does not negate this; Congress used the phrase “may render,” not “in every circumstance renders.” Moreover, if the E. coli bacteria is not considered to be “an added substance,” because it comes from some of the animals themselves and is not either applied or supplied during the slaughtering process (although we do not decide this), it cannot be said that the E. coli strain “does not ordinarily render [the meat on or in which it appears] injurious to health.” Accordingly, meat contaminated by E. coli O157:H7 is also “adulterated” under the second part of § 601(m)(1).

Now, why would Salmonella be different?

According to the CDC, it is estimated that 1.4 million cases of salmonellosis occur each year in the U.S.  95 percent of those cases are related to foodborne causes.  Approximately 220 of each 1000 cases result in hospitalization and eight of every 1000 cases result in death.  About 500 to 1,000 deaths - 31 percent of all food-related deaths - are caused by Salmonella infections each year.

Just in the last week, the reality (again) of antibiotic-resistant Salmonella Newport has surfaced (again), this time sickening dozens so far in several states, and leading to the recall of nearly a million pounds of tainted hamburger.  This follows a recall of nearly a half a million pounds of Salmonella-tainted burger in Colorado after sickening several a month ago.

Of course, this is not the first time that antibiotic-resistant Salmonella has hitched a ride in hamburger – there were illnesses in 1999, and it was reported by the CDC in 2002 and a WARNING issued by FSIS in 2007. The New Hampshire Department of Health and Human Services has urged a strategy to combat multidrug-resistant (MDR) Salmonella in ground beef.  The CDC, through NARMS has continued to raise concerns about the over-use of antibiotics in our food supply.  And, there is clearly no question that these bugs are in the cows we get our milk and the meat that we eat. 

The CDC has reported that Salmonella Newport is the third most common Salmonella serotype in the United States. During 1997 - 2001, the number of laboratory-confirmed Salmonella Newport infections reported to CDC increased from 1,584 (5%) of 34,608 reported Salmonella infections to 3,152 (10%) of 31,607 (CDC, unpublished data, 2002). The increasing number of Salmonella Newport infections in the United States appears to be associated with the emergence and rapid dissemination of multidrug-resistant strains of Salmonella Newport.  Since 1996, NARMS has identified an increasing number of Salmonella Newport isolates that are resistant to at least nine of 17 antimicrobial agents tested: amoxicillin/clavulanate, ampicillin, cefoxitin, ceftiofur, cephalothin, chloramphenicol, streptomycin, sulfamethoxazole, and tetracycline. In addition, these isolates exhibit decreased susceptibility (minimal inhibitory concentrations [MIC] ≥ 16mg/ml) or resistance (MIC ≥64mg/ml) to ceftriaxone, an antimicrobial agent commonly used to treat serious infections in children.

So, where do we stand with the existing USDA/FSIS law on adulteration?  Here is the law:

21 U.S.C. § 601(m)(4) - SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING - CHAPTER 12 - MEAT INSPECTION - TITLE 21—FOOD AND DRUGS

(m) The term “adulterated” shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; ...

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; …

Hmmm, it is hard to read the above and not think that the words in BOLD equate to all E. coli and Salmonella (frankly, all pathogens in food).  I know, I am just a lawyer, but don't ya think that when food with animal feces (and a dash of E. coli O157:H7) in it is considered an adulterant, that other animal feces (with dashes of other pathogens) in them, should be considered adulterated too?  But, hey, that is just me.

Another odd governmental fact, is that the FDA does not seem to make a distinction between pathogens it considers adulterants or not.  FDA's enabling legislation - Sec. 402. [21 USC §342] of the Food, Drug & Cosmetic Act also defines “Adulterated Food” as food that is:

(a) Poisonous, insanitary, or deleterious ingredients.

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health;

(2) If it bears or contains any added poisonous or added deleterious substance … that is unsafe within the meaning of section 406;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health …

It would be interesting, and perhaps entertaining, to have House and Senate hearings focusing on what should and should not be considered adulterants in our food.  I can see panels of scientists from various fields, FDA, USDA and FSIS officials, beef and produce Industry representatives and consumers discussing this. 

