Marler Blog : Food Poisoning Lawyer & Attorney : Bill Marler : Marler Clark

Part 1 and Part 2 of this series examined the historical context of the debate surrounding dairy product food safety, and the mechanisms by which pasteurized or raw dairy products may become contaminated with foodborne pathogens. Part 3 compared foodborne illnesses and disease outbreaks linked to raw and pasteurized dairy products. In this section, the potential risks and benefits that consumers must weigh when buying dairy products for themselves or their children are compared.

Recommendations to move this debate forward in a direction that promotes dairy food safety regardless of processing method will be published in a final summary of this series.

Making a Decision at the Dairy Case, Farmers’ Market, or on the Farm

As described in Part 1, there is considerable variation from state-to-state in the way raw dairy products are regulated in the US. Only a few states allow retail stores or farmers’ markets to sell raw milk, while others restrict sales to on-farm purchases, or ban raw milk altogether (Oliver et al, 2009). The FDA allows cheeses made with raw milk to be sold interstate so long as they have been aged for 60 days.

For consumers who live in states where both pasteurized and raw milk are sold legally for human consumption, there are three broad considerations to weigh when making a choice between the products:

I. Food Quality: including taste, nutrients and other health benefits

II. Food Safety: potential for contamination with dangerous pathogens or toxins

III. Value: including cost to purchase, as well as values such as environmental stewardship, support for community farms

I. Quality and Health

a. Nutrients

The websites that promote raw (unpasteurized) milk products often claim that there are substantial losses in nutrients due to the heat treatment used during pasteurization. In contrast, public health agencies such as the FDA and CDC cite nutritional analyses showing that the losses in nutritional content after pasteurization are negligible for the key nutrients that milk provides in the human diet. A comparison of the nutrition labels on raw and pasteurized milk purchased at a retail store shows very little difference between commercial raw, organic milk and organic or conventional pasteurized milk products.

A. Raw whole milk, organic, unhomogenized.

B. Pasteurized whole milk, organic, unhomogenized.

C. Pasteurized whole milk, conventional, homogenized, fortified with vitamin D

The Table below shows the differences on the labels (highlighted in yellow).  Comparison of nutrition labels from three commercial raw and pasteurized milk products.

b. Health Benefits

Overall, the medical benefits of dairy products (raw or pasteurized) beyond basic nutrition are unclear. The “raw milk pros” review published previously showed results from epidemiological studies in Europe that suggested consumption of raw milk products in childhood may help prevent some allergic conditions (e.g., asthma, hay fever, eczema). Both raw and pasteurized dairy producers have also made claims about beneficial or “probiotic” bacteria, and their effects on digestive health and immunity. The science behind probiotics in dairy products such as yogurts and kefirs is an active area of research (Sanders 2009).

Although dairy products may provide health benefits beyond nutrition, consumers should be wary of product claims that appear to be implausible, or "too good to be true." For example, WAPF promotes raw milk consumption for its curative effects on conditions ranging from autism to allergies to tooth decay to lactose intolerance and heart disease. It seems implausible that one food product could provide so many different and unrelated health benefits, which suggests that the claims may be primarily a marketing strategy not founded in sound medical research.

c. Taste

The sensory qualities of milk, cheeses and other dairy products include taste, texture, and aroma. These qualities are mostly subjective, and depend on personal preference. For example, traditional Mexican-style soft cheeses such as queso fresco made with raw milk have a distinctive flavor; however, these raw cheeses have also been associated with a number of outbreaks and illnesses. An interesting intervention to address an ongoing problem with Salmonella in queso fresco cheeses occurred in Yakima County, Washington. Several agencies worked together with the Hispanic community to develop a pasteurized milk queso fresco recipe with a taste and texture as desirable as the raw cheese product (Bell et al, 1999). The educational effort, termed “The Abuela Project” (“abuela” is “grandma” in Spanish) successfully reduced the incidence of Salmonella in that community.

II. Food Safety

In Part 3, CDC data on milk-related outbreaks from 1973-2005 was analyzed. To examine more recent food safety trends, data from surveillance records and the literature from 2000-2007, was analyzed and summarized in the attached tables. This period also coincides with the time that WAPF has been most active in promoting raw milk sales.

As before, the type of milk was divided into three categories:

• Pasteurized milk/cheese
• Raw milk/cheese
• Mexican-style fresh queso fresco cheese (see photo and description in Figure 1c, Part 3 )

The analysis summarized in the Table focused on the four pathogens most often implicated in dairy-related foodborne disease outbreaks: Campylobacter, E. coli O157:H7, Listeria monocytogenes, and Salmonella. The limitations and caveats relating to this type of analysis using surveillance data were described previously in Part 3. Most importantly, we know that many outbreaks and illnesses are not reported to health departments (Mead et al, 1999), thus these numbers are an underestimation of the true burden of illness. But, despite these limitations, the statistics provide a useful snapshot of differences between these three categories of milk products.

Summary of Findings for Four Major Pathogens Involved in Dairy-Related Outbreaks in the US, 2000-2007 are summarized in the table below.

Outbreaks:

• Raw dairy products caused 42 (75%) of 56 dairy-related outbreaks during this 8-year period due to the four major pathogens, which is almost 5 times more outbreaks compared with pasteurized dairy products and about 8 times more outbreaks compared with queso fresco cheeses.
• Outbreaks cause a burden on the public health system because each one must be investigated to determine the cause and prevent future illnesses. Furthermore, outbreaks often involve recalls, which hurt the industry through loss of product, and loss of consumer confidence in milk.
• Both pasteurized and raw milk outbreaks have resulted in farm closures including Whittier Farms in Massachusetts in 2007 (pasteurized milk, listeriosis) and, more recently, Simsbury Town Farm Dairy in Connecticut (raw milk, E. coli O157:H7).

Illnesses

• Pasteurized dairy products caused 2,181 (65%) of 3,371 milkborne outbreak-related illnesses for these four major pathogens, which was approximately 2 times as many illnesses compared with raw dairy products and queso fresco cheeses during this recent 8 year period.
• 84% of these pasteurized milk-related illnesses were due to campylobacteriosis from milk produced and distributed at prison facilities (not sold to the general public).
• These illnesses cause suffering and costs to individuals and their families, as well as increased stress on the health care system.

The Pathogens

Campylobacter: Raw dairy products caused 34 (94%) of the Campylobacter outbreaks compared with only 2 from pasteurized milk and none due to queso fresco from 2000-2007 (Table). The two large campylobacteriosis outbreaks due to pasteurized milk involving 1,844 illnesses were both associated with prison dairies, which suggests that prisoners may be at increased risk of Campylobacter infections if there is post-pasteurization contamination during processing at on-site dairies. The disproportionate number of Campylobacter outbreaks from raw milk is not a new trend. Indeed, since first identified as a human pathogen in the late 70’s, Campylobacter has repeatedly been linked to raw milk outbreaks. In a review of Campylobacter outbreaks in 10 different countries from 1978 to 2002, Miller and Mandrell (2005) identified only 5 outbreaks traced to pasteurized or heat-treat milk compared with 68 outbreaks from consumption of raw dairy products. Unfortunately, WAPF often uses conspiratorial arguments to discount the problem with Campylobacter in raw milk, rather than helping raw dairy producers address the ongoing contamination events with this foodborne pathogen in their products, or downplay the importance of the illnesses. Campylobacter infections usually result in full recovery, but about 1 in 1,000 patients may develop Gillain Barre syndrome (GBS) and become permanently paralyzed. As an example, there was a tragic case of GBS in a previously healthy woman who drank raw milk purchased through an unlicensed herdshare program in 2008; leftover raw milk still in her refrigerator tested positive for Campylobacter.

E. coli O157:H7: From 2000-2007, there were 5 raw milk-associated outbreaks with 232 illnesses including several HUS cases among children compared with 1 outbreak linked to queso fresco cheese and no outbreaks linked to pasteurized milk (Table). In general, milk-related outbreaks due to E. coli O157:H7 are uncommon, but almost always associated with raw milk products when they occur (Rangel et al, 2005; Hussein et al, 2005). The severity of some of the recent E. coli O157:H7 illnesses associated with raw milk and/or raw colostrum consumption by children should be a cause for concern, yet WAPF and other raw milk advocates frequently dismiss these illnesses despite strong epidemiological and laboratory evidence implicating raw milk. For example, two raw milk dairies that specifically followed WAPF principles were associated with 6 cases of HUS among children in Washington and California in 2005-2006 (CDC 2007; CDC 2008). During the Washington investigation, unsanitary conditions were found at the dairy, and the outbreak strain was isolated from the raw milk (see Figure 1a, Part 3 ). The California investigation revealed very high coliform counts in the raw milk and raw chocolate colostrum, which suggested fecal contamination. Although the outbreak strain was not isolated from raw milk during that investigation, other E. coli O157:H7 strains were found in feces from heifers on the dairy. Notably, the California dairy owner later admitted to buying and bottling raw colostrum from surrounding dairies not licensed to sell Grade A raw milk in order to meet his supply demands (a dangerous practice called “outsourcing”); thus, it is theoretically possible that the outbreak strain was introduced into the implicated raw milk dairy from colostrum that was destined to be consumed by calves and/or pasteurized. In 2008, two more E. coli O157:H7 outbreaks were linked to raw goat’s milk sold illegally in Missouri and raw cow’s milk from a Connecticut dairy, respectively. Three children were hospitalized due to HUS, and the Connecticut dairy ultimately closed down. An injunction was sought in the Missouri case.

Listeria monocytogenes: From 2000-2007, there were 3 queso fresco- and 2 pasteurized milk-related outbreaks involving several deaths, still births, premature deliveries (Table). During that same time period, there were no reported outbreaks linked to raw dairy products except those involving queso fresco or Mexican style cheese. In general, dairy products are considered moderate to high risk for listeriosis infections, second only to deli meats and other ready-to-eat processed meats (Swaminathan and Gerner-Smidt, 2007). Pregnant women and persons with weakened immune systems are at much great risk of serious illness from listeriosis than the general population. Historically, soft Mexican-style cheeses such as queso fresco have been associated with severe listeriosis outbreaks, especially cheeses prepared illegally under unsanitary conditions. Sanitation problems were identified as the key factors in both of the recent listeriosis outbreaks that were published. The North Carolina outbreak in 2000-2001, involved consumption of Mexican-style cheese made from raw milk. The cheese was manufactured illegally, and the “outbreak strain” was found in 4 cheese samples and raw milk taken from the farm that supplied the milk (CDC 2001). The Massachusetts outbreak in 2007, involved pasteurized milk from a local dairy and bottling facility that was likely contaminated with Listeria over an extended period of time; three patients died as a result of their infections, and the dairy ultimately shut down. The Massachusetts outbreak underscores the vulnerability of dairy products to becoming contaminated after pasteurization if stringent hygiene is not maintained throughout processing, bottling, and handling of the milk.

Salmonella: From 2000-2007, there were 4 (329 illnesses) pasteurized-, 3 (163 illnesses) raw-, and 1 (135 illnesses) queso fresco-related outbreaks of salmonellosis (Table). Notably, over one-third (233 of 588 illnesses) of the salmonellosis cases during this period were from multidrug resistant strains (MDR) of Salmonella Newport. These outbreaks from MDR Salmonella Newport were linked to raw cheese served at a picnic in 2001 (multistate), pasteurized milk in California in 2004, and Mexican-style cheese served in homes in Illinois in 2006 (Oliver et al, 2009; CDC 2008b), which suggests that the problem may be important in all three categories of dairy products (e.g., pasteurized milk, raw milk, and queso fresco cheese). Additionally, Olsen et al (2004) described an outbreak of MDR Salmonella Typhimurium linked to milk contaminated post-pasteurization involving 96 illnesses in 2000. The issue of antibiotic resistant Salmonella strains in dairy products (whether raw or pasteurized) is a cause for concern.

Although no recent review paper was available, the epidemiology of Salmonella in dairy products appears to be changing. It is also worth noting that a major shift in raw milk-associated salmonellosis occurred over the last three decades. Specifically, in the 70’s and 80’s, there were significant problems with Salmonella Dublin infections and deaths linked to a single, large certified raw milk dairy in California (Werner et al, 1979; Richwald et al, 1988). Since that dairy shut down, the salmonellosis problem with raw dairy products has been greatly reduced in the US. Likewise, in the 80’s and 90’s, two of the largest ever documented salmonellosis outbreaks were linked to pasteurized dairy products including milk (contaminated after pasteurization) and ice cream (cross-contaminated with raw eggs) (Ryan et al, 1987; Hennessey et al, 1996). No similar enormous salmonellosis outbreaks have been documented from pasteurized dairy products in 15 years.

Brucellosis and Bovine Tuberculosis: Although not shown in the table, these diseases continue to occur in the US, but are mostly a problem among travelers that consume raw dairy products in countries where the infections are endemic in cattle or goat populations. Illnesses have also been documented following consumption of raw dairy products imported illegally into the US. For example, from 2001-2004, 35 cases of human bovine tuberculosis were linked to fresh cheese (queso fresco) brought to New York City from Mexico (CDC 2005). Similarly, the two most recent reports of brucellosis outbreaks in California were traced to consumption of imported raw cheeses (CDPH 2009).

III. Values

In addition to food quality and food safety, consumers may also factor cost and other more subjective values into their decision about which type of dairy product they choose to buy. First, there is the actual cost to purchase the product. In general, commercial, Grade A raw milk sold in the US is more expensive than its organic or conventional pasteurized counterparts. For example, the organic, whole raw milk (photo A) cost ~$15/gallon compared with ~$10/gallon (photo B) for the organic, pasteurized whole milk, and ~$6/gallon (photo C) for the conventional, pasteurized milk (each were bought at the same food co-op).  These prices are likely to vary depending on regional differences, but overall raw milk is more expensive than pasteurized milk, and organic milk is more expensive than conventional milk.

Second, beyond the purchase price, many consumers consider other values such as how the milk was produced. Consumers may be willing to pay more for organic dairy products (raw or pasteurized) because of the perceived environmental benefits. Similarly, there is a growing desire to support local, smaller farmers in the community, which potentially creates new niches for dairy products.

IV.  Summary

In summary, consumers must weigh many different factors when choosing the most appropriate dairy product for themselves and their families. The data on outbreaks and illnesses show that there is currently more risk of exposure to foodborne pathogens such as Campylobacter and E. coli O157:H7 from raw milk products compared with pasteurized milk products. Children, pregnant women, and immune-compromised individuals are at higher risk of illness from contaminated raw dairy products and soft cheeses (raw or pasteurized). Both pasteurized and raw dairy products can be dangerous if produced under unsanitary conditions. Consumers should avoid any dairy products sold illegally, especially “black market” raw milk/cheeses, and soft Mexican-style cheeses such as queso fresco sold by unlicensed vendors, or imported illegally into the US.

References

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Sydney and I are packing today for the long flight between Seattle and Beijing. Although we plan a bit of Daddy/Daughter sightseeing, this food safety conference is important.

"The Chinese government attaches great importance to food safety because it is not only in the interest of the Chinese but also people in the world," Premier Wen Jiabao, People's Republic of China

I have two talks.  One a keynote speech where I am going to cover the Peanut Corporation of America Salmonella Outbreak and then a session later in the day on the legal issues surrounding Chinese food imports.  I also have been invited to speak at two universities about how civil litigation happens in the United States.  Click on image below to see the PowerPoints.  I did not attach the videos, but they can be seen here.

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On January 29, 2009, the Untied States Food and Drug Administration (FDA) implicated Peanut Corporation of America (PCA) of Blakely Georgia as the source of a massive Salmonella Typhimurium outbreak that sickened at least 700 sent about a dozen to early graves. Investigation into the outbreak revealed knowledge of product contamination at the highest levels of the PCA corporate structure, yet, ten months later, criminal charges have yet to be filed against PCA executives.

One can only imagine what thoughts are going through the head of PCA owner Stewart Parnell these days. Perhaps he’s grown complacent with the fact that it has been over three quarters of a year since the massive recall of PCA products and yet criminal charges are nowhere in sight. Perhaps he’s more concerned at the moment with his company’s bankruptcy proceedings. One thought that may not yet have occurred to him, however, is gratitude for the fact that, at worst, he’s subject to American tainted food laws. In other countries (read: China) Mr. Parnell might have more to worry about right now than shaky finances.

The facts of the PCA Salmonella outbreak are no light matter. What made the PCA outbreak particularly noteworthy was the huge number of products involved in the recall and the disastrous nation-wide health consequences resulting from the tainted products. The investigation following the outbreak revealed evidence of conditions unsanitary to a degree that would likely make Upton Sinclair turn in his grave. The most egregious findings from the investigation, however, came not from production facilities riddled with rat feces, but from internal communications that illustrated knowledge of shipping contaminated products that could be traced all the way to Mr. Parnell himself.

In an e-mail dated October 6, 2008, Mr. Parnell complained to Blakely, Georgia PCA plant manager, Sammy Lightsey, that positive Salmonella results were “costing us huge $$$$$ and causing obviously a huge lapse in time from the time we pick up peanuts until the time we can invoice.”  In the same e-mail, Mr. Parnell stated, “we need to protect our self [sic] and the problem is that the tests absolutely give us no protection.” (Link)

Subsequent statements from Michelle Pronto, the microbiology manager of the lab that warned PCA of dangerous test results, indicated that Mr. Lightsey “confirmed that because of high coliform results they were going to send samples to a different lab for a while.” (Link)  Ms. Pronto further indicated that her lab “did not receive any samples labeled ‘PCA’ between 8/26/08 and 11/24/08.” Additional evidence indicates that Mr. Parnell begged the FDA to allow PCA to continue shipping peanuts even after the FDA identified PCA’s Georgia plant as the source of the Salmonella outbreak. (Link)

In light of the fact that Mr. Parnell and Mr. Lightsey wanted to continue with business as usual, even though their products were dangerously contaminated, and the fact that those practices resulted in hundreds of illnesses and a dozen deaths, criminal charges in this case seem more than apt. And yet, to this day we have yet to see a single PCA employee or shareholder prosecuted. It is not as if there are no laws applicable to this situation.

Under federal law, it is a felony to adulterate or misbrand food and put it into interstate commerce. A person who commits such an act “with the intent to defraud or mislead” is guilty of a felony punishable by three years imprisonment.

Under the same federal law, a person may be convicted of a misdemeanor without a showing by the prosecution of proof of fraudulent intent, or even a showing of knowing or willful conduct. Instead, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation. Convictions under the misdemeanor provisions are punishable by up to one year imprisonment or a $1,000 fine.

In cases involving food adulteration or misbranding, individuals can be named as defendants along with corporate entities through which crimes were committed. (Link). Individuals named in such cases are usually high ranking officials who were in charge of the decision-making process that led to a violation of the law, as well as those persons who were actively involved in fraudulent activity. As a result, the presidents of corporations and the managers of the facilities where violations took place are often proper defendants.

These laws indicate that sellers of tainted food in America may at least be subject to some criminal penalties, however, such laws don’t hold a candle to the criminal penalties executives of Chinese companies have faced in similarly egregious matters. This fact is easily observed by looking at just a couple recent examples.

On September 16, 2008, a Chinese powdered milk company accused of selling poisoned product that left nearly 300,000 children ill fired its general manager and board chairwoman Tian Wenhua. That same day, Communist party officials from Hebei Province removed Ms. Tian from her position as secretary of the corporation committee of the Communist Party of China. The next day, Ms. Tian was formally charged with producing toxic food, a criminal charge punishable by up to life imprisonment or death.

