On March 7, 2017, The SoyNut Butter Company recalled all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products. On March 10, 2017, The SoyNut Butter Company expanded its recall to include Dixie Diner’s Club brand Carb Not Beanit Butter.  This after poisoning over 30 people – mostly kids – several that suffered from acute kidney failure.

The recall notice, drafted by I.M. Healthy, on the FDA website did not mention where the tainted product was sold.  Nearly six months later Food Safety News reported on September 5: “Earlier today, Amazon.com was still selling I.M. Healthy soy nut butter that was recalled in March when federal officials traced an E. coli outbreak to the product.”  Then on September 26 a friend of a client whose son nearly died from consuming the soy nut butter found the product on “Close Out” at Lucky’s Market on 200 Woodside Rd, Redwood City, CA 94061.

So, why does the FDA not release the names of retailers to retailers and consumers during a recall and/or an outbreak?

Caitlin Dewey of the Washington Post asked the same question in March of this year – “Why the FDA hides the names of grocery stores that sell contaminated food.”  I reread it today and it still makes my head hurt.

According to Caitlin: The FDA does not specify, however, which stores, centers or schools — because that would violate its interpretation of an obscure trade secret rule. 

This interpretation differs from that of other agencies in the federal food safety system, an overlapping and often illogical network of regulatory fiefdoms. The system, which is responsible for keeping food free of bacteria and other pathogens, frequently has to weigh the very real interests of private food companies against potential risks to the public. In the case of releasing retailer lists during major outbreaks, the FDA has historically sided with business, ruling that such lists constitute “confidential commercial information” and thus should not be available for public consumption. 

Critics say that the agency’s unwillingness to share this information poses a clear danger to public health, particularly in cases like the current E. coli outbreak, where parents may not know if their child consumed the recalled product.

 “Our mantra is that a more transparent food system is a safer food system,” said Thomas Gremillion, the director of food policy at the Consumer Federation of America. “And there are lots of instances where having that distribution list would help victims of food-borne illness.”

The FDA’s current recall process has been in effect for years, though the agency did gain more recall authority under the FDA Food Safety Modernization Act of 2011. It is, for the most part, a voluntary system — which means there’s some variance in how quickly recalls happen. While most companies are highly motivated to clean up any contamination, it takes time to evaluate and respond to possible threats. And that time can be multiplied several times over if a product has moved through the hands of several distributors, manufacturers or other middlemen, an issue that the FDA was faulted for in a June 2016 alert by the Inspector General’s Office.

When a company does issue a recall, it has wide latitude over the amount of information it shares; in some cases, a recall will never be made public. Recalls that are made public typically contain a description of the product and an explanation of the problem. But companies are not required to reveal where the product was sold — whether to a store, a school, a restaurant or another manufacturer that put it in other products.

The recall for SoyNut Butter, for instance, says that “products were distributed in multiple states and may have been purchased in stores or through mail order. They were also distributed to childcare centers and schools in multiple states.” Those states include Virginia and Maryland, where two people have fallen ill. I.M. Healthy did not respond to a phone call or email requesting comment, though a statement on its website called the contamination “deeply concerning” and said that the company had immediately issued a recall. A list compiled by the site eFoodAlert claims that the product was sold at a number of major grocery chains, including Kroger, Giant and Whole Foods.

“Industry argues that they don’t want to turn over who they sell to, because competition will know and try to undercut them,” said Bill Marler, a prominent food safety lawyer who is representing the parents of one of the children sickened in the SoyNut outbreak. “That’s all well and good under normal circumstances. But those rules should not and do not apply to a product that could cause people to become ill.”

In a statement to The Washington Post, the FDA affirmed that it believes its disclosure measures are sufficient and blamed the lack of downstream recall information on federal disclosure rules. Federal regulations do limit the sort of information that can be released to the public. Under the Freedom of Information Act and Title 21 of the Code of Regulations, government agencies — and specifically, the FDA — are told to exempt trade secrets and commercial information from any of their releases.