Readers, what are your thoughts?

As of July 1, 2009, the CDC reported twenty-three persons infected with a strain of E. coli O157:H7 with a particular "DNA fingerprint" have been reported from 9 states – Wisconsin included. Of these, 17 (likely more now) have been confirmed by an advanced DNA test (MLVA) as having the outbreak strain. All have been linked to JBS Swift Meat Recall.

The number of ill persons identified in each state is as follows: California (4), Maine (1), Michigan (6), Minnesota (1), New Hampshire (1), New Jersey (2), New Mexico (1), New York (1) and Wisconsin (6). The first reported illness began on April 2, 2009, and the last began on June 13, 2009. This number is growing. Among 17 ill persons for whom hospitalization status is known, 12 (70%) were hospitalized. Two patients developed a type of kidney failure called hemolytic uremic syndrome (HUS).

Interestingly, last evening I got a call from a concerned father. Both son’s have been hit by E. coli O157:H7 – one still hospitalized with HUS. Both children, as of last night, have been linked to JBS Swift meat purchased at a Brookfield Wisconsin Pic n’ Save. I assume that FSIS and CDC will update their numbers.

What is also interesting is that during the 2006 Dole Spinach E. coli O157:H7 outbreak, 49 E. coli O157:H7 cases where confirmed in Wisconsin out of 205 nationally. Dozens of those Wisconsin cases purchased their spinach at Pic n’ Save and several specifically in Brookfield. Go figure

According to the San Francisco Chronicle, the U.S. Department of Agriculture's Food and Safety Inspection Service is investigating 40 illnesses in nine states - including five people in the California counties of Orange and Tulare – who have been sickened. At least four people have been hospitalized.

The state public health department released a list of affected retailers, mostly Safeway stores in Northern California and Vons stores in Southern California. The meat was produced June 5-23 and would have been sold sometime last month. A Safeway spokeswoman said Thursday that ground beef purchased from June 6 to July 14 should be discarded or returned to the store for a refund. List of California stores impacted:

The strain of bacteria associated with the outbreak is Salmonella Newport, which is resistant to many drugs typically used to treat infections, according to the Food and Safety Inspection Service. Salmonella can be life-threatening, especially in people with weak immune systems such as babies, the elderly and people with HIV infection or undergoing chemotherapy.

I am showing my age that I remember the famous TV ad from the 1980's - "Where is the Beef?"  So, Cargill, where is the million pounds of Salmonella Newport?  We know it is in 11 States - which ones?  We know that Safeway and King Soopers is doing a recall - what others?  It would be nice to know where the beef really is.

I had a nice chat this morning with Jerry Hirsch from the LA Times on the resent recall of some 800,000 pounds of hamburger. As I said to Jerry:

Regulators probably jumped on the beef case out of concern for antibiotic resistant strains of salmonella, said William Marler, a Seattle attorney and food safety expert who specializes in food-borne illness litigation.

Unlike the often lethal food-borne bacterium E. coli O157:H7, salmonella is not considered an “adulterant” in federal food regulations and does not trigger an automatic recall, Marler said.

“I commend the company for recalling the beef because legally, they would be on strong ground not to do so,” he said.

The pathogens are treated differently because it takes only a small about of E. coli – just 50 organisms to infect a person – where it typically takes millions of salmonella bacteria to trigger an illness, Marler said.

Nonetheless, Marler would like to see regulation expanded to include salmonella and other pathogens that cause serious illness.

My quote of the day:

“I think that anything that can poison or kill a person should be listed as an adulterant,” he said.