By September 18, six days after the official announcement of the crisis, Chinese police had already arrested 18 people in connection with the powdered milk contamination, including 6 sellers of melamine and 12 milk suppliers accused of adding melamine to their products. Police also seized 300 kg of chemicals, including 223 kg of melamine. Additionally, 87 people were summoned for questioning and 28 were detained.

Over the next three weeks, the arrests continued. By October 10, Hebei police had arrested 36 people in total, including a dairy farmer who was accused of producing over 600 tons of a protein powder made of melamine and maltodextrin, which he subsequently sold to food additive vendors, cattle farm owners, and fresh milk purchasers.

Another notorious recent example was the execution of Zheng Xiaoyu, the former director of the Chinese State Food and Drug Administration. According to government authorities, during Mr. Zheng’s tenure as State Food and Drug Administration director, from its founding in 1998 to his removal in mid-2005, he accepted bribes totaling $850,000. In exchange, he allegedly approved drug production licenses for multiple untested and unsafe medicines, resulting an unknown number of deaths. In May 2007, after pleading guilty to charges of corruption and accepting bribes from pharmaceutical companies, Mr. Zheng was sentenced to death. The court that sentenced Mr. Zheng stated that he had approved at least six fake drugs during his tenure. Mr. Zheng was executed on July 10, 2007.

What makes these examples interesting is not only the harshness of the punishments compared to American law, but also the swiftness. In Ms. Tian’s case, a mere day passed between her firing and her facing severe criminal charges. In Mr. Zheng’s case, he was executed less than two months after sentencing. Whether such harsh punishments will deter future wrongdoing in China is yet to be seen, and certainly the Chinese legal system is not a place American courts or lawyers should turn to for inspiration. Nevertheless, PCA executives may want to take a moment to consider the fact that their reprehensible behavior is a capital offense in some parts of the world. Likewise, executives of similar food companies that may be looking for ways to cut costs in this difficult economic climate may want to think twice about putting profits before ethics. These executives owe it to their customers to ensure that the food they produce is safe. They owe it to their customers to work to produce safe products as if their lives depend on it.

I leave for China on Monday with my 10 year old daughter.  Thanks to Alex Ferguson of my office for the help on the above.

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Below - Linda Rivera and the Rivera family a few months before Linda was stricken with E. coli O157:H7.

Below - Linda Rivera and her husband, Richard, in the hospital where Linda has been since May 1, 2009 struggling for her life.  To date, medical bills at over $1,500,000.  She has lost her job and is now on COBRA insurance coverage.  She has suffered through kidney and liver failure and the removal of her large intestine and pancreas - she is now being weaned off a ventilator and she fights other infections.  One tough lady - the family hopes and prays for her recovery.  Here is an update I received a few moments ago:

Linda continues to remain in serious condition. They are trialing her on non-ventilator support, or independent, breathing. She is only modestly successful in that she stops breathing after some hours, probably from both respiratory fatigue and continued lung disease. She therefore requires mostly ventilator assisted breathing for now. Impaired respiratory muscles mechanics, muscle wasting, and lung tissue disease in the setting of severe nutritional deficits makes it difficult for her to maintain adequate independent, reliable, respiratory physiology.

Linda’s liver remains impaired. She is jaundiced and the liver enzymes remain elevated. Serum proteins are decreased, indicating that her liver’s ability to assemble dietary amino acids into sequences that results in specific proteins for essential body functions is impaired. This impacts her immunity, fluid balance, blood clotting ability, and drug clearance of all the medications required to treat her successfully.

Linda has a large decubitus ulcer on her buttocks. This is also known as a bed sore. Her bed sore is large and potentially deep. This can be an entry way for serious infections and must be brought under control. With nutritional deficits and poor regional blood flow to an area typically compressed by the weight of her body on her buttocks while in bed, progression of the ulcer (bed sore) tends to be greater than regression unless the wound care team at her hospital aggressively treats it. This ulcer is perhaps one of the greatest threats to her otherwise relatively stable condition.

Linda is moving both upper extremities but has very limited left leg movement. With all the muscle disuse and impaired nutrition, it hurts her to move her extremities. Linda is being trialed on a special “talking tracheotomy” tube that allows her to talk. Richard says she is able to speak but apparently only perhaps single words. Using one of these tubes requires a good respiratory reserve in a recovering patient. Linda has almost no real reserve to make this tube a realistic part of her care. Nonetheless, they will continue to train her for it. Rich said that she was a bit shocked to hear her own voice. She is oriented to her place and person, but obviously time is a big blur to her. The stroke of a few months ago seems improved.

S 510 is sitting in the Senate and needs to be passed.  Senator Reid, Senator Ensign, how about a bi-partisan effort for one of your constituents?  Move S 510 to the floor for a vote.  Get it to the President before Thanksgiving.

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Steve Bjerklie MeatPoultry.com

WASHINGTON — The real consequence of the continuing vacancy in the Undersecretary for Food Safety’s post at USDA is that there is no one "with the gravitas of a Senate appointment" to unite the industry, consumer organizations and regulatory agencies into an effort to pursue a plan to improve the safety of the meat and food supply.

So says Bill Marler, the influential E. coli victims’ attorney, based in Seattle, Wash., who has made a career from successfully suing meat companies in the wake of outbreaks of E. coli O157:H7 poisoning traced to adulterated meat. "We are missing the person who can see the big picture," he told MEATPOULTRY.com.

Marler thinks the longer the post goes unfilled – the Obama Administration has reportedly considered several candidates since last January, but no names have been officially announced – the deeper the problem becomes. "Although the focus lately has been on the FDA, with these new proposals being made in Congress, not having a real food-safety point person at either FDA or USDA is hampering a pretty unique opportunity to move forward on food safety in a unique way. I think there have been a lot of missed opportunities for the industry and consumer groups to work together to improve food safety," he said.

He pointed out that in the long article published on Oct. 2 in the New York Times that detailed lapses in testing protocols and other E. coli control problems, resulting in several deaths as well as cases of permanent disability, there was no one at USDA who could effectively address the issue beyond a general statement from Secretary of Agriculture Tom Vilsack and a couple of comments from executive assistants at the department’s Food Safety and Inspection Service. "To really not have anybody at USDA respond in a meaningful way to the issues the article brought up was telling," Marler said.

This week, a bill with bipartisan support to expand FDA’s authority to regulate the nation’s food supply made its way on to Congress’s crowded calendar. A sense of urgency has pushed politicians to pursue food-safety reform: In addition to the Times story, which inspired a roundtable discussion on beef safety on "Larry King Live," a survey conducted in July by the Pew Charitable Trusts found that nearly 90% of voters favored new food safety measures. While the legislation proposed this week would not directly impact FSIS, there is widespread agreement that a major overhaul of FDA would likely influence reform in the meat inspection program.

Marler said he thinks that "sometimes, FSIS forgets what its mission is. Its mission is public health and food safety. The person who takes the food-safety job at USDA has to wake up every morning and say, first thing, ‘My job is to protect the public health.’" He added: "But how do we get there? That’s the part that’s missing. You can’t try to strike a balance between food safety and industry needs, like one USDA person said in the Times article that they were trying to do, and not compromise on the safety. That’s the bottom line. The government’s job is to protect the public health."

Marler is disappointed, he told MEATPOULTRY.com, by remarks he still hears and reads on occasion from industry executives who say that if consumers simply cooked ground beef to the correct temperature, there wouldn’t be a problem. "The idea that it’s the consumer’s fault, that cow poop on meat is ‘natural’ – this is still pervasive in the packing industry. Look, I understand that large-scale food production is difficult to do. But it’s not impossible to do it and have the safety of the product be the top priority," he said.

In Marler’s view, the real culprit behind the industry’s struggle to eliminate E. coli and other pathogens from the meat and poultry supply is the commodity cost structure the industry is trapped in. "If food safety is all of our responsibility – the industry’s, the consumer’s and USDA’s – then the cost structure we have, where cheaper is always better, makes no sense whatsoever," he stated.

The attorney doesn’t buy excuses that the Administration hasn’t been able to find viable candidates for the USDA food-safety job who can meet the Administration’s no-previous-lobbying standard. "Frankly, that’s BS," he said. "There are a lot of people – and I’ll include myself here – who have a broad interest in and knowledge of food safety. My God, there are 300 million people in this country. Surely we can find one person who can do this job effectively."

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Not much really.

Last word from US Attorney's Office on the Peanut Corporation of America Investigation:

For Immediate Release
February 9, 2009 FBI Atlanta
Contact: Special Agent Stephen Emmett
(404) 679-6451

FBI To Assist FDA in Ongoing Investigation of the Peanut Corporation of America

ATLANTA, GA—Special Agent in Charge (SAC) Gregory Jones, FBI Atlanta, announces the FBI’s assistance to the Food and Drug Administration, Office of Criminal Investigations (FDA/OCI), in the ongoing investigation of the Peanut Corporation of America.

The FBI was asked to assist FDA/OCI in this matter, due to its ability to bring to bear a considerable amount of investigative resources. Although the FBI is fully involved in this investigation, FDA/OCI remains the lead federal investigative agency. As such, the FBI will defer to FDA/OCI for all public commentary regarding the details of this ongoing investigation.

For the time being, the FBI will make no further public comment on this matter.

Contact for USDA, Middle District of GA is:

Sue McKinney, Public Affairs Specialist, United States Attorney’s Office at 478-621-2602.

+++++++++++++++++++++++++

Last word from FDA as of a few moments ago:

"It is FDA's longstanding policy, consistent with the policy of the Department of Justice, not to comment or provide information with respect to on-going investigations. Inquiries should be addressed to the U.S. Attorney's Office in the Middle District of Georgia."

So, we go after "Balloon Boy's" dad, but not Stewart Parnell?  What the hell is that all about?

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I have been watching the Senate Committee on Health, Education, Labor and Pensions food safety hearing this morning by live video. Watching and listening to the Senators' opening comments gave me hope that S 510 may well pass - and before the end of the year. It would be great to see both the House and Senate pass a bi-partisan measure and have the President sign it - clearly, the time as long since come.

One interesting point that likely did not catch anyone’s attention was a question posed by Freshman Senator Al Franken to Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration. Mr. Franken asked the Commissioner what the status of the criminal prosecution of Peanut Corporation of America (PCA) was?

For those who have forgotten, PCA was responsible for knowingly shipping Salmonella-tainted peanut butter in late 2008 that made its way into some 4,000 products produced by 200 companies and causing at least nine, yes nine, deaths and over 700 other illnesses. Everyone agrees that those numbers are a gross undercount – deaths are likely over a dozen and illnesses over 20,000. A massive recall was announced in February 2009 causing business loss that has been estimated to be at least $1,000,000,000.

Dr. Hamburg’s answer to Senator Franken was that the criminal investigation and prosecution is ongoing. Is it really?

Someone needs to call the FDA, the Justice Department, the US Attorneys’ offices in both Georgia and Virginia and ask the status of the investigation and prosecution. Ask where the Grand Jury is impaneled? Ask what witnesses have been talked to? Who has testified? When will charges be filed?
I think the answer that you will get is a bit different that Dr. Hamburg’s response – under oath – was to Senator Franken.

Several months ago, I posted an overview of how a criminal prosecution of PCA and its principles would happen. In the end I said, “One thing to remember (before we try and convict PCA) is that in 17 years of involvement in every major foodborne illness case, there have been only a handful of prosecutions and fewer convictions. This has been true in cases involving acts as egregious or more so than those of PCA. Not to say they should not be prosecuted, just remember to keep it in context.”

Perhaps I am wrong and that somewhere the wheels of justice are slowly turning.  My guess, however, is that somethings seem to never change.  And, how do we explain that to the ill and the families of the dead?

We are going to prosecute "Balloon Boy's" dad?

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Committee: Senate Committee on Health, Education, Labor, and Pensions
Title: Keeping America’s Families Safe: Reforming the Food Safety System
Date: Thursday, October 22, 10:00 a.m.
Place: SD-430 - Click on picture below to watch live:

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This what I am reading as I board another plane:

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An interesting question and one that long needs answering.

Thus far I have found a dearth of negative research on the topic. In 2005 the American Meat Institute Petitioned FSIS “To Recognize the Use of E-Beam on Carcasses as a Processing Aid” and attached studies seem clearly to indicate that this is an effective technology in reducing the risks of bacterial contamination from carcasses. In late 2008, a Presentation on the topic was given both in written form and by the below PowerPoint (click on immage). A transcript of the Presentation is also available.

The real questions are:

1. Is the technology effective in killing bacteria?
2. Is the technology safe to humans and the environment? And,
3. Should the meat so produced be labeled with some type of irradiation designation?

I think the answers are yes, yes and yes.

Input from readers?

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The American Meat Institute (AMI) Patrick Boyle was quoted recently: “We are selling a raw product, however, and raw products by their nature may contain harmful bacteria. That’s why we are committed to providing consumers the information that they need to handle and cook ground beef safely.”

I like Patrick. I frankly thought our discussion on Larry King last week was the best part of the show. But, Patrick, since 1994 E. coli O157:H7 has been considered to be an adulterant in hamburger by the government – it is not supposed to be there. What you should be “committed” to is keeping cow shit out of “consumers” meat.

Here are some pictures to illustrate the point.

This:

Should NOT be in:

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Visit comes after victims and their families press Senate to pass legislation to protect the public from foodborne illness

Sixteen Americans who have been directly affected by foodborne illness gathered at the White House recently to share their personal stories and meet Sam Kass, assistant White House chef, who cooks for the Obama family and is an advisor on food policy; Mariano-Florentino Cuellar, who is the lead staffer for the White House Food Safety Working Group; and David Lazarus, senior advisor to the Secretary of Agriculture, who coordinates with the White House on food safety issues.

Representing the millions of Americans who fall ill each year from contaminated food, the victims and relatives of victims appealed to the Obama administration to urge congressional lawmakers to pass food safety legislation this year.

"Too many Americans are needlessly getting sick and many are dying from eating food that should be safe," said Peter Hurley, who traveled from Oregon to D.C. with his 5-year-old son, Jake. Jake became ill earlier this year after eating peanut butter crackers contaminated with Salmonella.

"Congress needs to pass this legislation," continued Hurley. "It makes the common sense changes our food safety system needs. We know the system can and must be improved and the time for action is now."

In March of this year President Obama created the White House Food Safety Working Group, which is charged with coordinating federal food safety efforts.  At the meeting on Oct. 9 administration officials reaffirmed their commitment to modernizing our food safety system and ensuring that America's food supply is both safe and healthy.

Advocates from the Center for Foodborne Illness Research & Prevention, The Pew Charitable Trusts, Safe Tables Our Priority (S.T.O.P.), the Center for Science in the Public Interest, Consumers Union, the Consumer Federation of America, and Food & Water Watch joined the 16 Americans who have personal stories about the impact of foodborne illnesses.

While in Washington the victims and relatives of victims also met with U.S. Food and Drug Administration Commissioner Margaret Hamburg, along with senators and Senate staff from their home states. Senators were urged to follow the example set by their colleagues in the House -- who passed a bipartisan food safety bill in July -- and approve companion legislation by Thanksgiving.

"We cannot afford to wait for another outbreak. Congress must act now and pass food safety legislation that protects families from facing the same hardships we have," said Maine resident Carol Kintner Gates, who lost a family member to a foodborne illness. "Nobody in America should have to worry about whether the food they eat and feed their family will cause severe illness or death."

Thousands of Americans die annually from foodborne illness, and about half of all reported cases of foodborne illness occur in children, according to the Centers for Disease Control and Prevention. Megan Kowalcyk, a 13-year-old from Ohio, lost her brother to foodborne illness and talked with Obama administration officials at the meeting about her efforts to improve food safety.

"I was 5 years old when my brother died," Kowalcyk said. "He was my best friend and I still miss him. It really bothers me that so many kids have been hurt or died because of foodborne illness."

Without immediate reform, the preventable outbreaks from contaminated food -- like those that occurred earlier this year -- are likely to continue.

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The Toronto Star is reporting that Ruby Chinese will close its doors for good following the public health crisis.  The three owners are reportedly set to file for bankruptcy.  The normally packed eatery on Sandhurst Circle was shuttered on October 7 after 37 people became ill after eating there.

Salmonella has been confirmed in 22 cases and is suspected in 15 others, including an elderly man who died of dehydration after a severe case of diarrhea.

“There were issues with proper handling and storing of the food to protect it from contamination. There was a cockroach infestation that was ongoing. It’s possible that these could have [led to the salmonella outbreak,]” revealed Dr. Howard Shapiro of Toronto Public Health.

When I am out speaking to companies, I always tell them that there is a moral (see above in bold) or a business (see picture above) to not poison customers.  Companies have a right to choose why it is a good idea not to poison customers, but for goodness sake, pick one.

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In what some in the Ag community seem to feel is a conspiracy to indoctrinate young minds to a different way to look at how our food is produced in the United States, Washington State University is moving forward with a Michael Pollan lecture scheduled for mid-January 2010.  Below is a letter I just received from WSU confirming the visit.  Click on image to download.

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The Committee just announced that it will have a hearing next week.  It might be a quick hearing considering that no one is listed as a witness.  Perhaps they are looking for my phone number?  Email?  Seriously, I assume they will be talking about S.B. 510.  If you were Senator Harkin who would you invite?

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I just finished reading an editorial from Capital Press “Food safety comes from market.”  The opinion writer opined:

But Seattle attorney Bill Marler, a veteran litigator of damage suits over foodborne illness incidents, had some of the trappings of the Spanish dreamer and idealist Don Quixote as he traveled to Washington, D.C., to try and pry a food safety reform bill, HR 2749, out of the U.S. Senate Committee on Health, Education, Labor and Pensions. It's reported that part of Marler's Capitol Hill visit included passing out T-shirts that said, "Put a Trial Lawyer Out of Business: Pass Meaningful Food Safety Legislation Before Thanksgiving."

First, the opinion writer is completely wrong when he or she sated: “It's [SB 501’s or HR 2749's] main thrust is to group all food inspection responsibilities -- growing, handling and processing -- with the Food and Drug Administration, phasing out Department of Agriculture's Food Safety Inspection Service.” Both the Senate version and the House version have nothing in either of them that do that. Both deal with FDA and FDA only. A single food safety agency has been shelved long ago, and is unlikely to rise from the dead.  Also, since I applied for head of USDA's FSIS, why would I want to loose that job too?

I do, however, happen to agree with the opinion writer’s main premise that “food safety comes from [the free] market” when the writer “applaud[ed] Costco for putting added testing for E. coli O157:H7 into its contract with Tyson. That's the marketplace at work, tightening up to keep a known cause of a sometimes fatal foodborne illness from reaching consumers.”

I could not agree with them more. However, those decisions, by Costco or others, are not made without a “Spanish dreamer” aiming a sharp lance and a charging horse directly at their pocketbook.

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A few weeks ago I posted “Petition for an Interpretive Rule Declaring all enterohemorrhagic Shiga Toxin-producing Serotypes of Escherichia coli (E. coli), Including Non-O157 Serotypes, to be Adulterants Within the Meaning of 21 U.S.C. § 601(m)(1),” and hand-delivered the Petition to USDA Secretary Vilsack.

