Bill Marler: E. coli O26 Outbreak and Recall Illustrate Urgent Need for Change

Food Safety Advocate has Petitioned USDA 

Seattle, WA (August 30, 2010) The recent outbreak of E. coli O26 linked to three illnesses and the recall of four tons of ground beef products produced by Cargill Meat Solutions is the precise reason these pathogen needs to be monitored, says Seattle food safety attorney, Bill Marler. 

“It took a massive outbreak in 1993 for the USDA and beef industry to accept E. coli O157:H7 as an ‘adulterant,’ which means that it is actively tested for in our food supply.  Its presence in beef halts distribution and triggers a recall,” said Bill Marler.  “The USDA and beef industry know well that there are at least six additional strains of shiga-toxin producing E. coli: O45, O111, O121, O145, O103 and O26 that are highly dangerous to humans and should not exist in food.”

Marler has been working since 2007 to get the additional E. coli strains added as adulterants, culminating in a $500,000 study to determine the prevalence of these toxins in the commercial beef supply.  The study found these pathogens in nearly 1% of the tests.  His firm, Marler Clark, in October 2009 filed a petition to the USDA requesting the change in USDA policy. It is estimated by the CDC that the six unregulated strains of E. coli sicken over 30,000 people a year and kills dozens.

“The food safety community has been extremely frustrated with the lack of action from the USDA and the beef industry,” continued Marler.  “I’m sure the families of the people affected in this most recent outbreak will be as outraged as I am that these pathogens, which can severely sicken and even kill, are allowed into the food supply unregulated.”

Cargill has now recalled 8,500 pounds of ground beef products due to E. coli O26; three are sick in Maine and New York.  In August 2008, an outbreak of E. coli O111 at an Oklahoma restaurant sickened 300 and killed one.  A May 2010 outbreak of E. coli O145 in lettuce sickened 26.

ABOUT BILL MARLER: An accomplished personal injury lawyer and national expert in foodborne illness litigation, William ‘Bill’ Marler has been a major force in food safety policy in the United States and abroad.  He and his partners at Marler Clark have represented thousands of individuals in claims against food companies whose contaminated products have caused serious injury and death.  His advocacy for better food regulation has led to invitations to address local, national, and international gatherings on food safety, including testimony to the US Congress Committee on Energy and Commerce.  Marler Clark is the nation’s foremost law firm representing victims of foodborne illness. 

Contact Mary Siceloff at msiceloff@marlerclark.com or (206) 719-4705.  For further information visit www.marlerclark.com and www.marlerblog.com

Press Advisory - Non-E. coli O157:H7 EHEC should be "Adulterants"

In light of this weekends recall by Cargill Meat Solutions of approximately 8,500 pounds of ground beef products that may be contaminated with E. coli O26, and the sickening of three people, it is time for the United States Department of Agriculture (USDA) and Food Safety and Inspection Service (FSIS) to deem another six “enterohemorrhagic (EHEC) Shiga toxin-producing serotypes of Escherichia coli (E. coli) strains - O26, O45, O111, O121, O145, and O103 – “adulterants.”

Non-E. coli O157:H7 EHEC as “Adulterants.”

According to the CDC, E. coli O157:H7 causes 73,000 illnesses and 50 deaths every year in the United States. Another six E. coli strains - O26, O45, O111, O121, O145, and O103 - are considered less pervasive, sickening “only” an estimated 37,000 people a year and killing nearly 30. E. coli O157:H7 is considered an adulterant in beef by the USDA (particularly ground beef), the other six strains are not.

Under 21 U.S.C. § 601 … (m), the Federal Meat Inspection Act (FMIA), 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; ...

It is hard to read the above and not think that the word “adulterated” does not apply to all E. coli. Presently, industry does not test for it because the USDA and FSIS does not require it – because they are not considered “adulterants.” In addition, only five percent of labs in the U.S. routinely test for these other E. coli leaving a gap in our food safety network and the true level of illness unknown.

Non-E. coli O157:H7 EHEC have been found in ground beef.

In 2008 Marler Clark hired a private lab to conduct a large-scale, nationwide study of ground beef, a key vector in E. coli O157:H7 cases. During the past year and a half, that lab has tested 5,000 samples from a variety of manufacturers. IEH Laboratories found that about 1 percent of the samples were tainted by E. coli O26, O45, O111, O121, O145, and O103. The results and the testing methodology have been shared with USDA and FSIS and the beef industry.

A history of E. coli O157:H7 as an “Adulterant” and why other EHEC’s should be.

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 650 persons ill (many with life-long complications) and 4 children dead. The “9/11 for the food industry,” 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 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 USDA. To promote its mission, FSIS has the power under the 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 FSIS 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 FSIS was allowed to interpret the FMIA and that the FSIS 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 E. coli 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 EHEC’s nationally notifiable. The CDC subsequently referred to non-O157 EHEC’s 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 EHEC 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 EHEC’s, not just O157:H7. Nearly three years ago, on October 17, 2007, the CDC, FDA and FSIS even went so far as to hold a public meeting to consider the public health significance of non-O157 EHEC’s. In the Notice of the meeting, FSIS referred to the “growing awareness that EHEC’s other than E. coli O157:H7 cause sporadic and outbreak-associated illnesses.” Nevertheless, following the meeting, FSIS failed to re-interpret its policies.

It is time for the USDA and FSIS to deem another six EHEC strains - O26, O45, O111, O121, O145, and O103 – “adulterants.”

This brings us to today. We’re nearing the end of 2010, closing in on eighteen 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 EHEC’s other than E. coli O157:H7.

It was 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 EHEC’s to be adulterants within the meaning of the FMIA. 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 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 EHEC’s 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.

President Obama does "recess appointment" of Elisabeth Hagen for Under Secretary for Food Safety, Department of Agriculture

Dr. Elisabeth Hagen is currently the USDA’s Chief Medical Officer, serving as an advisor to USDA mission areas on a wide range of human health issues. Prior to her current post, she was a senior executive in the USDA’s Food Safety and Inspection Service (FSIS), where she played a key role in developing and executing the agency’s scientific and public health agendas. She has been instrumental in building relationships and fostering coordination with food safety and public health partners at the federal, state, and local level. Before joining the federal government in 2006, Hagen taught and practiced medicine in both the private and academic sectors, most recently in Washington, DC. She holds an M.D. from Harvard Medical School, and a B.S. from Saint Joseph’s University. Dr. Hagen completed her specialty medical training at the University of Texas Southwestern and the University of Pennsylvania, and is board certified in infectious disease.

Agriculture Secretary Tom Vilsack made the following statement on the appointment of Dr. Elisabeth Hagen as Under Secretary for Food Safety.

"There is no higher priority at USDA than ensuring that Americans have access to a safe and healthy food supply, and Dr. Hagen's background as the Chief Medical Officer and senior executive within USDA's Food Safety and Inspection Service will enable her to successfully lead the effort to develop and execute the agency's scientific and public health agenda, and continue to build the coordination with public health partners at federal, state, and local level needed to achieve the objectives of President Obama's Food Safety Working Group."

S 510, the FDA Food Safety Modernization Act, Nears Vote

The bill appears to be moving to a vote shortly after Summer Recess.  If passed the bill would:

Hazard analysis and preventive controls: Requires facilities that manufacture, process, pack or hold food to have in place risk-based preventive control plans to address identified hazards and prevent adulteration, and gives FDA access to these plans and relevant documentation. These requirements do not apply to restaurants or most farms.

Imports: Requires importers to verify the safety of foreign suppliers and imported food. Allows FDA to require certification for high-risk foods, and to deny entry to a food that lacks certification or that is from a foreign facility that has refused U.S. inspectors. Creates a voluntary qualified importer program in which importers with a certification of safety for their foreign supplier can pay a user-free for expedited entry into the U.S.

Inspection: Gives FDA additional resources to hire new inspectors and requires FDA to inspect food facilities more frequently.

Mandatory Recall Authority: Gives FDA the authority to order a mandatory recall of a food product if the food will cause serious adverse health consequences or death and a company has failed to voluntarily recall the product upon FDA’s request.

Regulatory Balance: Achieves new requirements without being excessively burdensome. The legislation provides training for facilities to come into compliance with new safety requirements and includes special accommodations for small businesses and farms. It does not interfere with current organic farming practices and does not change the current definition of farm under the 2002 Bioterrorism Act. Any farm that is not currently required to register with FDA will not be required to do so under this legislation.

Surveillance: Enhances surveillance systems to detect food-borne illnesses.

Traceback: Requires FDA to establish a pilot project to test and evaluate new methods for rapidly tracking foods in the event of a food-borne illness outbreak.

Increased FDA Resources: Increases funding for FDA’s food safety activities through increased appropriations and targeted fees for food facility reinspection, food recalls, and the voluntary qualified importer program.

Here is the full bill.

Almond Producers Win Case, Right to Sell Untreated Almonds

A 2007 USDA rule requiring that US producers must pasteurize or chemically treat all almonds may soon no longer be in force.   Almond growers could be allowed to sell unpasteurized raw almonds, as the result of  a ruling Tuesday by the U.S. District Court of Appeals in Washington, D.C, according to a news report.

The  2007 rule was a response to prior outbreaks of Salmonella linked to the production and sale of raw almonds in the U.S.  The USDA rule requires that almonds produced in the United States must be pasteurized or chemically treated to prevent salmonella outbreaks.

In May, 2004, the FDA announced the nationwide recall of whole natural raw almonds connected with  cases of Salmonella Enteritidis poisoning in Alaska, Arizona, Oregon, Washington, and Utah. The recall was later expanded to include millions of pounds of raw California almonds sold worldwide, and by June 1, 2004, over two dozen illnesses had been linked to consumption of contaminated raw almonds.

The FDA then instituted a rule requiring all almonds sold in the US to receive some form of "kill step" to eliminate the risk of pathogenic contamination.  Imported almonds not subject to such a requirement, though, were still available for sale in the U.S.

According to the recent report, "several California almond producers filed suit, arguing that the rule is arbitrary and capricious, exceeds the USDA’s statutory authority, and violates various procedural requirements."

The Appeals Court ruling may now clear the way for U.S. producers to return to the sale of untreated almonds. 

Food Safety Study Concludes FDA Needs Revamp

A study by the Institute of Medicine and the National Research Council, titled "Enhancing Food Safety: The Role of the Food and Drug Administration," concludes that the Food and Drug Administration (FDA), the agency responsible for monitoring approximately 80% of the US's food supply, is in need of a serious revamp.

The study finds that shifting to a risk-based food safety system, utilizing a research infrastructure and integrated federal, state, and local government food safety program, can go a long way towards achieving the safer food supply we all desire.

In a recent article in the Canadian Medical Association, author Nancy Benac interviewed a number of key food safety players for input on the article's findings:

Lewis Grossman, a professor at American University's Washington College of Law who also was a member of the committee, says the FDA is taking steps in the right direction but needs "an overall systematic approach to their food safety mission. It's a bit scattershot right now."

***

Attorney Bill Marler, whose Seattle law firm specializes in food-related illnesses, says a lack of coordination among state, federal and local governments is one reason that outbreaks of foodborne illnesses aren't identified more quickly.

FDA is "underfunded and understaffed for what we expect them to do and it's only getting worse" as imports increase and food production becomes more complex, Marler says. "The risks are just larger. We've not kept up with the reality of how our food is produced."

As the continuing onslaught of outbreaks and recalls indicate, the importance of creating the best and most efficient food safety system cannot be overstated.

DeLauro Introduces E. Coli Traceability and Eradication Act

New legislation will strengthen food safety measures, protect consumers

Washington, DC – Congresswoman Rosa L. DeLauro (CT-3) introduced the E. coli Traceability and Eradication Act today, which will require stricter testing procedures for meat and processing facilities with the goal of completely eradicating the dangerous Shiga toxin-producing E. coli bacteria, and establishing a tracking procedure that will enable the USDA to implement faster recalls should any be found to be contaminated.

Shiga toxin-producing E. coli are bacterial pathogens similar to E. coli O157, the most commonly known and reported strain. It causes the same type of illness, and can be found in processed meat, ground beef, and can be transferred to other food products such as packaged lettuce. By implementing stricter and more comprehensive testing of meat, slaughterhouses, and grinding facilities, this critical legislation will ensure that our food supply is safer. The bill will require that these facilities to test ground beef and beef trim multiple times throughout the manufacturing process by an independent, USDA-certified testing facility, including ‘beef trim,’ leftover pieces from larger cuts of meat commonly used in ground beef, that have not previously been subject to analysis.

Should any facilities be producing products that are unsafe for either three consecutive days or ten days throughout a year, their company named will be posted to a list of safety offenders with the USDA. Additionally, the legislation will create a tracing protocol that will enable the USDA to track any contaminated meat or meat products, leading to faster recalls and less hazard to consumers. For facilities that are found to be producing contaminated meat, the USDA will test their products for 15 consecutive days following the positive test.

“By the end of this year, an estimated 57,000 people will have been made ill from E. coli, which represents an astounding failure on the part of our food safety system. We must do more to address the dangers American consumers face on a daily basis from these hidden killers, and ensure that the food entering the marketplace, our homes, and even our schools, is safe.

“This legislation will require rigorous new testing standards, calling for multiple examinations of products and specifically testing for all Shiga toxin-producing E. coli bacteria. And should test results reveal E. coli contamination, this bill will require slaughter facilities to report it to USDA immediately. Also, because this bill will require processors to test incoming beef trim, it would cease the current industry practice of processors being blackballed by their suppliers.

“Another important component of this bill is that, when E. coli is detected at a facility, it would require USDA to establish a traceback procedure all the way back to the original source of the contamination. This will allow USDA to recall products more quickly and prevent additional illnesses during an outbreak. Our current food safety system is not doing its job— contaminated meat is still hitting the shelves, and people are still getting sick. This legislation will establish higher standards for food safety and protect the public health.”

FDA Seeks Permanent Injunction Against NY Gourmet Salads, Inc.

An action has been commenced in the US District Court for the Eastern District of New York by the United States Food and Drug Administration (FDA) against New York food processor, NY Gourmet Salads, Inc.  NY Gourmet Salads makes ready-to-eat deli salads, seafood salads, and cream cheeses for its customers in New York and New Jersey.  For additional information, see the FDA's Press Release here.

FDA inspections have documented insanitary conditions at NY Gourmet's facility in Brooklyn and a failure to follow applicable FDA regulations concerning the production of food and seafood products. Although the company promised to address and correct deficiencies following inspections in 2006, 2007, and 2009, the FDA's most recent inspection in March 2010 confirmed that the company continued to operate without adequate controls.

More recently, FDA testing found Listeria monocytogenes (L. mono) throughout their facility and in a sample of finished product. The complaint also says that the strain of L. mono found in a sample of chickpea salad in 2010 was indistinguishable from the strain of L. mono found in the Brooklyn facility during a 2009 inspection, indicating that the L. mono had likely formed a lasting presence in the facility.

Listeria in food can lead to Listeriosis, a serious infection caused by eating food contaminated with the bacterium. Although there are other types of Listeria, most cases of listeriosis are caused by Listeria monocytogenes. Listeria is found in soil and water. Vegetables can become contaminated from the soil or from manure used as fertilizer. Animals can carry the bacterium without appearing ill and can contaminate foods of animal origin, such as meats and dairy products. Listeria has been found in a variety of raw foods, such as uncooked meats and unpasteurized (raw) milk or foods made from unpasteurized milk. Listeria is killed by pasteurization and cooking; however, in certain ready-to-eat foods, like hot dogs and cold cuts from the deli counter, contamination may occur after cooking but before packaging.

Unsafe at Any Meal - Eric Schlosser is the author of "Fast Food Nation" and a co-producer of the documentary "Food, Inc."

EVERY day, about 200,000 Americans are sickened by contaminated food. Every year, about 325,000 are hospitalized by a food-borne illness. And the number who are killed annually by something they ate is roughly the same as the number of Americans who’ve been killed in Iraq and Afghanistan since 2003.

Those estimates, from the Centers for Disease Control and Prevention, suggest the scale of the problem. But they fail to convey the human toll. The elderly and people with compromised immune systems face an elevated risk from food-borne pathogens like listeria, campylobacter and salmonella. By far the most vulnerable group, however, are children under the age of 4. Our food will never be perfectly safe — and yet if the Senate fails to pass the food safety legislation now awaiting a vote, tens of thousands of American children will become needlessly and sometimes fatally ill.

Almost one year ago, the House of Representatives passed the Food Safety Enhancement Act with bipartisan support. A similar bill, the F.D.A. Food Safety Modernization Act, was unanimously approved by the Senate Health, Education, Labor and Pensions Committee in November. This legislation would grant the Food and Drug Administration, which has oversight over 80 percent of the nation’s food, the authority to test widely for dangerous pathogens and improve the agency’s ability to trace outbreaks back to their source. Most important, it would finally give the agency the power to order the recall of contaminated foods — and to punish companies that knowingly sell them.

This bill is supported by an unusual set of advocacy groups: the American Public Health Association, Consumers Union, the Center for Science in the Public Interest, the United States Chamber of Commerce and the Grocery Manufacturers Association, among others. Last week, a poll for Consumers Union found that 80 percent of Americans want Congress to empower the F.D.A. to recall tainted foods.

You’d think that a bill with such broad support, on a public health issue of such fundamental importance, would easily reach the floor of the Senate for a vote. But it has been languishing, stuck in some legislative limbo. If it fails to gain passage by the end of this session, Congress will have to start from scratch again next year.

Food processors reluctant to oppose the bill openly will be delighted if it dies a quiet death. That’s because, right now, very few cases of food poisoning are ever actually linked to what the person ate, and companies that sell contaminated products routinely avoid liability. The economic cost is instead imposed on society. And it’s a huge cost. According to a recent study sponsored by the Pew Charitable Trusts, the annual health-related cost of food-borne illness in the United States is about $152 billion.

Without tough food safety rules, a perverse economic incentive guides the marketplace. Adulterated food is cheaper to produce than safe food. Since consumers cannot tell the difference between the two, companies that try to do the right thing are forced to compete with companies that couldn’t care less.

So the law of the jungle prevails, as Upton Sinclair noted more than a century ago. In those days, many companies had no qualms about selling children’s candy colored with lethal heavy metals and rancid food laced with toxic chemicals to disguise the stench; such abuses were widespread. And some of the strongest support for President Theodore Roosevelt’s food safety crusade came from processors (like the H. J. Heinz Company) that were outraged by the unfair advantage their competitors gained by selling cheap, dangerous, adulterated food.

The Pure Food and Drug Act of 1906 helped to eliminate many unsafe practices. But the recent centralization and industrialization of the American food system poses new kinds of threats.

Today, a problem at a single factory can swiftly lead to an outbreak that extends nationwide. Last year’s peanut butter recall illustrates what can go wrong. Executives at the Peanut Corporation of America knew that peanut butter from their filthy, rodent-infested plant was testing positive for salmonella — but shipped it anyway, for months.

Thousands of different products, manufactured by more than 200 companies, including candies and cookies marketed to children, were potentially tainted thanks to that one plant. And in the end, roughly 20,000 Americans got salmonella; about half of them were under the age of 16 and one-fifth were younger than 5.

The enormous rise in imported food also exposes American consumers to food safety lapses overseas. In recent years, China has been responsible for food scandals that bring to mind the United States in the days of Upton Sinclair: Chinese companies have been caught adding lead-based whiteners to pasta and selling beverages made with industrial alcohol. Two years ago, almost 300,000 Chinese infants were sickened by baby formula that had been adulterated with melamine, a cheap but toxic chemical. The overuse of antibiotics and pesticides in Chinese agriculture is rampant.

Despite those food safety problems, China has become the largest exporter of food to the United States after Canada and Mexico. About 60 percent of the apple juice in America — like peanut butter, a product consumed largely by children — now comes from China. This is yet another reason that passage of the F.D.A. modernization act is so urgent; it would, for the first time, subject foods from overseas to the same standards as those produced in the United States.

Last year, President Obama called for measures that would “upgrade our food safety laws for the 21st century,” and this bill is a good first step. The president has asked lawmakers to pass the legislation, saying that it would provide “the federal government with the appropriate tools to accomplish its core food safety goals.”

For months, however, the Internet has been rife with wild rumors and accusations: that the bill is really a subterfuge cleverly designed to eliminate small farms and strengthen the grip of industrial agriculture; that it would outlaw organic production; that it would hand over the nation’s food supply to Monsanto.

Those arguments may be sincere. But the bill very clearly instructs the Food and Drug Administration to focus its enforcement efforts on plants that pose the greatest risk of causing large-scale outbreaks. And the bill’s wording can still be clarified so that mom-and-pop producers aren’t threatened by heavy-handed government regulations.

What the legislation actually seeks is some restraint on unchecked corporate power. We’ve seen what happens when Wall Street is allowed to regulate itself and when the oil industry is allowed to regulate itself. How could it possibly make sense to let the food industry continue to write its own rules?

I’ve come to know families that were devastated by a food-borne illness. A great deal of harm, inflicted on some of the weakest members of society, can be avoided with a few simple reforms. Nobody should lose a child because the Senate lacks the will and the leadership to act.

Food Safety Advocates Call for Testing of Non-O157 Strains of E. coli

The AP is carrying the story today of efforts of food safety advocates, including us here at Marler Clark, to push the USDA to include several strains of E. coli known to be pathogenic to humans in its testing requirements for ground beef.  E. coli O157:H7 is the most well known of a group of pathogenic E. coli that cause severe food poisoning type symptoms in humans.  These pathogenic bacteria, both O157 and non-O157, are also associated with severe, and potentially fatal complications, such as HUS.  Shannon Dininny, reporter, explains:

The food industry and government regulators have focused for years on finding the most virulent strain of E. coli bacteria, which every year sickens thousands.  But they don't regularly test for six less-common E. coli strains that can cause illnesses equally as serious. Most recently, two dozen illnesses in four states were tied this spring to bagged romaine lettuce contaminated by an uncommon E. coli strain that can be difficult to detect.

The strain implicated in this years outbreak tied to Freshway lettuce was E. coli O145.  In 2008, hundreds in Oklahoma in an outbreak of E. coli O111 linked to a restaurant.  The outbreak was never traced to a single individual food item.   Among the ill was Marler Clark client Shiloh Johnson, who was hospitalized for six weeks.

In an effort to prevent such illnesses, Marler Clark has filed a petition with USDA asking that USDA classify six non-O157 strains of E. coli as adulterants, which would then require ground beef manufacturers to test for these strains.   Manufacturers are not currently required to test for these strains. 