We have been following the problem of Salmonella in hamburger for awhile.  Here is a recent article:

Prevalence and Characterization of Salmonellae in Commercial Ground Beef in the United States
Joseph M. Bosilevac,* Michael N. Guerini, Norasak Kalchayanand, and Mohammad Koohmaraie
U.S. Department of Agriculture, Agricultural Research Service, Roman L. Hruska U.S. Meat Animal Research Center, Clay Center, Nebraska 68933-0166

Received 5 November 2008/ Accepted 2 February 2009

Commercially produced ground beef samples (n = 4,136) were collected from seven regions of the United States over a 24-month period (July 2005 to June 2007) and analyzed for the presence of Salmonella enterica by using methods that concurrently provided total prevalence and enumerable levels. The overall prevalence of Salmonella strains was 4.2%. Enumeration showed that 94.2% were present at levels below 2 CFU/g. Regional monthly prevalences of Salmonella strains varied from 1.8% to 6.5% but were not statistically different (P > 0.05). All Salmonella isolates were serotyped and their antibiotic susceptibilities determined and analyzed by pulsed-field gel electrophoresis (PFGE). The most common serotypes identified were Salmonella enterica serotypes Montevideo, Anatum, Muenster, and Mbandaka, with these accounting for one-half of the isolates obtained. The prevalence of multidrug-resistant (MDR) Salmonella was determined to be 0.6%. The most common MDR serotypes were Salmonella enterica serotypes Dublin, Reading, and Typhimurium. MDR strains had resistance to between 2 and 10 antibiotics. There were no regional differences in prevalence of MDR Salmonella. PFGE analysis revealed that indistinguishable XbaI and AvrII restriction digest patterns (RDPs) could be observed in isolates of the same serotype found in different regions and months of sampling. The RDPs of 19 Salmonella strains were compared to RDPs in the PulseNet USA database. Thirteen were indistinguishable from existing patterns, and the number of records for each ranged from 1 to 478. These data show that Salmonella prevalence in commercial ground beef is low and suggest that attempts to identify sources contributing to Salmonella in ground beef by serotype, antibiogram, and PFGE cannot be made without additional documented evidence.

I have always been a bit amazed at the meat industry and the USDA. In the nearly 17 years of litigating E. coli O157:H7 cases – mostly on behalf of children – I am tired (and a bit disgusted) by the constant din of blaming the consumer. Sometimes the industry goes so far as to sue the parent of an injured child. One company went so far a few years ago as to sue the church that it had supplied with E. coli-tainted meat. So, several years ago I penned this Op-ed:

"It is not the failure of the Meat Industry in not keeping cattle feces out of hamburger that sickened the child, but it is the fault of the parent who handled and cooked the hamburger that was fed to the child." This is a typical response to a sickened child by the meat industry and their lawyers. At first I calmly tried to respond that the Meat Industry that makes a profit off of selling "USDA Inspected Meat" can not blame the consumer if the product actually contains a pathogen that can severely sicken or kill a child. What other product in the United States would a manufacturer expect consumers to fix themselves before they used it?

The reply to my calm response was "the consumer should know that meat may contain bacteria and they are told to cook it." My calmness has now faded. Think about the little labels on meat that you buy in the store - the ones that tell you to cook the meat to 160 degrees - of course they also say USDA inspected too. However, the labels do not say "THE USDA INSPECTION MEANS NOTHING. THIS PRODUCT MAY CONTAIN A PATHOGENIC BACTERIA THAT CAN SEVERELY SICKEN OR KILL YOU AND/OR YOUR CHILD. HANDLE THIS PRODUCT WITH EXTREME CARE."

I wonder why the Meat Industry does not want a label like that on your pound of hamburger. It knows that the label is truthful. Do you think it might be concerned that Moms and Dads would stop buying it? The day the industry puts a similar label on hamburger is the day that I will go work for them. The reality is that the Meat Industry cannot assure the public that the meat we buy is not contaminated. So, instead of finding a way to get cattle feces out of our meat, they blame parents (and presumably all the teenagers that work at all the burger joints in America) when children get sick.

Consumers can always do better. However, study after study shows that, despite the CDC estimated 76 million people getting sick every year from food borne illnesses, the American public still has misconceptions and overconfidence in our Nation's food supply. According to a study by the Partnership for Food Safety Education, fewer than half of the respondents knew that fresh vegetables and fruits could contain harmful bacteria, and only 25% thought that eggs and dairy products could be contaminated. Most consumers believe that food safety hazards can be seen or smelled. Only 25% of consumers surveyed knew that cooking temperatures were critical to food safety, and even fewer knew that foods should be refrigerated promptly after cooking. Consumers do not expect that things that you cannot see in your food can kill you. Consumers are being blamed, but most lack the knowledge or tools to properly protect themselves and their children.