Now the CDC suggests in “Recommendations for Diagnosis of Shiga Toxin--Producing Escherichia coli Infections by Clinical Laboratories”  increased testing for all E. coli that cause human illness. Here is the summary of the CDC publication:

Shiga toxin--producing Escherichia coli (STEC) are a leading cause of bacterial enteric infections in the United States. Prompt, accurate diagnosis of STEC infection is important because appropriate treatment early in the course of infection might decrease the risk for serious complications such as renal damage and improve overall patient outcome. In addition, prompt laboratory identification of STEC strains is essential for detecting new and emerging serotypes, for effective and timely outbreak responses and control measures, and for monitoring trends in disease epidemiology. Guidelines for laboratory identification of STEC infections by clinical laboratories were published in 2006. This report provides comprehensive and detailed recommendations for STEC testing by clinical laboratories, including the recommendation that all stools submitted for routine testing from patients with acute community-acquired diarrhea (regardless of patient age, season of the year, or presence or absence of blood in the stool) be simultaneously cultured for E. coli O157:H7 (O157 STEC) and tested with an assay that detects Shiga toxins to detect non-O157 STEC. The report also includes detailed procedures for specimen selection, handling, and transport; a review of culture and nonculture tests for STEC detection; and clinical considerations and recommendations for management of patients with STEC infection. Improving the diagnostic accuracy of STEC infection by clinical laboratories should ensure prompt diagnosis and treatment of these infections in patients and increase detection of STEC outbreaks in the community.

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According to Meatingplace.com, once again “Big Ag” seems to be stepping in the academic freedom cow pie. Apparently, the administration of Cal Poly is so worried about $150,000 from David Wood that it is bending to that donor’s will.

"Wood, according to the LA Times, has pledged $150,000 to help build a new meat processing plant on the Cal Poly campus. But in his letter, he said the Pollan lecture caused him to 'rethink my continued financial support of the university.'"

Interestingly, a few months ago I was pitched by Cal Poly for the same donation. Although I passed on the opportunity to invest in a slaughterhouse, I could not imagine that I would ever use a donation to thwart academic freedom.

David, don't be so cheap.  If you want to press your point of view, pay to have Big Ag come another day.

Frankly, Cal Poly should remember that freedom of inquiry by students and faculty members is essential to its core mission. Students and faculty should have freedom to teach or communicate ideas or facts, including those that are inconvenient to Big Ag.

True, according to meatingplace.com, “[i]nstead of a Pollan speech, the school on Thursday will hold a panel discussion including Pollan, a meat-scientist and a representative of one of the nation's largest organic growers. “ Pollan told the LA Times he earlier offered Cal Poly a choice of either having him lecture or participate in a panel. Pollan said Wood's letter posed a threat to academic freedom.

"The issue is about whether the school is really free to explore diverse ideas about farming," he said. "Is the principle of balance going to apply across the board? The next time Monsanto comes to speak at Cal Poly about why we need [genetically modified organisms] to feed the world, will there be a similar effort? Will I be invited back for that show?"

A Pollan/Mosanto “smackdown?” I’d pay to see that.

Disclosure, I donated money to Washington State University after it threatened to pull the invitation to Mr. Pollan, and I paid to have him speak at my kids' high school.

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The below GAO Report (click on image to download) that landed on my desk today points out the potential risks of imported foods and what our agencies, FSIS and FDA, can do lighten that risk.  The reality, however, in my 17 years of food litigation experience has been that domestically produced food does a marvelous job of poisoning us.

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According to OMB Watch:

When Congress finalized on Thursday the Department of Agriculture’s FY 2010 budget, it fulfilled President Obama’s request to give a modest funding boost to the Food Safety Inspection Service (FSIS). Unfortunately, it appears the agency will be unable to close the gap in its inspection force responsible for policing the nation’s supply of meat and poultry.

Funding and staff size are critical issues for FSIS. At no other regulatory agency does the size of the inspectorate need to be so closely aligned to the size of the industry it regulates. Under federal law, FSIS must inspect and approve all meat and poultry products before they can be sold – it’s the agency responsible for the USDA stamp of approval.

Population growth means increased nationwide demand for food, including meat and poultry. In 2003, FSIS inspected and approved over 96.4 billion pounds of meat and poultry. By 2008, the figure had risen to almost 110 billion pounds – a 3.5 percent average annual increase.

Over the years, FSIS’s budget has steadily increased, but its staffing levels have held steady or dropped. The FY 2010 budget continues that pattern: The budget gives FSIS about a 4.5 percent funding boost (not adjusted for inflation) but only calls for 25 new full-time employees – less than a one percent increase.

We cannot tell whether the 25 new employees will serve as inspectors or be employed elsewhere at the agency. Regardless, FSIS has room to absorb a lot more inspectors. In June 2007 (the last time I saw figures on the subject) the agency had a vacancy rate of 12.2 percent in its inspection force. As a result, the inspectors FSIS does employ are spread too thinly, and oversight of slaughterhouses and other facilities is insufficient.

According to Obama’s budget request, the agency will not significantly increase its inspection and enforcement activity. The budget predicts no change in the number of food samples analyzed or the number of corrective actions dictated by the agency, for example.

FSIS’s budget stands in stark contrast to the FDA’s. Obama has called for big budget increases for the other major food safety regulator, and Congress appears prepared to oblige.

(Part of the problem may be that, unlike FDA, FSIS is still without a Senate-confirmed head. More than eight months into his administration, Obama has yet to nominate someone to serve as the USDA Under Secretary for Food Safety, the official who leads FSIS).

Resource constraints aren’t the only problem for FSIS, but the agency needs a commitment from President Obama and Congress that they will appropriate enough funds to allow the agency to fulfill its mission.

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Contaminated Food Kills 5,700 Americans Each Year – Nation’s Food Safety Laws Have Not Been Overhauled In A Century

U.S. Senator Kirsten Gillibrand, the first New York senator to sit on the Senate Agriculture Committee in nearly 40 years, today announced a comprehensive plan to overhaul the nation's food safety laws by improving inspection, recall response, and public education. A cornerstone of Senator Gillibrand's plan is new legislation to mandate E. coli inspections of ground beef.

According to the Centers for Disease Control and Prevention (CDC), every year an estimated 87 million Americans are sickened by contaminated food, 371,000 are hospitalized with food-borne illness, and 5,700 die from food-related disease. While the U.S. Department of Agriculture (USDA) has made some progress improving food safety regulations, the nation's food safety laws have not been significantly overhauled in more than a century, according to the Congressional Research Service.

"In America, in 2009, it is unconscionable that food is still going straight to our kitchens, school cafeterias and restaurants without being properly tested to ensure its safety," Senator Gillibrand said. "It's spreading too many diseases and costing too many lives. We need to do a better job of catching contaminated food before it ever comes close to a kitchen table. My plan addresses the gaps in the inspection process and improves recalls and public education, so parents have access to the information to keep their families safe."

Across New York State, approximately 5 million people are afflicted with a food-borne illness each year.

READ Senator Gillibrand's new report on food safety.

Continue Reading...

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Larry King was a gracious host and I thought the discussion at beginning and with Mr. Boyle and Dr. Murano was useful.  The meat/no meat discussion got everyone off topic on what should have been the focus - the safety of our food supply.

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Short Term

1. The President must appoint an Undersecretary for Food Safety now whose sole mission is safe food. The Undersecretary should, and needs to be the responsible person within the FSIS on this important issue, advocating and making decisions solely on behalf of public health. That person and staff should spend time with Stephanie Smith and the family of Abby Fenstermaker.

2. Provide tax breaks for companies that push all types of food safety interventions, including vaccines, irradiation and employee training. Greatly expand traceability of high-risk meat products and work directly with the big retail chains to lessen price pressure on manufacturers.

3. There are too few legal consequences for sickening or killing customers by selling contaminated food. We should impose stiff fines, and even prison sentences for violators, and even stiffer penalties for repeat violators.

4. Develop uniform cooking and handling instructions that actually provide helpful guidance to consumers. Foster a campaign similar to Mothers Against Drunk Driving, which uses consumer power to promote safe food handling and a no-tolerance policy toward companies that produce tainted food. Create new quality certifications to aid consumers in making choices, and allow companies to capture price premiums for higher quality.

5. Enforce a real zero-tolerance policy for E. coli O157:H7 and non-O157 EHEC STEC on meat, and consider expanding it to all bacteria and viruses that cause serious human disease.

6. Do meaningful sampling and surveillance of meat for bacteria and viruses at all levels of production to determine real prevalence of all pathogens before it hits restaurants and grocery store shelves. All tests should be online in real-time. All Non-compliance Report (NR’s), and other enforcement documents, at slaughter plants and grinding operations should also be online in real-time. Consumers need transparency.

Long Term

1. Improve surveillance of bacterial and viral diseases. First responders, such as ER physicians, need to be encouraged to test for pathogens and report findings directly to local and state health departments and the CDC promptly. Right now, for every person counted in an outbreak there are some 20 to 40 times those that are sick but never tested. The more we test, the quicker we know we have an outbreak and the quicker it can be stopped.

2. These same governmental departments, whether local, state or federal, need to learn to “play well together.” Turf battles need to take a back seat to stopping an outbreak and tracking it to its source. That means resources need to be provided and coordination encouraged so illnesses can be promptly stopped and the offending company - not an entire industry - is brought to heal.

3. Increase food inspections. While domestic production has continued to be a problem, imports pose an increasing risk, especially if terrorists were to get into the act. Points of export and entry are a logical place to step up monitoring. We need more inspectors - domestically and abroad - and we need to require that they receive the training in how to identify and control hazards.

4. Reorganize federal, state and local food safety agencies to increase cooperation and reduce wasteful overlap and conflicts. These agencies need to be more proactive, and less reactive. This too requires financial resources and accountability. We also need to modernize food safety statutes by replacing the existing collection of often conflicting laws and regulation with one uniform food safety law of the highest standard.

5. We need to stop the overuse of antibiotics in animals. We are creating drug resistance bacteria that are beginning to catch up with the human population.

6. We have to ask hard questions about the safety and sustainability of the massed produced, oil and corn based, food production system we have created in our lifetime. A true fact – in 17 years of litigating nearly every food borne illness outbreak, almost all were caused in whole or in part, by mass produced food. I have never sued a farmer’s market. True, in a world of nearly 7 billion, we all cannot eat at farmer’s markets. However, the system we have now is not sustainable from either an energy or food safety perspective.

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Alan Maxwell (my arch enemy) and I will be co-chairing this ACI Conference in a few weeks in Chicago.  He and I put this Powerpoint together.  My suggestion is that every company interested in safe food should attend.  It has been a very busy year and I expect the same in 2010.

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Chuck Jolley is a free lance writer, based in Kansas City, who covers a wide range of ag industry topics for Cattlenetwork.com and Agnetwork.com.

I wanted to look into the food safety issue and Washington’s role in it from both sides of the table so I asked Richard Raymond and Bill Marler, two of the most formidable men in the business, to answer the same set of questions – point/counterpoint. Raymond has worked within the government and with many others in the food processing business. Marler has successfully sued many of those processors who failed to meet their obligations and stands ready to do it again-and-again until the industry “puts him out of business.”

Raymond answered from his experiences gained from long years of service to the industry. Marler answered from the experiences gained from too many years of taking miscreants to the financial wood shed.

Although they disagreed on a few points, I was surprised at how many of their answers were similar. Here is Five Minutes with Bill Marler and Five Minutes with Richard Raymond, ten minutes of fascinating answers to important questions.

Q. It's been just over a year since Mr. Raymond retired from his post as undersecretary for food safety. The position has remained unfilled. Has the lack of direct oversight harmed the effort to improve food safety?

Marler: “The position of undersecretary for food safety plainly exists for a reason, but if the failure to fill the position indicates that the Obama administration no longer thinks that the position has a role to play, then it should be abolished. I would, however, disagree with its abolition. In the absence of creating a replacement agency that has as its SOLE mission food safety, then the undersecretary for food safety should and needs to be the responsible person within the FSIS on this important issue, advocating and making decisions solely on behalf of public health.”

Raymond: "Career employees are very good at what they do, but they are not going to push the envelope and antagonize either the consumers or the industry with major regulatory changes. Dr Petersen's quote in the NYT article Sunday summarized that attitude. the Under secretary must be one who can put public health and food safety first and foremost, and take the heat from all sides when it comes, as it will. Plus there is that lack of visibility with Congress, the media and others without a Senate confirmed political appointee."

(Editor, Chuck Jolly's note: Raymond is referring to a statement attributed to Dr. Kenneth Petersen, an assistant administrator with the Food Safety and Inspection Service who said the department could mandate testing, but that it needed to consider the impact on companies as well as consumers. “I have to look at the entire industry, not just what is best for public health,” he said.)

Q. Why didn't/haven't the Bush and Obama administrations moved more quickly to fill the post?

Marler: “Because there is no reason for this position to exist unless it has a singular mission on behalf of food safety, which is to say, solely on behalf of the public health, the failure to fill this position can only be seen as a refusal, so far at least, to put the interests of public health before other competing, commercial interest.

Unfortunately, this conflict of interest is inherent (systemically and practically) in the USDA. FSIS has FOOD SAFETY as the main part of its name, and, to me, this mean that safety should be its sole mission, with the undersecretary for food safety as the keeper of this mission. Arguably, however, if the FSIS truly took to hearts its mission on behalf of food safety, then the FSIS administrator would be the keeper of the mission, making it unnecessary to have an undersecretary doing so.”

“But the bottom-line, I think, is that the theoretical desire to fill this position with someone would do nothing but put the safety of the public first is being undercut by the political and practical reality that appointing someone like this would be fiercely opposed by industry.”

Raymond: "Who knows the answer to this question? The President has said "our food safety system is a threat to the public's health. Yet the number one position in the US government for food safety goes unfilled"

Q. Would you both agree on two points made in Raymond's blog - the odds of getting a food borne illness from beef is extremely slim, but if it's your child "who becomes ill with O157 from eating beef, it is 100 percent for him or her, and you should be demanding even better odds?" Taking it to the next step, demanding better odds are a noble pursuit but not very effective. More importantly, the demand should be followed with action steps. What should be done to improve those odds?

Marler: “The odds of getting a foodborne illness from beef are NOT extremely slim, and it is silly to so suggest. Instead, the odds of an OUTBREAK of illnesses being linked to the consumption of beef are slim. As we have known for a long time, foodborne illness is hugely prevalent in the United States, it’s just that most is never linked to any particular food product.”

“Claims about the odds of foodborne illness simply cannot be seriously made without there being increased surveillance and testing. Indeed, right now, we barely have an inkling about the prevalence of pathogens in the meat supply given the paucity of testing over the years. So, sure the 100% odds for a child with a confirmed E. coli O157:H7 infection linked to a recalled meat product makes for a tragic story, but that shouldn’t be allowed to be a diversion from the reality of how much illness, injury, and death might be attributable to meat products that we simply do not know about.”

Raymond: “Make non-0157 STECs an adulterant. Make whole beef cuts contaminated with E coli adulterated. Make whole carcass low dose irradiation a processing aid, not an additive. Make all further processors test incoming product before fabrication and/or blending---then the big packers cannot black ball them as they do now, or no one would buy their products. Spend money on educating the consumer similar to that spent educating America on going digital for TV. Trace back to the source--the new bench trim policy is an example of fluff with absolutely no teeth in it because of the stance by the big packers. Sounds nice, but it could do a whole lot more without any more testing."

Q. Most people who are in the business of supplying food to the public are conscientious about their responsibilities; a few have proven themselves to be less so. First, how should we deal with those businesses that knowingly take shortcuts and put the public in danger?

Marler: “Most businesses are neither overly conscientious nor knowingly careless. Instead, businesses seek profits, and profits come first. To the extent that improved safety and quality are consistent with being profitable, companies will invest in the improvements. But to analyze food safety in terms of levels of conscientiousness versus levels of recklessness and malice is to create an either-or that does not really exist.”

“Businesses do not have consciences; they have bottom-lines. And the real utility of companies like Peanut Corporation of America, which was truly an example of a company that knowingly took shortcuts, is that the existence of PCA allows all the other businesses to more convincingly argue that they are different. The differences are, however, differences of degree, not kind.”

Raymond: "When found, they need to be heavily fined, maybe sentenced to jail time, and put out of business. If I knowingly endanger the public by drinking and driving, I pay a steep penalty. If a producer knowingly puts contaminated product out for sale, is s/he not equally endangering the public? And to find more of these bad apples, we need risk-based inspection but Congress said we could not do it. And the associations need to stop protecting these bottom feeders."

Q. Other businesses, despite their best efforts and the use of HACCP programs that are as up-to-date as the state-of-the-art allows, have had their products recalled. What is their responsibility? And is there a point when the consumer has to take some responsibility for illnesses caused by poor handling in the home?

Marler: I don’t even know what “despite their best efforts” might mean if used in a way that wasn’t sophistry. Similarly, what does it mean to say that “the consumer has to take some responsibility” when we are talking about meat contaminated with E. coli O157:H7? A consumer “takes some responsibility” when they get sick, end up in the hospital or die. So, if we are asking here whether we should deny some of these consumers a legal remedy, or full compensation—well, the answer is:

We already do.

Raymond: HACCP will not detect contaminated boxed beef and testing every three months will not, either. They need to test before blending and hold the product until negative results are in. Testing ground beef and still moving it out the door before results are back is ridiculous.

I do not know how to respond to the second question, except that parents are responsible for child car restraints, helmet wear when biking, teaching kids to look both ways when crossing a street, wearing a life jacket in a boat, having smoke and carbon monoxide detectors, etc., etc. Why it is not their responsibility to safely handle and cook meat I just do not understand. We can do better, but we cannot at this time and place, absolutely guarantee that raw meat and poultry do not contain pathogens."

Q. It's often been said "America has the safest food supply in the world." Do you agree? Are there other nations you can point to with outstanding food safety programs?

Marler: Saying that “America has the safest food supply in the world” is meaningless happy-talk. Safest compared to what? Now, if you want to compare particular kinds of food, then things start to be more meaningful. So, how about Denmark? Over a decade ago it eliminated Salmonella from ALL chickens and eggs. Are America’s chickens safer than that? I think not. And the list could go on.

Raymond: Absolutely and it is getting better all the time. But there are many things that can be done to make it even safer. New Zealand, Japan and Australia come to mind when looking at nations with good food safety programs."

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Part 1 and part 2 of this series examined the historical context of the debate surrounding dairy product food safety, and the mechanisms by which pasteurized or raw dairy products may become contaminated with foodborne pathogens. This section compares foodborne illnesses and disease outbreaks linked to raw and pasteurized dairy products.

Several sources were used to analyze the available data including Centers for Disease Control and Prevention (CDC) foodborne disease outbreak surveillance tables, an online outbreak database published by the Center for Science in the Public Interest (CSPI), public health reports such as the Morbidity and Mortality Weekly (MMWR), peer-reviewed manuscripts, and CDC Line List of dairy outbreaks from 1973-2005 produced in response to a Freedom of Information Act (FOIA) request to CDC by the Farm to Consumer Legal Defense Fund (FTCLDF).