The USDA has not issued a formal ruling on the petition.  The agency, for its part, claims that it is working on reliable tests to detect the six identified strains of E. coli. 

William Marler's Response to the American Meat Institute Statement on New Bill to Declare Additional Strains of E. coli as Adulterants

AMI:  We share Sen. Gillibrand’s desire to eradicate pathogenic bacteria, but we don’t believe that an act of Congress can make these bacteria disappear. We also are puzzled by the fact that this bill is being introduced at a time when the Centers for Disease Control (CDC) is tracking an outbreak of E. coli O145 (one of the strains in the bill) associated with romaine lettuce, yet the bill would only declare the pathogen an adulterant when found on meat.

MARLER:  Good for the Senator for doing something the FSIS and the Beef Industry should have done years ago. If a pathogen that can kill you is in your food – regardless of the type – it should be an adulterant. And, as AMI well knows, FDA has jurisdiction over lettuce and already does consider E. coli O145 an adulterant. The beef industry has been dragging its hoofs.

AMI:  It is even more interesting to consider that no confirmed outbreak of any of the six strains in her bill has ever been associated with a meat product.

MARLER:  Really? See this report put out by the CDC last week. True, there has ONLY been one outbreak linked to the consumption of beef, but there have also been outbreaks linked to animal contact. And, given the fact that few labs test for these bugs, is there any wonder that outbreaks are few and far between?

AMI:  At this point, there is no test available to detect the six additional strains included in the bill.

MARLER:  Hmm? Them why have the tests I have done on 5,000 retail samples and the 4,000 tests by USDA seem to work well? And, yes, why have the tests performed by FDA and CDC and various State labs worked?

AMI:  In addition, experts at USDA have said in public meetings that the food safety systems we have in place work equally well for non-157 and O157 STECS. These systems have reduced E. coli O157:H7 on raw ground beef by 63 percent since 2000 and have helped us achieve our Health People 2010 goal for reducing these infections.

MARLER:  The CDC estimates that non-O157 STECs cause 36,740 illnesses, 1,083 hospitalizations and 30 deaths in America each year. The CDC also estimates that E. coli O157:H7 still causes 73,480 illnesses, 2,167 hospitalizations and 61 deaths in America each year. AMI, do you really find this acceptable?

AMI: We are concerned that food safety resources in the private sector and the public sector are not infinite. It’s important to invest in technologies that will provide meaningful food safety benefits. We do not believe that declaring non-O157 STECS to be adulterants will enhance the food safety system, and we think that application of such a policy could consume resources that could be better spent elsewhere to achieve meaningful food safety progress.

MARLER: I like to keep things simple. If a pathogen that can kill my kid is in their food, it should be an adulterant. 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 apply to all E. coli (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.

USDA Sets New Standards for Ground Beef Purchases

Agriculture Secretary Tom Vilsack today announced that USDA had completed tough new food safety standards for ground beef purchased by the Agricultural Marketing Service (AMS) for Federal food and nutrition assistance programs including school lunches.

"The health of our school children is a top priority at USDA, and today we are moving ahead quickly with plans announced earlier this year to ensure that food provided to nutrition programs is as safe and nutritious as possible," Vilsack said. "The new standards announced today ensure our purchases are in line with major private-sector buyers of ground beef and are part of our continued effort to employ the best scientific knowledge to increase the safety of our nutritional programs."

This past February, Vilsack announced a series of initiatives to improve the safety of food purchased for school lunch and nutrition assistance programs, and standards announced today marks the completion of one of those initiatives. The standards are the result of a joint review by the USDA's Food Safety and Inspection Service (FSIS) and Agricultural Research Service (ARS) that has been ongoing since the February announcement.

The new requirements will be applicable to AMS ground beef contracts awarded on or after July 1, 2010.

In addition to continuing a zero tolerance for E. coli O157:H7 and Salmonella, the new AMS standards will: (1) tighten microbiological testing protocols; (2) tighten the microbiological upper specification and critical limits; (3) increase microbiological sampling frequency for finished products to every 15 minutes; and, (4) institute additional rejection criteria for source trimmings used to manufacture AMS purchased ground beef. AMS will also consider any vendor classified by FSIS as having a long term poor safety record as an ineligible vendor until a complete cause-and-effect analysis is completed.

The National Academy of Sciences (NAS) has begun its review of AMS ground beef purchase requirements. NAS brings together experts in all areas of science to provide an independent review of the program. The review is focused on three major areas: 1) a thorough evaluation of the scientific validity of current technical requirements and methods; 2) to benchmark those processes and methods against recognized industry leading programs, which supply product directly to consumers through retail sales or food service operations; and 3) provide recommendations to AMS on how to perform future periodic evaluations against industry recognized best practices.

Marler Clark, food safety advocates and lawyers, provide consumer informational site on E. coli O145 complication - hemolytic uremic syndrome (HUS)

Ongoing outbreak and recall of Romaine Lettuce tainted with E. coli O145

Freshway Foods and the Food and Drug Administration announced yesterday. An a press release, Freshway Foods said the E. coli O145 - tainted Romaine Lettuce was sold to wholesalers, food service outlets, in-store salad bars and delis in Alabama, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, West Virginia and Wisconsin. The affected lettuce has a "best if used by" date of May 12 or earlier. The recall also affects "grab and go" salads sold at Kroger, Giant Eagle, Ingles Markets and Marsh grocery stores.  The recall of Romaine Lettuce was prompted after illnesses were reported in Michigan, Ohio and New York - primarily impacting students at University of Michigan, The Ohio State university and Daemen University. The Food and Drug Administration reported the E. coli O145 illnesses included 12 people who have been hospitalized and with Hemolytic Uremic Syndrome (HUS).

What is Hemolytic Uremic Syndrome?  See, www.about-hus.com.

Hemolytic Uremic Syndrome is a severe, life-threatening complication that occurs in about 10 percent of those infected with E. coli O157:H7 or other Shiga toxin-producing E. coliHUS was first described in 1955, but was not known to be secondary to E. coli infections until 1982. It is now recognized as the most common cause of acute kidney failure in infants and young children. Adolescents and adults are also susceptible, as are the elderly, who often succumb to the disease.

Ongoing Outbreak Investigation

Given the time of the year, the most likely area for growing Romaine Lettuce is Arizona – likely Yuma. The investigation is likely hampered by the failure of health departments throughout the United States from actually testing ill persons stools for E. coli O145.  For a bit(e) of history on lettuce and E. coli, visit www.outbreakdatabase.com.

More Information on E. coli O145

In 2009, Marler Clark Petitioned the USDA to define E. coli O145 and other Shiga toxin-producing E. coli as adulterants.  The Petition has a very complete explanation of the dangers of E. coli O145.

NARMS Releases 2007 Executive Report

It was brought to my attention today that the National Antimicrobial Resistance Monitoring System (NARMS) released its 2007 Executive Report (pdf).  The report summarizes data collected on non-typhoidal Salmonella and Campylobacter isolates recovered in 2007 from food animals at federally inspected plants, retail meats, and humans, as well as susceptibility data on Escherichia coli isolates recovered from retail meats and chickens in 2007.

Browsing through the report, it was the data on E. coli positive samples of retail meat that caught my eye.  Of the samples of ground turkey collected, a whopping 93.2% cultured positive for E. coli.  Of the other types of retail meat sampled, 87.4% of chicken breasts, 74.6% of ground beef, and 42.7% of pork chops cultured positive for E. coli

The report unfortunately does not specify the type(s) of E. coli these numbers include.  For example, is it generic E. coli, or do the numbers include Shiga toxin-producing E. coli?  If so, what percentage of the positive cultures include Shiga-toxin producing E. coli?  This is important, of course, because Shiga-toxin producing E. coli, like the infamous O157 strain as well as many others, are the type that can cause severe illness and death in humans.

For those unfamiliar with NARMS, it is a collaborative effort between the Food and Drug Administration's Center for Veterinary Medicine (FDA CVM), U.S. Department of Agriculture (USDA), and the Centers for Disease Control and Prevention (CDC).

The NARMS program monitors changes in antimicrobial drug susceptibilities of selected enteric bacterial organisms in humans, animals, and retail meats to a panel of antimicrobial drugs important in human and animal medicine. Bacterial isolates are collected from human and animal clinical specimens, from healthy farm animals, and raw product from food animals. Retail meats collected from grocery stores were recently added to NARMS sampling. The primary objectives of NARMS include:

  • To provide descriptive data on the extent and temporal trends of antimicrobial drug susceptibility in Salmonella and other enteric bacterial organisms from human and animal populations, as well as retail meats.
  • To facilitate the identification of antimicrobial drug resistance in humans, animals, and retail meats as it arises;
  • To provide timely information to veterinarians and physicians on antimicrobial drug resistance patterns.

William Marler, Food Safety Lawyer - "It is well past time for the USDA to declare that all shiga-toxin producing strains of E. coli are adulterants and ban them from our food supply."

“It is a shame that, in 2010, after years and years of outbreaks, there are still lethal strains of E. coli that some parts of our government do not regulate in the food supply. E. coli O157:H7 has been considered an adulterant in food since 1994 by USDA/FSIS, but non–O157 strains, which can be just as devastating, are not,” says food safety lawyer, William Marler.

As a result, non-O157 strains of E. coli are not regulated or even regularly tested for in our meat supply. Currently, there are two separate outbreaks emerging involving the non-O157 strains E. coli O1111 and E. coli O145. More than 50 people in these two outbreaks have fallen ill since April 7th although neither has yet been linked to a specific food product.

Like their notorious counterpart E. coli O157:H7, E. coli serogroups O26, O111, O145, and others have truly become a major public health problem. Annually in the United States they account for 37,000 illnesses and 30 deaths (Mead et al., 1999; Tozzi et al., 2003; Sonntag et al., 2004). Strains of E. coli O145 isolated from patients with sporadic illness ranked among the top six non-O157 serogroups submitted to the CDC by 43 state public health laboratories between 1983 and 2002 (Brooks et al., 2005). In a recent study that my law firm commissioned to discover the prevalence of non-O157 E. coli in retail hamburger samples, we found that approximately 1.9% of the 1216 ground beef samples tested were positive. And, this was ground beef sitting on store shelves, ready to be purchased and consumed. Serotypes included O26 (n=6), O103 (n=7), O113 (n=1), O121 (n=6) and O145 (n=3) (Samadpour, Beskhlebnaya and Marler (2009). This study is ongoing and final report on the 5,000 samples will be published this summer.

In October of 2009, Marler Clark filed a Petition with the USDA/FSIS 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). FSIS has responded, but has only said that they are considering the petition. In addition to our Petition, recently the consumer advocacy group Safe Tables Our Priority (STOP) published a Press Release urging FSIS to declare "disease-causing E. coli's other than O157:H7 as adulterants in beef and begin testing for them." A few days ago, New York Senator Kirsten Gillibrand wrote to USDA Secretary Tom Vilsack, urging him “to respond formally to two petitions to the USDA’s Food Safety Inspection Services: 1) 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) - Petition #09-03; and, 2) S.T.O.P.-Safe Tables Our Priority’s Call to Action and Public Petition.”

“It is well past time for the USDA to declare that all shiga-toxin producing strains of E. coli are adulterants and ban them from our food supply, “ added Marler

William Marler and Marler Clark have represented thousands of victims of E. coli and other foodborne illness outbreaks since 1993. Mr. Marler has recovered in excess of $500 million on behalf of victims of E. coli outbreaks beginning with the Jack-in-the-Box outbreak of 1993. Mr. Marler also manages the not for profit Outbreak Inc., where he speaks frequently of food safety issues.

WOMAN SENTENCED TO JAIL TIME, HOME DETENTION FOR FALSE CLAIM OF GLASS IN BOTTLED WATER

BETTER BUSINESS BUREAU EMPLOYEE USED YOUNG DAUGHTER TO MAKE FALSE CLAIM FOR DAMAGE

April 20, 2010:

Food and Drug Administration
Office of Criminal Investigations

United States Attorney's Office Press Release

For Immediate Release
April 20, 2010
The United States Attorney's Office
Western District of Washington

KELSY MACOM, 36, of Buckley, Washington, was sentenced today to 30 days in jail, three months of home detention with electronic monitoring, and three years of supervised release for Tampering with a Consumer Product. MACOM claimed in April 2008, that her then 7-year-old daughter was injured by a piece of glass in a bottle of Dasani water – a Coca-Cola company product. MACOM demanded $3,000 from Coca-Cola to settle the matter. When she pleaded guilty on January 13, 2010, MACOM admitted she had made up the entire hoax. MACOM used her young daughter, and her employment at a consumer oriented agency, in hopes of getting a quick financial settlement. At sentencing U.S. District Judge Ronald B. Leighton labeled the crime “despicable.”

According to records filed in the case, on April 15, 2008, MACOM first contacted the Coca-Cola company in Atlanta, Georgia, claiming that her 7-year-old daughter had been injured by a small shard of glass in a bottle of Dasani water.

MACOM used her home e-mail address on the initial contact, but later used the e-mail address and contact information for her employer – the Better Business Bureau. MACOM contacted Coca-Cola representatives on numerous occasions claiming that the back of her daughter’s throat had been cut and that she could not eat hard foods. MACOM claimed she had had to stay home from work to care for her daughter. A few days after her first complaint, MACOM e-mailed Coca-Cola asking for a monetary settlement. Coca-Cola sent MACOM a mailer asking her to forward the bottle and glass shard. When an insurance investigator contacted MACOM, she claimed that her daughter coughed up blood – a claim she had never made in contact with the company. MACOM also filed complaints about Coca-Cola with the State of Georgia Office of Consumer Affairs, and with the Better Business Bureau for Oakland, California, and Atlanta, Georgia. MACOM also contacted the California Food and Drug Administration claiming the same lot of bottled water had gone to California.

On May 29, 2008, MACOM was interviewed by agents from the Food and Drug Administration Office of Criminal Investigations (FDA-CI). After agents confronted MACOM with the fact that she had filed a similar complaint against another product in 2007, MACOM admitted that she had made up the whole story. In the 2007 complaint, MACOM received $1500 after claiming her then 6-year-old daughter had cut her mouth on a glass shard in a chocolate bar.

In asking for prison time for the hoax, Assistant United States Attorney Susan Dohrmann noted that it was troubling that MACON used her employment with a consumer rights organization to further her efforts to get compensation. “Defendant has provided the United States Probation Office and the government with several supporting letters, some of which are from Defendant’s co-workers who describe her as professional, honest and fair. In this regard, it appears that some may not be fully aware of the false claims to Coca-Cola and the Better Business Bureau that were part of her scheme to obtain money from Coca-Cola, nor that she actually used her Better Business Bureau e-mail address and work phone number as contacts,” Ms. Dohrmann wrote in her sentencing memo.

The case was investigated by the Food and Drug Administration Office of Criminal Investigation (FDA-OCI).
The case was prosecuted by Assistant United States Attorney Susan B. Dohrmann.

For additional information please contact Emily Langlie, Public Affairs Officer for the United States Attorney’s Office, at (206) 553-4110 or Emily.Langlie@USDOJ.Gov <mailto:Emily.Langlie@USDOJ.Gov> .

Standards For Beef Too Lax, According To USDA

When it comes to consuming beef manufactured and sold in the US, a new report by the USDA warns there are many more concerns for the consumer beyond the usual pathogens mentioned in this journal (ie, E. coli, Campylobacter, etc.).  As reported today by CNN, contained within the average cuts of meat available at the local butcher are a potential multitude of unappetizing components you may not suspect, like antibiotics, pesticides, and even heavy metals.

According to the USDA's inspector general, federal agencies have failed to set limits on many potentially harmful chemical residues, which "has resulted in meat with these substances being distributed in commerce."  When it comes to pesticide traces, only one type is tested for, according to the report. There are also no set limits for some heavy metals, like copper.

This should be of no small concern.

"Some of the residues that the inspector general cited could be carcinogenic, as they accumulate over a period of time in the body," he said.

The study focused on contamination by chemical residues, rather than bacteria. While bacteria like E. coli and Salmonella can cause an illness that is acute but brief, chemical residues are more like to build up over time, and no amount of cooking will destroy them.

in response to the report, the USDA pledged to "swiftly implement the corrective actions" recommended by the inspector, which including testing for more kinds of residue and setting limits on how much of each substance is allowable. A department spokesman pointed out that this kind of fix, which is expected to require coordination with the FDA and the EPA, was one of the main reasons President Obama created a Food Safety Working Group last year. 

 

Peter Hurley Continues Push For Food Safety Reform

Many readers of this journal will likely recall 2008 and 2009's national Salmonella outbreak linked to peanut product manufactured by Peanut Corporation of America (PCA). Since news of the outbreak first hit the media, the case has been a regular fixture in the press. The outbreak is notable both for its enormous scope—over 700 sickened in 46 states, including at least 9 deaths—as well as for the actions of PCA’s president, Stewart Parnell, who knowingly allowed Salmonella- contaminated product to be shipped into commerce.

One such person affected by the outbreak was Jake Hurley, then three years-old. His father, Peter Hurley, a cop from Portland, Oregon, was introduced to the term “Salmonella” when Jake became severely ill from the bacteria.  Through the combined efforts of various medical and health department folks, his infection was traced to a PCA product.  Unbeknownst to the family, the innocuous looking peanut butter crackers they had been consistently feeding him contained the potentially deadly pathogen.

Since then, Peter has become a vocal proponent of food safety reform and has appeared numerous times in Washington, DC on food safety-related matters. The Hurleys’ story is being featured this week on the North Carolina Public Radio program, The Story. To hear an audio stream of Peter’s interview retelling his family’s experience, click HERE.

In related news, Senate hearings are set to begin shortly on the Food Safety Modernization Act mentioned by Peter in the interview.  Click HERE to read more about this important piece of legislation.

Raw Milk - Real Risks - Wisconsin, Idaho, Georgia and Alaska Raw Milk Debate

I really was not going to jump too much further into the Wisconsin Raw Milk debate until I read this quote the other morning: "We just don't see that as an issue.” That’s what Kathy Kramer, nutritionist and office manager at the Weston A. Price Foundation in Washington, D.C., told Mike Nichols of the Wisconsin Journal Sentinel Online when he asked, what if people get sick from drinking raw or unpasteurized milk?  

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 a review of peer-reviewed literature on the topic of the "pros" of the consumption of raw milk. I then posted about the "cons."

Until the proponents admit that the outbreaks are more than FDA conspiracies against them and learn something, they can never take the high moral ground that they desire.  The fact is that Raw Milk produced by your favorite local farmer or hamburger or cookie dough made by some faceless mega-corporation, can sicken or kill your child if it is contaminated with a food borne pathogen like E. coli O157:H7, Campylobacter, Listeria or Salmonella. 

I would ask the proponents – small dairy farmers trying to make a buck, retailers trying to make even more, the Weston A. Price Foundation, people who believe that drinking raw milk cures everything from asthma, autism, eczema, and erectile dysfunction, to policy makers considering allowing the sales of raw milk – PLEASE read the above links, "Comparing the Food Safety Record of Pasteurized and Raw Milk Products," and read what happened in the following outbreaks to consumers. 

Organic Pastures - On September 18, 2006, the California Department of Health Services (CDHS) opened an investigation of a possible outbreak of E. coli O157:H7 infections after receiving reports of two patients who had been hospitalized with HUS. See CDHS and CDC Reports. One was culture confirmed as infected with E. coli O157:H7. Interviews revealed that both patients had consumed unpasteurized cow milk sold by Organic Pastures in the week prior to the onset of illness. In the following days, four additional cases of E. coli O157:H7 were identified. All of the additional cases had consumed raw milk or raw cow product sold by Organic Pastures. Isolates of the E. coli O157:H7 cultured from the five culture-positive patients had indistinguishable “genetic fingerprints” as determined by pulsed-field gel electrophoresis (PFGE) testing. These PFGE patterns were new to the national PulseNet database. In other words, the pattern associated with all of these children was unique, and had not been seen before in conjunction with any other outbreaks of E. coli O157:H7.  

CDHS conducted an epidemiological and environmental investigation of the cluster of illnesses. A review of 50 consecutive E. coli O157:H7 cases reported to CDHS from October 2004 to June 2006 revealed that 46 of 47 cases asked about raw milk consumption reported consuming no raw milk. In contrast, five of the six patients in the cluster being investigated reported definite consumption of Organic Pastures raw dairy products. The sixth denied consuming the raw milk, but his family routinely consumed Organic Pastures raw milk during the suspected time frame. 

The California Department of Food and Agriculture conducted an environmental investigation. As part of the investigation, fecal samples were collected from dairy cows at Organic Pastures. E. coli O157:H7 was isolated from five of the samples, although the PFGE patterns differed from the pattern associated with the outbreak. Testing of Organic Pastures product revealed abnormally high aerobic plate counts and fecal coliform counts. CDHS ultimately concluded: “the source of infection for these children was likely raw milk products produced by the dairy.” 

Chris Martin, then age seven, developed an E. coli O157:H7 infection in September 2006 following consumption of raw milk. He was hospitalized beginning on September 8, suffering from severe gastrointestinal symptoms, including bloody diarrhea. Shortly thereafter, he developed hemolytic uremic syndrome (HUS). In an effort to properly treat his rapidly deteriorating condition, Chris was moved to multiple medical facilities, twice by life-flight. His HUS was remarkably severe, marked by prolonged renal failure, pancreatitis, and severe cardiac involvement. He required 18 days of renal replacement therapy. On two occasions his cardiac problems became so severe that he was placed on a ventilator. At several junctures, the possibility that he might not survive was very real. Ultimately he was hospitalized through November 2, after incurring over $550,000 in medical bills. Renal experts have opined that Chris is likely to develop severe renal complications in the future. These complications include end stage renal disease (ESRD) and kidney transplant. 

Whole Foods - On July 16, 2008, the Connecticut Department of Public Health (CDPH) was investigating two cases of HUS as part of its routine surveillance. Interviews conducted in these investigations revealed that both children had consumed raw milk in the week before the onset of their illnesses. Both children had consumed raw milk produced by the Simsbury Town Farm Dairy. CDPH notified the Connecticut Department of Agriculture (CDA), and opened an investigation. In the following two weeks five additional confirmed and seven additional probable cases of E. coli O157:NM infection, each associated with consumption of raw milk from the Simsbury Town Farm Dairy. 