The FDA has stated, "unlike other pathogens, E. coli O157:H7 has no margin for error. It takes only a microscopic amount to cause serious illness or even death." Over the last few years our Government and the Meat Industry have repeatedly told the consumer to cook hamburger until there is no pink. Yet, recent university and USDA studies show meat can turn brown before it is actually "done." Now the consumer is urged to use a thermometer to test the internal temperature of the meat. However, how do you use one, and who really has one? Many consumers wrongly believe the Government is protecting the food supply. How many times have we heard our Government officials spout "The US food supply is the safest in the world.” Remember, however, that it was the USDA that sat on positive E. coli tests for over a week that allowed this recent Con Agra E. coli outbreak to spiral out of control.

Where is the multi-million dollar ad campaign to convince us of the dangers of hamburger, like we do for tobacco? The USDA's FightBAC and Thermy education programs are limited, and there are no studies to suggest that they are effective. Most consumers learn about food safety from TV and family members - If your TV viewing habits and family are like mine, these are highly suspect sources of good information. The bottom line is that you cannot leave the last bacteria "Kill Step" to a parent or to a kid in a fast food joint. The industry that makes billions off of selling meat must step up and clean up their mess. They can, and someday will, if I have anything to say about it. That day will come much faster if they start working on it now, and stop blaming the victims.

So yesterday, I almost spilled my hot coffee on my lap when I read James Marsden’s Op-ed in “Meating Place” – “Why "just cook it" won't cut it:”

For almost 20 years, I have heard people from the meat industry say, “if consumers would only cook their burgers, the E. coli problem would go away”. Here are 10 reasons why the “just cook it” approach will not work:

1. E. coli O157:H7 is a unique pathogen. The levels of this organism necessary to cause infection are very low.

2. The severity of the disease E. coli O157:H7 can cause, especially in children is devastating.

3. In many cases, parents order hamburgers for their children and rely on restaurants to cook them properly. In restaurants, parents really have no control over whether the hamburgers they order are sufficiently cooked to eliminate possible contamination from E. coli O157:H7.

4. If consumers unknowingly bring this pathogen into their kitchens, it is almost impossible to avoid cross contamination. Even the smallest amount of contamination on a food that is not cooked can cause illness. Many of the reported cases of E. coli O157:H7 have involved ground beef that was clearly cooked at times and temperatures sufficient to inactivate E. coli O157:H7. Some other vector, i.e. cross contamination was probably involved.

5. Even if consumers attempt to use thermometers to measure cooking temperature, it is difficult to properly measure the internal temperature of hamburger patties. They would have to use an accurate thermometer and place the probe exactly into the center of the patty. In addition, the inactivation of E. coli O157:H7 is dependent on cooking time and temperature. For example, if they cook to 155 degrees F, they should hold that temperature for 16 seconds. It is not realistic to expect that consumers, many of which are children will scientifically measure the internal temperature of hamburgers.

6. The way ground beef is packaged, it is virtually impossible to remove it from packages or chubs and make patties without spreading contamination if it is present.

7. Sometimes ground beef appears to be cooked when it really isn’t. There is a phenomenon called “premature browning” that can make ground beef appear to be fully cooked when in fact it is undercooked.

8. E. coli O157:H7 may be present in beef products other than ground beef. For example, in non-intact beef products, including tenderized steaks that are not always cooked to temperatures required for inactivation.

9. There have been many cases and outbreaks of E. coli O157:H7 associated with foods that are not cooked (i.e. fresh cut produce).

10. As Senator Patrick Leahy said after the 1993 Jack-in-the-Box outbreak – “The death penalty is too strong a punishment for undercooking a hamburger”. He was right –consumers will make mistakes. There needs to be a margin of safety so that undercooking does not result in disease or death.

For these and many other reasons, the problem of E. coli O157:H7 in ground beef and other food products must be solved. Of course proper cooking is important. However, telling consumers to “just cook it” is not the answer.

Mr. Marsden, well done.