These data sources are useful in comparing trends and potential risk factors, but several limitations must be noted. First, not all foodborne illnesses are reported to CDC as described by Mead et al (1999). For example, two notable outbreaks in California are missing from both the CDC and CSPI databases: a large outbreak of campylobacteriosis in 2006, involving over 1,644 illnesses among inmates that was linked to pasteurized milk produced by an on-site prison dairy (Jay et al, 2007) and another campylobacteriosis outbreak in 2007, that caused 8 illnesses following consumption of commercial raw milk and/or raw colostrum (CDPH 2008). There are additional examples of discrepancies between the CDC surveillance line listings, public health reports, and the peer-reviewed literature; however, these differences exist for both raw and pasteurized milk, as well as other food products. Second, state and local health departments vary in the level of resources available for foodborne disease outbreak investigations; therefore, some outbreaks are investigated more intensively than others. Given all of these considerations, there is no indication of a “systematic bias” against raw milk, as suggested by the Weston A. Price Foundation (WAPF).

Foodborne Disease Surveillance and Outbreak Investigation: The Smoking Gun

A major misconception by WAPF is that outbreak investigations involving raw milk are conducted in a substantially different (and biased) way compared with the techniques used for pasteurized milk, or other foods (e.g., spinach, deli meats, ground beef, etc.). In reality, outbreaks from raw and pasteurized milk are investigated using the same approaches, and both are subject to the same limitations as described above.

Below are some examples of misleading statements from WAPF in their response to outbreak papers cited in the Raw Milk Cons review:

“When they tested the milk for C. jejuni, however, none could be found...Over and over again, investigators blame C. jejuni outbreaks on raw milk despite negative milk samples.”

Isolation of the “outbreak strain” from a food product provides strong support (“The Smoking Gun”) for epidemiological studies implicating the same food; however, a positive food sample is not a requirement to take action to prevent new illnesses (e.g., recall and/or stopping distribution of an epidemiologically implicated food). Often, there is no leftover food product to test, especially if it is perishable such as milk or produce. Or, the test may be negative because the pathogen already died-off in the leftover milk due to the lag between the time the patient drank the milk and the time the outbreak investigation started.

Despite these limitations, the “outbreak strain” has been isolated from raw milk during investigations (Table 1, Figure 1a). Likewise, many examples of pasteurized milk-related outbreaks exist where milk samples tested negative (Table 2, Figure 1b), but investigators still concluded that the pasteurized milk was the most likely source. Note that when resources permit, DNA fingerprinting is used during both pasteurized and raw milk outbreak investigations to compare isolates from patients, milk products, and the farm environment.

“VERDICT: no evidence of illness”

WAPF repeatedly uses this phrase when dismissing a raw milk-related outbreak, usually citing negative milk sample tests. Yet, they do not provide any caveats or dismissals of pasteurized milk–related outbreak investigations where milk testing results were negative. This double standard used by WAPF is inherently biased, and could mislead consumers. Their press release concerning a recent campylobacteriosis outbreak in Wisconsin illustrates this point.

“Finally, most studies associating raw milk with illness never pinpoint where along the line of production the contamination occurred.”

In most dairy outbreaks, regardless of pasteurization status, the exact mechanism of contamination is never found. However, a commonality in virtually all milkborne outbreaks is sanitation. Dairies are not clean environments, regardless of whether it is a small “grass fed” farm, or a large CAFO. Cows produce copious amounts of manure, and can readily contaminate the milking parlor and equipment (Figures 1a and 1b). Sanitation can also be a major problem during the production of Mexican-style soft cheeses such as queso fresco (Figure 1c).

Figure 1a. Photo taken during the investigation of a raw milk-associated E. coli O157:H7 outbreak in Washington State, 2005. Eighteen illnesses including 4 cases of HUS were linked to “grass fed” raw milk from an unlicensed cow-share program. The farm milked 5 cows in a parlor with a dirt floor and mats shown in the photo. The outbreak strain was isolated from raw milk and floor samples. Investigators concluded that unsanitary conditions contributed to the outbreak (CDC 2007).

Figure 1b. Photo taken during the investigation of a pasteurized milk-associated Campylobacter jejuni outbreak in California, 2006. Over 1,600 illnesses at 11 state correctional facilities were linked to drinking pasteurized milk supplied by an on-site dairy at one of the prisons. The inmates milked ~500 cows in a parlor adjacent to the pasteurization building. The outbreak strain was isolated from recycled wastewater shown in the photo (lagoon water is being “flushed” through the cow stall barn). Investigators did not determine how the milk was contaminated after pasteurization, but suggested the need for further evaluation of manure management practices on the dairy (Jay et al, 2007).

Figure 1c. Photo of queso fresco, a Mexican-style soft cheese sometimes produced illegally under unsanitary conditions (“bathtub cheese”). In 2000-2001, an outbreak caused by Listeria monocytogenes involving 12 illnesses, 5 still births, 3 premature deliveries, and 2 infected newborns was associated with consumption of Mexican-style cheese made from raw milk in North Carolina. The cheese was manufactured illegally, and the “outbreak strain” was found in 4 cheese samples and raw milk taken from the farm that supplied the milk (CDC 2001).

The Outbreaks

A combination of data sources were used to create Table 1 (raw milk outbreaks) and Table 2 (pasteurized milk outbreaks). Oliver et al (2009) also recently published tables showing reports of raw and pasteurized milk outbreaks from 2000-2007. Additional references on raw milk-related illnesses and outbreaks were documented last year in the raw milk cons paper, and Kansas State University and Cornell University have compiled online listings of raw milk-related outbreaks.

Taken together, the data shows that both pasteurized and raw milk products can be important sources of foodborne illness. However, as discussed in Part 1 of this series, dairy products as a whole currently cause the fewest outbreaks of all the major food categories (e.g, beef, eggs, poultry, produce, seafood) (CSPI 2008).

Results from FTCLDF FOIA Request Analysis

A more in-depth analysis of the outbreaks was conducted using the Line List from CDC obtained through a FTCLDF FOIA request. This dataset was chosen because WAPF and other raw milk advocacy groups often refer to it. The data sent by CDC included “Year,” “Estimated Total (illnesses),” “Food,” and “Pathogen.” This information was entered into an Excel file, and a new variable was added called “Category.”

For several outbreaks, the line listing did not specify if the “Food” was “raw/unpasteurized” or “pasteurized.” For example, the food is listed as just “milk” or “chocolate milk.” For the purpose of this analysis, an assumption was made that the unspecified foods were most likely pasteurized products.

A total of 134 outbreaks were listed from 1973-2005, mostly from bacterial causes. Figure 2 shows the number of outbreaks and percentages by “Food” type as originally described in the line listing. Figure 3 shows the number of outbreaks and percentages using the food assigned to three general “Categories:” pasteurized, raw, or queso fresco Mexican-style cheese. Queso fresco was described as a separate category because it is often not known how the product was produced (outbreaks are commonly linked to illegal “bathtub cheese” operations, or illegal imported cheeses from Mexico).

Figure 2. Milkborne disease outbreaks by Food category, United States, 1973-2005 (source: FTCLDF via CDC).

Disproportionate Number of Outbreaks due to Raw Milk Consumption: Only ~1% of people drink raw milk in the United States, yet raw dairy products cause over 50% of the milkborne outbreaks

WAPF and public health officials generally estimate that only 1% of the population drinks raw milk (Headrick et al, 1997). If the risk from raw and pasteurized dairy products was equal, or if raw dairy products were actually safer as WAPF states in their documents, we would expect that raw dairy-related outbreaks would be 1% or less of the total number of outbreaks. Instead, raw dairy products (excluding queso fresco) caused 75 (56%) outbreaks compared with 47 (35%) outbreaks associated with pasteurized milk products (Figure 4). In other words, there should have been only 1-2 raw dairy-related outbreaks among the 134 reported during that time period given the small estimated number of raw milk drinkers.

Figure 3. Milkborne disease outbreaks by food category, United States, 1973-2005 (source: FTCLDF via CDC).

Figure 4. Estimated percentage of people who drink pasteurized and raw milk, United States (Headrick et al, 1997).

Most Pasteurized and Raw Dairy Outbreaks involve less than 50 illnesses

As discussed previously in Part 2, pasteurized milk can be more susceptible to massive outbreaks involving large numbers of illnesses because more consumers drink pasteurized milk, and there is wider distribution of the product. However, outbreaks with more than 1,000 illnesses are relatively rare, and appear to occur about once per decade (Table 2).

An analysis of the illnesses from dairy products using the CDC line listing from FTCLDF is shown in Table 3. The majority of outbreaks for both pasteurized and raw dairy products, as well as queso fresco Mexcian style cheese, usually involved fewer than 50 illnesses. In this database, 4 raw milk outbreaks were associated with over 100 illnesses. Notably, a multi-state outbreak of Salmonella Enteritidis involving over 200,000 illnesses from ice cream (Hennessy et al, 1996) was not listed in this database, possibly due to the fact that cross-contamination of the ice cream by raw eggs during transportation most likely caused the outbreak (thus the outbreak may have been classified as “egg” rather than “dairy” related).

Table 3. Number of illnesses associated with outbreaks due to milk products, 1973-2005 (source: FTCLDF via CDC).

Campylobacter and Salmonella cause the largest number of dairy-related outbreaks

Table 4 shows a breakdown of the reported outbreaks in the FTCLDF CDC line listing by agent (bacterial, viral, or chemical). The majority of outbreaks were due to bacterial pathogens. Notably, Campylobacter was the most common cause of raw milk-related outbreaks with almost 80% attributed to raw milk/cheeses despite claims by WAPF that raw milk “kills” pathogens, especially Campylobacter. Salmonella was the second most commonly reported pathogen overall, and the most frequent agent linked to pasteurized milk outbreaks.

Table 4. Agents causing foodborne outbreaks associated with milk products, 1973-2005 (source: FTCLD via CDC)

The final part of this series will examine more broadly the risks from specific pathogens associated with pasteurized and raw dairy products, and provide consumers information to help them assess these risks when making a decision between consumption of pasteurized and raw dairy products.

References

Continue Reading...

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Tune in at 6:00 PM Pacific Time to find out.

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Listeria monocytogenes (Listeria) is a foodborne disease-causing bacteria; the disease is called listeriosis. Listeria can invade the body through a normal and intact gastrointestinal tract. Once in the body, Listeria can travel through the blood stream but the bacteria are often found inside cells. Listeria also produces toxins that damage cells. Listeria invades and grows best in the central nervous system among immune compromised persons, causing meningitis and/or encephalitis (brain infection). In pregnant women, the fetus can become infected, leading to spontaneous abortion, stillbirths, or sepsis (blood infection) in infancy.

Approximately 2,500 cases of listeriosis are estimated to occur in the U.S. each year. About 200 in every 1000 cases result in death. Certain groups of individuals are at greater risk for listeriosis, including pregnant women (and their unborn children) and immunocompromised persons. Among infants, listeriosis occurs when the infection is transmitted from the mother, either through the placenta or during the birthing process. These host factors, along with the amount of bacteria ingested and the virulence of the strain, determine the risk of disease. Human cases of listeriosis are, for the most part, sporadic and treatable. Nonetheless, Listeria remains an important threat to public health, especially among those most susceptible to this disease.

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Or, what I would do if I changed jobs?

The position, although still unfilled, of Undersecretary for Food Safety plainly exists for a reason. Its sole mission should be food safety and public safety. The Undersecretary for food safety should, and needs to, be the responsible person within the FSIS on this important issue, advocating and making decisions solely on behalf of public health.

If, or when, the President appoints an Undersecretary here are some of the things they should do:

1. Have the FSIS update and finalize the E. coli O157:H7 Risk Assessment that it started about ten years ago, including especially an in depth look at cross-contamination (thus changing the agency’s operating assumption that somehow cooking alone solves all problems).

2. Develop uniform cooking and handling instructions that actually provide helpful guidance (in contrast, for example, of the suggestions to “cook thoroughly”), while also requiring that alternate or additional handling and cooking instructions on packages must be supported by tests and other evidence before being approved for use on the package.

2. Enforce a real zero-tolerance policy for E. coli O157:H7 and non-O157 EHEC.

3. Do meaningful sampling and surveillance of meat to determine real prevalence of all pathogens.

4. All Non-compliance Report (NR’s) and other enforcement documents at slaughter plants and grinding operations would go online in real-time (like restaurant health inspections are).

5. You should be able to go online, enter a USDA establishment number, and see not only all NR’s but testing results too.

6. Create new quality certifications to aid consumers in making choices, and allow companies to capture price premiums for higher quality.

7. Support small and medium sized agriculture by growing local and regional markets for produce and meat.

8. Improve surveillance of bacterial and viral diseases. First responders - ER physicians and local doctors - need to be encouraged to test for pathogens and report findings directly to local and state health departments and the CDC promptly.

9. Increase food inspections. While domestic production has continued to be a problem, imports pose an increasing risk, especially if terrorists were to get into the act. Points of export and entry are a logical place to step up monitoring. We need more inspectors - domestically and abroad.

10. We need to use our technology to make food more traceable so that when an outbreak occurs authorities can quickly identify the source and limit the spread of the contamination and stop the disruption to the economy.

Sure, there are more things (advice and comments requested), but this would give us a hell of a start.

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The Honorable Tom Vilsack
Secretary
United States Department of Agriculture
Room 200-A, Jamie L. Whitten Building
12th Street & Jefferson Drive, SW
Washington, DC 20250-0002

Dear Mr. Secretary:

I am writing to strongly urge the U.S. Department of Agriculture (USDA) and Food Safety and Inspection Service (FSIS) to investigate the disturbing allegations that were revealed in Sunday’s New York Times article about the beef inspection process and to examine the necessary steps to hold accountable large slaughterhouse facilities for distributing adulterated products into the market. I am certain you are equally alarmed by the articles’ allegations regarding the current flaws in the beef inspection system that allows low-grade ingredients from being grounded into beef sold in stores without any testing for food-borne pathogens. According to the article, grinding logs and other records showed that hamburgers made from low-grade trimmings and mash-like products from a mix of slaughterhouses in Wisconsin, Nebraska, Texas and Uruguay, were labeled ‘Angus Beef Patties.’ While meat companies rely on their suppliers to check for bacteria, unwritten arrangements between some companies prevents ingredients from being tested more frequently.

Perhaps the most disturbing allegations outlined in the article relates to actions and statements by USDA officials. Although USDA inspectors found serious problems at 55 meat plants that were failing to follow their own safety plans during the investigation into the Cargill outbreak in 2007, no fines or sanctions were imposed. Also, Dr. Kenneth Peterson, FSIS assistant administrator, noted that USDA would have to consider the impact on companies before mandating any testing for ingredients that are sent to processors. However, he is quoted in the article as stating, “I have to look at the entire industry, not just what is best for public health.” This is a very disturbing quote from a USDA official whose primary objective should be to protect the public health.

Given the claims and allegations in the article, please provide responses to the following questions:

·Beef from Uruguay was able to get past the port-of-entry inspection without proper food safety certificates and ended up in ground beef products in the U.S. How was this able to occur? Meat shipments that enter a U.S. port-of-entry without the proper food safety certificates should be rejected and the foreign plant from where it came should be delisted immediately.

·Why did USDA refrain from imposing any sanctions during the investigation into the Cargill outbreak in 2007, despite finding serious problems at dozens of plants?

·Has FSIS considered any proposals that would hold large slaughterhouse facilities accountable for sending adulterated meat into the marketplace while minimizing the burden on processing facilities?

·As you know, very small processing facilities often suffer economic harm due to adulterated products sent from large slaughterhouses. In an attempt to resolve this issue, FSIS discussed a proposal in 2006 that would improve food safety infrastructure capacity of very small processors. What is the status of those discussions?

·Sec. 11017 of the 2008 farm bill requires all meat plants to have reporting requirements and mandates recall procedures. Had this provision been in effect, what would have been Cargill’s obligations during the 2007 recall referenced in the article? What is the status of the implementation of this provision?

The primary objective of USDA’s meat and poultry inspection responsibilities should be to protect the public health. Any suggestion that industry considerations should minimize the department’s ability to protect consumers from deadly food-borne pathogens should be rejected immediately.

I would appreciate responses to these questions as quickly as possible. Thank you very much for your attention to this matter and I look forward to working with you on this issue.

Sincerely,

ROSA L. DeLAURO
Chairwoman
House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies

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These packets (t-shirt, op-ed and post card) are being hand-delivered to Senators and staff today and Tuesday as part of an effort to jump-start the Senate to pass meaningful food safety legislation - before Thanksgiving.

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I received quite a few emails and calls from a variety of people - mostly from DC - telling me I was being a bit too hard on the Secretary in my post yesterday - they said I was especially hard on him if I ever expected to get the job of Undersecretary of Food Safety (yes, I did actually apply).  Point made.  But, I mean really, why would I give up my day job suing Cargill and Nestle anyway?

I did, however, re-listen to his interview with Minnesota Public Radio and was struck by this quote by the good Secretary:

"Until we get the number of food-borne illnesses down to zero, and the number of hospitalizations down to zero, and the number of deaths down to zero, we still have work to do." 

Perhaps I should get t-shirts made with that quote and the below picture.  Perhaps all inspectors in all plants across the United States could wear them?

Today other t-shirts with the below picture are being handed out to Senators across Capitol Hill along with an Op-ed I wrote seven years ago.

Four Steps to Safer Food

Bill Marler’s Op-Ed Pleads for Industry and Government to put him out of Business

The Denver Post, August 4, 2002. This summer, scores of Americans, most of them small children or senior citizens, have already or will become deathly ill after eating ground beef boldly labeled “USDA approved.”

The now infamous ConAgra case started with a few sick kids in Colorado and quickly spread coast-to-coast, eventually triggering the recall of 18 million pounds of ground beef tainted with E. coli.

Now we know that this recall came weeks late, after innocent consumers from Washington State to New Jersey had consumed most of that meat. Because they trusted government’s food inspections, several kids suffered kidney failure and spent days or weeks hooked up to kidney dialysis machines. For some, the long-term prognosis is grim, with the risk of further kidney failure, dialysis, transplants or worse.

I know this because I am a trial lawyer who has built a practice on food pathogens. Many of those kids’ parents have hired me to help them get compensation for hundreds of thousands in medical costs. Which may prompt some readers to consider me a blood-sucking ambulance chaser who exploits other people’s personal tragedies.

If that’s the case, here’s my plea: Put me out of business. Please.

For this trial lawyer, E. coli has been a successful practice - and a heart-breaking one. I’m tired of visiting with horribly sick kids who did not have to be sick in the first place. I’m outraged with a food industry that allows E. coli and other poisons to reach consumers, and a federal regulatory system that does nothing about it. Stop making kids sick - and I’ll happily move on. Here’s how:

Actually inspect and sample food. At present, the U.S. Department of Agriculture employs thousands of inspectors across the nation to inspect hundreds of plants that produce millions of pounds of beef at processing plants and retail outlets. The General Accounting Office has warned that the USDA’s food samplings are so scattered and infrequent that there is little chance of detecting microscopic E. coli or any other pathogen. So hire more inspectors and give them real authority to sample meat and stop its distribution as soon as a pathogen is detected. Implement a sampling system that provides a reasonable chance of preventing another outbreak. Doing so might add a nickel a pound - maybe less - to the price of hamburger. But it will also cut into my business. And isn’t that the idea?