As part of the investigation of the outbreak, CDA conducted an environmental inspection of the Simsbury Town Farm Dairy. CDA found a number of troubling practices at the dairy. These included: manual bottling of raw milk directly from the bulk tank; failure to cap valves; an improper seal around the shaft of the transport tank; and a biofilm protein residue found inside the transport tank. In addition, investigators found a number of “poor hygienic practices” at the dairy. Among these was the storage of a stainless steel milk tank in an exposed unsanitary bucket. In addition, investigators found a lack of hand soap, a lack of hot water and the hand-washing sink, and soiled floors. Flies were observed in the bulk milk storage tank room. The dairy workers were unable to identify the dairy’s sanitization process for glass milk bottles that were re-used. It was also noted that the glass bottles from the dairy did not feature the statutorily required consumer advisory language. 

A laboratory study was also conducted. Of the six patients that cultured positive for E. coli O157:NM, 5 had a “genetic fingerprint” that was indistinguishable. The sixth varied very slightly on one test. Samples of feces from the cows at the dairy were also tested. One of the tests was positive for E. coli O157:NM of a strain matching that of the group of five patients. The CDPH concluded: “several findings from this investigation indicated that consumption of raw milk from Farm X [Simsbury] was the cause of the outbreak.” See CHD Report. 

Kalee Prue, a 27-year-old mother of one, became infected with E. coli O157:NM in June 2008, as the result of consumption of raw milk. Her symptoms began in early July, and intensified for several days. On two occasions, Kalee sought treatment in the emergency room. On July 12, it became apparent that she was developing hemolytic uremic syndrome (HUS). She was then admitted to the hospital on July 13. Kalee’s renal failure was complete and prolonged, and she required plasmapharesis from July 13 through August 11. Severe anemia necessitated repeated transfusions with packed red blood cells as well. By the time she was released from the hospital on August 14, she had incurred over $230,000 in medical bills. Kalee has not recovered full renal function. She is at severe risk for long-term renal complications, including end stage renal disease (ESRD), dialysis, and transplant. 

Alexandre Eco Farms Dairy - On October 2, 2008, the California Department of Public Health (CDPH) issued a report linking an outbreak of Campylobacter illnesses to unpasteurized milk from Alexandre Eco Farms Dairy. The report was the result of an investigation commenced on July 14, 2008, when Dr. Thomas Martinelli, the County Health Officer for Del Norte County, California reported four cases of laboratory confirmed Campylobacter infections and five additional cases of diarrhea in Del Norte County residents. Eight of the original nine sick individuals were members of the Alexandre Eco Farms “cow-leasing” program. Eight of these individuals had consumed milk produced on the farm. The ninth sick individual worked with cattle on the Alexandre EcoDairy Farms. One of the eight individuals who was sick, Mari Tardiff, had already been hospitalized with GBS, following the onset of acute gastroenteritis after consumption of the milk. 

As part of the investigation, health department officials retrieved a refrigerated carton of partially consumed Alexandre EcoDairy Farms milk from Mari Tardiff’s home. Mari had consumed a portion of the milk before her illness. The specimen tested positive for Campylobacter jejuni DNA using a test called polymerase chain reaction (PCR). Testing indicated that multiple strains of Campylobacter jejuni were present in the milk. Del Norte County officials eventually identified 16 cases of Campylobacter jejuni associated with the outbreak. Fifteen of those were persons who consumed milk from Alexandre EcoDairy Farms. The 16th case was the farm employee. CDPH and Del Norte county officials concluded that “the available epidemiologic and laboratory data support the conclusion that this cluster of acute diarrheal illness in Del Norte County was an outbreak of C. jejuni infections caused by consumption of unpasteurized milk from [Alexandre EcoDairy Farms.]” 

There was a causal link between the Alexandre EcoDairy Farms milk and Mari’s illness. This link cannot be seriously questioned. This causal link was so clear, and Mari’s injuries so remarkable, that the physicians that treated her are publishing a report on her case entitled, “Investigation of the First Case of Guillain-Barre Syndrome Associated with Consumption of Unpasteurized Milk – California, 2008.” Amy K. Earon, T. Martinelli, W. Miller, C. Parker, R. Mandrell, D. Vugia. The authors explained the laboratory methods used in investigating Mari’s illness: 

We reviewed the patient’s medical record and interviewed her husband to assess her symptoms and exposures. We used polymerase chain reaction (PCR) and multilocus sequence typing (MLST) to test a six-week old unpasteurized milk sample, obtained from the cow leasing-program and partially consumed by the patient, for genes encoding the bacterial membrane component lipooligosaccharide (LOS) in GBS-associated Campylobacter jenuni. 

In addition to the DNA testing, the authors also tested Mari’s blood for anti-bodies to GBS. The authors then explained that the PCR and MLST testing of the milk detected Campylobacter jejuni gene. In addition, the blood test was positive for anti-bodies that indicated the presence of GBS. The authors concluded: “Combined laboratory and epidemiologic evidence established the first reported association between GBS and unpasteurized milk consumption.” See Article. 

This conclusion echoes the conclusions reached by investigating officials with Del Norte County and the State of California, as noted above: “the available epidemiologic and laboratory data support the conclusion that this cluster of acute diarrheal illness in Del Norte County was an outbreak of C. jejuni infections caused by consumption of unpasteurized milk from [Alexandre EcoDairy Farms.]” See CDPH Report. 

Mari Tardiff was one of those sickened in the 2008 outbreak of campylobacter connected to raw milk sold by Alexandre EcoDairy Farm. As a result of her campylobacter infection, Mari developedGuillain Barré syndrome, or GBS, a potentially fatal inflammatory disorder. GBS is an infrequent, but well-known risk of campylobacter infection. By the time she was hospitalized in mid June, Mari was essentially paralyzed. On June 15, Mari was intubated and placed on mechanical ventilation. For weeks on end, Mari’s condition remained unchanged. She was heavily sedated, unable to move, and entirely dependent on mechanical ventilation for survival. In August, there were indications of slight improvement, and the very slow process of weaning Mari off mechanical ventilation began. At the outset, it was not clear that the process was successful. Through incredible effort on Mari’s part, she was fully weaned off mechanical ventilation by August 20, and discharged to a rehabilitation facility. She spent more than two months at the rehabilitation facility diligently attempting to re-acquire the ability to speak, breathe, and move her arms and legs on her own. She was discharged home on November 1, still in need of essentially 24-hour care. Since that time, she has worked every day toward achieving her goal, as yet unreached, of walking again. Medical expenses to date exceed $1,000,000. 

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

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

Larry Pedersen had just turned one year old when he developed an E. coli O157:H7 in May 2008. When his diarrhea turned bloody, his parents took him for medical treatment. He was admitted to the hospital on May 8. Shortly thereafter, Larry developed hemolytic uremic syndrome (HUS) and was transferred to a specialty care facility. As is typical of HUS, Larry was then suffering from acute renal failure. He was started on dialysis, which was necessary at that point for his survival. He required 15 days of dialysis before his kidneys recovered enough to function on their own. Larry was discharged on May 29, to continue recovery and treatment on an outpatient basis. The medical bills associated with his care approached $90,000. As the result of damage to his kidneys suffered during his bout with HUS, Larry is at significant risk for severe renal complications in the future. These complications include end stage renal disease (ESRD) and kidney transplant. 

Nicole Riggs developed an E. coli O157:H7 infection in May 2008 from consumption of raw goat’s milk. She was nine years old at the time. Nicole suffered from symptoms typical of E. coli O157:H7 infections – bloody diarrhea, cramping, and nausea – that quickly intensified and led to her hospitalization on May 8, 2008. Once hospitalized, Nicole developed renal failure, anemia, and thrombocytopenia (low platelet count) indicating that she was developing HUS. She was transferred to a Children’s hospital and started on dialysis in order to save her life. She received dialysis for 18 days. Nicole’s renal function slowly returned to the point that she was deemed healthy enough for discharge on June 1. After discharge, she remained under the care of a nephrologist. In addition, damage suffered during her HUS has required that her gall bladder be removed. Medical costs to this point exceed $180,000. As the result of damage to her kidneys suffered during her bout with HUS, Nicole is at significant risk for severe renal complications in the future. 

Raw Milk - Real Risks

Marler Clark Clients Speak to Senators about Foodborne Illness

Victims of foodborne illness gathered in the nation's capital last week to speak to Senators about the need to move food safety legislation forward. Senate bill 510 (S510, the Food Safety Modernization Act) passed unanimously out of committee in November, but has yet to come to the floor of the Senate for a vote.

"We all know that Congress has been focused on health care and the economy," said food safety attorney William Marler. "But with last week's report that foodborne illness is costing the US $152 billion dollars annually, moving this legislation forward will address both of those issues, and make our country a safer place to live."

The attorneys at Marler's firm, Seattle-based Marler Clark, have represented victims of contaminated food since the landmark outbreak of E. coli O157:H7 at Jack in the Box in 1993. As part of its food safety advocacy, the firm is active in connecting clients past and present with outlets to make their stories known. On March 4, more than a dozen clients were part of a daylong effort organized by the Make Our Food Safe coalition to convince Senators to bring S510 to a vote.

"I think it went really well," said Peter Hurley, whose three-year-old son Jake Hurley fell ill to Salmonella during the 2009 Peanut Corporation of America peanut butter outbreak. Hurley has taken an active roll in lobbying members of Congress to strengthen food safety laws. "We had some really good meetings with Senators and their staff. Everybody is on board with this."

"Most of the Congressmen we spoke with were very receptive to our message," said Elizabeth Armstrong, whose children were sickened by E. coli O157:H7-tainted spinach in 2006. "Most of them did see the need for stricter food safety legislation. The frustrating part for us, though, was the general feeling that it was going to take some time to make this happen."

Lauren Bush explained how the trip affected her: "Going to Washington to lobby for food safety altered my perception of what happened to me. When I contracted E. coli O157:H7, I felt like a powerless victim whose entire life had been turned upside down by an invisible force that didn't have a face to confront. However, being involved with S.T.O.P. and going to D.C. changed that because I was able to sit in front of people who have the power to modify the laws that shape our country. It was incredibly powerful to discover that my voice matters."

ABOUT MARLER CLARK: Marler Clark has represented victims of every major foodborne illness outbreak since 1993. The firm's attorneys have litigated high-profile food poisoning cases against such companies as ConAgra, Wendy's, Chili's, Chi-Chi's, and Jack in the Box, securing over $500,000,000 for their clients. Marler Clark currently represents thousands of victims of outbreaks traced to tenderized steaks, ground beef, tomatoes, peppers, lettuce, peanut butter, and spinach, as well as other foods. For further information contact Mary Siceloff at 206-719-4705 or msiceloff@marlerclark.com or visit www.MarlerClark.com and www.marlerblog.com.

Enzi Praises Reportable Food Registry Longtime Advocate of Registry Lauds Focus on Prevention

Washington, D.C. – U.S. Senator Mike Enzi (R-Wyo.), Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee today commended the U.S. Food and Drug Administration (FDA) for using the Reportable Food Registry to take prompt action to protect the public following the early identification of Salmonella in a Las Vegas, NV food company flavoring product. “This is exactly how the Reportable Food Registry is supposed to work,” Enzi said. “I have long advocated the rapid development and implementation of the Reportable Food Registry, and I am pleased to see it work to quickly and effectively protect the public.” One year ago, Enzi began an effort to ensure that FDA implement the Reportable Food Registry, as Congress intended with passage of the bipartisan “Food and Drug Administration Amendments Act of 2007,” a bill he helped write and pass through the Senate. “Our tools, expert knowledge and innovative spirit must continue to protect the public health from contaminated food. The Reportable Food Registry is one of our best resources in this effort,” Enzi said.

U.S. Sen. Harkin: Salmonella outbreak demonstrates urgency of passing comprehensive food safety legislation

Harkin: Salmonella Outbreak Demonstrates Urgency of Passing Comprehensive Food Safety Legislation

WASHINGTON, D.C. – Senator Tom Harkin (D-IA) released the following statement today after the Food and Drug Administration (FDA) launched an investigation into findings of Salmonella Tennessee in hydrolyzed vegetable protein (HVP) manufactured by Basic Food Flavors, Inc., in Las Vegas. HVP is a commonly used ingredient used as a flavor enhancer in many processed foods, including soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings.

“Consumers should not have to think twice about the safety of a food item when they reach into their pantry. Unfortunately, our nation’s food safety system is outdated, lacks proper resources and, quite simply, does not adequately protect American consumers. This most recent outbreak demonstrates once again that we cannot wait any longer to pass comprehensive food safety legislation.

“Fortunately no one was made ill with this most recent case of Salmonella, but we are not always so lucky. We must give FDA the tools to prevent a food borne illness outbreak before it happens, rather than react when it is already too late. And when food is tainted, we must provide the tools to respond quickly and protect consumers. Both the House and Senate bills do just that and it is my hope that we can have a comprehensive food safety bill on the President’s desk in the very near future.”

Harkin is the Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee. On November 18, 2009 the Committee reported out S. 510, the FDA Food Safety Modernization Act, without a single dissenting vote.

Experts to discuss legal aspects of food at Feb. 26 symposium

Experts on legal aspects of food will visit the University of Iowa Friday, Feb. 26 to discuss recipe copyrights, food safety and marketing, community-based agriculture, and a century-long ban on yellow margarine in Quebec.

Experts on legal aspects of food will visit the University of Iowa Friday, Feb. 26 to discuss recipe copyrights, food safety and marketing, community-based agriculture, and a century-long ban on yellow margarine in Quebec.

"From Field to Tablet: A Symposium on Food, Culture, and the Law," is scheduled from 10 a.m. to 6 p.m. in the Old Capitol Senate Chamber. The free, public talks are sponsored by the UI Obermann Center for Advanced Studies and the Center for Ethnic Studies and the Arts in the UI College of Liberal Arts and Sciences. Additional funding was provided by the UI College of Law.

At 10 a.m., Christopher Buccafusco, who teaches law at Chicago-Kent, will explain how chefs' creations are not afforded formal intellectual property protection, even though the original dishes are essential to their economic success. He argues that granting chefs copyright protection would have negative consequences for chefs and the dining public, and says despite their lack of formal property rights, chefs are more creative than ever.

At 11 a.m., Penelope Pether, who teaches law at Villanova University, will discuss Southern and African-American chef and food writer Edna Lewis, co-founder of the Society for the Revival and Preservation of Southern Food.

At 1:30 p.m., Fabio Parasecoli of New York University and Gustolab, a center for food and culture in Rome, will address geographical indications, which are used to associate food products with specific regions. He'll discuss whether geographical indications encourage community-based, sustainable, quality-oriented agriculture, or whether they are essentially for marketing purposes.

At 2:30 p.m., Charlene Elliott, who teaches communication studies at the University of Calgary, will explain a longstanding law prohibiting the sale of yellow margarine in Quebec. She'll provide a history of the buttery imposter's experience in Canada, illustrating how the scandal of "miscommunication" can be used to serve particular ends.

The symposium will conclude with a 4 p.m. talk ( reception following ) by Denis Stearns, a founding partner of Marler Clark law firm in Seattle, Wash., the nation's preeminent firm representing people injured by unsafe food. He'll explain how laws initially favored food manufacturers and sellers, but cases involving unsafe and defective food led to more consumer-friendly product liability laws. Stearns says high-profile outbreaks in the past decade have renewed consumers' interest in face-to-face food exchanges, such as the local food movement.

For more information on the symposium, visit http://www.uiowa.edu/~cesa , or contact 319-384-3490 or cesa@uiowa.edu.

STORY SOURCE: University of Iowa News Services, 300 Plaza Centre One, Suite 371, Iowa City, Iowa 52242-2500

STOP - Six Other E. coli's Could Be Lurking In Your Valentine Day's Dinner

CHICAGO, Feb. 11 /PRNewswire-USNewswire/ -- S.T.O.P.-Safe Tables Our Priority is asking the USDA to give a life-saving gift this Valentine's Day by declaring disease-causing E. coli's other than O157:H7 as adulterants in beef and begin testing for them.

E. coli O157:H7 was declared an adulterant in ground beef in 1994 in the aftermath of the west coast outbreak that sickened over 700 people and killed at least 4. The Centers for Disease Control and Prevention (CDC) has identified 6 additional strains of shiga-toxin producing E. coli (STEC) -- O26, O111, O103, O121, O45 and O145 -- that are associated with severe illness and death. Just like E. coli O157:H7, these other STEC strains are found in cattle and get into our beef supply when feces contaminate the meat during slaughter and processing.

"The USDA and CDC have known for decades of the public health risk posed by non-O157 STEC. In 2000 they mandated public health laboratories report positive test results for these strains," said Nancy Donley, S.T.O.P.'s President whose 6-year-old son died from E. coli O157:H7-contaminated ground beef.

S.T.O.P. member Dana Boner lost her 14-year-old daughter to E. coli O111 in 2007. "If anything else but food had killed her, we would be looking for the cause," said Dana. "But USDA policy makes it impossible. You can't find what you're not looking for, and USDA needs to start actively looking for these pathogens. It's too late for Kayla, but not too late for others."

In 2007 and 2008 USDA had public meetings on this issue, but has failed to enact any prevention-based strategy for these pathogens. Instead, USDA declared that it would first conduct testing of ground beef and components to determine the extent of non-O157 STEC and implement a regulatory program if needed.

"While S.T.O.P. has no objection to conducting a baseline study, we object to holding up declaring these additional E. coli strains as adulterants in beef," said Donley. "We have been urging USDA for years to enact health-based prevention strategies for these killer strains of E. coli. S.T.O.P. supports many families like Dana's, whose loved ones have been ill from the non-O157 STEC's. The American public is tired, and getting sick, from waiting."

Congresswoman Rosa DeLauro Praises and Pans President's 2011 Budget for FDA and FSIS

Washington, D.C. – Congresswoman Rosa DeLauro (CT-3), Chairwoman of the Agriculture, Rural Development, Food and Drug Administration Appropriations Subcommittee, released the following statement today in reaction to President Obama’s proposed budget for the Department of Agriculture and the Food and Drug Administration for fiscal year 2011:

“I commend President Obama for his understanding of the important work being done at the Food and Drug Administration. Supporting the FDA in their role of maintaining the safety of our food and medicine is essential, and I am pleased that the president has increased the FDA’s budget by 6 percent.

“The proposed focus on transforming food safety, protecting patients, and advancing regulatory science, reflects the president’s commitment to a strong food safety system, and I am very pleased with his continued support. However, while there are new food safety initiatives that deserve consideration, I am concerned that funding for USDA’s Food Safety and Inspection Service remains essentially frozen with a miniscule 1.9 percent increase.

“The FSIS is responsible for front-line inspections and recalls, and will be stretched beyond its capacity by the growing population of our country and the resulting increase in food consumption. Recent food-borne illness outbreaks, such as a recent recall involving salami that has sickened 202 people in 42 states, clearly demonstrate that the FSIS is confronting ever more serious and widespread food safety concerns. FSIS should be given the resources to perform the critical food safety activities that comprise USDA’s public health mission area.”

Op-ed - Jeff Almer and Louis Tousignant: Food safety: What are we waiting for?

An antiquated system exposes Americans to unnecessary risks.

By JEFF ALMER and LOUIS TOUSIGNANT

Shirley Almer was a cancer survivor and a fighter who had twice defied her doctor's prediction by beating both lung and brain cancer.

Clifford Tousignant was a fighter, too. A decorated veteran of the Korean War, he earned three purple hearts in battle, faithfully serving his country for over 22 years.

The two Minnesotans never met but will forever be linked because they are among the nine people who died last year as a result of contaminated peanut products.

Shirley and Clifford were our parents. Had a strong food-safety law been in place, they would likely still be with us.

It wasn't until well after their first trips to the hospital that we found out they were part of a group of 700 Americans from 46 states to be sickened by peanut products in which the dangerous pathogen salmonella had been found.

Over time, we learned that the outbreak was not just a random occurrence, but part of a pattern of outbreaks impacting tens of millions of Americans every year.

Like many Americans who have watched a loved one suffer from a preventable foodborne illness, we were both shocked and appalled to find out that the nation's food-safety system is based, in large part, on century-old laws. Furthermore, the agency charged with overseeing about 80 percent of the U.S. food supply -- the Food and Drug Administration (FDA) -- inspects domestic food-processing facilities on average only once every 10.5 years.

In the area of inspections, as well as other components of our food-safety system, the laws and regulations are severely lacking and simply unsatisfactory in successfully managing what has evolved into a complex global food supply.

William Marler, Food Safety Attorney calls on FSIS to Label Mechanically-Tenderized Steaks

FSIS must follow the advice given by the Safe Food Coalition:

• Issue a press release as soon as possible indicating that the current cooking guidelines and temperatures for intact beef products are not safe for all beef products that look intact. [Specifically, that mechanically tenderized steaks should be cooked to an internal temperature of 160 degrees, just like hamburger.]

• Take immediate steps to develop regulation that will require labeling to clearly identify mechanically tenderized, non-intact beef and pork products for all processing facilities, retail purchasers and consumers.

• Initiate a FSIS program to assess the effectiveness of public health messaging, so that effective food safety messages can be delivered to all food safety stakeholders.

On Christmas Eve 2009, National Steak and Poultry and U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) recalled 248,000 pounds of mechanically tenderized beef products contaminated with E. coli O157:H7.  Within days the CDC confirmed 21 persons infected with the outbreak strain of E. coli O157:H7 from 16 states liked to the recall. The number of ill persons identified reside in each of the following states: CA (1), CO (1), FL (1), HI (1), IA (1), IN (1), KS (1), MI (1), MN (3), NV (1), OH (2), OK (1), SD (2), TN (1), UT (2), and WA (1).

Last week my firm, Marler Clark, filed a lawsuit against National Steak and Poultry in Utah on behalf of a 14-year-old boy who had been infected with the outbreak strain of E. coli O157:H7 in October 2009. He was sick for weeks and hospitalized for several days. Generally, it has been believed that steaks were not considered a high-risk source of E. coli O157: H7. However, when steaks are mechanically or needle-tenderized that process may transfer the bacteria from the surface to the inside of the product.

In recent years, several outbreaks and illnesses have been associated with mechanically tenderized meat products. These products, such as steaks and roasts, have been tenderized through a process that repeatedly inserts small needles or blades into the product. These needles or blades pierce the surface of the product increasing the risk that any pathogens located on the surface of the product can be transferred to the interior of the product.

In March 2003 six persons developed E. coli O157:H7 infections. The illnesses were subsequently linked to the consumption of steaks produced by Stampede Meat, Inc., of Chicago, Illinois. The steaks had been blade tenderized and injected with marinade.

In August 2004 Quantum Foods, a Bolingbrook, Ill., firm voluntarily recalled approximately 406,000 pounds of frozen beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service announced. The recall was linked to illnesses at Applebee’s in Colorado.