The Outbreak

On May 12, 2008 the Lawrence County Health Department (LCHD) was notified of a case of HUS in a child with a history of bloody diarrhea. The health care provider reported that the child had consumed unpasteurized goat’s milk obtained from a local store, the Herb Depot, in Barry County, Missouri. The milk had been purchased on April 29, 2008. LCHD began an investigation of the illness. It was quickly learned that an additional Barry County child that had cultured positive for E. coli O157:H7 had also consumed unpasteurized goat’s milk from the same store. As a result, LCHD began a full epidemiological and environmental investigation of the illnesses. The investigation revealed that the milk consumed by both ill children had been produced at Autumn Olive Farms.

At the conclusion of its investigation, LCHD ultimately announced that there were four cases of E. coli O157:H7 associated with the outbreak. Of these, three were laboratory confirmed, and one was identified as a probable case (not stool culture positive but Epidemiologically linked to the outbreak). Each of these individuals resided in different counties in Southwest Missouri, and did not have any relation to each other. Nonetheless, each shared a common exposure to milk from Autumn Olive Farms. In addition, the three culture-confirmed cases shared a common, indistinguishable genetic strain of E. coli O157:H7. The strain was identified as a unique subtype of E. coli O157:H7, never before reported in Missouri. Each of the four cases had consumed milk from Autumn Olive Farms within 3-4 days of onset of illness. LCHD reported, “no other plausible sources of exposure common to all four cases were identified [other than the milk.]” LCHD ultimately concluded “the epidemiological findings strongly suggest the unpasteurized goat’s milk from Farm A [Autumn Olive] was the likely source of infection for each of the cases associated with this outbreak.”

The Children

We represent two of the HUS cases. Nicole Riggs is 9 years old. She lives in Willard, Missouri with her mother, Julie; father, Dustin; and her younger sister, Christina. Larry Pedersen is a 2-year-old toddler. He lives in Monett, Missouri with his parents, Brian and Angela, and his two older sisters, Hailey and Kelsey.

Their Acute Illness

Both had a severe episode of HUS as demonstrated by over a week of anuria [no urine output], oliguria [low urine output] for an additional week. Both needed dialysis to survive. Both were hospitalized for over a month. Medical bills were over $100,000 for each.

Their Future

It is likely that both children will develop renal complications in the future, including hypertension and renal insufficiency. Hypertension and renal insufficiency eventually lead to end stage renal disease (ESRD). The development of ESRD means they will require dialysis or transplantation for survival. Most Americans who suffer ESRD opt for a kidney transplant, but the wait for a donor kidney is often a year or more. The preferable course in a transplant situation is for a deceased or living relative (e.g. a parent or sibling over age 18 and compatible) to donate a kidney. While awaiting a donor, an ESRD patient must undergo dialysis treatment while on the waiting list for a deceased donor transplant. Children have the shortest waiting time on the deceased donor transplant list. The average waiting time for children age 0-17 years is approximately 275-300 days; the average waiting time for a transplant candidate who is 18-44 years old is approximately 700 days.

The Effects

Following transplantation the children will require immunosuppressive medications for the remainder of their lives to prevent rejection of the transplanted kidney. Medications used to prevent rejection have considerable side effects. Corticosteroids are commonly used following transplantation. The side effects of corticosteroids are Cushingnoid features (fat deposition around the cheeks and abdomen and back), weight gain, emotional instability, cataracts, decreased growth, osteomalacia and osteonecrosis (softening of the bones and bone pain), hypertension, acne, and difficulty in controlling glucose levels. The steroid side effects, particularly the effects on appearance, are difficult for children, particularly teenagers, and non-compliance with the treatment regimen is a problem with teenagers due to unsightly side effects. Cyclosporine and tacrolimus are also commonly used immunosuppressants. Side effects of these drugs include hirsutism (increased hair growth), gum hypertrophy, interstitial fibrosis in the kidney (damage to the kidney), as well as other complications. Meclophenalate and imuran are also commonly used, each of which can cause a low white blood cell count and increased susceptibility to infection. Many other immunosuppressive medications and other medications (anti-hypertensive agents, anti-acids, etc) are prescribed in the post-operative period. Immunosuppressants like those described above function to reduce the body’s immune response, thereby preserving the transplanted kidney, which the body would otherwise recognize as foreign and dangerous, thereby setting off a chain of events that would culminate in kidney rejection. But because a healthy and timely immune response is a critical host defense against illness, life-long immunosuppression necessarily dictates a life-long, heightened susceptibility to infection, accelerated atherosclerosis (hardening of the arteries), cancer, and chronic kidney rejection.