Consider mandatory recall authority. This authority was required in Sen. Tom Harkin’s Safer Meat, Poultry and Foods Act of 2002. Under the present system of voluntary recalls, no company has actually refused to recall contaminated product. But in its recent report, the GAO did document several instances where companies delayed complying with recall requests. Delays mean tainted product has more time to reach consumers.

Require the meat industry to document where specific lots of food are sold. That way, it can be recalled quickly if a pathogen is detected. In most E. coli outbreaks, there is no recall because retailers don’t know where the meat came from and processors rarely step forward. ConAgra deserves credit for owning up to its responsibility to track down as much of the tainted meat as possible and for covering the medical costs of its victims. But ConAgra is the exception. Timely online records would allow meat to be efficiently tracked down and recalled as soon as inspectors get a positive test result. Those plastic club cards issued by grocery chains could enable stores to contact specific individuals who have bought suspect ground beef.

Merge the two federal agencies responsible for food safety. Right now USDA’s Food Safety Inspection Service and the inspection arm of the Food and Drug Administration share this mission. The system is bifurcated, which leads to turf wars and split responsibilities. We need one independent agency that deals with food-borne pathogens.

None of this will stop E. coli entirely. This invisible poison has been around a long time and is bound to pop up again. But these steps will enable us to detect it far more quickly, to alert stores and families, and to keep our most vulnerable citizens - kids and seniors - out of harm’s way. And, with a little luck, it will force one more damn trial lawyer to find another line of work.

The other option would be for the Secretary to watch this video every morning:

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This Petition to the USDA's Food Safety Inspection Services is being filed Tuesday.  Click below to download the Petition and attachments.  Be patient, it is a big document and takes time.

As I said in a post the other day, the petition details the scientific and legal bases for the requested action, but perhaps more importantly it details the suffering that food contaminated with non-O157:H7 enterohemorrhagic E. coli inflicted upon three individuals: June Dunning, Megan Richards, and Shiloh Johnson. Ms. Dunning, whose infection was caused by E. coli O146:H21, unfortunately succumbed to her illness, passing in 2006. Ms. Richards and Ms. Johnson endured lengthy hospitalizations, kidney failure, and will both endure a lifetime of medical complications as a result of their E. coli O121:H19 and E. coli O111 infections (respectively).

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It seems that any serious discussion of E. coli O157:H7 always has to start with one event: the 1993 outbreak associated with the Jack in the Box restaurant chain. This, of course, is with good reason. That outbreak left over 700 persons ill and 4 children dead. The “9/11 for the food industry,” as a certain trial lawyer has occasionally referred to the outbreak, precipitated a whirlwind of events including media coverage, consumer outrage, lawsuits, and stricter federal regulations regarding meat safety. Though the swell of emotion that spiraled out of the Jack in the Box disaster dulls somewhat with each passing year, the federal regulations that sprung up in its wake continue to generate more questions.

To understand the significance of these regulations, a little background information is useful. The Food Safety and Inspection Service’s (FSIS) stated mission renders it “responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.” FSIS operates as part of the United States Department of Agriculture (USDA). To promote its mission, FSIS has the power—under the Federal Meat Inspection Act (FMIA)—to, among other things, seek the recall of products that have been deemed “adulterated.” FSIS drastically shifted how it interpreted and enforced the FMIA in 1994 when, following the Jack in the Box outbreak, the agency declared E. coli O157:H7 to be an adulterant. This marked a dramatic change from its previous stance that pathogens in raw meat were not adulterants.

The declaration of E. coli O157:H7 as an adulterant was met with strong opposition from the meat industry. In a lawsuit filed soon after the 1994 declaration, the industry accused the USDA of not following proper rulemaking procedures and of acting in an arbitrary and capricious manner beyond its legal authority. The United States District Court held, however, that the USDA was allowed to interpret the FMIA and that the USDA has the power to declare substances to be adulterants with the intended purpose of spurring the meat industry to create and implement preventative measures.

During the early part of this decade, however, it became readily apparent that O157:H7 was not the only deadly pathogen in E. coli family—in fact, far from it. The Centers for Disease Control (CDC) recognized this fact when, in 2000, the agency made all Shiga toxin-producing E. coli (STEC) nationally notifiable. The CDC subsequently referred to non-O157 STEC as emerging pathogens that pose a significant health threat, with more strains reported every year. Still, FSIS remained steadfast in its stance that O157:H7 is the only enterohemorrhagic E. coli strain that should be deemed to be an adulterant.

So what’s wrong with FSIS’s position regarding E. coli O157:H7? The simple answer is this: the people of this nation do not deserve another Jack in the Box-sized catastrophe as a pre-requisite for currently needed agency action. The scientific and medical communities have recognized the dangers of all enterohemorrhagic E. coli, not just O157:H7, again and again. Representatives of the CDC estimate that non-O157 STEC causes 36,700 illnesses, 1,100 hospitalizations, and 30 deaths annually. Nearly two years ago today, on October 17, 2007, the CDC and FSIS even went so far as to hold a public meeting to consider the public health significance of non-O157 STEC. In the Notice of the meeting, FSIS referred to the “growing awareness that STECs other than E. coli O157:H7 (non-O157:H7 STECs) cause sporadic and outbreak-associated illnesses.” Nevertheless, following the meeting, FSIS failed to re-interpret its policies.

This brings us to today. We’re nearing the end of 2009, closing in on seventeen years since the Jack in the Box outbreak. Millions of Americans have suffered foodborne illnesses, injuries, and deaths in that time, thousands of them likely due to enterohemorrhagic E. coli other than O157:H7. It is on behalf of those persons that the law firm of Marler Clark has authored a petition to FSIS requesting the agency to issue an interpretive rule declaring all enterohemorrhagic STEC, including non-O157:H7 serotypes, to be adulterants within the meaning of the Federal Meat Inspection Act.

The petition details the scientific and legal bases for the requested action, but perhaps more importantly it details the suffering that food contaminated with non-O157:H7 enterohemorrhagic E. coli inflicted upon three individuals: June Dunning, Megan Richards, and Shiloh Johnson. Ms. Dunning, whose infection was caused by E. coli O146:H21, unfortunately succumbed to her illness, passing in 2006. Ms. Richards and Ms. Johnson endured lengthy hospitalizations, kidney failure, and will both endure a lifetime of medical complications as a result of their E. coli O121:H19 and E. coli O111 infections (respectively).

It would be naïve to assume that a change to FSIS policy will immediately rid the world of all foodborne E. coli infections. It has been unequivocally proven, however, that all enterohemorrhagic E. coli are potentially lethal pathogens that we must fight tooth and nail to keep out of this nation’s food supply. If we trust science, and do our part to push government agencies to enact regulations to require better monitoring, we can no doubt begin to prevent further harm. In the end, after all, the requisite wading through the mess of bureaucracy required to change federal regulation is all worth it, so long as the outcome prevents at least one more case like that of June Dunning, Megan Richards, or Shiloh Johnson.

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Raw milk, for its proponents, brings images of grandpa’s idyllic farm – Bessie being milked as the cats meow around her legs. For the FDA and state and local health officials, raw milk brings up a different image: people sickened – mainly children – sickened by E. coli O157:H7, Campylobacter, Listeria or Salmonella.

For me personally, raw milk generates mixed images. Growing up on a farm, milking cows and consuming raw milk in the 1970s is one image. Thirty plus years later, however, my mind is drawn to images of children sickened by drinking raw milk. These children were sickened by bugs that we did not know existed in the 1970s. Each and every one of the parents who bought or served the raw milk thought that they were doing something good for their child. They believed that the “organic,” “natural,” “fresh,” and “raw,” nature of raw milk meant that it had properties that would be good for their child, not bring them to death’s door.

Presently, raw milk cannot be sold across state lines for human consumption. However, there have been multiple instances where raw milk producers have violated the law directly or have sold the milk as animal food knowing that humans were likely consuming it.

In-state raw milk sales are limited to about a dozen states, with most states limiting raw milk sales to direct farmer to consumer transactions. Many of the states that allow these direct sales are quick to point out the exceedingly low price of pasteurized milk, touting the high price a farmer can get for raw milk as a method of “helping the small, family farmer” – a laudable goal I might add. This goal, however, is not without risks to the consumer.

Over the past several years, I have represented several families of children whose parents purchased raw milk directly from the farmer. The children came away with E. coli O157:H7 bacteria-mediated Hemolytic Uremic Syndrome, months of hospitalization, hundreds of thousands of dollars in medical expenses, and millions of dollars in risk of future complications – including end stage renal disease and the need for multiple kidney transplants.

Some states allow “cow-shares” or, as I call them, “cow condos.” This is where non-farmers “buy” a portion of the cow (and its milk) and attempt to get around any law banning the sale of raw milk. Again, states rationalize allowing this ownership fiction as another way of supporting the cost of maintaining the “small, family farmer” – also, a laudable goal.

I currently represent a woman in California who “purchased” raw milk as part of a “cow-share” – albeit, an illegal one. The milk she consumed was contaminated with Campylobacter and she subsequently developed Guillain-Barre Syndrome. She was hospitalized for months, much of the while dependent on a ventilator. She is now, in essence, a quadriplegic. Her past medical bills are nearly one million dollars. Her cost of future care is in the tens of millions of dollars.

There are also a handful of states that allow retail (grocery store) sales of raw milk and raw milk products. This is capitalism at its finest. Raw milk in retail sells for about eighteen dollars per gallon. Organic pasteurized milk sells for less than half of that. Farmers want to sell their raw milk to a larger market as efficiently as possible and there is demand from consumers who would rather shop at their favorite market than drive to the farm or own a “condo cow.” In short, selling raw milk in a retail setting is the raw milk farmer’s Holy Grail. Even retailers love it, seeing as how it creates a consumer draw and has a nice mark-up.

I have represented (and still represent) victims of E. coli O157:H7 cases linked to raw milk purchased (some illegally) in retail settings. In Missouri, one consumer purchased raw goat milk that was being sold illegally – the consumer did not know that the sale was illegal. This sale led to the consumer’s child suffering severe Hemolytic Uremic Syndrome, being hospitalized for a month, and spending weeks on dialysis to save his life. He now faces a lifetime of risks that may likely cost millions of dollars.

In California, E. coli O157:H7-tainted raw milk sold in small “health food” retail outlets sickened several children. Two children developed severe Hemolytic Uremic Syndrome. Both spent over a month in the hospital, both on dialysis and one on a ventilator. Medical bills were nearly one million dollars. One child may require a kidney transplant – the other surely ill. The future costs to these children may well be several million dollars. 

I also presently represent two people (one child and one adult) from Connecticut who consumed raw milk purchased at a Whole Foods. The milk was tainted by E. coli O157:H7. Both developed Hemolytic Uremic Syndrome. Once again, hundreds of thousands of dollars in medical expenses have been incurred. One victim, a twenty-eight year old mother, will likely require a kidney transplant – again, at a multiple million-dollar cost.

Now for the risky part. Most, if not all, raw milk farmers have limited insurance and very few assets that are not owned solely by the bank. If they face litigation for poisoning a customer, bankruptcy is always an option and what insurance is available is paid.

But, what about the risk to the retailer? True, in selling raw milk they are “only” selling a product that has a history of sickening consumers – they did not manufacture it. So, is a retailer, like Whole Foods, liable for paying millions of dollars to its customers if they are sickened by raw milk? The short answer is – Hell yes!

The reality in most states is that the entire “chain of distribution,” whether you are a manufacturer (a farm is) or retailer, is responsible if a product (raw milk is a product) causes harm. That means the farmer, the shipper, and the retailer will be responsible (morally and legally) to the consumer for all damages caused by the product. It is true that, depending on the state, a court may apportion damages between various members of the “chain.” However, and this is key, if the original manufacturer (the farmer in this instance) is bankrupt or has limited assets (including insurance), the retailer may be left “holding the bag” – partially empty – that the retailer will need to fill.

By way of example – assume that raw milk sold at a Whole Foods sickens five people. Two develop Hemolytic Uremic Syndrome. Assume further that the farm has only one million dollars in insurance and limited assets. Also assume that the total value of all cases (settlement or verdict) is ten million dollars. Guess who pays the nine?

So, why would a retailer, like Whole Foods, sell raw milk? Perhaps eighteen dollars a gallon?

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Great site, with some common sense ideas:

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Salmonella is a leading cause of foodborne illness worldwide, with an estimated 1.4 million cases each year in the United States alone. Salmonella infections are typically due to consumption of food products of animal origin. Several lines of evidence indicate that antibiotic-resistance among human Salmonella infections results from the use of antimicrobial agents in food animals. The most recent post at www.salmonellablog.com is an overview of antibiotic-resistance and Salmonella and what it means for human health.

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I asked on a Food Safety Listserve what foods are considered the most unsafe.  You see, I feel a bit guilty always beating up on Hamburger, Leafy Greens and Raw Milk.  Someone on the list gave me a link to a list of at risk foods for people undergoing cancer treatments.  Here is the list.

Some foods have a higher risk of food poisoning. Here are some foods that can become tainted with bacteria, such as Listeria (causing an infection called listeriosis), E. coli, Salmonella, Campylobacter, and Vibrio, in addition to Toxoplasma, a parasite.

• Cold hot dogs or deli lunch meat (cold cuts)—always cook or reheat until the food is steaming hot
• Dry-cured, uncooked salami
• Unpasteurized (raw) milk and milk products, including raw milk yogurt
• Soft cheeses made from unpasteurized milk, such as blue-veined (a type of blue cheese), Brie, Camembert, feta, goat cheese, and queso fresco or blanco
• Cold smoked fish
• Deli-prepared salads with egg, ham, chicken, or seafood
• Refrigerated pâté
• Unwashed fresh fruit and vegetables
• Unpasteurized fruit juice or cider
• Raw sprouts, such as alfalfa sprouts
• Raw or undercooked beef, especially ground beef, or other raw or undercooked meat and poultry
• Raw or undercooked shellfish (such as oysters)—these items may carry the hepatitis A virus and should be cooked thoroughly to destroy the virus
• Some types of fish, raw or cooked, as it may contain high levels of mercury
• Sushi and sashimi, which often contain raw fish—commercially frozen fish (especially those labeled “sushi-grade” or “sashimi grade”) is safer than other fish, but check with your doctor before eating these foods
• Undercooked eggs, such as soft boiled, over easy, and poached; raw unpasteurized eggs, or foods made with raw egg, such as homemade raw cookie dough

Any other ideas?

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It is long past time for meaningful changes in the safety of the food our children eat.  Whether the food is raw, local, organic, small farm, big farm, mass-produced or slow, if it contains E. coli O157:H7, or another pathogen, it can kill.  It can kill your child, grandchild or the child of a friend.  It can kill just like it killed Abby.  Here is her story:

 It is time to step up and make Abby and her family the last to suffer this horror.  Mr. President, Senators, Congress Members, do your jobs!

Abby’s illness, and her Grandfather's, were linked to a Class I Recall by FSIS in May 2009 - Illinois Firm Recalls Ground Beef Products Due To Possible E. coli O157:H7 Contamination

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Next week many consumers (several past and present clients) will be walking the hallowed halls of the Senate meeting with Senators and staff.  The goal is to make food safety real to those that have the opportunity to in part increase FDA funding, increase inspections of plants that manufacture our food (including foreign companies) and to increase the resources for the CDC to catch outbreaks earlier.

I will be delivering the Senators t-shirts with the following on them:

Whatever gets them to do the right thing is OK with me.

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Parke Wilde keeps the U.S. Food Policy blog. He teaches graduate level courses in food policy and statistics at the Friedman School of Nutrition Science and Policy at Tufts University. In this list, he looked beyond the excellent sites that already appeared in a recent list at Culinate, which included Ethicurean, Green Fork, ChewsWise, Food Politics, Politics of the Plate, Grist, Civil Eats, and Obama Foodorama. Parke's list adds some more blogs from within what might loosely be called the "good food movement," but it emphasizes other selections that he reads to maintain diversity in his information stream.

10 Excellent Food Policy Blogs - Marler Blog - Commentary on food poising outbreaks and litigation.

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On September 25, 2009, I posted Part 1 of a 4-part series that examines the food safety record of both pasteurized and raw dairy products. Below is Part 2, which provides background on the occurrence of foodborne pathogens in milk products, and mechanisms of contamination.

Occurrence of Foodborne Pathogens in Milk and the Dairy Environment

Dairy animals such as cattle and goats may carry foodborne pathogens (e.g., Campylobacter, E. coli O157:H7, Listeria monocytogenes, Salmonella; see “cons” for a more extensive list). Often cows and goats that harbor foodborne pathogens in their gastrointestinal tracts do not appear to be ill. Occasionally, some of these bacteria cause mastitis (infection and inflammation of the udder), and may be shed directly into the milk. Certain strains of Salmonella and Listeria monocytogenes can cause serious systemic illness in ruminants. For example, Salmonella Dublin is a strain that is host adapted to cattle, and can lead to severe diarrhea and death in both cattle (especially calves) and humans.

Several authors have conducted extensive surveys of foodborne pathogens in bulk tank raw milk (BTM) and the dairy environment (Hancock et al 1998; Jayarao et al, 2006; LeJeune et al, 2009; Oliver et al, 2005; Oliver et al, 2005; Shere et al, 1998). BTM is milk from multiple cows mixed and stored in a container. Modern conventional dairies usually ship their milk in tanker trucks off-site for pasteurization. Milk from multiple farms may be mixed together. The majority of milk produced for pasteurization comes from confined animal feeding operations (CAFOs). In contrast, most commercial raw milk produced for human consumption in the US comes from pasture-based management systems as promoted by the Weston A. Price Foundation (WAPF). Milk from multiple cows may be mixed together and stored in a container, but raw milk from multiple farms is not usually combined. An exception would be “outsourcing” where the dairyman purchases additional milk from surrounding dairies to meet supply needs. This practice is probably uncommon, but considered dangerous because outsourced milk is not produced as required for the Grade A raw milk designation.

The most recent review of the literature on foodborne pathogens in BTM was published by Oliver et al (2009). The range in prevalence for BTM was summarized as follows:

Campylobacter: 2 – 9.2%
E. coli O157:H7: 0 - 0.75%
Listeria monocytogenes: 2.8 - 7.0%
Salmonella spp: 0 – 11%
Shiga-toxin E. coli: 2.4 - 3.96%
Yersinia enterocolitica: 1.2 – 6.1%

WAPF has raised a valid concern about using these surveys when assessing the occurrence of foodborne pathogens in commercial raw milk (e.g., raw milk sold legally on- or off-farm in the US). Because the BTM tested in these surveys was likely destined for pasteurization, the data does not specifically address the microbial quality or pathogen prevalence in Grade A raw milk sold for human consumption. Additional research is needed that compares BTM samples from licensed raw milk dairies to BTM intended for pasteurization. Furthermore, to fully understand the risk of pathogen contamination in raw milk being purchased and consumed in the US, surveys are needed that examine the prevalence of foodborne pathogens in raw milk produced by licensed, inspected raw dairies; unlicensed, “black market” raw dairies; and raw dairies selling their products as “pet food.”