In May 2007 Davis Creek Meats and Seafood of Kalamazoo Michigan recalled nearly 130,000 pounds of beef products in 15 states because of possible E. coli O157:H7 contamination. The products were linked to E. coli O157:H7 illnesses. The items being recalled include boxes of mechanically tenderized steaks and ground beef.

Also in May 2007 the Fresno County Department of Community Health announced that the agency investigated an E. coli O157:H7 outbreak among several Fresno County, California, residents. FCDCH urged consumers who had purchased tenderized, cooked tri-tip from The Grill at the Meat Market on May 18 or 19 to discard the product, as it may be contaminated with E. coli O157:H7.

In September 2008 300-400 people attended a fund-raiser for the volunteer fire department of Forest Ranch, CA. Twenty-four of the people who ate at the BBQ fundraiser tested positive for E. coli O157:H7, including a 6-year-old girl who was airlifted to UC Davis Medical Center in Sacramento. Health officials have linked the outbreak to tenderized tri-tip beef served at the event.

Several studies [as recently as 2009] have been undertaken to determine if the mechanical tenderization process transfers pathogens from the surface to the interior of beef products. A study by Luchansky et al., found that, depending on the level of surface contamination, mechanical tenderization of beef products transferred E. coli O157:H7 into the topmost 1 cm of product in 90% to 100% of samples and into the topmost 2 cm of product in 55% to 98% of samples.

For these reasons the recommendations of the Safe Food Coalition must be adopted by FSIS.

Rep. Delauro calls for Independent Food Safety Advisory Board

Washington, DC— Congresswoman Rosa DeLauro (CT-3) released the following statement today in reaction to the recall of approximately 864,000 pounds of beef products potentially contaminated with E. coli by the Montebello, California-based company Huntington Meat Packing Inc. The recalled products include foodstuffs produced as far back as 2008.

“While any food safety recall is a major concern to me, this one is especially alarming as some of the products included were produced almost two years ago. This is a glaring indication that the current inspection system for meat and poultry is inherently flawed and not sufficient to protect the public health.

“Contaminated meat products continue to enter our food supply at a disturbing rate. And as recalls like this attest, it is time for the meat and poultry inspection system at USDA to be subject to a comprehensive review by an external, independent science board to ensure that the current system is adequately protecting the public health. Such a board would support and advise USDA, ensure that the inspection process is rigorous and scientifically robust, and recommend changes to any practices that are insufficiently protecting our food supply.”

Salmonella Victims Press Lawmakers to Keep Promise of Reform

A year after outbreak of contaminated peanut products, Congress has yet to pass food-safety legislation

WASHINGTON, Jan. 14 /PRNewswire-USNewswire/ -- Victims and families of those who were sickened and in some cases died due to an early 2009 foodborne-illness outbreak are calling on congressional lawmakers to keep their promise to implement food-safety reform.

The group representing 27 victims who fell ill as a result of contaminated peanut products is seeking a Senate floor vote on legislation that would boost the food-safety authority under the Food and Drug Administration (FDA) and help limit future outbreaks.

"Americans cannot afford to wait for another outbreak for Congress to pass food safety legislation that protects families from facing the same hardships we have faced," said Jill Summers, the mother of Makayla Stephens, a victim from Quapaw, Oklahoma. "It took over a month after Makayla first got sick for there to even be a recall on the products. No one in America should have to worry whether the food they eat and feed their families will make them sick."

The January 14 letter from the victims and family members from 22 states notes the need for a strong, comprehensive food-safety reform law. According to the Centers for Disease Control and Prevention (CDC), peanut butter and peanut paste contaminated with Salmonella Typhimurium resulted in nine deaths and over 700 illnesses in 46 states, with many more cases never reported to CDC. Thousands of items – including cookies, crackers, candy, and ice cream – that contained Peanut Corporation of America (PCA) peanut products were eventually recalled.

The letter was sent exactly one year to the day after a major announcement in which The Kellogg Company put a hold on two popular brands of peanut butter crackers because of potential contamination. This action came two days after Minnesota state officials confirmed a genetic match between the strains of Salmonella bacteria found in a container of King Nut brand creamy peanut butter and those associated with 30 illnesses in Minnesota and nearly 400 illnesses around the country.

President Barack Obama and leaders from both parties in the U.S. House of Representatives and Senate have called for action on food safety, and according to a poll commissioned by The Pew Charitable Trusts, nine out of 10 Americans favor legislation to strengthen food-safety laws.

The bills in Congress, which would establish minimum inspection frequencies, require that food processors establish food safety plans, and grant FDA mandatory recall authority, would shift the agency's regulatory approach from reaction to prevention.

Had these provisions been in place before the peanut product outbreak, the company would have been required to develop a food-safety plan, which would have identified the risks of contamination and implemented steps to minimize them. Moreover, FDA would have been inspecting the plant on a regular basis and should have discovered and required remediation of some of the unsanitary conditions at the plant that were all too apparent after the incident, such as a leaky roof, rodent droppings and unclean surfaces.

The House passed a strong food-safety bill (H.R. 2749) last July by a wide majority and to great acclaim from both parties. Consumer, public health, and victim advocacy groups, as well as food industry trade associations, strongly supported the bill.

The Senate Health, Education, Labor & Pensions Committee approved a bipartisan bill (S. 510) in November 2009. The victims and their families are urging congressional lawmakers to contact Senate leadership and ask that S. 510 be scheduled for a floor vote, finalized by a conference committee, and presented to the president for signature before Valentine's Day, February 14.

"Strong, comprehensive FDA reform legislation is long overdue. The Senate needs to act now to ensure FDA puts measures in place to spare more families the pain and suffering like what occurred in the PCA outbreak. This massive outbreak and recall touched the lives of nearly every American a year ago. But, with care, foresight and effective FDA regulation, future outbreaks can and must be prevented," says Donna Rosenbaum, executive director of S.T.O.P.- Safe Tables Our Priority, a coalition member.

HOUSE AGRICULTURE COMMITTEE HOLDS HEARING ON FOOD SAFETY; CONSUMERS UNION URGES CONGRESS TO TAKE ACTION ON FOOD SAFETY ENHANCEMENT ACT

Concerns that the Bill Will Unduly Impact Small and Organic Farmers Unfounded

Washington, D.C.—Consumers Union, nonprofit publisher of Consumer Reports, urges Congress to take swift action on the Food Safety Enhancement Act of 2009 (FSEA), H.R. 2749, before its August recess. Today the Committee on Agriculture of the U.S. House of Representatives will hold a hearing on current issues in food safety. Consumers Union supports the testimony of Carol Tucker-Foreman of the Consumer Federation of America (CFA) and commends the committee for holding a hearing to explore current congressional efforts to address the serious food safety problems that confront the country.

“Our current food safety system is broken and has been in need of reform for more than a decade,” said Jean Halloran, Director of Food Policy Initiatives at Consumers Union. “Last week, the White House announced new food safety recommendations which represent an important step forward, but which can only work within existing, outdated food safety laws. In order to have real food safety reform and give FDA the enforcement power and resources it needs, Congress must move promptly to pass the FSEA. This is a strong bill that can only be weakened by delay and every day without action means more lives needlessly lost to food contamination.”

Each year, 76 million Americans are sickened from consuming contaminated food and 5,000 of these people die. Continued outbreaks of food contamination over the last several years—from spinach to peppers to peanuts, pistachios and cookie dough—have demonstrated that these outbreaks are not random, unpreventable occurrences, but are due to widespread problems with our food safety system.

The FSEA contains several provisions long advocated by Consumers Union. It would require facilities to have written food safety plans, give FDA authority to recall contaminated products and require FDA to inspect high risk facilities at least once a year. Consumers Union has pushed hard for one of the bill’s important provisions: requiring high-risk food processors to test for contaminants and tell the FDA when they find them in a finished product. “Had this provision already been in place, it is possible that the deadly peanut product debacle of early 2009 could have been avoided,” said Halloran.

Speculation that FSEA could “destroy” small farms and organic growers has circulated online and elsewhere, focusing primarily on provisions that direct FDA to develop on-farm standards for produce to prevent problems like deadly E. coli in spinach. The FSEA has sought to address small-scale and organic farmer concerns by requiring FDA to take into account the impact the regulations would have on small-scale and diversified farms, wildlife habitat, conservation practices, watershed protection efforts, and organic production methods.

“The provisions of the FSEA that direct FDA to address on-farm food safety practices, such as whether workers have bathroom facilities, are not as comprehensive as the sections for food processing,” said Halloran. “The FSEA stipulates that food processors must be inspected within certain time periods, but does not set any requirements for FDA inspection of farms. Nevertheless, we think this is a very good bill overall that will address the most important causes of contamination of food with deadly bacteria.”

Consumers Union urges the House of Representatives not to delay further, and to pass H.R. 2749 before Congress adjourns for the August recess.

School Food Safety Programs

USDA FNS is issuing a final rule requiring school food authorities participating in the National School Lunch Program (NSLP) or the School Breakfast Program (SBP) to develop a school food safety program, based on the hazard analysis and critical control point (HACCP) system.

Organization: USDA Food and Nutrition Service (FNS)

Source: Federal Register: December 15, 2009 (Volume 74, Number 239)

Effective Date: January 14, 2010

Web site: The Federal Register notice is at http://edocket.access.gpo.gov/2009/E9-29799.htm

Contact: William Wagoner or Marisol Benesch, Policy and Program Development Branch, Child Nutrition Division, Food and Nutrition Service at (703) 305-2590, William.Wagoner@USDA.gov or Marisol.Benesch@USDA.gov

Summary: Section 111 of the Child Nutrition and WIC Reauthorization Act of 2004 (Pub. L. 108-265; June 30, 2004) amended section 9(h) of the Richard B. Russell National School Lunch Act (NSLA) (42 U.S.C. 1758(h)) by adding the requirement that school food authorities (SFAs) implement a food safety program at each food preparation and service facility participating in the NSLP or the SBP. The food safety program, which became a requirement in the school year beginning July 1, 2005, must be based on the HACCP system established by the Secretary of Agriculture. A HACCP-based food safety program should enable SFAs to identify potential food hazards, identify critical points where hazards can be controlled or minimized through control measures, and establish monitoring procedures and corrective action.

Prior to Public Law 108-265, there was no federal requirement for a HACCP-based food safety program for SFAs participating in the NSLP and SBP. Program regulations only required SFAs to follow State and local sanitation and health standards. SFAs were expected to check food temperatures per State and local regulations, but were not required to follow a systematic food safety program.

To provide guidance and help SFAs implement the required food safety program in School Year 2005-2006, FNS issued two memoranda in January 2005 and July 2006, as well as ``Guidance for School Food Authorities: Developing a School Food Safety Program Based on the Process Approach to HACCP Principles'' in June 2005, http://www.fns.usda.gov/cnd/CNlabeling/Food-Safety/HACCPGuidance.pdf This practical guidance was followed by a proposed rule published in the Federal Register on August 5, 2008 (73 FR 45359). The FNS guidance and the proposed rule recommend the Process Approach because it is considered easier to implement than the traditional HACCP method. The Process Approach, developed by the Food and Drug Administration, simplifies traditional HACCP by grouping foods according to preparation process and applying the same control measures to all menu items within a group, instead of developing a HACCP plan for each item. The proposed rule also gave SFAs the option to implement traditional HACCP.

This final rule codifies the requirements set forth in the proposed rule. The statutory requirement has already been implemented by program operators with the assistance of guidance, technical assistance, and training from FNS and the National Food Service Management Institute (NFSMI).

Prepared by: This message was distributed by Cindy Roberts, who may be reached at e-mail: car@fien.com or 202-669-6951

This article (#11745) was distributed by e-mail on December 15, 2009 to those whose names are on the FIEN, LLC Subject Matter Distribution Lists for Food Safety

Another Beef Recall Produces Call For Cargill Plant Closing - Are Congressional Hearings Next?

Rep. DeLauro says firm is repeat offender

Last week's recall of approximately 22,723 pounds of ground beef because of possible salmonellosis contamination has drawn an angry response from a long-time Congressional food industry critic.

Rep. Rosa DeLauro (D-CT) says the processor, Beef Packers, Inc., of Fresno, Calif., should be shut down. DeLauro says the firm has been the subject of a recent investigation by USA Today regarding their participation in the National School Lunch Program, and has been suspended from the program three times for safety concerns.

"This is another glaring example of the problems we face in our nation's food safety system. Beef Packers, Inc. has repeatedly shown their inability to meet current safety measures, and continues to pose a health risk not only to the general population, but to our children through the school lunch program," DeLauro said. "Given the repeated violations of Beef Packers, Inc., the USDA should close this facility and undertake a comprehensive examination into the process at Cargill-BPI to identify and correct any major problems internally or with their suppliers."

The Cargill-owned company has a history of food safety issues, including a nearly 860,000 pound recall earlier this year of meat contaminated with the same strain of salmonellosis suspected in this recall.

According to the U.S. Food Safety and Inspection Service, the suspect ground beef products were produced on September 23, 2009 and bear the establishment number "EST. 31913" printed on the case code labels. The ground beef products were distributed to a retail distribution center in Arizona.

Because these products were repackaged into consumer-size packages and sold under different retail brand names, consumers should check with their local retailer to determine whether they may have purchased any of the products subject to recall, according to FSIS.

Senator Feinstein on Processed Food Safety Act

Senator Dianne Feinstein (D-Calif.) today introduced legislation to require that food producers take responsibility for keeping food free from harmful pathogens.

The bill would amend the Poultry Products Inspection Act, the Federal Meat Inspection Act and the Federal Food, Drug and Cosmetic Act to prohibit the sale of any food that has not been certified to be pathogen free.

“Food producers must be obligated to produce food that is free of pathogens.” Senator Feinstein said. “It is the responsibility of the food producer, not the consumer, to make sure our food safe to eat.”

“Anyone who visits the websites of the USDA or the FDA can see that recalls are not a rare occurrence. In the last month, these two federal agencies recalled thousands of pounds of beef because of E. coli contamination, packages of apples and carrots which contained botulism spores, and dried plums which contained traces of lead.

Serious reform is needed. This bill would require companies that process any kind of food, from ground beef to frozen pot pies, to test their finished products and their ingredients to make sure that they are safe to eat and pathogen free.”

Last month, The New York Times reported two people from New Hampshire and New York died after eating ground beef that may have been tainted with E. coli. Fairbank Farms, a producer in western New York State, has issued a voluntary recall for 545,699 pounds of ground beef products that are suspected to have caused the deaths, according to the newspaper.

The Centers for Disease Control and Prevention estimate that foodborne illnesses sicken up to 76 million people, cause 325,000 hospital visits and result in more than 5,000 deaths each year.

Bill Summary

The Processed Food Safety Act requires everyone in the food chain to take responsibility for keeping food free of harmful pathogens. Specifically, the bill:

* Amends the Poultry Products Inspection Act, the Meat Inspection Act and the Food, Drug, and Cosmetic Act to prohibit the sale of any processed poultry, meat and FDA-regulated food that has not either undergone a pathogen reduction treatment, or been certified to contain no verifiable traces of pathogens.

* Requires that labels on ground beef, or any other ground meat product, specifically name every cut of meat that is contained in the product, and;

* Does away with loopholes in current laws that allow for producers to add coloring, synthetic flavorings and spices to their products without informing the consumer.

By enacting these simple changes, the Processed Food Safety Act will drastically reduce the presence of pathogens in our food and improve the ability of the consumer to make informed choices about the products they wish to eat.

Unique Food Safety Conference Tomorrow - Dr. David Kessler, William Marler Highlight Day-Long Conference

November 20, the Government Accountability Project (GAP) and American University Washington College of Law will sponsor a day-long conference focusing on problems with the current food safety system in America, and how to improve it. The conference, Empowering Employees to Protect Food Integrity, starts at 9:30 a.m. tomorrow morning (registration begins at 8:45 a.m.).

Dr. David Kessler, former FDA Commissioner and best-selling author, is a featured speaker. In 2007, Kessler flatly stated that, "Simply put, our food safety system is broken." He will discuss steps to fix that system, including the centrality of enacting new legislation providing strong whistleblower protections for all food safety industry workers - both corporate and government - so they will feel empowered to blow the whistle on unsafe foods. Kessler has noted that without the insider guidance of whistleblower Jeffrey Wigand, a former tobacco company executive, FDA would not have been able to make the case that nicotine should be regulated as a drug.

The luncheon speaker is William Marler, one of the nation's most prominent food safety/poisoning attorneys. Marler and his law firm, MarlerClark, have represented thousands of individuals in claims against food companies whose contaminated products have caused serious injury and death.

"People doing their jobs well at every level of the food production chain is critical to food safety," said Marler. "It's just as critical that employees can speak out if they see actions being taken that could jeopardize the safety of the food product being made, and consequently the safety of the consumers who might purchase it. Food workers are our first defense, and I applaud GAP for highlighting the importance of their contributions."

This symposium acknowledges the role of employees as a first line of defense against food adulteration. Expert panelists will discuss food integrity issues, as well as new and pending laws (including whistleblower protections). Specifically, panelists will address legal and legislative reforms, immigrant rights, humane handling, corporate farming, and the role of labor in food safety.

When: November 20, 2009

Where: American University, Washington College of Law

4801 Massachusetts Avenue, NW, Room 603

Washington, D.C. 20016

Time: 8:45 a.m. - Continental Breakfast and Registration

9:30 a.m. - Conference Begins

Panel & Interview Schedule

Panel 1: A Case Study of the PCA Salmonella Outbreak (10:00 a.m.): This panel will review the events leading up to the PCA recall, and what measures need to be implemented to prevent a similar event from occurring. Panelists will explore the interplay between both federal and state food safety agencies and why these agencies were unable to prevent and promptly identify the foodborne pathogen that sickened and killed unsuspecting consumers. PCA panelists will discuss the local public health response to the outbreak, insufficient employee protections, and failures regarding interoperability of food safety agencies.

Panel 2: Lessons Learned from the Largest Meat Recall in History (11:15 a.m.): This panel will discuss the conditions that led to the nation's largest beef recall in history. Panelists will review tactics that can be employed to prevent similar food safety disasters, discuss the failings and inadequate enforcement of public health and USDA regulations, and detail what steps are necessary to improve the existing system.

Luncheon Address: William Marler (1:15 p.m.): An accomplished personal injury lawyer and national expert in foodborne illness litigation, William Marler is a major force in food safety policy in the United States and abroad. He and his partners at Marler Clark, a Seattle-based law firm specializing in food poisoning, have represented thousands of individuals in claims against food companies whose contaminated products have caused serious injury and death. His advocacy for better food regulation has led to invitations to address local, national, and international gatherings on food safety, as well as congressional testimony.

Panel 3: Food Safety and Whistleblowing (2:00 p.m.): This panel includes presentations by those working in food production, as well as those fighting for greater worker protections. Panelists will share anecdotes, case studies, successes, failures and forecasts for progress in the realm of food integrity. The implications of food safety laws, with a special emphasis on the role of new food technologies vs. hands-on safety inspection, will be covered.

A Conversation with Dr. David Kessler (3:15 p.m.): GAP Executive Director Mark Cohen will interview former FDA Commissioner and best selling author Dr. David Kessler, covering a broad array of topics ranging from food integrity and safety to food wholesomeness, the public health implications of overeating, and the centrality of whistleblower protections to strengthen the food safety net. This interview will be recorded live for GAP's television program, Whistle Where You Work, and telecast on the Free Speech TV channel via the DISH satellite network, over 60 cable channels nationwide, and in the United Kingdom.

All questions should be directed to GAP Communications Director Dylan Blaylock at dylanb@whistleblower.org, or 202.236.3733

The Government Accountability Project (GAP) is a 30-year-old nonprofit public interest group that promotes government and corporate accountability by advancing occupational free speech, defending whistleblowers, and empowering citizen activists. We pursue this mission through our Nuclear Safety, International Reform, Corporate Accountability, Food & Drug Safety, and Federal Employee/National Security programs. GAP is the nation's leading whistleblower protection organization.

Dairy Groups Urge Senators to Include Raw Milk Facilities in Food Safety Regulations

Other Requests: Harmonize Regulations and Avoid Duplicate Fees

Although unpasteurized, or raw, milk products pose a significant food safety hazard, facilities producing these products are not covered by any of the food safety regulations proposed so far this year by Congress. These facilities also remain exempt from existing regulations enforced by all states, which are know as the Pasteurized Milk Ordinance (PMO), that set the standard for maintaining the safety of the nation's milk and milk product supply. Cheeses made from unpasteurized milk that have been aged to eliminate the risk of food borne illnesses are not considered raw milk products.

The International Dairy Foods Association and the National Milk Producers Federation have asked senators planning to mark up key food safety legislation next week to rectify this omission. In a letter to Senators Tom Harkin (D-IA), chair of the Senate Committee on Health, Education, Labor and Pensions, and Michael Enzi (R-WY), the committee's ranking member, the dairy groups called for requiring all facilities producing raw or unpasteurized milk products for direct human consumption to register with FDA and adhere to the tried-and-true food safety requirements that are followed by all other facilities producing milk products.

"Before pasteurization became widely utilized during the 1920s, human consumption of raw milk was one of the major sources of food borne illnesses and one of the primary causes of infant mortality," said IDFA CEO Connie Tipton and NMPF CEO Jerry Kozak in the letter. "It is important to the health of the American public, and for the continued confidence in the dairy industry, that the new food safety legislation bolsters the success of the PMO program and applies any new FDA requirements to raw milk and raw dairy products."

The PMO covers all aspects of hazard analysis, planning and monitoring from farm to plant to delivery of finished milk products to retail outlets. These extensive requirements are enhanced and updated every two years through a coordinated program between FDA and state regulatory departments, resulting in very low numbers of food safety problems for pasteurized dairy products.

Raw milk products intended for human consumption have been associated with a much higher incidence of food-related illnesses. But these products and facilities producing them are not required to comply with food safety plans, record keeping and access, and other regulations that are triggered by registration with FDA.

IDFA and NMPF support the proposed "FDA Food Safety Modernization Act" and urge the senators to expand the regulations to include facilities producing raw milk products for direct human consumption. In addition, the dairy groups would like the bill to recognize that state inspections of dairy facilities under the PMO already meets necessary food safety requirements and no duplicate functions are warranted.

Because facilities following the PMO already pay fees for state licensing and inspections, IDFA and NMPF recommend that these state fees be credited against any new FDA registration fees if such fees are added to the food safety bill.