Bone disease is nearly universal in patients with chronic renal failure. As a result, the children will be prone to develop bone pain, skeletal deformities and slipped epiphyses (abnormal shaped bones and abnormal hip bones) and have a propensity for fractures with minor trauma. Treatment of the bone disease associated with chronic renal failure includes control of serum phosphorous and calcium levels with restriction of phosphorus in the diet, supplementation of calcium, the need to take phosphorus binders and the need to take medications for bone disease.

Another common complication of chronic renal failure is anemia. Patients with chronic renal failure gradually become anemic. The anemia can be treated with human recombinant erythropoietin (a shot given under the skin one to three times a week or once every few weeks with a longer acting human recombinant erythropoietin).

Another complication of ESRD is growth failure. Growth failure ultimately leading to short height as an adult is a very common complication of chronic renal failure in children. Growth hormone therapy with human recombinant growth hormone has been approved for use in children with chronic renal failure and such therapy has been shown to accelerate growth, induce persistent catch up growth and lead to normal adult height in children with chronic renal failure. Growth hormone therapy requires giving a shot under the skin once a day.

As the children develop ESRD, they will not immediately receive a kidney transplant. Instead they will require dialysis. There are two modes of dialysis he might undergo. They can be on peritoneal dialysis or on hemodialysis. Peritoneal dialysis has been a major modality of therapy for chronic renal failure for several years. Continuous Ambulatory Peritoneal Dialysis (CAPD) and automated peritoneal dialysis also called Continuous Cycling Peritoneal Dialysis (CCPD) are the most common form of dialysis therapy used in children with chronic renal failure. CAPD/CCPC. In this form of dialysis, a catheter is placed in the peritoneal cavity (area around the stomach); dialysate (fluid to clean the blood) is placed into the abdomen and changed 4 to 6 times a day. Parents and adolescents are able to perform CAPD/CCPD at home. Peritonitis (infection of the fluid) is a major complication of peritoneal dialysis. Hemodialysis has also been used for several years for the treatment of chronic renal failure during childhood. During hemodialysis, blood in taken out of the body by a catheter or fistula and circulated in an artificial kidney to clean the blood. Hemodialysis is usually performed three times a week for 3-4 hours each time in a dialysis unit.

Finally, no kidney transplant lasts forever. United States Renal Data Systems states that the half-life—i.e. the time at which 50% of transplanted kidneys are still functional and 50% have stopped functioning—is 10.5 years for children 0-17 whose transplanted kidney came from a deceased, unrelated donor, and 15.5 years where the kidney comes from a living, related donor. Similar data for a transplant at age 18 to 44 years is 10.1 years and 16.0 years for a deceased donor and a living related donor, respectively. Each transplant will be preceded by ESRD, dialysis, an increase in kidney-related medical problems and then the recovery from transplantation.

The Lesson?

Was and is the consumption of raw goats milk worth the risk?

It is clear that most of the people chattering across the Internet on either side have never read the bill (arguably, many who voted on did not either). Below is a summary as I read the bill. In order to effectively read it, you have the Food, Drug and Cosmetic Act, Chapter IV open to track the amendments and changes – especially the definitions. So, here we go - H.R. 2749 – Food Safety Enhancement Act 2009:

State Law not preempted.

USDA Regulated Food products exempt from the requirements of the Act if the facility is regulated exclusively by the USDA. This includes Farms that are regulated by the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.  Read the following carefully, it should help explain that farms; private residences of individuals; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer are exempt.  (1) DEFINITION OF FACILITY.—Paragraph (1) of section 415(b) (21 U.S.C. 350d(b)) is amended to read as follows:  

(1)(A) The term ‘facility’ means any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food.