Raw Bovine Colostrum

Colostrum is the “first milk” produced by the mammary gland of an animal after giving birth. Consumption of raw bovine colostrum appears to be increasing in popularity among raw milk drinkers, and has been associated with two recent foodborne disease outbreaks in California (CDC 2008; CDPH 2008). Unlike raw milk, raw bovine colostrum is regulated as a nutritional supplement. A recent survey of dairies in Pennsylvania by Houser et al (2008) found Salmonella in 15% of the colostrum samples; the mean standard plate counts (SPC) and coliforms were very high: 977,539 CFU/ml and 323,372 CFU/ml, respectively (see Oliver et al, 2009, for a broader discussion of sanitation standards). It was not specified in the paper if these dairies surveyed in Pennsylvania sold raw bovine colostrum for human consumption. Additional surveys are needed to study foodborne pathogens and sanitary standards in raw bovine colostrum from dairies that market the product as a nutritional supplement for humans.

Addressing the WAPF Claim: “Clean Grass Fed Cows” are Safe

WAPF and their Chapter members strongly promote the idea to their customers that raw milk is safe if produced by “clean grass fed cows.” Yet, the organization does not provide any survey data to support these claims. The only studies that potentially relate are found in the literature on grass vs. grain feeding and prevalence of E. coli O157:H7. This topic was reviewed previously. Briefly, the scientific evidence at this time does not support a broad conclusion that grass feeding significantly and consistently reduces the risk of E. coli O157:H7 or other dangerous foodborne pathogens from entering the food chain. More importantly, none of the surveys or experiments that WAPF cites examined raw milk operations, and instead focused primarily on dietary effects for cattle in feedlot conditions.

Most of the data on foodborne pathogen occurrence in the raw milk dairy environment comes from outbreak investigation reports. There are several examples where foodborne pathogens were found in the milk, cattle feces, and/or milking barn at dairies that follow WAPF principles including pasture-based, grass only feeding. In 2005, Washington state investigated an outbreak of E. coli O157:H7 linked to a cow-share, and found the outbreak strain in raw milk and environmental samples at the dairy (CDC 2007). In 2006, retail raw milk and colostrum were implicated in an outbreak of E. coli O157:H7 among children in California (CDC 2008). The outbreak strain was not found on the farm, but E. coli O157:H7 was present in the herd. In 2007, Campylobacter jejuni was isolated from 35% of fecal samples from cows at that same dairy in California; the outbreak strain was found in 4 fecal samples from those cows (CDPH 2008).

Addressing the WAPF Claim: Raw Milk Kills Pathogens

Another unsubstantiated claim by WAPF relates to the idea that raw milk is safe because the “good” bacteria and specific components in the unheated milk will destroy pathogens. A comprehensive review of this topic is beyond the scope of this paper. Briefly, the evidence that WAPF uses to promote this claim comes primarily from a paper by Doyle and Roman (1982) where Campylobacter jejuni was found to die-off at a more rapid rate in raw milk compared with sterile milk. However, the number of C. jejuni organisms in raw milk did not drop to a level below the infectious dose until about 7 days after inoculation. Furthermore, most C. jejuni stains also died-off in sterile milk, but not until a couple days later. WAPF does not make this distinction when promoting the safety of raw milk. Another consideration not addressed adequately by WAPF in their claims about raw milk safety is the importance of temperature abuse. Both raw and pasteurized milk are rich in nutrients, and if stored above refrigeration temperatures, can serve as an excellent medium for growth of pathogens (Wang et al, 1997).

A more extensive discussion on competitive exclusion and consumer perceptions was recently published by Rose (2009) as a White Paper.

How is Milk Contaminated with Pathogens?

There are 3 important points to consider about how milk becomes contaminated:

1. The initial mechanisms for raw milk contamination with pathogens are the same whether the milk is destined to be consumed raw, or pasteurized:

• Mastitis and shedding of the pathogen directly from the cow’s udder into the milk
• Entry of manure or dirt into the milk during the milking process
• Transfer of pathogens by vectors if they come in contact with the raw milk (for example, flies may carry pathogens on their legs and mouthparts)
• Human carriers transferring pathogens from their hands to the milk

2. The major difference between raw and pasteurized milk is the fact that the heat treatment during pasteurization destroys pathogens that may have entered the raw milk as described above.

3. Both raw and pasteurized milk can be contaminated during bottling, shipment, and storage. Pasteurization only destroys the pathogens in the milk at the time of processing; if unsanitary conditions allow pathogens to re-enter the milk later, it will be contaminated again.

There are two general causes of contamination of pasteurized milk:

1. Equipment failure: The pasteurization equipment fails and there is raw milk in the product sold as pasteurized. This can happen if the temperature is not high enough, or if the milk is not heated long enough. For example, in 1984, an outbreak of Salmonella Typhimurium occurred in a convent in western Kentucky (CDC, 1984). There were 16 illnesses and one patient developed a Guillain-Barre-type illness. The convent had a steam pasteurizer and investigators believe that the temperature may not have been high enough and/or the holding time was too short. The convent had no time-temperature gauge to record and monitor the process.

2. Post-pasteurization contamination: the milk is contaminated after pasteurization, usually through unsanitary handling of the milk. An example of post-pasteurization contamination involving a multi-drug resistant strain of Salmonella Typhimurium occurred in Pennsylvania and New Jersey in 2000 (Olsen et al, 2004). There were 93 illnesses and at least 6 hospitalizations. No Salmonella was isolated from the milk, but investigators concluded that the milk was most likely contaminated after pasteurization due to unsanitary conditions at the processing plant. For example, high humidity and excessive condensation in the plant could have produced droplets carrying Salmonella that fell into open containers of the pasteurized milk.

In the Age of Bioterrorism

Intentional contamination of the food supply through a bioterror attack has become an increasing concern. Wein and Liu published a provocative paper in 2005, where they modeled the vulnerability of pasteurized milk though the farm-to-consumer supply chain using botulinum toxin. They considered milk a possible target because of its symbolic value in society. The authors concluded that due to the rapid distribution and consumption of milk, an attack could result in several hundred thousand individuals poisoned with botulinum toxin.

It is worth noting that the conventional pasteurized milk supply is far more vulnerable to a massive poisoning compared with today’s raw milk supply. Several enormous, natural foodborne disease outbreaks involving pasteurized dairy products illustrate this point (Ryan et al, 1987; Hennessy et al, 1996). However, recent petitions to FDA to expand the raw milk supply chain by lifting the interstate ban on shipment could potentially increase the vulnerability of raw milk to larger outbreaks because a single contaminated lot would be consumed by many more individuals across a wider geographic area.

“Good” vs. “Bad” Bacteria: Probiotics and Dairy Products

One of the major concerns expressed by WAPF and other raw milk advocacy groups is that heat treatment by pasteurization destroys “good bacteria,” as well as pathogens. An example of “good” bacteria would be probiotics. A simple definition of a probiotic is a live microorganism (such as Bifidobacteria and Lactobacilli) that is beneficial to health when consumed. An example of a benefit from probiotics would be improved digestion.

Although raw milk may contain “good bacteria,” it is debatable whether raw dairy products fit the scientific definition of a probiotic food (see my previous review on Raw Milk Pros). Animals do not excrete “good bacteria” in their milk (usually milk is sterile when it exits the mammary gland). Both “good” and “bad” bacteria enter milk by the same mechanisms as described above. Sanitation during milking and processing at a raw milk dairy to prevent pathogens from entering the milk will very likely also lower the levels of probiotic bacteria. The ultimate question for the consumer is whether the trade off is worth the risk. It is worth noting that there is very little research on this topic. For example, studies are needed to measure the species and concentration of “good” bacteria in commercial raw dairy products to determine if they are sufficient to confer a probiotic effect.

In recent years, pasteurized dairy products containing probiotic bacteria have become increasingly popular. Products such as Activia® and DanActive® contain specific species and numbers of live probiotic microorganisms that are added to the dairy product after pasteurization to kill harmful bacteria.

The next segment of this review will compare foodborne illnesses and disease outbreaks linked to raw and pasteurized dairy products.

References

Continue Reading...

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Tennessee Lawyer John Day is a reader of Food Safety News.

Food Safety News is a new publication sponsored by food safety expert Bill Marler and his firm Marler Clark. It contains information on the food safety issues of the day, whether they pertain to foodborne illness outbreaks, recalled products, or food politics. The online newspaper has bureaus in Seattle, Denver, and Washington, DC and has invited contributors from government, industry, academia, and consumer groups to share their viewpoints on food safety-related issues.

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Blogs With Bite, by Mike Licht - Blogs with Bite is an occasional omnivorous sampling of food blogs and sites we find particularly tasty. Follow the trail of bread crumbs back to earlier editions, starting here:

Food Safety News — Comprehensive “daily Web-based newspaper … reporting on issues surrounding food safety.” Presented by Marler Clark LLP, PS, a law firm “dedicated to representing victims of food poisoning.”

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Mr. Cox of the Farm-to-Legal Defense Fund (FTCLDF) informed me (through several emails that he says are just from him, not on behalf of FTCLDF - although he is General Counsel for FTCLDF) that I was mistaken and I agree with him. 

I assumed that the farmer in a 2008 raw goat milk E. coli O157:H7 outbreak that nearly killed two children, who claimed that he consulted with FTCLDF, had also consulted with FTCLDF about disclosing communications between the farmer and the FTCLDF.  According to Mr. Cox, FTCLDF did not at all work on this case and did not have an attorney client relationship with the farmer.  I accept that from Mr. Cox. 

I expect to see the documents the Court ordered disclosed that the farmer - not FTCLDF - tried not to disclose in the next few days.  Here is the recent Court Order:

But, on to more important issues:

Comparing the Food Safety Record of Pasteurized and Raw Milk Products – Part 1

“Milk and milk products—particularly those that are unpasteurized—are potentially hazardous; even pasteurized products have been implicated in outbreaks. Contamination may occur after pasteurization, and no process works perfectly 100% of the time.” John M. Leedom

A week or so ago I posted, "Raw Milk Debate Set to Heat Up." 

Over the last years I have tried to bring some level of rationality to the debate over the consumption of raw milk. I first published on my blog a summary of the findings of my review of peer-reviewed literature on the topic of the "pros" of the consumption of raw milk. Several people from both sides of the raw milk debate have told me that the “pros” review is one of the most comprehensive compilations of peer-reviewed literature examining the potential benefits of raw milk beyond basic nutrition. I then posted about the "cons." What about the “cons?” As I said, the overwhelming “con” of drinking raw milk according to the literature relates to food safety hazards.

Since publishing these reviews last year, many readers have asked how the safety of pasteurized milk compares with raw (unpasteurized) milk. The Weston A. Price Foundation (WAPF) went so far as to produce an extensive, highly repetitive, 132 page response to my paper, "Raw Milk Cons: Review of the Peer-Reviewed Literature." WAPF claims that there is a systematic bias against raw milk. In reality, pasteurized milk-related outbreak reports were not analyzed in the raw milk cons review. In response to the erroneous statements by WAPF, and in an effort to provide consumers with accurate information, I examined the food safety record of both pasteurized and raw dairy products.

This 4-part series begins with an overview of the history and definitions that are important to know in order to understand how dairy food safety became a lightening rod for controversy.

Historical Perspective

Early last century milk products caused approximately 1 out of every 4 outbreaks due to food or water in the United States (Weisbecker 2007). As we begin the 21st century in this country, dairy products cause the fewest outbreaks of all the major food categories (e.g, beef, eggs, poultry, produce, seafood) (CSPI 2008). This drastic improvement in the safety of milk over the last 100 years is believed to be due primarily to pasteurization, and improved sanitation and temperature control during the processing, handling, shipping and storage of fresh milk products.

In 1948, Michigan was the first state in the US to require pasteurization. In 1987, the FDA mandated pasteurization of all milk and milk products for human consumption effectively banning the shipment of raw milk in interstate commerce with the exception of cheese made from raw milk, provided the cheese has been aged a minimum of 60 days and is clearly labeled as unpasteurized. A recent survey conducted by state agriculture departments found that 29 states currently allow some form of on- or off-farm raw milk sales, but only 13 permit retail sales (Oliver et al, 2009).

Definitions: Milk is Milk?

A typical dairy case at a major grocery store today contains numerous choices for the customer. There is milk labeled with different levels of fat content, and where retail raw milk sales are allowed, the consumer may choose between conventional, organic, and raw milk products, as well as homogenized or non-homogenized. In addition to fluid milk, other dairy products include butter, cheese, cream, ice cream, colostrum, yogurt, kefir, and other fermented dairy products.

Below are some basic definitions of raw and pasteurized milk.

Raw (unpasteurized): for disease surveillance purposes, “raw” or “unpasteurized” refers to a dairy product that has received no heat treatment to destroy pathogens or spoilage organisms. WAPF promotes a more refined definition for raw milk, termed “real milk,” that also includes organic, non-homogenized, “grass fed,” and produced from certain breeds of cattle as criteria.

Pasteurized: Pasteurization was named after Louis Pasteur, who discovered the process for the preservation of wine. When talking about milk, pasteurization refers to the heating of milk or milk products to a certain temperature for a specific period of time. The purpose of pasteurization is to destroy disease causing and spoilage organisms. The Grade A Pasteurized Milk Ordinance allows for different combinations of time and temperature:

• High Temperature Short Time (HTST): uses metal plates and hot water to raise milk temperatures to at least 161° F for not less than 15 seconds following by rapid cooling

• High Heat Short Time (HHST): similar to HTST, but uses slightly different equipment and higher temperatures for a shorter time

• Ultra Pasteurized (UP): milk is heated to not less than 280° F for two seconds

• Ultra High Temperature (UHT): milk is heated until sterile

Among these methods, only UHT milk is sterile (shelf stable), and does not require refrigeration. The other methods of pasteurization do not destroy all organisms, thus milk whether raw or pasteurized eventually spoils, and must be refrigerated to prevent the growth of pathogens.

Homogenization: Homogenization is a process that breaks the fat globules in milk into smaller particles, which prevents the cream layer from separating and floating to the top of the milk. Most conventional pasteurized milk is homogenized whereas organic pasteurized milk and raw milk are often non-homogenized.

The Debate

The controversy over banning raw milk sales has raged since pasteurization was first introduced over 100 years ago. Throughout decades of debate, the public health and medical communities have remained steadfast in their support of pasteurization as a key measure to protect the public health. In the 1980’s, a fierce legal battle was fought in California, which culminated in the closure of the largest raw milk dairy in the nation at the time and a Citizen’s Petition that successfully banned interstate shipment of raw milk. Today, the Campaign for Real Milk created by WAPF is currently among the most vocal of the groups that promote consumption of raw dairy products and eschew pasteurization.

WAPF has made bold claims that raw milk produced by “clean grass fed cows” is safer than any other food. Public health officials have made similarly bold claims that raw milk is an inherently dangerous food. In the next segment of this review, the mechanisms by which milk can become contaminated, and the occurrence of food borne pathogens in the dairy environment, are described.

References

CSPI. 2008. Outbreak Alert! 2008: Closing the gaps in our Federal food safety net. Available at: http://www.cspinet.org/new/pdf/outbreak_alert_2008_report_final.pdf

Leedom, J. M. 2006. Milk of nonhuman origin and infectious diseases in humans. Clin Infect Dis 43:610-5.

Oliver, S. P., K. J. Boor, S. C. Murphy, and S. E. Murinda. 2009. Food safety hazards associated with consumption of raw milk. Foodborne Pathog Dis 6:793-806.

Weisbecker, A. 2007. A legal history of raw milk in the United States. J Environ Health 69.

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Eric first called out Marion Nestle’s famous site – Food Politics. He then gave Food Safety News the following tip o’ the pen:

The second site – Foodsafetynews.com – is a new effort by lawyer and food safety expert, Bill Marler. At first glance, it would be easy to dismiss Marler because he specializes in food safety litigation, and has represented hundreds of cases for people injured because of food poisoning and related matters. Obviously, he’s making money on this, but take another look. Unlike many attorneys who have found food litigation to be a virtual hot water tap for revenue, Marler uses his position to fight for food safety, and researches and writes extensively on the matter. He knows his stuff and has testified before Congress and various state legislatures, as well as addressed numerous organizations about food safety issues. Did I say he’s blunt? A recent blog entry was titled “BBC reports that Godstone Farm animals test positive for E. coli - No S**t!” but without those family-friendly little asterisks. Marler’s a bulldog.

While he and his staff have written and blogged extensively about food safety, his new site is more consumer oriented and easy to navigate. I’m eager to see what happens with it.

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The other evening when the President was pitching his health legislation, his biggest ovation - from both sides - came when he threw medical malpractice trial lawyers under the bus in an effort to get a few republican votes.  It was not much of a surprise.  Lawyers have been hated throughout the ages. In Shakespeare's ''Henry VI,'' Part II, Act IV, Scene II, Line 73, Dick the Butcher stated: ''The first thing we do, let's kill all the lawyers.''

The US Chamber of Commerce is not quite so direct – well, at least less violent:

We know from our own polling that 9 out every 10 Americans believe that there are too many frivolous or unfair lawsuits. We know that 84% of all Americans say that meritless lawsuits are clogging our courts, denying justice to those who truly have been hurt. And, we know that 75% of all Americans think that the current lawsuit system benefits lawyers the most, while only 6% think that it helps the victims. 83% percent of voters said the number of frivolous lawsuits was a serious problem, including 77% of Democrats; 80% of Independents; and 92% of Republicans.

The “bottom line” is that Congress and the President can do something good by passing comprehensive food safety legislation. Not only will it protect consumers from unsafe food, but it will protect society from at least one of those damn trial lawyers – a win, win.  I am thinking of selling the below on Marlerblog on t-shirts:

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It has been a great first week at Food Safety News.  Hopefully we are covering stories that the larger media is not and in a way that is helpful.  If some of my readers here on Marler Blog have story ideas and/or want to write a contributed article on FSN, please click here. 

Here are my favorites articles of the last week:

• Mandatory Recalls? Careful what you ask for
• Healthcare Reform Requires Safe Food
• Reid Promises Family Senate Action
• Settlement Reached In Spinach Lawsuit
• Theno Q&A: Food Safety Since Jack in the Box Outbreak

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My 10 year old daughter's soccer team, the "butt kickers," lost 5 to 0 today.  Still was fun to watch.

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Spending most of the week in DC gave me a chance to promote and get feedback on the now six day old online publication - www.foodsafetynews.com.  So far, so good.  Not only are we able to highlight some of the best sources of Food Safety information on the web - like Bites and Barfblog - but we will be adding in several more "foodie feeds."  Most exciting is that we are adding two more reporters to the mix and are receiving numerous requests for guest contributors.

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Click on image to download PowerPoint:

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I must admit I like Washington DC.  Every time I get here I seem to pack much in, because there is always so much to do.  I had a full day today and will be on the Hill all Friday pitching food safety.

I started out the morning with a presentation to the American Insurance Association.   I presented to them ways to get food manufacturers to pay more attention to the details of safe food production.  My pitch was that if food manufacturers took care of their customers (stopped poisoning them), insurance companies would spend a lot less money on my clients.

I then had meetings with the folks at Pew Food and Consumer Product Safety and the Center for Science in the Public Interest Food Team.  Both are doing good work to protect consumers.

I even had time to get stuck in traffic because the street near my hotel was blocked due to the White House Farmers Market.

Also, www.foodsafetynews.com gets a few more mentions.  Tom Karst, over at the Packer, wrote today - "Bill Marler is everywhere (again)."

Food safety attorney Bill Marler has created another level to his omnipresence. Check out this Web site called Food Safety News. The site seems to be well-staffed – I met one FSN.com reporter at the United Fresh WPPC event. I’m not sure what the revenue model is…perhaps this is what Bill will do after a perfected food production system “puts him out of business.”