The International Dairy Foods Association (IDFA), Washington, D.C., represents the nation's dairy manufacturing and marketing industries and their suppliers, with a membership of 550 companies representing a $110-billion a year industry. IDFA is composed of three constituent organizations: the Milk Industry Foundation (MIF), the National Cheese Institute (NCI) and the International Ice Cream Association (IICA). IDFA's 220 dairy processing members run more than 600 plant operations, and range from large multi-national organizations to single-plant companies. Together they represent more than 85 percent of the milk, cultured products, cheese and frozen desserts produced and marketed in the United States. IDFA can be found online at www.idfa.org.

The National Milk Producers Federation, based in Arlington, VA, develops and carries out policies that advance the well being of dairy producers and the cooperatives they own. The members of NMPF's 30 cooperatives produce the majority of the U.S. milk supply, making NMPF the voice of more than 40,000 dairy producers on Capitol Hill and with government agencies.

SOURCE International Dairy Foods Association

Five Minutes With Bill Marler, Richard Raymond & The New Food Safety

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.

On September 29 Richard Raymond used his Meatingplace blog to talk about an important but unnoticed anniversary. It had been one year since he retired from his post as the USDA’s undersecretary for Food Safety, a position that has been curiously unfilled since the day he walked away.

In the week following his blog, the New York Times savaged the ground beef business with a front page bombshell of a story powered by some truths, a few dozen half truths and a laundry list of misconceptions. Right behind that punch to the gut came a cold slap to the face of most of the rest of the food processing industry; the Center for Science in the Public Interest’s list of the 10 most dangerous foods.

The list, published by major broadcast news services, dozens of national and regional print publications and an uncountable list of internet-based outlets, included leafy greens, dairy products and seafood. Ground beef got nary a mention. Every effected trade association screamed in agony, pointing out the often large holes in the NY Times and CSPI studies. If the reports are to be believed, ground beef, most of our favorite vegetables, some seafood and all dairy products are highly suspect. Take all those things off the table and our national weight problem is solved overnight as we enjoy a starvation diet of all that seems left: purified water and plain oatmeal.

But it brings a serious issue to America’s dinner table. Who and what do we trust? Has the American Food supply become so tainted that we can’t put anything in the oven without worry? Has the amalgam of local, state and federal agencies charged with insuring a safe supply of food become so toothless that there is no ‘bite’ left in their oversight? Why is Raymond’s old post still standing empty even after the Obama called improvements in food safety one of the primary goals of his administration and backed up his claim by creating an all star laden Food Safety Working Group?

Talking about the group, USDA Secretary Tom Vilsack said, "Shortly after coming into office, the Administration created a high-level Food Safety Working Group to coordinate food safety policies, focus greater resources on prevention, and improve response to outbreaks.”

FSWG is just a few months old but it has already launched an initiative to cut down E. coli contamination, issued draft guidelines for industry to further reduce the risk of O157 contamination, appointed a chief medical officer within USDA's Food Safety Inspection Service to reaffirm its role as a public health agency, started testing additional components of ground beef, including bench trim, issued new instructions to USDA employees asking that they verify that plants follow sanitary practices in processing beef carcasses and designed the Public Health Information System (PHIS) in response to lessons learned in past outbreaks.”

For most federal groups, that’s a decade’s worth of work but it was done in just a few short months. It indicates a seriousness of concern unappreciated and virtually unnoticed by the public or the press.

But still, there’s the little problem of a key post, the undersecretary of food safety, unfilled by two administrations. It certainly isn’t for want of qualified candidates.

Our colleges and universities can offer up dozens of experts with stunning credentials. Industry can match them man for man, woman for woman.

We’re at a watershed moment when it comes to food safety issues. The public, perhaps over-stimulated by broadcast and print exposes of questionable scientific validity, is starting to demand changes in the system that are prohibitively expensive or technically impossible. As the nation moves generationally farther from the farm and understands less and less about basic food care and preparation – the microwave is the kitchen tool of choice for an astonishing number of households – there is less room for error in food processing.

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.

Continue Reading...

Battle over timing of food safety legislation shaping up in the Senate

Sitting on yet another airplane coming from yet another case where a US consumer – this one another child – was poisoned by yet another food - I missed Phil Brasher’s call as he was preparing his story, “D.C. lawmakers feel pressure to strengthen food safety rules.”

Mr. Brasher covered another former client of mine who suffered “[a] near-death experience after eating E. coli-tainted lettuce [that] turned Karen Hibben-Levi into an activist for changing the way the government regulates food safety.”

She met with Senator Tom Harkin, and as Mr. Brasher said:

No one in the Senate is better positioned to do something about the legislation than Harkin. The Democrat recently took over the chairmanship of the Senate Health, Education, Labor and Pensions Committee, and Hibben-Levi wanted him to act on the bill.

Karen got a chance to ask Senator Harkin when he is going to move the food safety legislation – legislation that has already passed the House:

"Is it feasible that there's a chance of being done yet this year?" Hibben-Levi asked Harkin.

She didn't hear the answer she was looking for.

The Senate has been bogged down in the debate over health care reform, and Harkin said his staff is tied up working on other must-pass bills. He said he hoped to have the committee take up the bill in December, but he assured her the issue wouldn't die.

"We're going to get it done," he said.

Interestingly, just a few weeks ago, the Washington Post profiled one of my clients, Linda Rivera.  She is still hospitalized after consuming E. coli-tainted cookie dough.  That story prompted this letter from Senate Majority Leader Harry Reid:

Dear Rivera Family:

I want to express my personal thoughts and prayers to you as you struggle with Linda’s illness. I hope you will keep your faith strong and your hopes up that Linda will recover and find peace and comfort.

I want you to know that the seriousness of Linda’s illness highlights the need for action to improve our food safety laws and inspection systems. This fall, I plan to bring food safety legislation before the Senate so that we can strengthen our laws, better detect food borne pathogens, and better trace our food supply. As I work on this legislation it will be with the goal of ensuring that more families do not suffer as you do now.

Best wishes to you, Linda and your entire family.

It does set up a question - "If not now, when?"

ABA Journal Shines Spotlight On Food Safety Regulation

As most readers of the Food Poison Journal are aware, change is afoot in Washington, D.C. over the future regulation of the US’s food safety system. From President Obama’s recently-formed Food Safety Working Group to Congress’s proposed Food Safety Enhancement Act and FDA Food Safety Modernization Act, the issue of food safety has—after years of neglect—finally made its way to the head of the table. And we couldn’t be happier.

I was therefore particularly pleased today when I was sent Hungry For Change from American Bar Association Journal writer, Kristin Choo. Kristin tackles the subject of food safety from multiple angles—consumers, industry, and government—spending a large portion of her article discussing the current state of food safety regulation and the approaching changes to that fractured system that will hopefully coming to fruition. As optimistically stated by Marler Clark’s managing partner, William Marler, “We have a Congress that’s interested, a president who’s interested and perhaps more importantly, business is interested in it as well.” 

I particularly appreciate her not-so-hypothetical highlight of the absurdity in current food safety funding and resource allocation:

From the beginning, the USDA was given more power and money than the FDA, and that remains the case today. While regulating about 20 percent of the food supply, the USDA is allocated twice the amount of money as the FDA, which is responsible for the other 80 percent of the food supply, according to the Gov­ern­ment Account­ability Office, the investigative arm of Congress. Further, every facility that produces or handles meat, poultry or eggs is required to have a hazards analysis and critical-control-points plan that identifies vulnerable links in the food processing chain and institutes safety measures to counteract the risk. The FDA requires such plans for dairy products and seafood, but not for produce.

This leads to some peculiar outcomes. An open-faced, packaged chicken sandwich, for instance, is considered a meat product and regulated by the USDA, which would inspect the sandwich manufacturer daily. A packaged chicken sandwich with an extra slice of bread on it would fall under the purview of the FDA, which might inspect the manufacturer of the sandwich an average of once every five years.

Head over to the ABA site and read Kristin’s article in full.

Marler Explains New News Site - Food Safety News

Q & A with Bill Marler, managing partner of Marler Clark LLP:

Q: What is Food Safety News?

A: Food Safety News (FSN) is a daily online newspaper dedicated to covering food safety news--all the news that's fit to eat! FSN writers will be reporting on everything from foodborne illness outbreaks to food politics to international food safety policy. We have bureaus in Seattle, Denver, and Washington, DC and have invited contributors from government, industry, academia, and consumer groups to share their viewpoints on food safety-related issues. It's a one-stop shop for all things food safety.

Q: Why are you creating an online newspaper dedicated to food safety?

A: Though the top food safety agencies disseminate food recall and outbreak information, and state, local, and regional health departments make an effort to inform their constituents, there is no up-to-date one-stop place for food safety information. I've 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. I think food safety is an important beat to cover, especially as food policy issues begin to take center stage in our national discourse. FSN can offer a forum for discussion on these issues for consumers, industry leaders, and public health officials alike.

Q: Will Food Safety News be balanced in its coverage of food safety issues?

A: Yes, our FSN team is dedicated to ensuring we have balanced reporting. Our reporters will be reaching out to a variety of stakeholders and experts as they report the daily food safety news. We have also invited a wide variety of experts and food safety leaders to contribute to the site.

Q: What do you hope readers will take away from Food Safety News?

A: Whether you're a parent or a public health official, food safety is a pertinent issue. We hope readers will get their fill of food safety-related news from FSN on a daily basis. We aim to be the go-to place for anyone looking for information on the issues of the day, whether they pertain to foodborne illness outbreaks, recalled products, or food politics. FSN will have something for everyone. When there is something going on in the food supply, FSN will be serving up the top news.

Op-ed By William D. Marler JD - Real Health Care Reform Requires Safe Food

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.

Is China Leaping to the Forefront of Food Safety?

The Chinese media is reporting today on sweeping changes announced for the nation's food safety standards.  In a bold statement, a senior health official declared that the new system "is expected to guarantee people's health and be more compatible with international norms."  The primary focus points of the changes are the amount of pathogenic microorganisms, pesticide residue, microorganism residue, heavy metals and pollutants in food products, as well as the use of food additives are the priority areas.

Some of the changes being touted include:

  • the integration of existing food safety standards, elimination of areas that overlap or contradict each other, and establishment of new standards for areas that previously lacked regulation;
  • transparency in the making of the new system, including subjecting the new system to the opinions of international organizations and other countries, in line with a request from the World Trade Organization (WTO);
  • stepping up efforts to establish an efficient food safety coordination mechanism, improve the health emergency response system, and set up a food safety risk-monitoring and assessment system.

In sum, there are a lot of very exciting and potentially excellent elements being discussed that are necessary for a comprehensive food safety system.  All this has me wondering: Is China going to legitimately be in a position to tout itself as having the world's safest food supply?  Washington, are you paying attention?

Let's keep our fingers crossed that these changes are actually put into effect and enforced.  After all, China has some of the most impressive and far-reaching environmental laws on the books, but with almost no meaningful enforcement or violation penalties they are essentially worthless.

The True Cost of "Cheap" Food Is Higher Than You Think

I have recently had some interesting, and heated, conversations with various folks about the current state of the US's food system.  Everything from prolific foodborne pathogens, like E. coli and Salmonella, to widespread obesity and environmental degradation issues can be traced in some profound way to our highly industrialized food system.  What does this system mean for our long-term health?  How can we shift to a more sustainable, healthy food system when a majority of Americans are priced out of healthy food options and instead caught up in a dangerous cycle of cheap, buy-five-for-five fast food items to feed a family?

My attention was therefore caught in the check-out line at the grocery store by Time magazine's recent cover story, "Getting Real About the High Price of Cheap Food."  The writings of the author, Bryan Walsh, along with others like Eric Schlosser and Michael Pollan, are hopefully starting a dialogue in the country and abroad about the incredible damage, on many fronts, that "cheap food" is having on our lives. 

Bryan's article starts off with an effective kick-to-the-gut summary of the life and care of a typical US-raised pig that will likely end up as a piece of bacon next to someone's breakfast pancake.  I'll let you digest this little snippet before you head over to Time.com and read the full article.

Somewhere in Iowa, a pig is being raised in a confined pen, packed in so tightly with other swine that their curly tails have been chopped off so they won't bite one another. To prevent him from getting sick in such close quarters, he is dosed with antibiotics. The waste produced by the pig and his thousands of pen mates on the factory farm where they live goes into manure lagoons that blanket neighboring communities with air pollution and a stomach-churning stench. He's fed on American corn that was grown with the help of government subsidies and millions of tons of chemical fertilizer. When the pig is slaughtered, at about 5 months of age, he'll become sausage or bacon that will sell cheap, feeding an American addiction to meat that has contributed to an obesity epidemic currently afflicting more than two-thirds of the population. And when the rains come, the excess fertilizer that coaxed so much corn from the ground will be washed into the Mississippi River and down into the Gulf of Mexico, where it will help kill fish for miles and miles around. That's the state of your bacon — circa 2009.

I don't know about you, but I'm compelled to make another grocery store run and stock up on fruits and veggies.

Might Iowa Agriculture Like Having Harkin In Charge Of What Happens To Food Safety Bills In Senate?

If Iowa agriculture had the choice, would it prefer that its most powerful Senator, Tom Harkin, remain as chairman of the Senate Agriculture Committee with its great sway over all farm bills or take to the late Edward M. Kennedy’s powerful Health Education Labor and Pensions Committee?

For not only does the HELP Committee, as it is known, have one whale of a job to do if President’s Obama’s health care reform is ever going to see the light of day, but Kennedy’s old committee also control the future of food safety legislation that has already passed the House.

“Politics in our nation’s capitol stops for the death of almost no man—even if that man is the “Lion of the Senate,” one Senator Edward M. Kennedy, “ a blog writer for the American Agricultural Law Association observed over the weekend.

Before Senator Harkin gets to pick between chairing Agriculture or HELP, Connecticut Democrat Christopher Dodd has to decide if he wants to give up the Banking Committee gavel in order to succeed Kennedy.   Dodd’s is the ranking Democrat on HELP, right ahead of Harkin.

While most are thinking about how these chairmanship choices will impact either heath care or the country’s financial mess, Harkin’s role in the future of food safety could be critical to millions of Americans.

Just before the summer recess, the House passed the Food Safety Enhancement Act of 2009, which has now been read by the Senate and assigned to the HELP Committee.

H.R. 2749 imposes fees on food companies to fund increased inspections by the U.S. Food and Drug Administration.   It also focuses on traceability and makes both domestic and imported foods subject to the same safety standards.   The bill, authored by Michigan Democrat John Dingell, is largely the product of testimony of victims and families of victims of food-borne illness outbreaks during the past three years.

Illinois Democrat Richard Durbin’s food safety bill, S. 510, has also been assigned to the HELP Committee. Interestingly, while Democrats Kennedy and Dodd are listed as co-sponsors, Harkin is not. It also has Republicans Judd Gregg (NH), Richard Burr (NC), Lamar Alexander (TN), and Johnny Isakson (GA) as co-sponsors.

Prior to the House passage of H.R. 2749, grain, livestock, and other big agricultural interests worked mostly behind the scenes, but very effectively, to limit the impact of the reforms.   FDA’s expanded powers are not suppose to impact beef, pork, and poultry operations regulated by the United States Department of Agriculture.

The new food safety law has also run into opposition from an assortment of rural Americans, including organic growers, roadside fruit and vegetable peddlers, and folks who don’t want to be part of any animal identification and tracking system.

Most observers say Harkin likes chairing Agriculture and what could be a better fit with Iowa? Still, he just got the last multi-year farm bill adopted last year and Iowans might like to see him in the historic role of handling health care. On the side, Harkin could trim to the sails on whatever food safety legislation passes to make sure it does hurt Iowa agriculture.

The only thing certain now is that Dodd must decide first. 

Food Safety Regulators Voice Support for Animal ID System

High-profile food safety regulators recently explained the need for a national animal identification system, according to this report on Drovers.com. The comments were made at the "ID Info Expo 2009" in Kansas City, Missouri.

Proposals for such a tracking system often draw criticism from the livestock industry, centering around concerns over cost and bureaucracy. Speakers at the Expo, though, explained that such a system could offer significant protection to the industry. Greg Hugoson, Minnesota Department of Agriculture commissioner stated,

“It’s like having an insurance policy against a catastrophic health event.. If a problem occurs, it will allow authorities to isolate where the problem is and keep other, uninfected herds from being sacrificed.”

 

This sentiment was echoed by Douglas Meckes, acting director of food, agriculture, and veterinary defense for Homeland Security. According to Drovers, Meckes also stated that an animal ID system would help “mitigate damage” in a major disease event.   Meckes specifically mentioned the example of the 2008 Salmonella Saintpaul outbreak.   During the outbreak, tomato growers lost millions in sales while the FDA struggled to determine the source of the outbreak that sickened over 1,000 people. The 2008 Salmonella Saintpaul outbreak has been pointed to, on this blog and elsewhere, as an example of the importance of food traceability to industry health.

 

Regulatory support for an animal identification system marks a change from the past. The final line of the Drovers report struck me as wholly unsurprising: “Under the Bush Administration, Secretary of Agriculture Mike Johanns was adamantly opposed to mandatory animal ID.” 

Huge Ground Beef Recall Returns Attention To USDA's Role In Food Safety

Beef Packers Inc.’s recall of 825,769 pounds of ground beef possibly contaminated with antibiotic-resistant Salmonella Newport draws attention to the United States Department of Agriculture’s role in the federal food safety system after last week’s legislative battle over Food and Drug Administration’s reforms.

“It points to the fact that while we are all involved in FDA reform, we have to keep an eye on the USDA,” said Donna Rosenbaum of the victims rights group Safe Tables Our Priority (S.T.O.P), who added that S.T.O.P would be pressing the USDA to address the prevalence of “alarming” antibiotic-resistant pathogens in the food supply.

Though Rosenbaum said it was unlikely that the recall would affect the upcoming debate over food safety legislation in the Senate, which largely deals with FDA reform, it reminds the food safety community of the need to “split time” focusing on the improvement of both agencies.

Over the last 25 years, the USDA has consistently said that it does not consider Salmonella an adulterant. Bill Marler, managing partner of Marler Clark, the leading food safety law firm in the country, commended Beef Packers Inc.  (acquired three years ago by Cargill) for recalling the beef voluntarily because “legally they would be on a strong ground not to do so.”

Denis Stearns, also a partner at Marler Clark, noted that the recall was “surprising” and “inexplicable” considering the USDA’s previous admissions, in court-papers and in policy statements, that it lacks the authority to regulate the presence of Salmonella in meat products like ground beef. “That said,” Stearns added, “I most definitely think that the USDA should declare Salmonella an adulterant.”

According to food blogger Eddie Gehman Kohan, author of Obamafoodorama.com, the lack of authority is “an unfortunate policy leftover from previous administrations…despite big Obama [administration] movement in food safety, including new guidelines from President Obama's Food Safety Working Group, and the recent passage by the House of a landmark food safety bill.”

In addition to alarm over the USDA’s authority over Salmonella, advocates remain concerned that the USDA’s top food safety post remained unfilled. “With the management of something like this, we need top down leadership,” said Rosenbaum, who emphasized that S.T.O.P. was “very, very concerned” about FSIS leadership.

Editor's Note: Helena Bottemiller in Washington, D.C. assisted in the research and writing of this article.

BPI Ground Beef Salmonella Recall: Will the Meat Industry Sue, and Who Will the USDA stand up for?

Today the USDA Food Safety and Inspection Service (FSIS) announced a recall of ground beef products due to possible Salmonella contamination. According to the press release, “Beef Packers, Inc. [BPI]…is recalling approximately 825,769 pounds of ground beef products that may be linked to an outbreak of salmonellosis.” The link between confirmed Salmonella infections and consumption of BPI ground beef products was first discovered by the Colorado Department of Public Health, and a subsequent traceback investigation conducted by FSIS.

This recall was, for me, surprising news—and also inexplicable given the USDA’s long-held position that Salmonella is not an adulterant per se in raw meat, and the meat industry’s prior success in getting a court to invalidate Salmonella performance standards that the USDA had tried to implement as part of its Pathogen Reduction, HACCP regulations adopted in 1996. So when I read about this recall, my first thought was to wonder why BPI agreed to the recall. (Remember: FSIS lacks the statutory authority to compel a recall.) And my second thought was: I wonder if the meat industry is going to sue the USDA to try and prevent the Agency from seeking a second recall in the future based on possible Salmonella contamination.

I obviously cannot answer either of these questions. But I can provide some useful background information about why this particular recall is so surprising, and so inexplicable. (And, by the way, by inexplicable I mean that it is nearly impossible to explain how FSIS could take this action in light of 25 years worth of policy and court decisions that would appear to suggest that the Agency has no authority to do what it did. The recall is certainly NOT inexplicable from a public health and safety perspective, which is certainly ironic given the fact that the FSIS has the term “safety” in its name, and doing something in favor of safety should not be inexplicable.)

And so now onto some history:

Continue Reading...

More antibiotic-resistant Salmonella cases reported in Colorado

Salmonella outbreak in ColoradoThe Colorado Department of Public Health and Environment (CDPHE) issued an updated Salmonella outbreak alert on Juy 31. In it, CDPHE announced that 21 cases of antibiotic-resistant Salmonella Newport have been reported in Colorado. Most ill individuals sick with Salmonella Newport reported experiencing symptoms of Salmonella infection beginning in late June or early July, and while CDPHE did not announce that a second ground beef recall had been issued, the agency did warn consumers about the possibility that ground beef they have in their freezers could be contaminated with antibiotic-resistant strains of Salmonella.

This most recent drug-resistant Salmonella outbreak follows on the heels of a July 22, 2009 USDA announcement that King Soopers was recalling ground beef for Salmonella contamination. The recalled meat was also contaminated with antibiotic-resistant Salmonella (DT104), and was source of a Salmonella outbreak among residents of several states. According to news reports, most of the illnesses reportedly associated with the earlier Salmonella DT104 outbreak were also among Colorado residents. 

In its July 31 press release, CDPHE stated:

This is the second large Salmonella outbreak that the department has investigated in July. Both outbreaks have been linked to ground beef. Further investigation with the USDA in to the source of the meat in this outbreak is ongoing.

Alicia Cronquist, the foodborne disease epidemiologist at the state health department, said, “We can’t be certain that ground beef is the source of these infections, but we are concerned enough that it might be and want consumers to be aware.”