“(B) Such term does not include farms; private residences of individuals; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21, Code of Federal Regulations, or any successor regulations).

“(C)(i) The term ‘retail food establishment’ means an establishment that, as its primary function, sells food products (including those food products that it manufactures, processes, packs, or holds) directly to consumers (including by Internet or mail order).

“(ii) Such term includes—

“(I) grocery stores;

“(II) convenience stores;

“(III) vending machine locations; and

“(IV) stores that sell bagged feed, pet food, and feed ingredients or additives over-the-counter directly to consumers and final purchasers for their own personal animals.

“(iii) A retail food establishment’s primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers.

“(D)(i) The term ‘farm’ means an operation in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both.

“(ii) Such term includes—

“(I) such an operation that packs or holds food, provided that all food used in such activities is grown, raised, or consumed on such farm or another farm under the same ownership;

“(II) such an operation that manufactures or processes food, provided that all food used in such activities is consumed on such farm or another farm under the same ownership;

“(III) such an operation that sells food directly to consumers if the annual monetary value of sales of the food products from the farm or by an agent of the farm to consumers exceeds the annual monetary value of sales of the food products to all other buyers;

“(IV) such an operation that manufactures grains or other feed stuffs that are grown and harvested on such farm or another farm under the same ownership and are distributed directly to 1 or more farms for consumption as food by humans or animals on such farm; and

“(V) a fishery, including a wild fishery, an aquaculture operation or bed, a fresh water fishery, and a saltwater fishery.

“(iii) Such term does not include such an operation that receives manufactured feed from another farm as described in clause (ii)(IV) if the receiving farm releases the feed to another farm or facility under different ownership.

“(iv) The term ‘harvesting’ includes washing, trimming of outer leaves of, and cooling produce.

“(E) The term ‘consumer’ does not include a business.”

Alcohol-Related Facilities exempted.

Require yearly registration for domestic facilities and foreign facilities that export to the United States. Much more detailed requirements to explain the type of facility, what is produced and contact information. Registration can be canceled or suspended for violations of the Act.

Fees Relating to Food – Beginning 2010 an annual fee will be collected of $500 from each registered facility, not to exceed $175,000 for multiple facilities. Fee is to offset inspection costs and food safety activities. The fee provision even has a “sunset provision.”

Hazard Analysis, Risk-Based Preventive Controls, Food Safety Plan, Finished Product Test Results From Category 1 Facilities. This includes the facility conducting a hazard analysis, identifying and validating preventive controls and keeping records of such efforts. The HHS Secretary may establish by regulation or guidance preventive controls for specific product types to prevent intentional and unintentional contamination throughout the supply chain. HHS Secretary will review international standards.

HHS Secretary may exempt from compliance facilities that are solely engaged in a) the production of food for animals other than man or the storage of packages foods that are not exposed to the environment, b) the storage of raw agricultural commodities for further processing.

HHS Secretary shall consider the impact on small business in making rules and regulations.

HHS Secretary may take into account the differences between food intended for human or animal consumption.

Finished Product Test Results from Category 1 Facilities will be required to be submitted to HHS Secretary.

HHS Secretary will review and review and evaluate epidemiological on significant food-borne contaminants.

HHS Secretary shall establish scientific-based regulations for growing, harvesting, processing, packing, sorting, transporting, and holding raw agricultural commodities, and shall take into consideration, consistent with ensuring enforceable public health protection, the impact on small-scale and diversified farms, and on wildlife habitat, conservation practices, watershed protection efforts and organic production methods.

Inspection of domestic and foreign manufacturers will be pursuant to a risk-based schedule. Category 1 – high - risk facilities – inspected once every 6-12 months. Category 2 – low – risk facilities – inspected once every 18 months to 3 years. Inspections can occur more frequently depending on the type of food and facility compliance.

Each person who produces, manufactures, processes packs, transports, distributes, receives, or holds an article of food in the US or for import to the US shall produce records (paper or electronically) bearing on whether the food may be adulterated. Records must be kept for 6 months to 3 years.

HHS Secretary shall by regulation establish a tracing system for food that is located in the US and for imports to the US. Direct sales by farms to consumer, restaurant or grocery store are exempted.