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A little over a year ago, I hosted a fund-raiser for Cy’s run for Manhattan District Attorney.   It was a bit of the “who’s who” of the Seattle legal community – primarily white-collar criminal types (that being the lawyers for those criminals). It was what you would expect from a Cy event – a suite at one of the oldest and finest hotels with a commanding view of the city where Cy made a name for himself far away from being the son of Cyrus Vance Sr.

Seldom shy at these types of events (I tend to be the “one stop shop” for Democratic candidates who find themselves low on funds in Seattle), I offered to say a few words in support of Cy and his candidacy. I decided to tell the story about how Cy and I almost first crossed paths. The story goes like this:

In 1988 after nearly a year of being a lawyer, I was casting about for another place to hang my shingle (why is another much longer story). One of the premier firms of trial lawyers in the city was the firm, Culp, Dwyer, Guterson and Grader (a few years later Dwyer became a well-respected Federal Judge and Guterson’s son, David, wrote a best seller, “Snow Falling on Cedars”).

So, I sent in my resume. Within a week I got a call for an interview, and then another, and then lunch with several associates, and then a meeting with several partners, and then a dinner with a few more and my new girlfriend (now my long-suffering wife of 21 years). I thought I had the job nailed.

I waited for the offer.

Finally, after a few days I got a call from one of the partners who I had met with several times. He said, “Bill, I have good news and bad news.” I asked for the bad. “Bill, we are not offering you the job.” I asked for the good. “At least we are offering the job to Cyrus Vance Jr., as I am sure you understand.”

Well, I want to thank Cy for being at the right place at the right time. Had Cy not been there to take that job, I might have actually been hired. And, if hired there, I would not have been at the firm where I eventually secured the Jack-in-the-Box E. coli case in 1993. And, well, the rest is history.

I am happy to raise money for Cy and I wish him all the very best.

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Professor Donna M. Byrne of William Mitchell College of Law gave us a “shout out” about Food Safety News today:

Kudos to Marler Clark for launching a promising and informative new website. Food Safety News is a news site rather than a blog (Bill Marler's MarlerBlog is still going strong too). The site has reporters who are not lawyers, as well as contributed articles by lawyers and others. I've added it to my favorites bar - I like it that much.

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Richard L. Cupp, Jr.'s article, Moving Beyond Animal Rights: A Legal/Contractualist Critique 46 San Diego Law Review 27 (2009), was chosen for the award.  Cupp's article critiques the analogy made by some animal rights theorists between granting rights to animals and granting rights to corporations and to mentally incapable humans.  The article documents the rapid expansion of "Animal Law" in United States law schools, and argues that both humans and animals are better served by courts and legislatures focusing on human responsibility for humane treatment of animals than by distorting the concept of legal rights to include animals.  The article may be downloaded without charge at:

http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1411863

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Dan Mitchell of Slate’s “Daily Bread” wrote this morning "Lawyers Launch Food Safety News Site:"

Marler Clark, perhaps the best-known law firm involved in food-safety litigation, has launched a news site that the firm describes as "a daily Web-based newspaper dedicated to reporting on issues surrounding food safety."

Bill Marler, the firm's managing partner, will continue writing his opinionated MarlerBlog, in addition to contributing to the new site, called Food Safety News.

In a Q&A on the site, Marler said that until now, there was no "up-to-date one-stop place for food safety information." He's also "been disappointed to see reporters on the food, health, and product safety beats lose their jobs to the fall of print journalism and the rise of consolidated media."

Despite Marler's standing as a fierce critic of (and lawsuit filer against) the food industry, he promises the site will offer "balanced reporting" as well as commentary.

The site's editor, Dan Flynn, has worked both in public relations and journalism. He is working from Denver, while other staffers work out of Washington, D.C., and Seattle, where Marler Clark is based.

The site is well-designed, clean, and user-friendly—all relatively rare, especially among news sites. In addition to news of outbreaks of foodborne illnesses and product recalls, there are sections for policy and law, litigation, and international food-safety news.

Dan Mitchell has written for The New York Times, Chicago Tribune, Minneapolis Star-Tribune, and Wired.

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So, goes to figure, we launch:

And, the government launches:

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We are a bit excited that this has now gone live.  Love to hear your comments.  Click on image to access site:

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Over the last years I have tried to bring some level of rationality to the debate over the consumption of raw milk.  I first published on my blog a summary of the findings of my review of peer-reviewed literature on the topic of the "pros" of the consumption of raw milk.

Here is the Weston Price Association's response - Response to Anti-Raw Milk Position Paper - by Bill Marler, JD - Prepared by the Weston A. Price Foundation.

I then posted about the "cons."  What about the “cons?”  As I said, the overwhelming “con” of drinking raw milk according to the literature relates to food safety hazards.

Here is the Weston Price Association's response - Response to Anti-Raw Milk Position Paper - by Bill Marler, JD - Prepared by the Weston A. Price Foundation.

True, given that I have represented many people, mainly children sickened with E. coli O157:H7 or adults with Campylobacter, who have suffered severe illness due to raw milk consumption, I may seem a bit biased against raw milk.  But, frankly, no more biased that I am against any producer of food - small or large - that poisons its customers.

I hope to have finished in the next week a rebuttal to both of the Weston Price Association's responses.  Let the Raw Milk debate continue - stay posted.

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Had a great chat with Evan Kleiman of KCRW Radio a few weeks ago.  I am about 8:22 into the podcast - click below:

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Lately it seems I seldom have time to unpack, less alone prepare for another speech.  However, I am looking forward to this DC trip.  I still believe that insurance companies have the ability to positively influence food manufacturers through auditing before issuing a policy and in giving incentives to those manufacturers that adopt food safety measures.  I also will get a chance to visit the DC office of Food Safety News dot com.

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It is not live yet, but by Monday we should have all the "bugs" worked out.  Our goal here is to have a place were "all the news fit to eat" can be found along with all the best information about recalls, new technology and politics.  We will have contributors from government, industry, universities and consumer groups.  A lively discussion will be had.  The link is www.foodsafetynews.com.

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My 10-year-old daughter, Sydney and I were almost packed for the Conference at the end of the month when it was canceled due to the 60th Anniversary of the revolution.  We are looking forward to attending the Conference on its new dates on November 4 and 5.  I am going to also speak at a few law schools.  Sydney is going to attend elementary school for a day - between visiting the Great Wall, etc.  I urge all to attend.  This says it all:

"The Chinese government attaches great importance to food safety because it is not only in the interest of the Chinese but also people in the world," Premier Wen Jiabao, People's Republic of China

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I just learned that AQSIQ Minister Wang Yong has called for CIFSQ to be postponed until after the 60th anniversary of the Revolution Celebration (first week of October) is completed.  The Conference is now likely to be set in late October or early November.

What strikes me about this, is the power of the Government.  Hopefully that same Government continues its "great leap forward" on Food Safety.

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Secretaries Sebelius and Vilsack at National Food Policy Conference in DC today announced a redesigned www.foodsafety.gov.  However nice it looks, is our food any safer?  Follow live tweets from conference @foodsafetynews and @obamafoodorama and @AgLawLLM

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Here is another perspective on non-O157:H7 that seems to indicate that they cause illness, but less severe illness that E. coli O157:H7.  That being said, it is also quite likely that the severe illnesses related to non-O157:H7 are under counted due to a lack of surveillance.  This presentation also did not take into account the Oklahoma E. coli O111 outbreak that sickened over 300, dozens with severe Hemolytic Uremic Syndrome and one death.  Perhaps we could focus on, test for and list as adulterants, the top 6 reported non-O157 STEC in the US (all of these have been associated with HUS according to the CDC) - O26, O111, O103, O121, O45, and O145?

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Here is a CDC PowerPoint that walks through the "Isolation and detection challenges" of Non E. coli O157:H7.  Clearly, the CDC sees the fact that Non-O157:H7 Shiga toxin-producing E. coli causes human illness, but that our ability to detect it using current lab techniques and resources makes the scope of the problem less clear.  These slides do not include discussion of the multiple E. coli strains found in the 2006 Dole E. coli outbreak, the 2006 Wendy's E. coli O21:H19 outbreak or the 2008 Oklahoma E. coli O111 outbreak.

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Non-O157 shiga toxin-producing Escherichia coli (STEC) are the causative agents of zoonotic emerging infectious diseases, often of bovine origin. Below is a general review of non-O157 STEC prevalence studies in humans, cattle, and beef products.

Humans

Non-O157 STEC infections are under-recognized and under-reported due to inadequate epidemiological and laboratory surveillance. In the United States, E. coli O157:H7 became nationally notifiable in 1994, whereas non-O157 STEC infections were not reportable until 2000, following adoption of a position statement (2000 ID#1) by the Council for State and Territorial Epidemiologists (CSTE). At that time, the CSTE recognized that the threat to public health from STEC infections extended beyond just the E. coli O157:H7 serogroup.

In recent years, improved diagnostic assays for non-O157 STEC have contributed to an increased appreciation of the severity of disease caused by these strains including hemolytic uremic syndrome (HUS). Notably, the number of non-O157 STEC cases reported to CDC’s FoodNet has risen steadily each year; from 2000-2006, there was an overall 4-fold increase in incidence (0.12 cases per 100,000 to 0.42 cases per 100,000 population) at FoodNet sites. The most common serogroups reported to cause foodborne illness in the United States are O26, O111, O103, O121, O45, and O145 (Brooks et al, 2005).

Johnson et al (2006) evaluated the emerging clinical importance of non-O157 STEC and concluded that these strains may account for up to 20 to 50% of all STEC infections in the United States. Clearly, the prevalence of non-O157 STEC infections is placing an enormous burden on society and the health care system in the United States.

Cattle as Reservoirs

Beef and dairy cattle are known reservoirs of E. coli O157:H7 and non-O157 STEC strains (Hussein, 2007; Hussein and Sakuma, 2005). In reviews of STEC occurrence in cattle worldwide, the prevalence of non-O157 STECs ranged from 4.6 to 55.9% in feedlot cattle, 4.7 to 44.8% in grazing cattle, and 0.4 to 74% in dairy cattle feces. The prevalence in beef cattle going to slaughter ranged from 2.1 to 70.1%. While most dairy cattle-associated foodborne disease outbreaks are linked to milk products, dairy cattle still represent a potential source of contamination of beef products when they are sent to slaughter at the end of their useful production life (termed “cull” or “spent” dairy cows); this “dairy beef” is often ground and sold as hamburger.

The high prevalence of non-O157 STEC in some cattle populations, combined with the lack of effective on-farm control strategies to reduce carriage, represents a significant risk of contamination of the food supply and the environment.

Beef Products

Numerous non-O157 STEC serotypes known to cause human illness are from bovine origin, thus putting the beef supply at-risk. Both E. coli O157:H7 and non-O157 STEC may colonize the gastrointestinal tract of cattle, and potentially contaminate beef carcasses during processing. Although not as well studied, the risk factors for contamination of beef products from cattle colonized with non-O157 STECs are probably the same or very similar to E. coli O157:H7. For example, cattle hides contaminated with E. coli O157:H7 during slaughter and processing are a known risk factor for subsequent E. coli O157:H7 contamination of beef products. One study showed that the prevalence of non-O157 STEC (56.6%) on hides is nearly as high as that found for E. coli O157:H7 (60.6%) (Barkocy-Gallagher et al, 2003).

Hussein and Bollinger (2005) evaluated published reports from over three decades and found that non-O157 STEC were more prevalent in beef products compared with E. coli O157. In their study, the prevalence of non-O157 STEC ranged from 1.7 to 58% in packing plants, from 3 to 62.5% in supermarkets, and an average of 3% in fast food restaurants. In a recent survey of retail ground beef products in the United States, 23 (1.9%) of 1,216 samples were contaminated with non-O157 STEC (Samadpour et al, 2009). In another study, researchers found a 10 to 30% prevalence of non-O157 STEC in imported and domestic boneless beef trim used for ground beef (Bosilevac et al, 2007).

Non-E. coli O157:H7 Outbreaks

Worldwide, non-O157 STEC outbreaks emerged in the 1980’s, and the first reported outbreaks in the United States occurred in the 1990’s (Hussein 2007; Brooks et al, 2005). The number of reported outbreaks due to non-O157 STECs remains relatively low in the United States, but experts agree that documented outbreaks probably represent the “tip of the iceberg.” From 1983-2002, seven non-O157 STEC outbreaks were reported in the United States (Brooks et al, 2005). During the following five-year period from 2003-2007, CDC documented an additional five non-O157 STEC outbreaks (CDC Outbreak Surveillance Data, http://www.cdc.gov/foodborneoutbreaks/outbreak_data.htm).

Products Implicated in Previous Outbreaks

There is a paucity of information on the vehicles of transmission for human non-O157 STEC infections, but contaminated raw dairy products, produce, and water have been implicated in the United States (Brooks et al, 2005). A review of non-O157 STEC in Connecticut showed that exposures, including ground beef, were similar in both non-O157 STEC and E. coli O157:H7 cases, suggesting that the routes of transmission are similar (CDC 2007). Considering the relatively high prevalence of both E. coli O157:H7 and non-O157 STEC in cattle populations and their products, it is not surprising that ground beef and other beef products could be a common food vehicle.

Non-O157 STEC outbreaks attributed to ground beef and its sausage products have been documented outside the United States including Argentina, Australia, Germany, and Italy. These beef-related outbreaks involved 8 STEC serogroups (O1, O2, O15, O25, O75, O86, O111, and O160). HUS cases were reported in five of the six outbreaks, mostly striking children and the elderly.

More rigorous investigation into the cause of non-O157 STEC outbreaks is needed to better understand the role of beef products and other foods in the contamination of the human food supply with these strains. Bettelheim (2007) described non-O157 STECs as “under-rated pathogens.” Indeed, the surveillance trends suggest that if left unchecked, it is only a matter of time before the United States experiences large non-O157-related outbreaks. Amending FMIA regulations to include pathogenic non-O157 STEC strains under the definition of “adulterated” is an urgently needed step in the prevention and control of these potentially deadly pathogens.

References

Barkocy-Gallagher, G. A., T. M. Arthur, M. Rivera-Betancourt, X. Nou, S. D. Shackelford, T. L. Wheeler, and M. Koohmaraie. 2003. Seasonal prevalence of Shiga toxin-producing Escherichia coli, including O157:H7 and non-O157:H7 serotypes, and Salmonella in commercial beef processing plants. J Food Prot. 66:1978-86.

Bettelheim, K. A. 2007. The non-O157 shiga-toxigenic (verocytotoxigenic) Escherichia coli: under-rated pathogens. Crit Rev Microbiol. 33:67-97.

Bosilevac J. M., M. N. Guerini, D. M. Brichta-Harhay, T. M. Arthur, and M. Koohmaraie. 2007. Microbiological characterization of imported and domestic boneless beef trim used for ground beef. J Food Prot. 70:440-9.

Brooks, J. T., E. G. Sowers, J. G. Wells, K. D. Greene, P. M. Griffin, R. M. Hoekstra, and N. A. Strockbine. 2005. Non-O157 shiga toxin-producing Escherichia coli infections in the United States, 1983-2002. J Infect Dis. 192:1422-9.

CDC. 2007. Laboratory-confirmed non-O157 shiga toxin-producing Escherichia coli – Connecticut, 2000-2005. MMWR. 56:29-31.

CDC. 2008. Shiga toxin-producing Escherichia coli: burden and trends. FoodNet News, Winter 2008. Available at: http://www.cdc.gov/FoodNet/news/2008/January_FoodNet_News.pdf

Hussein, H. S. and L. M. Bollinger. 2005. Prevalence of Shiga toxin-producing Escherichia coli in beef. Meat Sci. 71:676-89.

Hussein, H. S. 2007. Prevalence and pathogenicity of shiga toxin-producing Escherichia coli in beef cattle and their products. J Anim Sci. 85:E63-72.

Hussein, H. S. and T. Sakuma. 2005. Prevalence of shiga toxin-producing Escherichia coli in dairy cattle and their products. J Dairy Sci. 88:450-65.

Johnson, K. E., C. M. Thorpe, and C. L. Sears. 2006. The emerging clinical importance of non-O157 shiga toxin-producing Escherichia coli. Clin Infect Dis. 43:1587-95.

Samadpour, M., V. Beskhlebnaya, and W. Marler. 2009. Prevalence of non-O157 enterohaemmorrhagic Escherichia coli in retail ground beef in the United States. 7th International Symposium on Shiga Toxin (Verocytoxin)-producing Escherichia coli Infections. Buenos Aires, Argentina.

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I have a bit too much to do this week on the legal front to get to the "other Washington," but we have the DC Bureau of Food Safety News covering both conferences.  So, hopefully if the internet gods play nice, you should be able to read it at www.foodsafetynews.com soon.

United Fresh Produce Association's Washington Public Policy Conference

Food Policy Conference sponsored by Consumer Federation and GMA

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Linda Rivera’s excruciating case of food-poisoning (Washington Post, Sept. 1) should shine some light on a crucial reality that is missing from all or most health care reform plans: You can’t fix America’s health care unless you provide Americans with a safe food supply.

The mother of six lies comatose in her Las Vegas hospital room as a consequence of eating cookie dough contaminated with E. coli O157:H7 – a vicious microbe previously associated with hamburger, spinach, lettuce, raw milk and countless other products.

But she is not an isolated case. According to federal health authorities, she is just one of the 76 million Americans who are sickened each year by tainted food, adding billions in costs to individuals, to food-producers and to our beleaguered medical system.

Yet food safety is rarely mentioned in the absurd scream fest that passes as a national health care debate in and around Congress. In fact, that national squabble threatens to scuttle any hope for the much-needed food safety legislation that overwhelmingly passed the House this summer.

That law would give the Food and Drug Administration (FDA) the authority it needs to inspect food-processing plants and stop the distribution of food tainted with E. coli, Salmonella, Listeria or any of the other usual suspects. It would increase the agency’s ability to use emerging technologies to trace contaminated foods and additives back to their source, while imposing new safety standards on both domestic and imported food products.

The potential benefits – to our children, our parents, and our neighbors and to the U.S. economy – are enormous. While the food industry insists that we have the world’s safest food supply, the authoritative Centers for Disease Control suggest otherwise – 76 million sick people per year, 208,000 per day, 8,675 per hour.

Most of those cases are relatively mild. But the CDC says 325,000 of them will be hospitalized, and at least 5,000 of them will die of food poisoning.

Consider the costs to the health care system, such as it is. The Department of Agriculture estimates the combined medical costs, productivity losses, and the costs of premature death at a minimum of $6.9 billion per year. But that estimate excludes costs such as lost business opportunities, public costs, pain and suffering and much more.

The Food and Drug Administration assigns a cost of $5 million per death, reaching a total of $17 billion per year. Also, using a more complete analysis – “willingness-to-pay” to avoid the illness, the societal cost, would be as much as $357 billion to avoid those millions of illnesses.

These are not paper costs. They are real. For 17 years I have been representing the victims of foodborne illness. Over that time, we have collected more than $500 million in settlements and verdicts against food manufacturers, much of it to cover the costs of medical bills, lost wages and the pain and suffering incurred by people whose only crime was to believe processors’ claims that their products were safe.