Antibiotic-resistant Salmonella contamination in ground beef has increasingly been implicated as the source of human illness. On its drug-resistant Salmonella page, the World Health Organization states:

The emergence of Salmonella strains that are resistant to commonly used antimicrobials should be particularly noted by clinicians, microbiologists and those responsible for the control of communicable diseases, as well as the food producers including the food industry. Control of drug-resistant Salmonella is most efficiently achieved through the reduction of antimicrobial use. Prudent usage in food animals should be combined with good husbandry, good abattoir practice and good hygiene at all stages in the food production chain, from processing plants to kitchens and food service establishments. These combined efforts should reduce the numbers of the relevant strains in food animals and lower the risk of contamination by resistant Salmonella at all stages in the food production chain.

While activities addressing the occurrence of antimicrobial resistance in foodborne microorganisms are ongoing, the magnitude of the problem is largely unknown in many countries. International collaborative efforts, including efforts in support of surveillance and risk assessment, need to be increased.

H.R. 1549 - Preservation of Antibiotics for Medical Treatment Act of 2009 proposes the restriction of antibiotic use in feed animals to therapeutic purposes only to prevent the emergence of additional antibiotic-resistant strains of Salmonella and other foodborne pathogens in our food supply. The passage of this bill could be a huge step toward preventing future outbreaks like the two that have struck in Colorado this summer. 

Op-ed William D. Marler - Job Wanted - Food Poisoning Lawyer Looking for Work

Today, after a bit of drama yesterday, HR 2749 - The Food Safety Enhancement Act of 2009 - passed overwhelmingly and with serious bi-partisan support. It is now headed to the Senate with a likely stop over at a Conference Committee before it lands on the President’s desk.

Frankly, I may need to start looking for a new job. As I penned a few days ago, in 2002, in the middle of the recall of 21,000,000 pounds of E. coli O157:H7-tainted ConAgra beef that sickened 50 Americans and killed one grandmother, I wrote an Op-Ed saying that it was time to “put me out of business.” My argument was that since people generally hate trial lawyers like me, the best way to get rid of me would be to stop poisoning people with contaminated food.

Since that outbreak, millions more have been sickened and permanently disabled by food tainted with Salmonella, E. coli O157:H7, Listeria, Campylobacter, and other pathogens. Thousands have lost their lives. In that same time period Congress had more than 20 hearings on food safety - many attended by my clients - but had not enacted comprehensive legislation. Well, “change,” the official Obama phrase, has come to Capitol Hill.

The bill, many times amended (Why? Perhaps, a later blog post), and nearly 200 pages long, will greatly strengthen the FDA’s power to regulate 80% of food economy. HR 2749 will give the FDA the power to order food recalls and set record-keeping standards for food facilities. It will mandate increased frequency of inspections and have the fees to pay for them. There will be stiffer criminal penalties and imports will have to meet the same standard as products produced in the US. What it certainly will do is reduce the enormous number of foodborne illness outbreaks, keep kids out of ICUs and off dialysis, and increase the overall safety of our food.

HR 2749 is the first meaningful food safety legislation in 50 years. It was time for the left to stop making perfect the enemy of good. It was time for the right to get out of the way of consumer protection in the name of industry protection. It was time for all of us to acknowledge that ensuring safety in a sprawling, global food system is not free, nor without pain. It was past time for every part of the food economy – regardless of size - to become part of the system, to share in the costs of the system, and to promote the safety of the system. It has always been really long past time to “put me out of business.”

Statement by the President on House Passage of the Food Safety Enhancement Act of 2009

From the Office of the Press Secretary

For Immediate Release                      

"Today the House of Representatives passed H.R. 2749, the Food Safety Enhancement Act of 2009, legislation that will raise food safety standards, allow the FDA to issue mandatory recalls of harmful products,and enhance our oversight of imported food.

This action represents a major step forward in modernizing our food safety system and protecting Americans from foodborne illness. Those are the goals of the Food Safety Working Group I convened in March and charged with making recommendations to improve our food safety system.

And that is why we announced a new rule to control Salmonella contamination in eggs and are working to reduce the presence of harmful pathogens such as E. coli in meat and produce; strengthen our capacity to trace the source of outbreaks; and update our emergency operations procedures.

I commend the House of Representatives for its action today and look forward to working with the Senate to enact critical food safety legislation."

Food Safety Enhancement Act HR 2749 Passes on Second Try, Consumer Advocates Relieved

Consumer advocates breathed a sigh of relief today as the House took a major step towards FDA reform by passing H.R. 2749, The Food Safety Enhancement Act of 2009.

After the provision fell just short of the supermajority needed under a suspension of the rules yesterday, the bill passed easily (283-142) under a closed rule.

Caroline Smith DeWaal, Food Safety Director at the Center for Science in the Public Interest, released a statement hailing the passage of the bill. “FDA has been operating under the same law for 70 years and can do little more than respond to outbreaks after the fact. This bill gives the FDA more authority and real enforcement teeth to help prevent more outbreaks, illnesses, and deaths.”

“I think it’s a credit to the hard work of a lot of people and yeomen’s work of 3 years of hearings,” said Toni Corbo of Food & Water Watch. “It took a coalition of consumer groups to really put this issue on the front burner for this session.”

Corbo also was quick to add that the bill’s success was a tribute to the victims of foodborne illness, noting that the family members of lost ones played a key role in shoring up support for the measure.

Food Safety Advocate Bill Marler followed the debate and vote closely. “It was great to see consumers, producers and manufacturers come together to support the first real food safety legislation in 50 years,” he said. “Now, however, the real work comes in working with the Senate and eventually a Conference Committee before it lands on the President’s desk.”

After meeting with over 200 members of Congress and over 80 Senators, Pat Buck, executive director of the Center for Foodborne Illness Research & Prevention whose grandson, Kevin, died from eating an E. coli-tainted hamburger, was ecstatic over HR 2749’s success. “This was a victory for the consumer today, it really was.”

“It is very exciting. It shows me that, finally, the very people who should be taking leadership are acting in a timely fashion. Congress is really responding to a 21st century need.” Buck stressed the importance of today’s success, adding that some advocates were worried food safety would not have received another chance in the 111th Congress had HR 2749 failed.

Though HR 2749 was a key success, it only marks the beginning of a long fight to bring legislation to President Obama’s desk.

“This is the first step,” said Corbo, who noted that Food and Water Watch would work hard to ensure a similar bill in the Senate in the face of a legislative agenda dominated by health care reform and appropriations bills. “It’s quite an agenda. We’re going to make sure food safety is in the queue before the end of the year. We need this legislation on the books so FDA can do its job properly.”

The food safety bill continues to garner broad support from consumer, health, and industry groups and it is expected to come before the Senate this fall.

Click to see the final text of the bill - HR 2749 - PDF.

Click to see the final roll call vote for The Food Safety Enhancement Act of 2009.

US House Passes Food Safety Enhancement Act Of 2009 With Large Bipartisan Majority

Republicans did not like how the Democrats did it, but they provided enough votes Thursday to see the Food Safety Enhancement Act of 2009 pass the U.S. House of Representatives with a strong bipartisan vote of 283-to-142.

Just before passing the biggest food safety reform since 1938, the House Democrats had to turn back a “last stand” attempt led by mostly rural Republicans to send the bill back to committee "with instructions."   That died by an almost perfect party-line vote of 186 - to- 240.

Those “instructions” called for half the funds from new registration fees to be used to reimburse farmers for losses like those experienced last year by tomato growers when FDA erroneously thought they were responsible for a salmonella outbreak.  Growers claim that mistake by FDA cost them $100 million.

Defeat of the GOP motion cleared the way for passage of the most comprehensive reform of food safety in the United States since 1938 . It was adopted after a rule limiting amendments and limiting debate to one hour passed 249 to 180.

Michigan Democrat John Dingell, the longest serving member of the House, said H.R. 2749 “was old enough to vote” itself in that he has been working on reforms contained in the bill for 21 years.

Dingell read many sections of the bill aloud before the vote to assure small and organic farmers, livestock and grain farmers, and those concerned about environmental practices that the U.S. Food & Drug Administration (FDA) is not going to run wild as a result of the legislation.

Rep. Collin Peterson, Chairman of House Agriculture Committee, said with those changes Ag groups were either supportive or neutral on the FDA bill.

Yesterday, the same bill fell just short of getting the required two-thirds vote for fast-track passage with 280 votes in favor and 150 against.

Florida Republican Adam Putnam said H.R. 2749 would result in a “modern, effective regulatory system” becoming a reality.

FDA, which gets new risk-based inspection and trace-back authority along with a $500 per facility fee for the food-making facilities it regulates, will oversea both domestic and foreign food products that are imported to the U.S. 

“Foreigners now have to meet the same standards as Americans,” Dingell said.

Proponents argued that the reforms contained in H.R. 2749 are needed as much by consumers as producers.   “We have to have confidence in our food supply,” said Illinois Republican John Shimkus. 

Under H.R. 2749, FDA gets recall authority, immediate access to records, and subpoena authority.

New York Democrat Louise Slaughter, who managed the rule on the floor,  said 76 million food-borne illnesses and 5,000 deaths are reasons enough to bring H.R. 2749 back for a vote.  

The 132-page bill now goes to the Senate where Illinois Democrat Dick Durham is waiting with his own bill.   Likely as not, any Senate bill will contain enough differences to require a Conference Committee to work out differences. President Obama endorsed the House bill before today’s vote. 

U.S. House Again Takes Up H.B. 2749 On The Floor; Later Afternoon Vote Scheduled

The U.S. House of Representatives at 2:41 p.m. EDT began debating the rule under which H.B. 2749, the Food Safety Enhancement Act of 2009 will be considered later today.   Debate on the rule is scheduled to take one hour and debate on the bill is scheduled for another hour.  Here is a PDF copy of H.R. 2749 as it came to the floor.

House Ready To Resume Consideration of H.R. 2749, The Food Safety Enhancement Act of 2009

Here is what is going to happen today on the floor of the U.S. House of Representatives to get H.R. 2749, the Food Safety Enhancement Act of 2009, passed:

After the House gets through with the Defense Appropriations Act of 2010, it will turn to House Resolution 691, the rule for consideration of H.R. 2749. There will be one hour of debate on the rule. 

The rule provides that in lieu of the amendment in the nature of a substitute recommended by the Committee on Energy and Commerce, the amendment in the nature of a substitute printed in the Rules Committee report accompanying the resolution shall be considered as adopted and the bill, as amended, shall be considered as read.  The rule provides one motion to recommit the bill with or without instructions. 

It is possible there will be a vote on a Democratic motion ordering the previous question; and then on the adoption of the rule.

Once it adopts the rule, the House will again consider H.R. 2749, the Food Safety Enhancement Act of 2009. There will be one hour of debate on the bill. There could be a Republican motion to recommit the bill (send it back to committee). Today, the vote on final passage will require only a majority to support it.

The Congressional Master John Dingell Will Get Food Safety Bill Adopted--You Can Count On It!

Congress today knocked H.R. 2749, the Food Safety Enhancement Act of 2009, off the fast track.   It fell six votes short of achieving the two-thirds necessary to pass without amendments under a suspension of House rules.

In the next couple of days, it will come up under regular order, meaning it can be adopted with a simple majority after being subjected to amendments on the floor.

However, the 280-150 vote H.R. 2749 won today was proof positive that there is still one master lawmaker in the House. 

The Food Safety Enhancement Act of 2009 is the bipartisan product of the House Energy & Commerce Committee and its prime sponsor, Michigan’s John Dingell.

For years, Dingell chaired the Energy and Commerce Committee. He lost the post before the 111th Congress convened in a 137-122 caucus vote to the more liberal Henry Waxman of California.

Dingell, who has served in Congress since 1955, used the time he gained by not being chairman to focus on legislation, like the food safety reform, that he really cares about.

He  built H.R. 2749 initially by molding it out of legislation that was introduced by Committee Democrats. He used the regular bill markup sessions to work with Committee Republicans and ended up with a unanimous bipartisan vote to get H.R. 2749 to the floor.

Prior to today’s floor action, Dingell worked with both the Majority and Minority on the House Agriculture Committee – eliminating feed grains and livestock from the bill for example---with enough changes to require three re-writes of the bill by late morning.

Clearly, Dingell’s spade work on both sides of the isle and crossing committee lines was helped move 50 Republicans to vote for the bill today. In an age of fierce partisanship and the Majority Party locking the Minority out of the process entirely, Dingell provided an unusual steady and fair hand at the helm.

“We are handling this bill in the way it should be handled in the proper bipartisan fashion,” Dingell said.

And after the GOP Floor Leader complained about new versions of the bill being filed right up until the House went into session, Rep. Joe Barton , the ranking Republican on the Energy & Commerce Committee, said:

"What our Minority Leader said is true, but as Paul Harvey use to say, it is not the rest of the story. Those different bills have been introduced as a result of changes I’ve asked for...In this bill, in this case…we have had an open bipartisan process.

That’s why 280 Members of Congress are now on record supporting H.R. 2749, and why it will pass the House before the August recess.

Consumer Advocates Frustrated by Defeat of HR 2749, Food Safety Enhancement Act of 2009

Today’s failed attempt at comprehensive food safety reform left consumer advocates deeply disappointed, but ready to resume the fight.

Many in the food safety community expected to have the votes to pass HR 2749, a bipartisan measure that unanimously passed out of committee in June, but the measure fell just short of the supermajority required under a suspension of the rules.

Pat Buck, the executive director of the Center for Foodborne Illness Research & Prevention whose grandson, Kevin, died from eating an E. coli tainted hamburger said she was frustrated about today’s vote, “Personally, I’m devastated. Really what happened was that some Congressional members put special interests ahead of public health.”

“Congress lost sight of the bigger picture,” said Buck, who points to issues over the special rules and the burden on small farmers as distractions from the larger issue: that we need stronger regulations for a safer food supply. “It doesn’t matter where food comes from, it needs to be safe. No one wants to see small farmers suffer, but right now, American families are suffering and that's not right.”

“It is disappointing,” adds Donna Rosenbaum, executive director of Safe Tables Our Priority (S.T.O.P.). “A combination of things happened here. It was unfortunate timing with the recess. Changes to satisfy certain groups weren’t made public in time, there was a lot of misinformation about small and sustainable farmers.”

A spokesman for Food & Water Watch agreed, explaining that even with last minute changes to appease small farmers many key farm groups still voiced opposition to the legislation this morning, a move that helped pressure key members to withdraw support.

Rosenbaum’s frustration over the legislative setback is clear. “Hairdressers pay a similar annual fee in some states! We’re talking about the food we ingest! To us, improving regulation and funding is a no brainer.” Rosenbaum was also frustrated by the debate on the House floor, pointing out that several lawmakers furthered the “ridiculous” notion that the U.S. has the safest food supply in the world. “I am not sure where they got their information, but we have found that, on a comparative basis, that is really not true, we are behind other countries.”

Food safety advocate and attorney Bill Marler added “Frankly, after a dozen years without any significant positive change in food safety legislation, I really thought congress and business – both small and large – would put public safety before narrow commercial interests. Consumers suffered today because of congressional inaction.”

After the disappointing vote, a spokesman for Speaker Nancy Pelosi announced that the House will take up the bill again tomorrow under rules requiring a simple majority for passage, which will leave the legislation vulnerable to weakening amendments. Meanwhile, consumer advocates gear up for another fight against special interests. As Rosenbaum puts it, “We’re not going anywhere anytime soon. There are still opportunities and we will try again.”

Click to see which members of Congress voted against HR 2749.

 

H.R. 2749 Killed (For Now) On Floor of U.S. Congress

John Dingell came up six or seven votes short today, and failed to get food safety reform legislation passed through Congress.

Dingell, the once powerful Michigan Democrat who lost his chairmanship of the Energy & Commerce Committee before the start of the 111th Congress, fell just short of getting the necessary two-thirds majority vote to suspend the rules and adopt H.R. 2749 as amended.

The House voted 280 in favor and 150 against suspending the rules and passing H.R. 2749. Twenty-three Democrats voted with 127 Republicans to deny Dingell the two-thirds majority vote required under the rules.   Fifty Republicans voted for the bill that Dingell had carefully crafted with help with Texas GOP Rep. Joe Barton.

While the proponents of the food safety legislation dominated the floor debate that stretched into a second hour,  House Minority Leader John Boehner, R- Ohio, compared the late number of rewrites of the food safety legislation filed with the House Clerk as repeating the bad behavior on the part of the Majority that was used to get the stimulus bill passed.  "Did anyone read this bill?" Boehner asked.

"What our Minority Leader said is true," Barton said, " but it is not, as Paul Harvey use to say, the rest of the story. Those different bills have been introduced as a result of changes I’ve asked for."

Barton seemed to be pleading with his Republican colleagues by saying : "In this bill, in this case…we have had an open bipartisan process."

House Agriculture Committee members acknowledged Dingell had consulted them and make changes in the bill, such as exempting feed grains and livestock; but they complained it was outside the regular process.

Dingell Makes Move To Get H.R. 2749 Vote On House Floor

The U.S. House of Representatives is now on the floor debating H.R. 2749 "to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other purposes."

Forty minutes of debate will be followed by a vote to suspend the rules and allow voting on final passage. A two-thirds vote will be necessary.

Michigan Congressman John Dingell made the motion to suspend the rules. "This is a piece of legislaltion that will stop Americans from being killed by bad food," Dingell said.

Both Democrats and Republicans are speaking out for the bill, but Rep. Frank Lucas, R-OK, has been given time to mount speakers against it. Lucas argues the bill actually being debated was not available until last night, and it would harm agriculture interests.

We will be back once the voting begins.

 

William Marler Op-ed: Dave Theno had it right - Secretaries Vilsack and Sebelius should pay attention

Lauren Beth Rudolph died on December 28, 1992 in her mother’s arms due to complications of an E. coli O157:H7 infection - Hemolytic Uremic Syndrome. She was only 6 years, 10 months, and 10 days old when she died. Her death, the deaths of three other children, and the sicknesses of 600 others, were eventually linked to E. coli O157:H7 tainted hamburger produced by Von’s and served at Jack in the Box restaurants on the West Coast during late 1992 and January 1993. Roni Rudolph, Lauren’s mom, I have known for 16 years.

Dave Theno became head of Jack in the Box’s food safety shortly after the outbreak. I too have known Dave for 16 years. However, I only learned recently a significant fact about Dave – one that made me admire him even more – one that I think, not only that all leaders in corporate food safety should emulate, but one that both Secretaries Vilsack and Sebelius should pay attention too.

Dave and I shared the stage at the Nation Meat Association annual convention a few months ago. The NMA is an association representing meat processors, suppliers, and exporters. Dave, spoke just before I did and was rightly lauded as someone who takes food safety to heart. However, it was his story about Lauren Rudolph and his relationship with Roni that struck me. Dave told the quiet audience about Lauren’s death. Dave also told us that the death of Lauren and his friendship with Roni had changed him. He told us all that he had carried a picture of Lauren in his brief case everyday since he had taken the job at Jack in the Box. He told us that every time he needed to make a food safety decision – who to pick as a supplier, what certain specifications should be – he took out Lauren’s picture and asked, “What would Lauren want me to do?”

I thought how powerful that image was. The thought of a senior executive holding the picture of a dead child seeking guidance to avoid the next possible illness or death is stunning, but completely appropriate. I wonder if Secretaries Vilsack and Sebelius do anything similar when they do their work on President Obama’s Food Safety Working Group? If they do not, perhaps they should?

Secretaries Vilsack and Sebelius right now there are hundreds of families struggling right now due to illnesses and death related to food that you oversee that has been tainted with E. coli O157:H7.

Yesterday, I spent time with a family in South Carolina whose 4 year old ate cookie dough and suffered months of hospitalizations, weeks of dialysis and seizures. She faces a lifetime of complications. And, there is a woman in Nevada who is still hospitalized, who has lost a portion of her large intestine, was on dialysis until a few days ago. She faces months if not years of rehabilitation. Both ate cookie dough that was watch over by Secretary Sebelius’s FDA.

Today I sat across the kitchen table with a family who lost their only daughter because she died from an E. coli O157:H7 infection from meat inspected by Secretary Vilsack’s USDA/FSIS. I then visited families in a Cleveland hospital whose children are struggling in their battle against Hemolytic Uremic Syndrome – again E. coli O157:H7 tainted hamburger is to blame.

Secretaries Vilsack and Sebelius you should be like Dave Theno. Run your departments like Dave ran food safety at Jack in the Box. Go meet these families. Sit across their kitchen tables. Go to their child’s hospital room and see more tubes and wires than you can count. Understand what these people have lived though. Take their stories into your heart. It is hard, very hard, but it will give you a real reason to do your jobs.

Consent Degree Reached Between Listeria Plagued Peregrina Cheese Inc. & FDA; Brooklyn Factory To Remain Open; Now Recalls Everything Since March 17, 2009

Brooklyn’s Listeria plagued Peregrina Cheese Inc. and the U.S. Attorney for the Eastern District of New York have entered into a 16-page Consent Degree with many requirements---including the recall of all food products the food company has distributed since March 17, 2009.

The Consent Degree was filed with the U.S. District Court for Eastern New York on Monday.

U.S. District Attorney Benton J. Campbell, representing the U.S. Food & Drug Administration, had asked the federal court to shut down the Peregrina Cheese factory at 342 Ten Eyck Street in Brooklyn.

FDA cited Peregrina’s problems with listeria contamination and inspections failures. The federal government also sought to bar Javier and Isabel Peregrina from the food business as individuals.

The Consent Degree requires Peregrina Cheese Inc. and the Peregrinas to:

  • Retain an independent laboratory to collect product and environmental samples.
  • Retain an independent sanitation expert to inspect the cheese factory and determine whether methods, facilities, and controls conform with federal law.
  • Require the sanitation expert and laboratory to review FDA and New York State findings since March 2003 and develop a written Listeria Monitoring Program.
  • Require reports and written document be provided to FDA.
  • Recall to the retail level all foods distributed since March 17, 2009.
  • Permits FDA to conduct all necessary inspections.
  • Requires Peregrina to pay all associated costs, including those incurred by FDA.

Assistant U.S. Attorney Seth D. Eiehenholtz represented the government and Arthur Morgan, Esq. represented the cheese-makers in the negotiations leading to the Consent Degree. 

 

Antibiotic use in food animals addressed by House committee

The New York Times reports on yesterday’s House Committee on Rules hearing on "H.R. 1549 - Preservation of Antibiotics for Medical Treatment Act of 2009." In today’s article, titled, “Administration Seeks to Restrict Antibiotics in Livestock,” the Times refers to testimony by FDA Deputy Commissioner, Joshua M. Sharfstein, M.D. 