HHS Secretary can assess fees for violations and costs of additional inspection during recalls.

Imported food must be certified as complying with the Act.

Auditors and Laboratories must all be certified and audited. Test results of food items and environmental testing must be reported.

A facility shall recall an article of food, or ingredient, that presents a reasonable probability that it is a threat to human health. HHS Secretary may request a recall if the secretary has reason to believe the food is adulterated or misbranded. HHS Secretary my order a facility to cease distribution of a food product. HHS Secretary may order a recall.

Additional requirements on infant formula manufacturers to keep records and for additional clinical studies that the formula supports normal physical growth in infants. HHS Secretary must also report to Congress on Bisphenol A in food and beverage containers.  Also, a lead warning on ceramics was added.

The CDC shall enhance food-borne illness surveillance by coordinating Federal, State and Local food-borne systems.

HHS Secretary shall design and implement a national public education program on food safety.

HHS Secretary shall conduct food safety research.

HHS Secretary may seize food likely to have serious adverse health consequences and quarantine any geographic are of the US where the food originated after notification.

Criminal penalties increased to 10 years the penalties for selling misbranded or adulterated food.

Civil penalties now range from $20,000 to $7,500,000 for violating or knowingly selling misbranded or adulterated food.

Country of origin and disclosure of ingredients required.

A facility, including a farm, is prohibited against delaying, limiting or refusing inspections. HHS subpoena authority clarified.

Creation of a dedicated foreign inspectorate.

Whistleblower Protections – protections to employees who refuse to violate the Act or who disclose violations.

My suggestions as this moves to the Senate, Conference Committee and the President's Desk:

1.  Raise more money - have a sliding scale based upon risk of contamination and size of operation.  Frankly, I would require registration of all who produce and sell food, but charge little, if anything, to farms that sell directly to consumers.  Raise enough money to actually fund all of this.

2.  Clearly excluded are all direct sales between farmer and customer (including direct sales to consumer, restaurant and farmer's markets) from the necessity of most, if not all, the provisions of this legislation.  However, I would recommend and give resources so that State and Local Health and Agriculture authorities can work with farmers to produce safe food.

3.  Bottom line, regardless of size, if food is produced and put into the larger stream of commerce, the producer, small or large, must play by the same food safety rules.

4.  Perhaps not in this bill or the Senate version at this time, but we need to start dealing with creating a sustainable and regionalized agriculture.  We need to balance safety with environmental policy - both energy/global warming and protection of biodiversity.  We need a food policy that helps create healthy humans.

Here is the link to the bill that has passed. 

When introduced in early June, the Food Safety Enhancement Act of 2009, which would amend the Federal Food, Drug, and Cosmetic Act was summarized. It required each food facility to: (1) conduct a hazard analysis; (2) implement preventive controls; and (3) implement a food safety plan.

Required the Secretary of Health and Human Services to: (1) issue science-based performance standards to minimize the hazards from foodborne contaminants; (2) establish science-based standards for raw agricultural commodities; (3) inspect facilities at a frequency determined pursuant to a risk-based schedule; (4) establish a food tracing system; (5) assess fees relating to food facility reinspection and food recall; and (6) establish a program for accreditation of laboratories that perform analytical testing of food for import or export.

Authorized the Secretary to: (1) order an immediate cessation of distribution, or a recall, of food; (2) establish an importer verification program; and (3) quarantine food in any geographic area within the United States.

Defined the term "color additive" to include carbon monoxide that may affect the color of fresh meat, poultry products, or seafood.

Required country of origin labeling on food and annual registration of importers.

Provided for unique identifiers for food facilities and food importers.

Deemed a food to be adulterated if an inspection is delayed or refused.

Required the Secretary to establish a corps of inspectors dedicated to inspections of foreign food facilities.

Set forth provisions governing the reorganization of Food and Drug Administration (FDA) field laboratories and district offices.

Gave the Commissioner of Food and Drugs subpoena authority with respect to a food proceeding.

Established whistleblower protections.

I am going to work my way through the bill this weekend and report back on what finally passed.