So what if we passed meaningful food safety legislation? What if we saved billions of dollars in medical care and treatment by avoiding being poisoned in the first place? What if Linda Rivera and thousands of Americans like her never became infected with E. coli or Salmonella or Listeria?

Ms. Rivera has been hospitalized since May. Her medical bills to date for dialysis and surgeries to remove her large intestine and gall bladder are well over $1 million. If she survives, her medical costs for future care could run millions of dollars more.

It’s time to tone down the rhetoric on health care and do something positive: Pass meaningful food safety legislation that will put lawyers like me out of business, while saving money and the lives and wellbeing of innocent Americans.

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I am off to the Arkansas School of Law later this week to give a series of lectures on Food Safety and how the law can assist in making our food supply safer.  I am using a video from Jack-in-the-Box and a recent Raw Milk case to add to why it is "a bad idea to poison your customer."  Click on below to see my PowerPoint.  Between suing Dole, Nestle, JBS Swift and McDonalds in the last few weeks, I still have speeches to give in Washington DC and Beijing before the end of the month - cloning anyone?

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The House has passed its version of the Food Safety Act, now it is the Senate's turn - We shall see if they can pass anything.  Here is my summary:

Inspections of Records

• Secretary can access business records relating to any food (under FDA jurisdiction) the Secretary believes is adulterated or any other food the Secretary believes is likely to be affected in a similar manner.
• Records access provisions do not apply to farms or restaurants.
• Applies to all records relating to manufacturing, processing, packing, distribution, receipt, holding, or importation.

Registration of Food Facilities (1)

• Facilities (not including farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or most fishing vessels) engaged in manufacturing, processing, packing, or holding food for consumption in the United States must renew registrations every two years, alerting the Secretary to, among other things, any changes in food manufactured at the facility.
• The registration must contain an assurance that the Secretary will be permitted to inspect the facility at the times and in the manner permitted by the Act.
• The Secretary may suspend a registration if the Secretary determines that a food product is reasonably probable to cause adverse health consequences to humans or animals.
• If the registration of a facility is suspended, such facility shall not import food or offer to import food into the United States, or otherwise introduce food into interstate commerce in the United States.

Hazard Analysis and Risk-Based Preventive Controls

• Requires owners, operators, or agents in charge of facilities to evaluate the hazards that could affect the food manufactured, processed, packed, or held by the facility and create preventive controls to minimize the risk.
• The Secretary may, by regulation, exempt or modify the requirements for compliance under this section with respect to facilities that are solely engaged in the production of food for animals other than man or the storage of packaged foods that are not exposed to the environment.
• Nothing in this subsection can be construed to provide the Secretary with the authority to apply specific technologies, practices, or critical controls to an individual facility.
• Does not limit the Secretary from revising, issuing, or enforcing product and category-specific HACCP regulations under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act.

(1)  Farm means a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting. The term farm includes: (i) Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and (ii) Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.

Continue Reading...

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We decided to create a "one stop shop" for everything food safety.  This will be the place to get "all the news that fit to eat" - and warnings what not to eat too.  There will be news and opinion feeds from Bites, Blogs (www.marlerblog.com) and Twitter.  There will be recall notices from industry and government.  We hope to have a complete listing of food safety jobs in industry and government as well as a calendar of upcoming conferences.  Of course, there will be more information on the bugs that harm us.  The site is not live yet, (www.foodsafetynews.com), but we have bureaus in Seattle, Denver and Washington D.C. operational with other contributors around the world.  Keep tuned in.

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From the University of Arkansas School of Law Press Room:

William Marler, a noted food safety lawyer who has secured more than $500 million for victims of food-borne illness, will make a presentation to the law school’s Food Law & Policy class from 8 to 10 a.m. Friday, Sept. 11, in Room 342 of the School of Law. His presentation is free and open to the public.

Since 1993, Marler and his firm, Marler Clark, have represented individuals who have been seriously injured by food contaminated by E. coli, salmonella, hepatitis A and other contaminants. His first food-borne illness case resulted in a landmark $15.6 million settlement for a seriously injured child who was a victim of the Jack in the Box E. coli outbreak.

In addition to his litigation, Marler founded OutBreak, a nonprofit consulting firm dedicated to advocating for food safety initiatives and training the food industry in how to prevent outbreaks. Marler routinely challenges the food industry to "put me out of business" through food safety initiatives. In addition to his nonprofit work, he lectures widely on food-borne illness and publishes frequently on the subject. Among his many honors is the 2008 Public Justice Award, given to him by the Washington State Trial Lawyers Association.

“We are honored to welcome Bill Marler to the University of Arkansas,” said Susan Schneider, professor of law and director of the master’s program in agricultural and food law. “He is among the nation’s top food-borne illness litigators, and he is a strong voice for the safety of our food system, working with industry, community groups, schools and government.”

Marler is the first of several distinguished speakers this year who will be presenting their perspectives to the Master of Laws program. The University of Arkansas School of Law offers the only advanced law degree in agricultural and food law, a program noted for its coverage of the wide range of legal and policy issues relating to food and agriculture.

In addition to giving his presentation at 8 a.m., Marler will meet with the staff and candidates of the Journal of Food Law & Policy, meet with the director and staff of the National AgLaw Center and have lunch with the Master of Laws candidates.

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I sat in a mediation today in San Francisco until it became painfully obvious that Dole, Natural Selection Foods, Mission Organics and Pic-n-Save were unwilling to fairly compensate a Wisconsin woman who nearly died after eating E. coli O157:H7-tainted spinach in 2006.  She was hospitalized for months and incurred nearly $500,000 in medical bills.  Good news is that I get to sue them in the morning.  I am sure a good jury in Wisconsin will treat her much more fairly.

I had time to draft an Op-ed on the interconnectedness of the the health care debate and food safety.  If I do not get it published, I'll post it here in a few days.  I also had time to finish up my keynote speech at an upcoming food safety conference in Beijing China in a few weeks.  I think China can learn from our mistakes.  Click below to download the PowerPoint.  Click here to see video.

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I would rather be here:

Doing this:

But, I am in an airport working on this (click to download):

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It is always good to give a legal perspective to the Food Industry - click below to download PDF.

Posted with permission from Food Safety and Quality Magazine

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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.

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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.

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Recipes can be handed down from generation to generation and so can myths surrounding food safety -- sometimes with sickening consequences. September is National Food Safety Education Month and the Partnership for Food Safety Education (PFSE), in cooperation with the Food and Drug Administration, the Centers for Disease Control and Prevention, and the U.S. Department of Agriculture, is marking the occasion with an outreach to consumers aimed at debunking four common food safety myths:

* Myth: Lemon juice and salt will clean and sanitize a cutting board.

Fact: Sanitizing is the process of reducing the number of microorganisms that are on a properly cleaned surface to a safe level to reduce risk of foodborne illness. Lemon juice and salt will not do this. An effective way to sanitize cutting boards and other kitchen surfaces, is with a diluted bleach and water solution -- just 1 tablespoon unscented liquid chlorine bleach (not more) to 1 gallon of water. To clean your cutting board, first wash it with hot water and soap. After rinsing it off with clean water, sanitize by letting the diluted chlorine bleach solution stand on the cutting board surface for about a minute. Rinse and blot dry with clean paper towels. It is important to clean and sanitize - just because a surface looks clean, does not mean it is free of disease-causing bacteria!

* Myth: Putting chicken in a colander and rinsing it with water will remove bacteria like Salmonella.

Fact: Rinsing chicken in a colander will not remove bacteria. In fact, it can spread raw juices around your sink, onto your countertops, and onto ready-to-eat foods. Bacteria in raw meat and poultry can only be killed when cooked to a safe minimum internal temperature, which for poultry is 165 F, as measured by a food thermometer. Save yourself the messiness of rinsing raw poultry. It is not a safety step and can cause cross-contamination.

* Myth: Once a hamburger turns brown in the middle, it is fully cooked.

Fact: You cannot use visual cues to determine whether food has been cooked to a safe minimum internal temperature. The ONLY way to know that food has been cooked to a safe minimum internal temperature is to use a food thermometer. Ground meat should be cooked to a safe minimum internal temperature of 160 F, as measured by a food thermometer.

* Myth: You should not put hot food in the refrigerator.

Fact: Hot foods can be placed directly in the refrigerator. A large pot of food like soup or stew should be divided into small portions and put in shallow containers for quicker cooling in the refrigerator. If you leave food out to cool and forget about it, then toss it! Bacteria grow rapidly in the "danger zone" between 40 F and 140 F. Always follow the "two hour rule" for cooked foods - eat them or refrigerate them within two hours at a refrigerator temperature of 40 F or below. And, if left out in a room or outdoors where the temperature is 90 F or above, food should be refrigerated or eaten within just 1 hour - or discarded.

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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.”

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Law and Politics Magazine yearly picks lawyers who are voted in by other lawyers as "Super Lawyers."  This year I actually made it on the cover when they did an issue of food poisoning litigation.  Nice to have the recognition.  Perhaps we need a magazine for "Super Clients," so we do not forget what being a trial lawyer is really all about.

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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:

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 I am in the process of reading S 510 - FDA Food Safety Modernization Act.  Click below to download and read.  This was introduced in March 2009 by Senator Durbin.  The bill is presently in the Committee on Health, Education, Labor and Pensions.

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Adapted from AP:

The first hurricane of the 2009 Atlantic season has gathered strength with sustained hot air of up to 135 mph, the US National Hurricane Centre said.

Hurricane Bill at this time posed no threat to food manufacturers in the Gulf of Mexico but authorities in Bermuda have warned restaurants to be prepared.

With winds extending 45 miles from the eye of the storm, Bill is expected to push well past the Leeward Islands late on Wednesday and early on Thursday. Hurricane centre officials are urging all food manufacturers, shippers and retail outlets on the East Coast to be on the alert.

"The core of this dangerous hurricane will be passing well to the northeast of the northern Leeward Islands late today and early Thursday," the centre said in an advisory statement. Bill has the potential to grow in the next 24 hours and turn toward the Northwest.

Hurricanes of Category 3 or higher on the five-step Saffir-Simpson intensity scale are considered "major" and are the most destructive type.

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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?

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Click on below to get to link:

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When we hear that there has been a recall of hamburger tainted with Salmonella Newport, how many of us would know which company slaughtered the cow and ground the meat?  Would we know that the meat came from Beef Packers Inc. (a.k.a. Cargill), or would we only know the store we bought the meat from?  My guess it would be the store only.  So, why do we not yet know completely where the contaminated meat was sold?  Here is what we do know.

On August 6, 2009 Fresno-based Beef Packers Inc. (a.k.a. Cargill) recalled nearly 826,000 pounds (over 400 tons) of ground beef produced from June 5-23.  Health officials in three Western states said last Friday at least 40 people have reported illnesses tied to the recalled ground beef.  Colorado health officials said 21 people there have been sickened.  California officials said five people have reported sick (we know one has been hospitalized).  Wyoming health officials reported that two people have fallen ill.  Officials are investigating other reported illnesses in Arizona, Idaho, Illinois, Nebraska, New Mexico, Nevada, South Dakota and Texas that may be linked to the same strain of Salmonella.

The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) says the beef was sent to retail distribution centers in Arizona, California, Colorado and Utah, but has been silent on what stores sold the tainted beef.  California Department of Health, however, has announced that some of the meat was sold at Safeway Inc. and Sam's Club.

So, why the silence from FSIS and Beef Packers Inc. (a.k.a. Cargill)?  Here is some history - on August 18, 2008 after years of hand wringing, the FSIS finally put public health before “proprietary” business interests when it made the following rule: 9 C.F.R. § 390.10 Availability of Lists of Retail Consignees during Meat or Poultry Product Recalls:

The Administrator of the Food Safety and Inspection Service will make publicly available the names and locations of retail consignees of recalled meat or poultry products that the Agency compiles in connection with a recall where there is a reasonable probability that the use of the product could cause serious adverse health consequences or death.

The Bottom Line: The FSIS is now supposed to make available to the public names and locations of retail consignees (grocery stores, etc.) of meat and poultry products recalled by a federally-inspected meat or poultry establishment if the recalled product has been distributed to the retail level.  The rule will only apply to Class I recalls (like this one).  The information is supposed to be posted on the FSIS website, generally within three (3) to ten (10) working days, following the announcement of the recall.

So, why can California give the public a list in days but FSIS can not?  More to the point, why can not  Beef Packers Inc. (a.k.a. Cargill) give the same information?

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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?

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So, the dairy industry pumps the cows full of antibiotics and then when done with them sends them to slaughter to be fed to us.

Use of antibiotic susceptibility patterns and pulsed-field gel electrophoresis to compare historic and contemporary isolates of multi-drug-resistant Salmonella enterica subsp. enterica serovar Newport, Appl Environ Microbiol. 2004 Jan;70(1):318-23, Berge AC, Adaska JM, Sischo WM, Veterinary Medicine Teaching and Research Center, University of California-Davis, Tulare, California 93274, USA.

Recently, multi-drug-resistant (MDR) Salmonella enterica subspecies enterica serovar Newport reemerged as a public and animal health problem. The antibiotic resistance of 198 isolates and the pulsed-field gel electrophoresis patterns (PFGE) of 139 isolates were determined. Serovar Newport isolates collected between 1988 and 2001 were included in the study. One hundred seventy-eight isolates were collected from the San Joaquin valley in California and came from dairy cattle clinical samples, human clinical samples, bulk tank milk samples, fecal samples from preweaned calves, and waterways. Twenty clinical isolates from humans from various regions of the United States were also included in the study. Resistance to 18 antibiotics was determined using a disk diffusion assay. PFGE patterns were determined using a single enzyme (XbaI). The PFGE and antibiogram patterns were described using cluster analysis. Although the antibiotic resistance patterns of historic (1988 to 1995) and contemporary (1999 to 2001) isolates were similar, the contemporary isolates differed from the historic isolates by being resistant to cephalosporins and florfenicol and in their general sensitivity to kanamycin and neomycin. With few exceptions, the contemporary isolates clustered together and were clearly separated from the historic isolates. One PFGE-antibiogram cluster combination was predominant for the recent isolates, which were taken from human samples from all parts of the United States, as well as in the isolates from California, indicating a rapid dissemination of this phenotypic strain. The data are consistent with the hypothesis that the reemergence of MDR serovar Newport is not simply an acquisition of further antibiotic resistance genes by the historic isolates but reflects a different genetic lineage.

Chloramphenicol-resistant Salmonella newport traced through hamburger to dairy farms. A major persisting source of human salmonellosis in California, New England Journal of Medicine, Volume 316:565-570, March 5, 1987, Number 10, JS Spika, SH Waterman, GW Hoo, ME St Louis, RE Pacer, SM James, ML Bissett, LW Mayer, JY Chiu, B Hall, and et al.

Animal-to-human transmission of drug-resistant salmonella and the role of antimicrobial use in food animals in the emergence of these bacteria are controversial subjects. Investigation of a 4.9-fold increase in Salmonella newport isolations from Californians in 1985 showed that 87 percent of the isolates had an unusual antimicrobial-resistance pattern (including chloramphenicol resistance) and a single, identical plasmid. Interviews of 45 patients and 89 matched controls in Los Angeles County showed that illness was associated with penicillin or tetracycline use during the month before onset (P less than 0.001) and with eating ground beef during the week before onset (P = 0.052). The epidemic strain was isolated from hamburger products eaten by cases, abattoirs where the animals from which the meat came were slaughtered, dairies that sent cows for slaughter on days when culture-positive products were processed, and ill dairy cows. Isolation of salmonella from beef carcasses in abattoirs correlated with the proportion of dead or moribund animals received for slaughter (r = 0.60, P less than 0.05). Isolation of chloramphenicol-resistant salmonella from dairy farms was associated with the use of chloramphenicol at those dairies. We conclude that food animals are a major source of antimicrobial-resistant salmonella infections in humans and that these infections are associated with antimicrobial use on farms.

Multi-Drug-Resistant Salmonella Newport in Northern California, CHEUNG M, MOHLE-BOETANI J, ABBOTT S, WERNER S, VUGIA D; Interscience Conference on Antimicrobial Agents and Chemotherapy (42nd : 2002 : San Diego, Calif.), Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2002 Sep 27-30; 42: abstract no. LB-15, California Department of Health Services, Berkeley, CA.

BACKGROUND: In late 2001, the California (CAL) Department of Health Services Microbial Diseases Laboratory noted an increase in Salmonella Newport (SN) isolates. Screening for chloramphenicol (C) resistance (R) revealed a large number with probable multi-drug resistance (pMDR), as CR has been used as a proxy for MDR [ampicillin (A), (C), streptomycin (S), sulfisoxazole (Su), tetracycline (T)].

METHODS: To determine possible risk factors for pMDR-SN infection, we conducted a case-control study of 27 patients from Northern (N) CAL with pMDR-SN from specimens collected in January 2002 and 27 age- and ethnicity-matched controls. We calculated matched odds ratios (mOR) for food exposures. We also tested isolates for R to A, C, S, Su, T, sulfamethoxazole/trimethoprim (SXT), ceftriaxone (CTX), and ciprofloxacin (CIP) and compared isolates by pulsed field gel electrophoresis (PFGE).

RESULTS: 95% of pMDR-SN patients were Hispanic and 61% were children; 37% were hospitalized. Consumption of Mexican-style (MS) cream (mOR 8.0, p=0.05) and MS cheese or cream (mOR 5.0, p=0.04) were significantly associated with illness. Purchasing cheese (mOR 10.0, p=0.02) or cream (mOR 5.0, p=0.04) at a Mexican market was also associated with illness. 100% of isolates had R to C, S, Su, and T. In addition, 85% had R to A, 74% to SXT, 85% to CTX, but 0% to CIP. Twenty of 27 isolates had an identical PFGE pattern; all 20 had R to ACSSuT plus CTX and SXT. Random screening of SN isolates from 2001 revealed 85% of NCAL isolates to be pMDR-SN.

CONCLUSIONS: MDR-SN infections have increased in NCAL, disproportionately affecting Hispanics and children and resulting in substantial hospitalization. Most isolates are resistant to antibiotics previously used to treat serious Salmonella infections. We identified an epidemiological association between MS dairy products and MDR-SN infection. Despite warnings to the public about unpasteurized dairy products, cases of MDR-SN infection continue to occur and addressing this public health problem is challenging.

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I missed Ms. Cole's presentaion at the AVMA Conference a few weeks ago and just received a copy of her PowerPoint.  I really liked the pictures of the cows from the Dee Creek Farm that was linked to an E. coli O157:H7 Raw Milk Outbreak in 2005.  Click below to see her presenation:

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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.

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My kids have been telling me it for years, but I have always been a bit suspect. However, this morning I was informed that I had been selected by my peers for inclusion in the 2010 edition of "The Best Lawyers in America®" in the specialty of Personal Injury Litigation.

According to the website, inclusion in Best Lawyers is based entirely on peer review. For 25 years, the top lawyers in the U.S. have helped make The Best Lawyers In America the leading legal referral guide by candidly evaluating the work of other top lawyers in the same specialties and geographic areas.

Lawyers are nominated to Best Lawyers in three ways. First, all of the lawyers in the previous edition of Best Lawyers are automatically nominated into the next edition. Second, during the voting process, voting lawyers are asked to nominate any outstanding lawyers who have not yet been nominated. These lawyer nominations are generally for lawyers at other firms and register as votes as well as nominations.

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Click on above image to see final bill passed from the House, or see my post below.

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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