In his testimony, (pdf) Dr. Sharfstein explained that antimicrobial resistance has emerged as a threat to public health for multiple reasons, including:

  • Physicians prescribing antimicrobials too frequently or inappropriately
  • Patients failing to complete a prescribed course of antimicrobial, making it more likely that surviving microbes will develop resistance
  • Antimicrobial use in animals
  • Nontherapeutic use of antimicrobial drugs of human importance in food-producing animals

In his written testimony, Dr. Sharfstein stated:

To avoid unnecessary development of resistance under conditions of constant exposure (growth promotion/feed efficiency) to antibiotics, the use of antimicrobials should be limited to those situations where human and animal health are protected. Purposes other than for the advances of animal or human health should not be considered judicious use. Eliminating these uses will not compromise the safety of food.

In short, Dr. Sharfstein advocated for the discontinuation of the use of administering antibiotics to otherwise healthy food animals for the sole purpose of generating growth or promoting feed efficiency. 

To further Dr. Sharfstein’s point, in his testimony (pdf) before the House Committee, Robert P. Martin, Senior Officer of The Pew Environment Group, presented the findings of The Pew Commission on Industrial Farm Animal Production, an independent commission funded by a grant from The Pew Charitable Trusts Health to investigate the problems associated with industrial farm animal production. Mr. Martin stated:

antibiotic resistant bacteria in food animalsThe Commission released its full report on April 29, 2008, that included 24 primary recommendations. The Commission was so concerned about the indiscriminate use of antibiotics in food animal production, and the potential threat to public health, that five of those recommendations deal with antibiotic use. The top two public health recommendations call for the end on the non-therapeutic use of antibiotics in food animal production and set strict definitions for their use.

The top recommendation, submitted in Mr. Martin’s written testimony, is to testrict the use of antimicrobials in food animal production to reduce the risk of antimicrobial resistance to medically important antibiotics. According to the Commission, this can be achieved by:

  1. Phasing out and banning the use of antimicrobials for non-therapeutic (i.e. growth promoting) use in food animals
  2. Immediately banning any new approvals of antimicrobials for non-therapeutic uses in food animals and retroactively investigating antimicrobials previously approved.
  3. Strengthening recommendations in FDA Guidance #152 which requires the FDA determine that the drug is safe and effective for its intended use in the animal prior to approving an antimicrobial for a new animal drug application.
  4. Facilitating the reduction in industrial farm animal production use of antibiotics and educating producers on how to raise food animals without using non-therapeutic antibiotics, the USDA’s extension service should be tasked to create and expand programs that teach producers the husbandry methods and best practices necessary to maintain the high level of efficiency and productivity they enjoy today.

H.R. 1549, which is supported by the American Medical Association and other public health-related organizations, is opposed by the National Pork Producers Council and other farm organizations. 

According to the Times article, the Union of Concerned Scientists estimates that up to 70 percent of antibiotics used in the United States is given to healthy animals used in food production (chickens, pigs, cattle) to promote growth or prevent illness. 

All testimony from yesterday’s hearing can be found on the Committee on Rules website.

More Doubletalk from USDA on E. coli and Swift Meat Recall

     Blatantly (and self-servingly) rewriting history, in Friday’s Wall Street Journal, the USDA is reported as stating the following:

The USDA has been considering for more than a year a policy change that would allow whole beef cuts to be considered "adulterated" -- and thus subject to recall -- even if they aren't "intended for use in ground beef," according to Daniel Engeljohn, a deputy assistant administrator for USDA's Food Safety and Inspection Service, or FSIS.
The policy change is still under consideration, he said.

See Bill Tomson, U.S. Beef Safety Plan Languishes Amid New Illnesses, Wall Street Journal, July 10, 2009, see: online.wsj.com/article/SB124725846273124757.html

     Despite the fact that it has been pressed on the problem for over eight years, the USDA is now trying to act as if the serious risk of E. coli O157:H7 contamination of primal and subprimals, so-called intact cuts of meat, is a recent problem that is currently subject to ongoing policy review. This, to put it mildly (and aptly), is a bunch of cow-sh*t. Confusion has reigned since the FSIS E. coli O157:H7 policy on intact vs. non-intact meat was first announced on January 19, 1999. See 64 Fed. Reg. No. 11, 2803-05, see ftp.resource.org/gpo.gov/register/1999/1999_2805.pdf (hereinafter “Intact Meat Policy Statement)”.

For a complete and accurate history of how long this issue has been before the USDA, without it taking any action to address the risk, please click on the Continue Reading link.

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Department of Justice Closes Cheese Plant

In a press release issued July 7, 2009, the United States Department of Justice (DOJ) announced that it had filed a complaint seeking an injunction against Peregrina Cheese, Inc, of Brooklyn, NY, and two of its officers. If granted by the Court, the injunction would temporarily stop the company from manufacturing and distributing food.

According to the complaint, which was filed on behalf of the Food and Drug Administration (FDA), the company has a history of producing cheese contaminated with Listeria monocytogenes, a foodborne pathogen. A search of the FDA website revealed that FDA has cited insanitary conditions at the Peregrina Cheese factory several times over the last five years, and that Peregrina Cheese has recalled cheese products for Listeria contamination in the past. 

Listeria is the common name for the pathogenic or disease-causing bacterium known as Listeria monocytogenes. It is a foodborne illness that when ingested causes an infection known as listeriosis. Approximately 2,500 illnesses and 500 deaths are attributed to listeriosis in the United States annually.

In the DOJ press release, FDA acting associate commissioner for regulatory affairs, Michael Chappell, stated:

This company has consistently failed to make corrections to improve the insanitary conditions under which it processes cheese products, despite frequent warnings to do so. The FDA will not tolerate food companies that fail to provide adequate safeguards.

According to the complaint, FDA and New York State Department of Agriculture and Markets (NYSDAM) inspections have revealed violations of current Good Manufacturing Practice requirements for foods. Inspectors have noted such food safety violations as standing water in food processing equipment and a dead rodent inside the plant. NYSDAM has also assessed fines against the company.

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Back to the Future: Obama Recycling Clinton-Era Food Safety Initiatives as New

 At 10:30 AM today, Agriculture Secretary Vilsack, HHS Secretary Sebelius, and Vice-President Biden will issue “key finding,” according to an email from Nick Shapiro, Office of the Press Secretary, in The White House, that was sent to several media outlets. According to press release, entitled President’s Food Safety Working Group: Delivering Results, the Obama administration is going to implement “a new public health-focused approach to food safety based on three core principles: (1) prioritizing prevention; (2) strengthening surveillance and enforcement; and (3) improving response and recovery.” Although these principles are laudable, and anything would be an improvement over the Bush administration’s efforts to put industry profits above the public health, most of what is being announced today is recycled from Clinton years, and all are incremental steps that seek improvements around the edges rather than the much needed structural change to the U.S. food safety system.

What follows is a point-by-point commentary and critique of today’s announced policy changes and renewed initiatives. As I think you will see, there is not a lot radical going on here. (Please click on the Continue Reading link to read more.)

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Consumer Trust in Food Safety in the U.S. Plummets Because of Rise in Recalls

A little over two weeks ago, IBM released the results of a survey that it had conducted among adult grocery shoppers in the ten largest cities in the United States (100 in each city). The survey was intended to gather opinions about food safety issues, and what it found is as disappointing as it is not surprising. For example, less than 20% of consumers trust food companies to develop and sell food products that are self and healthy. Moreover, 60% of consumers are concerned about the safety of the food that they purchase. And the cause of this significant drop in trust? The rise in food recalls linked to contaminated and unsafe food products. According to the survey results, 83% of the people surveyed were able to name a food product that had been recalled in the last years, with nearly half (46%) naming peanut butter as a recently recalled product.

The irony here is that the rise in contamination-related recalls can be explained, in large part, by the drive for greater profits through: the use of cheaper ingredients purchased from suppliers willing to cut-corners (see, e.g. Peanut Corporation of America and its customer Kelloggs); the failure to update and maintain manufacturing facilities to ensure the highest standards of safety (see, e.g., Cargill and its peanut butter plant); insufficient product testing and quality control (see, e.g. Dole baged Spinach); and over-reliance on the consumer to cook the product "properly" as a means of making it safe, when it should have been safe to begin with (see, e.g., Banquet pot pies and Topps-brand and American Chef's Selection brand frozen ground beef patties).  But by putting profits above safety, food manufacturers are trading short term gains for long term losses.  If consumers lose trust in manufactured food products, they will stop buying them.  Look, for example, at peanut butter sales, which still  have not recovered, and may never do so.

To read the full press release discussing the survey results, please click on Continue Reading.

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Food Democracy Now Weighs in on Food Safety and Inspection Service (FSIS) Leader

Dave Murphy - Food Safety First - Help Send Bill Marler Packin’ to DC!

It’s time to get serious about food safety.

The USDA has yet to appoint the Under Secretary for Food Safety and Inspection Service (FSIS) – and it’s time that we had a real reformer at the USDA.

Every year in the U.S. an estimated 76 million people get sick with food borne illnesses and 5,000 die. One person who knows this fact better than anybody else in the country, is food safety lawyer Bill Marler.

You may remember him as the generous patron who offered to pay for author Michael Pollan’s visit to Washington State University after his best-selling book, The Omnivore’s Dilemma, had been removed from the freshman reading program. But Marler’s been known as a leading advocate for food safety for nearly two decades.

In 1993, Marler served as the lead attorney in the famous Jack in the Box E.coli outbreak. Since then, he’s led the charge in protecting the rights of consumers against unsafe practices by major corporations.

As someone who’s been on the front lines of America’s food safety crisis for nearly 20 years, he has seen first hand the devastation that can be left in the wake of poor food safety practices. We believe that Marler understands the problems that create food safety outbreaks and knows the solutions. He believes that inspection is an important process that not only protects consumers but could save farmers, hospitals and businesses money as well. He understands the importance of regionalizing our food system to build more processing plants that will create a safer food supply and real jobs for rural America.

Known as a fair and fierce opponent, Marler is the perfect candidate to help reform America’s bankrupt food safety system from the ground up. As unprecedented food safety legislation winds its way through Congress that will redefine the Food and Drug Administration’s role in keeping America’s food safe, it’s important that the USDA has an individual with a strong commitment to food safety and consumer health. Bill Marler is that candidate.

Write to President Obama and Secretary Vilsack today and ask them to appoint Bill Marler as the next Under Secretary for food safety at the USDA.

It’s time that America leads the way in having the safest food possible. Bill Marler can make that happen.

Click here to send Bill Marler to the USDA and make our nation’s food supply more safe. http://www.fooddemocracynow.org/?p=428

Sustainably yours,
Food Democracy Now!

Please write President Obama and Secretary Vilsack today!

SAMPLE LETTER:

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The "Guess Who Inspects It Game": Nestle E. coli Cookie Dough Edition

The recent (and still unfolding) E. coli O157:H7 outbreak linked to contaminated Toll House cookie dough manufactured by Nestle has no shortage of lessons to teach, including the reminder that this deadly pathogen can find its way into nearly any food product if sufficient care is not taken during its manufacture. But this sad outbreak is also a case study in the ridiculously complicated, and too-often ineffective, state of food safety inspection in the United States. What makes the outbreak such an excellent case-study is the fact that the Nestle plant located in Danville, Virginia was not only manufacturing Toll House cookie dough products, but also a variety of Buitoni flat and stuffed pastas, and pasta sauces. This made the plant what is called a “dual jurisdiction establishment” that fell under the regulatory authority of both the FDA and the USDA. And to make things even more interesting, Virginia Department of Agriculture and Consumer Services (VDACS) was performing routine plant inspections under contract with the FDA. So how come with all these agencies involved no one prevented the outbreak?

By way of background, the FDA has jurisdiction over all domestic and imported food products, except meat, poultry, or processed egg products, which fall under the jurisdiction of the USDA. But not all food products fall neatly on one side of the jurisdiction line or the other. For example, the products that Nestle manufactured for its Buitoni-brand fell on both sides of the line, with a few falling almost on the line. Meat-flavored pasta sauce would be inspected by the FDA, while meat sauce containing 3% or more of meat would be inspected by the USDA. The ravioli stuffed with cheese would be the responsibility of the FDA, while those stuffed with pork or prosciutto would be the responsibility of the USDA. Thus, if you look at the FDA Inspection Report from September 11 and 12, 2006, you will see that the inspector takes note of fettuccini and linguine being manufactured (FDA products), and chicken tortellini being manufactured (USDA product). Only the Toll House cookie dough products feel solely within the jurisdiction of the FDA. Nonetheless, the FDA plainly took note of all products being manufactured, without, however, making mention of whether or how what was found would be communicated to the USDA. Of course, since the USDA had an inspector onsite, and the FDA showed up in the plant only every year or so, it is the USDA that presumably knew much more about the plant.

Given the presence of the USDA in the plant on a daily basis, the obvious question then is what did the USDA know, and when did it know it? Another obvious question is: Could the USDA have prevented this outbreak from occurring? And, indeed, was it potentially in a better position to prevent this outbreak. (NOTE: As part of my firm’s investigation into this outbreak we are currently attempting to obtain the USDA inspection records for this plant.)

For more, please click on the Continue Reading link.

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4th of July Recess Gives Opponents To HR 2749, The Food Safety Enhancement Act of 2009 Time To Mount Grassroots Lobbying Campaign

 Small farmers, organic growers, raw milk drinkers and many others are organizing themselves on the Internet to kill HR 2749, the Food Safety Enhancement Act of 2009

And if there is not a vote on the floor of the U.S. House before the ten-day 4th of July break, opponents will have more time to rally others to their cause.

Typical of the electronic rhetoric being used against HR 2749 is this:

“The first Patriot Act was passed using fear of terrorism. This Patriot Act is more coy, hiding under a cloak of “food safety” and but also using fear – fear of food contamination, “ says The Writers’ Collective on Food Freedom.

 “Evidently, Americans are supposed to be so frightened by the slightest possibility of a terrorist or of E-coli, they would trade away all their precious, hard fought freedoms for the promise of safety.”

It was only a week ago that HR 2749 was sent to the floor on a unanimous bipartisan vote of the powerful House Energy and Commerce Committee.

The Committee vote followed some compromises, including exempting meat and poultry producers from regulation by the Food & Drug Administration (FDA), and halving annual registration fees to $500 per food facility.

The reforms---to widely expand FDA authority---are now under fire on as many as 100 Internet sites. Within the first week of the Committee’s action, the Farm-to-Consumer Legal Defense Fund had generated 3,270 responses to its call for congressional contacts.

The group says the expanded FDA powers would diminish judicial restraints on the agency and impose a “one size fits all” regulatory scheme on “small farms and local artisanal producers.”

Farm-to-Consumer claims to be for food safety, but says HR 2749 does not address “problems such as industrial agriculture practices and consolidation of our food supply.”

Some of the blogs enlisting the campaign go much further, calling FDA a “fascist” organization and claiming people will be jailed for ten years in a federal prison for selling home-made bakery items at a local farmers market.

Advocates for victims of food-borne illnesses and consumer groups for food safety have also been active in the halls of Congress.   However, most of that activity appears to have come before the Committee vote.  Opponents have pushed hardest in the last week.

Broader FDA inspections and traceability are at the heart of the new food safety law. FDA persuaded the Committee that it couldn’t do adequate inspections without access to company records and the funding to do the job.

According to Committee estimates, 378,000 domestic and 223,000 foreign food facilities will pay the annual $500 fee. Farms are exempt. The new fees will raise about $300 million for inspections.

Generally speaking, the corporate food industry was supportive of the bill that passed the Committee.   They did work to cut the annual inspection fees in halve and gained a cap of $175,000 for companies with multiple facilities. 

Beef and pork producers have lobbied hard to maintain their exclusive regulatory treatment by the Food Safety & Inspection Service (FSIS) of the U.S. Department of Agriculture, and NOT FDA.

The House appears unlikely to get to HR 2749 before it leaves for the July 4th break (which includes time for work in their districts next week). Thursday it worked on the Defense Authorization Bill and on Friday the so-called “Cap & Trade” Energy Bill is suppose to be up debate and votes.

That means food safety legislation will likely have to wait—at least until the Representatives return to Washington, D.C. on July 6th.

Food Safety Still Getting A "D" In Obama Era, Despite Early Moves To Enter 21st Century

Consumer Confidence Has Crumbled Regarding Food Safety, Thanks to Massive Product Recalls...And That "D" Grade Is For Dangerous.

By Eddie Gehman Kohan, Editor in Chef of Obama Foodorama

A new study from IBM finds that sixty percent of eaters surveyed are worried that the food they consume may well be poisoned. That's not a surprise, given the terrible foodsafetyscape that President Obama inherited. But it's not just an inheritance problem anymore: The Obama administration is being rocked with the same kinds of recalls that have plagued every other presidential administration. In the last two months, there's been more than 300,000 pounds of ground beef recalled, the Nestle Toll House cookie dough recall is scaring the heck out of cookie lovers everywhere, and now comes even worse news that points to how ineffective FDA still is at managing recalls of contaminated food. The salmonella-tainted pistachio nuts that were recalled for contamination two months ago were not destroyed--they were simply repackaged, and are now back in the food chain. That's harrowing, and yet to be expected...because FDA has no firm recall powers, cannot enact criminal sanctions, and is still overburdened and underfunded.

The President's new Food Safety Working Group is a swell idea, but the gang needs to be meeting on a weekly basis. To date, there have been two meetings, one glossy website, and no visible action. Membership in the group has also been kept a tightly guarded secret; Ag Secretary Vilsack is on board, as is HHS Secretary Kathleen Sebelius, and Drs. Hamburg and Sharfstein of FDA...but who else is giving advice? And what does that advice entail? Worried eaters everywhere want to know: 83 percent of the respondents to the IBM survey could identify, by name, a food product that was recalled in the past two years due to contamination. 63 percent confirmed they would not buy the food until the source of contamination had been found and addressed (adios, Nestle profits, because no one has any idea how E Coli got into the cookie dough; E coli is usually a pathogen associated with cow dung). 49 percent of the respondents also said that they'd be unlikely to purchase a food product again if it was recalled due to contamination. Food safety is not only a public health issue, it's also a huge economic issue, at a time when the country can ill afford any more debilitating economic crises.

As food safety issues continue to plague the American food chain, the USDA remains devoid of an under secretary to head its own division, the Food Safety and Inspection Service (FSIS), which monitors all of the nation's meat, poultry and eggs. Agriculture Secretary Tom Vilsack has cited conflict of interest issues with vetted candidates as the key reason FSIS remains unguided, but now there's a new campaign brewing, from Food Democracy Now! and other food activist groups, to encourage the Secretary to finally name pre-eminent food poisoning attorney Bill Marler as his meat man.

Ob Fo has long been an advocate of Mr. Marler, who is a world renowned food safety specialist, thanks to a long career as both a safety activist and the most successful prosecutor of food poisoners in the history of the US. Mr. Marler has gone through the entire administration vetting process for FSIS under secretary, including visits from the FBI, and trips to Washington. Happily, he's also paid his taxes, and he's never been registered as a lobbyist for food and Ag issues...so no worries there.

Secretary Vilsack has shown himself to be quite visionary in the last six months, as he's taken on the herculean task of reforming and managing the USDA, which has an almost unbelievably huge mandate. He's made all kinds of terrific appointments, and surrounded himself with experienced professionals who will help bring the USDA into the 21st century. Bill Marler would be just this kind of visionary appointment to lead FSIS. And the timing couldn't be better, because it's BBQ season after all, and the hamburgers are going to be hitting the grill in record numbers...as meat recalls continue to flood the marketplace.

A Big Reason Outbreaks involving meat are so big: Mega-Meat Plants

In 1992 and 1993 when the Jack in the Box E. coli O157:H7 Outbreak occurred, and I got my introduction as an attorney to outbreak-related litigation, the meat industry looked very different than it does so today. The company that manufactured the hamburger patties for Jack in the Box—Vons Companies, Inc.—purchased meat to grind into hamburger from numerous companies, including Beef Packers Inc., Cattleman's Choice, Fresno Meat Co., Monfort Inc., Orleans International Inc., RBR Meat Co., Service Packing Co. and Westland Inc. At the time, most of these companies were regionally-based, and not vertically integrated. Consequently, there were separate companies that ran slaughterhouse, boning operations, and packers, each sourcing from within their more immediate area of operations. There were also local and regional feedlots.

Today, that has all changed. Instead, there are huge mega-plants that combine all aspects of meat-production in a single, tightly integrated operation that produces meat products that are then distributed nationwide. That is why when you have E. coli O157:H7 outbreak involving meat products, the illness and death are widely spread, and the initial source of the contamination is sometimes difficult to trace back to its source. Back in the day, it simply was not possible to have product recalls involving millions of pounds of meat because no one was really producing and distributing it on that scale.So if you are looking for an additional argument in favor of a more local and regional based food supply, the prevention of mega-outbreak, courtesy of “Big Meat” (also known as the mega-meat industry, or  Cargill/Conagra/Tyson triumvirate), is definitely a compelling one--in my humble opinion.

With this thought in mind, click on the Continue Reading link and check out a press release that was forwarded to me yesterday, which announced a recently released report about the demise of local small meat processing operations. And if you’re so inclined, read the entire report. It’s worth your time.

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Dear Mr. President and Secretary Vilsack - Calling for Real Food Safety Reform: Bill Marler for FSIS

June 24th, 2009 By David Murphy

Just when America thought it was safe to go back into the grocery store, another food outbreak wakes us up to the fact that there is something seriously wrong with our food safety system. This time it’s Nestle Toll House cookie dough with E.coli, a treat that nearly every kid in America reaches for a few times a month during the summer. This is yet another reminder why it’s important to get the new food safety legislation, currently winding its way through Congress, right.

Last week a new food safety bill passed unanimously out of the House Energy and Commerce Committee and opinions of it vary widely. Known as H.R. 2749, the Food Safety Enhancement Act of 2009, the bill is being hailed as everything from as “the most sweeping reform of the food safety system in nearly 50 years” or the “totalitarian control of the food supply” depending on what you read.

Civil Eats reported on the intricacies of the legislation and its supporters.

As the debate rages on about how the U.S. will create a new food safety system, with all of the attention focused on FDA’s failure to assure the safety of the food it regulates, a very quiet controversy is brewing at the USDA over the fact that the agency has yet to name an Under Secretary for the Food Safety and Inspection Service (FSIS).

So far, the two leading candidates for the job, both with close ties to the food industry, have been knocked off track due to the efforts of a small collection of food safety advocates and a few advocacy groups who believe that food safety is not something that you should create a “Team of Rivals” around.

After watching the new administration’s efforts to select political appointees that conform to the plot line of a popular nonfiction book, it’s time to remind them why they won the election. Last year when Americans went to the polls in record numbers, they voted for change and the hope of reform.

What is becoming more evident every day is that while Republicans reward their base, Democrats kick theirs to the curb.

As one food safety expert who has been leading the charge for food safety reform in Washington for over twenty years said recently, “It’s funny. When Republicans win the election I have to fight the meat industry and when Democrats win I have to fight the meat industry. When is somebody going to stand up for the American consumer?”

We couldn't’t agree more.

If the Obama Administration is Serious About Food Safety – We Need a Reformer

Every year in the U.S. an estimated 76 million people get sick with foodborne illnesses and 5,000 die, according to the U.S. Centers for Disease Control and Prevention. One person who knows this fact better than almost anybody else in this country, is food safety lawyer Bill Marler.

Marler recently came to the public’s attention with his generous offer to pay for author Michael Pollan’s visit to Washington State University, after his book had been removed from the freshmen reading program. What many may not know is that he’s been known as a leading advocate for food safety for nearly two decades.

Marler first leaped to national prominence as the lead attorney in the famous 1993 Jack in the Box E.coli outbreak. Since that time, Marler has led the charge in protecting the rights of consumers against unsafe practices of major corporations. While dedicated to a high standard of food safety protocols, Marler is also pragmatic about the real economic need for food safety.

Poor food safety practices also have a major negative impact on the bottom line of business, costing U.S. companies more than $6.9 billion each year, which Marler believes could be better spent to keep America’s food supply truly safe.

Despite the food industry’s long contempt for personal injury attorneys, Marler could end up being their dream pick for the FSIS spot if they were willing to allow the motivated attorney to oversee the much needed change in food safety policies at the USDA.

Known as a fair but fierce opponent, Marler draws as much criticism from the industrial meat crowd as he does from proponents of local agriculture, with strong stances on the need for inspection and a concern on the growing interest in raw milk.

Why select Marler as the head of the FSIS? Because he’s a champion of citizen’s rights to safe food and he knows the system better than anyone. He’s also willing to balance the concerns of the meat industry and local foods at the same time.

If the Obama Administration is serious about reforming America’s food safety system, there really is only one choice – Bill Marler for FSIS. Now’s the time.

David Murphy is the founder and director of Food Democracy Now!, a sixth generation Iowan, and a writer and advocate for sustainable agriculture.

Food Safety Enhancement Act Passes Committee

The Food Safety Enhancement Act of 2009 passed out of Committee in the House today, without opposition.  The full House is expected to vote on the bill before the July 4th recess. 

According to an article in The Packer, the bill is receiving some lukewarm support -or at least, something less than all out resistance - from food industry lobbyists. 

“Clearly the Democrats and Republicans worked together this past week to try to create something they both support,” said Tom Stenzel, president of the Washington, D.C.-based United Fresh Produce Association. “A number of the changes we wanted to see were able to get in.”

I am usually bashing lobbying groups for the food industry here, and was tempted to laud their willingness to accept the Bill (even though they should be actively supporting it.)

Reading more quotes, though, its really more of the same.   The lobbyists may recognize that increased inspection and traceback are actually good things, long term, for the industry.  More likely they realize that after the parade of foodborne illness outbreaks, these changes are inevitable.  And so, they worked to water down the Bill, decreasing the user fees charged to industry associated with inspections from the originally proposed $1,000 to $500.   And they are not done:

“(Committee members) have shown a willingness to listen and create a system that works,” said Tom O’Brien, Washington, D.C.-based representative for the Newark, Del.-based Produce Marketing Association.

O’Brien said there is more work to do — notably in relation to user fees — but said the process has been remarkably collaborative so far.

In other words, lobbyists will work until it is the tax-payers are covering the cost of ensuring that the industry adopts long overdue changes and improvements in food safety.

Fees Lowered as Food Safety Enhancement Act Moves Through House

As the "Food Safety Enhancement Act of 2009" was passed out of the House subcommittee last week, the fees associated with production facility inspection were decreased.  According to a story in the Packer:

The bill approved June 10 was revised from an earlier draft version, dropping user fees for inspections from $1,000 to $500 per facility and the overall cap limit per company to $175,000.

Food safety advocates were disappointed with the change:

Erik Olson, director of food and consumer product safety at The Pew Charitable Trusts at Georgetown University in Washington, D.C., said Pew would have liked to see the $1,000 fee per facility remain in place.

"It's not an inconsequential change in terms of the money that could be raised," he said, adding that Pew also prefers more frequent inspection for high-risk facilities than is outlined in the legislation.

It strikes me that $500 seems like quite a small amount of money to pay for an inspection of your facility.  How much would industry pay for such an inspection on the open market?  Could you really get one or more inspectors to review your process and records, and provide you a report for $500?

Remarkably enough,  Tom Stenzel, president of the Washington, D.C.-based United Fresh Produce Association, told the Packer that the industry would like to move the fees from the Bill entirely before passage.

Food Safety Enforcement: How the Brits Do It.

This last Thursday, June 11, 2009, I had the pleasure (and honor) of presenting at the 2009 Conference on Law of Food and Drink, sponsored by the British Institute of International and Comparative Law.  The program of presentations was interesting and, for me, quite informative. (For a look at the program, see here: www.biicl.org/files/4231_programme_11.06.pdf 

One of the highlights, was the Keynote Speech by Dame Deirdre Hutton, the current chair of the Food Standards Agency (FSA) in Britain.  Although the FSA can be compared to USDA's Food Safety and Inspection Service, or the parts of the FDA responsible for food safety, it is really more like the U.S. Federal Reserve, because it is an independent agency.  As described on its website, (which can be found here, www.food.gov.uk/aboutus/how_we_work/#h_2):

Although the FSA is a Government agency, it works at 'arm's length' from Government because it doesn't report to a specific minister and is free to publish any advice it issues.
The Agency is led by a Board that has been appointed to act in the public interest and not to represent particular sectors. Board members have a wide range of relevant skills and experience.
We base our decisions and advice on the best evidence available. And we aim to ensure that our decision-making process is as open and transparent in as possible.
Whenever possible, we seek the views of interested parties before reaching conclusions, and always explain the reasons for its decision and advice in a straightforward manner.
The Agency also obtains independent expert advice from its scientific advisory committees and commissions research to support its functions.
 

Imagine that--an independent agency that makes evidence-based decisions in the public interest, without regard to the private interests of industry, or to the government politics of the moment.  Now that is certainly a model that the U.S. should think of following.

Pork Producers Fight Against New Food Safety Bill

The National Pork Producers Council (NPPC) is waging a fight against food saftey refoms in the pending "Food Safety and Enhancement Act of 2009" according to Wisconsin Ag Connection.  The bill was recently approved by in subcommittee and will head next to a full comittee in the House. 

The NPPC claims to support efforts to strenghten U.S. food saftey, but then argue against virtually every aspect of the pending legislation that might apply to them.  For example, the NPPC argues against giving the FDA authority over production at the farm level.  This is despite a number of high profile outbreaks that suggest that contamination often occurs at that stage of the process, such as the 2006 Dole spinach E.coli O157:H7 outbreak. 

NPPC also argues against better tracking of food from "farm to fork."   This one is hard to understand as it provides significant protection to those in the industry as well as consumers.   Strong product traceback allows for the quick and accurate identification of potentially contaminated foods.  This limits outbreak illnesses and leaves producers of the non-implicated products out of the spotlight - and still putting products on the shelves.

The safety of the U.S. food supply will not improve with general well-wishes and "support" for reform.    The status quo was reached, in part, through industry's resistance to reform, and it is time to make a real change.

Health Subcommittee Sends Food Safety Reform Bill To Full Committee: Vote Next Week

After years of just listening those injured and the survivors of those killed by outbreaks of food-borne illnesses in the United States, the House Health Subcommittee finally took some action today.

On the back of deal that halves the amount of a new registration fee for food producing facilities, the Subcommittee was able to send its food safety reform bill to the full House Energy & Commerce Committee on a unanimous bipartisan voice vote.

Chairman Henry Waxman, D-CA, says the full committee will likely vote the measure out to the House floor next Wednesday.

Moving the bill came during its formal markup today after an agreement was reached to set registration fees for food-making facilities at $500 per year, down from the original $1,000 sought by Committee leaders. The deal also caps the total amount any one company would have to pay for annual registrations at $175,000.

That concession brought Subcommittee Republicans on board and ended any effective opposition to the bill by food industry. The fees help pay for stepped up inspections by the U.S. Food & Drug Administration (FDA), which regulates 80 percent of the nation’s food supply.

The U.S. Department of Agriculture’s Food Safety & Inspection Service (FSIS) is responsible for regulating the other 20 percent---meat, poultry and eggs. FSIS has traditionally had more money and legal authority than FDA has for its responsibilities.

According to Philip Brasher of the Des Moines Register, 345 facilities in Iowa will have to pay the new fees. “In Iowa, the rules would affect everyone from mom-and-pop businesses to huge corn mills and cereal operations owned by multinational firms such as Cargill and General Mills,” Brasher reports.

Food safety legislation has also been introduced in the Senate, but the House is clearly moving faster.  See more in the Des Moines Register here,  and/or the Wall Street Journal here.

Changes on the horizon for food recall procedures?

hamburger recallThe June issue of Food Protection Report contains an article titled, “Seeking Ways around Information Roadblocks,” which provides an analysis of different issues that impact the flow of information regarding recalled food products. The current recall system prohibits the distribution of vital recall information from federal to state public health agencies, preventing state health officers from receiving word regarding the distribution of recalled products such as hamburger that may be contaminated with E. coli O157:H7. States are then unable to communicate to appropriate retail establishments and consumers regarding the recalled products.

Food Protection Report points out:

It can be very frustrating to the states, which have been collecting information on illnesses and exposure and sharing that with CDC and FDA, that the federal agencies “are not in a position to share with the states what we found,” [Sharri McGarry, emergency coordinator in the office of Food Defense, Communications and Emergency Response in FDA’s Center for Food Safety and Applied Nutrition] said.

USDA’s Food Safety and Inspection Service partially solved this problem for itself by issuing a new rule last year. Under the rule, if the agency gathers information through its traceback activities and finds where adulterated product has been, it can share that information with states to which the product has been shipped, explained David Goldman, assistant administrator for the FSIS Office of Public Health Science. However, the agency can’t just get a distribution list from a company and publish that, Goldman said.

According to its Website on food recall policy, USDA currently measures food recall effectiveness by FSIS “effectiveness checks” to make sure that the firm recalling product makes reasonable efforts to notify consignees of recalled product that the product should be removed from commerce. FSIS conducts a number of effectiveness checks to verify that the firm recalling product is contacting consignees. After these effectiveness checks are complete and FSIS is satisfied that the recalling firm has contacted all consignees or has made reasonable efforts to do so, FSIS notifies the recalling firm that the recall is complete. No further action is expected.

Marler Clark epidemiologist Patti Waller and attorney Denis Stearns wrote a column titled, “Where’s the Meat? The Need for Full Public Disclosure in Meat Recalls” for the Journal of Environmental Health’s June 2006 issue. The article focuses on the USDA’s proposed rule on changing policy regarding public disclosure of the names of retail outlets that received potentially contaminated meat during a meat recall. The authors argue, “The revised recall policy proposed by USDA represents a commonsense approach that balances industry concerns and the public’s right to know. It is thus deserving of widespread public support.”

The sooner these issues are resolved, the better.

Another Voice Calling for Strengthening and Funding of FDA

Count the editorial board of the San Jose Mercury News as another vote in support of reform for the FDA.  This editorial outlines the fight against the bill being put up by the food industry and their Republican supporters.

As I discussed here last week, food industry lobbyists and Republicans are now balking at several desperately needed portions of the bill.   For example:

Increased "traceability":  The bill would require significantly more detailed tracking of a food's origin, and its subsequent distribution.   The food industry claims the new regulations to be too onerus.   The piece correctly argues though, that:

they can't afford not to track their products. The 2006 spinach E. coli outbreak cost that industry $50 million; the 2008 tomato scare resulted in a $100 million loss to the tomato industry. A tracking system would not only contain problems faster but would also enable companies to say with confidence that their products are safe, reassuring consumers and maintaining profits.

Idustry Fees for Increased Inspection:  New legislation would require increases in government inspection of food production facilities, requiring a higher level of inspection for high risk foods.   This efficient approach should be hailed by industry, but instead they have focused on the short term increase in costs:

[Another] objection stems from the $1,000 annual fee that food facilities would pay, raising just under $400 million a year toward the cost of additional FDA inspections.

Grocery companies say the fee and the FDA's expanded powers would give it too much control over their operations.

Actually, the regulations don't go far enough. They provide for inspections of food facilities every four years, and every 18 months for high-risk facilities. That's better than now, but annual inspections, and every six months for high-risk operations, should be the target.

It's good to see the short-sighted, fail to see the forest for the trees, arguments of the food industry be exposed.   The long-term health of our food production system, for consumers AND for industry,  needs this long overdue overhaul and strengthening of the FDA.    Let's hope our legislators can see past industry lobbyists and do what is right.

Baby Steps: USDA Implements Increase in E. coli O157:H7 Testing.

As I noted in an earlier post on a different blog about the USDA’s decision to, in a matter of speaking, take its head out of the sand and recognize that E. coli O157:H7 is a problem that starts (and someday will hopefully end) with the slaughter and dressing process, the agency is finally appearing to take a more reality-based (which is to say, less industry-biased) approach to ensuring food safety.  For the earlier post, see here:www.foodpoisonblog.com/2009/05/food-policy-regulation/usda-sees-the-light-on-e-coli-o157h7-and-meat/#comments

Specifically, the only way that meat gets contaminated is because insufficient care was taken during slaughter and feces or ingesta cross-contaminates the previously uncontaminated carcass. Knowledge that this cross-contamination is commonplace is what has given rise over the years to post-slaughter “interventions” like steam-pasteurization and organic acid washes. Put bluntly, there is no need to try to remove the poop on the meat if it does not end up there in the first place.

Since the Pathogen Reduction; HACCP Final Rule was issued in 1996, it has been the stated policy of the USDA that E. coli O157:H7 be reduced to an "undetectable level." This is the so-called zero-tolerance policy for this deadly pathogen, which is based on the irrefutable fact that if the “presence [of E. coli O157:H7] can be prevented, no amount of temperature abuse, mishandling, or undercooking can lead to foodborne illness.” See HACCP Final Rule, 62 Fed. Reg. at 38,962. Now, seemingly more intent at make zero-tolerance a reality, USDA yesterday issued notice that it was mandating an increase in the frequency of its in-plant testing for E. coli O157:H7 in raw ground beef. While this is an improvement, it is but a baby step, since the most frequent testing that will occur under this policy is 4 times per month, and this is only at plants that produce volumes of ground beef greater than 250,000 pounds PER DAY.


For more on this change in policy, please click on CONTINUE READING.
 

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New Obama Policy Allows States to Be Tougher on Food Safety

During the Bush administration, and its do-anything-help-big-business approach, agencies were required to insert "preemption" language into all regulations, rules, and policies that  the agencies promulgated.  This was intended as an attempt to "protect" corporations from state laws and regulations that had the effect of imposing stricter requirements, especially with regard to product safety.  One big "win" for this approach was the U.S. Supreme Court decision in Reigel v. Medtronic, which held that people injured by a medical device "pre-approved" by the FDA could not file a lawsuit claiming that the device was defective as a matter of state law.  A not so successful attempt to use preemption for food cases was that tried by the Excel Corporation in litigation arising from an E. coli O157:H7 outbreak linked to a Milwaukee-area Sizzler restaurant. In those cases, Excel argued that its admittedly contamianted meat was neither defective nor unsafe because USDA policy at the time only prohibited this deadly pathogen from being in ground beef. (For an op-ed piece I wrote about this USDA policy, see Who does the USDA Really Protect, which can be found here: www.marlerblog.com/2008/08/articles/lawyer-oped/who-does-the-usda-really-protect-when-it-comes-to-deadly-e-coli/)

But now most of the arguments in favor of preempting state law in favor of "uniform" federal regulations are going to be undercut by a just-issued Executive Order that declares a new (or renewed) era of states rights.  The introductory paragraph of the Order is telling and compelling:

From our Nation's founding, the American constitutional order has been a Federal system, ensuring a strong role for both the national Government and the States. The Federal Government's role in promoting the general welfare and guarding individual liberties is critical, but State law and national law often operate concurrently to provide independent safeguards for the public. Throughout our history, State and local governments have frequently protected health, safety, and the environment more aggressively than has the national Government.

Not only does this Order announce a new direction, it requires the heads of all federal agencies to "review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law," and to remove them.  So once more the role of the state in protecting its citizens from unsafe food and other products is restored to its rightful place.  More importantly, the next time that a big food company argues that the USDA said it was okay to poison people, it will likely get laughed out of court. Or at least we can hope so.

To read the full text of the Executive Order, please click on the Continue Reading link.

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FDA Takes Step One: Admits It Has A Problem

In a bit of news that is less surprising than it should be, the AP today reports that the FDA has for the last several years failed to perform a large percentage of required audits for inspections being conducted (under contract) by the States.  According to today's report (based on documents recently released to Congress:

The Food and Drug Administration conducted only about half the state food safety audits it promised in the two years before the recent peanut salmonella outbreak, according to new documents the agency sent to Congress.

The documents show the agency did not do any of the required audits of state-run food inspections in five states during those states' budget years spanning 2007 and 2008. And the FDA was unable to say whether audits were conducted at all in 11 additional states during that time, including Georgia and Texas, where salmonella was found in two peanut plants during a wide-ranging peanut recall earlier this year.

Only 14 states saw 100 percent of the audits completed.

As you will recall, the failure of state-performed inspections was a key contribution the recent nationwide Salmonella outbreak linked to contaminated peanuts processed by the Peanut Corporation of America.  Ditto the Conagra pot pie Salmonella outbreak, and the Peter Pan peanut butter Salmonella outbreak.  Double ditto the Veggie Booty Salmonella outrbeak. 

But at least the FDA seems to starting its long overdue recovery process, taking the first step by admitting it has a problem.  As the AP story reports:

Stephen R. Mason, acting assistant commissioner for legislation at the agency, said the recent salmonella outbreak "has highlighted limitations in our current approach and has prompted internal discussions on potential enhancements to the audit program." 

An agency spokesperson, trying hard to put the best spin on things, goes on to offer the following lame rationalization:

FDA spokeswoman Susan Cruzan says the agency is "evaluating approaches" for improving the audits.

"Although FDA has not been able to fulfill the goal of conducting 100 percent of the audits expected under FDA's internal auditing policy, FDA has audited each state at least once, has good knowledge of the state programs and state inspection personnel, and works to improve the programs as needed," she said.

Having admitted the problem, one can now only hope that the FDA will move on to the crucial next step: Stop Being in Denial.

Before Food Was Fast: Some Looks Back to a Time when Food was Local, Slow, and Safe

In addition to being a lawyer, I am a longtime foodie.  So my attention was definitely grabbed this morning when I was listening to NPR and there were segments on two food-related books that I defintely will be reading soon.  The first is Watching What We Eat, by Kathleen Collins.  It is a history of cooking shows, from its beginning on radio, to its current near-ubiquity on television, like on the Food Network.  Here's a link to the author's fun blog. www.watchingwhatweeat.com/

The other book that merited a segment on NPR is The Food of a Younger Land: A Portrait of American Food--Before the National Highway System, Before Chain Restaurants, and Before Frozen Food, When the Nation's Food Was Seasonal by Mark Kurlansky, who also brought us a fascinating history of a fish: Cod: A Biography of the Fish that Changed the World. Here is an except from the new book's description on Amazon:

In the 1930s, with the country gripped by the Great Depression and millions of Americans struggling to get by, FDR created the Federal Writers’ Project under the New Deal as a make-work program for artists and authors. A number of writers, including Zora Neale Hurston, Eudora Welty, and Nelson Algren, were dispatched all across America to chronicle the eating habits, traditions, and struggles of local people. The project, called “America Eats,” was abandoned in the early 1940s because of the World War and never completed.

The Food of a Younger Land unearths this forgotten literary and historical treasure and brings it to exuberant life. Mark Kurlansky’s brilliant book captures these remarkable stories, and combined with authentic recipes, anecdotes, photos, and his own musings and analysis, evokes a bygone era when Americans had never heard of fast food and the grocery superstore was a thing of the future. Kurlansky serves as a guide to this hearty and poignant look at the country’s roots.

I have not read Kurlansky's latest yet, but I have read a great book that covers the same territory, and does so really well. It's called: America Eats!: On the Road with the WPA - the Fish Fries, Box Supper Socials, and Chitlin Feasts That Define Real American Food, and its author is Pat Willard.  I highly recommend reading it.  (Did I mention that I have over 100 cookbooks?)

For an excerpt from Kathleen Collin's book, copied from the NPR website, please click on the Continued Reading link.

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USDA Sees the Light on E. coli O157:H7 and Meat

For years, the USDA Food Safety and Inspection Service (FSIS) has allowed meat plants to divert meat that has tested positive for E. coli O157:H7 (or some other pathogen) to a further-processing facility where it is cooked for a time and at a temperature sufficient to kill the pathogens.  What FSIS has not done, however, is require immediate corrective action of the plant's slaughter and sanitary dressing procedures so as to determine how the meat came to be contaminated in the first place.  Because, let us be clear: ground beef, trimmings, an intact cuts of meat do not get contaminated with E. coli O157:H7 unless the carcass is contaminated, or cross-contaminated, druing the slaughter or carcass-dressing process.  Bottom-line: Meat is not contaminated but for the manner of its slaughter and dressing. 

So lax has been the FSIS focus on and oversight of the slaughter and dressing process that it has routinely allowed plants to send meat that has tested presumptively positive for E. coli O157:H7 to be sent for further-processing without requiring that confrimatory testing be done.  This give the plant a free pass by avoiding a confirmed positive test result for E. coli O157:H7, something that would be higly likely to prompt a comprehenisve assessment at the plant, and the requirement that the plant's HACCP plan be re-assessed and re-validated.  This also allows both the plant and FSIS to pretend that the Slaughter HACCP plan has not failed for not reduciing E. coli O157:H7 to an "undetectable level"--something that FSIS policy has required since October 7, 2002.

Now, if in reading the above the image of an ostrich with its head in the sand came to mind, then you are definitely grasping the gist of my criticism here.  But, that said, I am happy to report that FSIS finally seems to have pulled its proverbial head out of the sand and seen the light. 

Yesterday the agency issued FSIS Directive 6410.1, and it is a very good thing indeed.  For more on this, please hit the CONTINUED READING link.

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