“Examples of [confidential consumer information] include raw material supplier lists, finished product customer lists, trace back information, etc.,” said Peter Cassell, a spokesman for the FDA. “CCI is exempt from Freedom of Information Act requests, but can be shared through certain information sharing agreements (including with other Federal agencies).”

“The FDA publicizes recall notices, including pictures of affected products, and uses social media accounts to reach consumers as swiftly as possible,” he later added. “In some cases, the FDA can release certain information that is otherwise exempt from disclosure if it is necessary to effectuate a recall. In many cases, it is most efficient for the company to directly notify its distributors so they can take appropriate action.”

Cassell declined to make an agency lawyer available for comment or explain how the FDA had arrived at its definitions. But it’s probably worth noting that when another agency considered similar precedents, it came to different conclusions.

In the early 2000s, the Food Safety and Inspection Service — the branch of the U.S. Department of Agriculture that regulates meat, poultry and egg products — decided to revisit its own interpretation of the trade secrets rule. During a lengthy comments period, industry groups concerned with protecting their distribution lists from competitors faced off against consumer advocates. In 2008, after several years of debate, FSIS’s final rule concluded that it would “not cause substantial harm to the competitive position of any business” to disclose retailer names.

“FSIS now routinely posts these lists,” said Deirdre Schlunegger, the chief executive of STOP Foodborne Illness, an advocacy group for patients that lobbied FSIS 10 years ago. “We obviously believe consumers should have as much information as possible to make safe food decisions.”

Today, when FSIS issues a Class I recall — those that seem “reasonably” likely to cause health problems — it also issues a list of all the retail locations that have, or have had, the product. During last month’s massive cheese recall, for instance, FSIS published a list of every Safeway, Albertsons and Pak ’n’ Save that sold Taylor Farms salads containing Sargento pepperjack. But because FDA regulates the cheese itself, there was no such list of stores that sold the cheese outside salads.

“It does makes me wonder why the FDA can’t do the same,” said Sandra Eskin, the director of the Safe Food Project at Pew Charitable Trusts. “The fundamental issue is — is this information important to consumers during a recall? I would argue yes.”

But the man who led the effort to reform FSIS’s traded secrets rule has his own suspicions as to why the FDA hasn’t followed his lead. Richard Raymond, who was the undersecretary of agriculture for food safety under President George W. Bush, says that the fiercest opposition to the change came from the food industry. Raymond, who had been the chief medical officer in his home state of Nebraska, came to Washington, D.C., determined to change the rules on confidential information. He found himself surprised by the level of resistance.

“They were scared to death it would hurt their business,” Raymond said. “The retail stores want to protect their brand. … When you ask why FDA hasn’t done it, I suspect they don’t want that fight themselves.”

The FDA did not respond to Raymond’s comment by press time. But Gremillion, of the Consumer Federation, would like to see the agency take action.

“Why do confidential business interests trump public health in some cases and not others?” he asked. “We need more transparency around this.

I think it is past time for the FDA and the industries it oversees to be transparent – willingly or not.

There are now 16 dead with 292 sickened with hepatitis A in San Diego – mostly in the ignored homeless population. And, the numbers of people with this preventable disease is spiking in Colorado (57 ill with 1 death), Michigan (319 ill with 14 deaths), New York (46 ill) and other states and cities (Los Angeles has at least 10 sick, Salt Lake City 21).  Lately, we have also seen the spread to food service workers, potentially exposing hundreds of unsuspecting consumers.

This is all preventable.

In 2006, health officials recommended routine hepatitis A vaccination for all children ages 12-23 months, that hepatitis A vaccination be integrated into the routine childhood vaccination schedule, and that children not vaccinated by two years of age be vaccinated subsequently. The vaccine is also recommended for the following persons:

  • Travelers to areas with increased rates of hepatitis A
  • Men who have sex with men
  • Injecting and non-injecting drug users
  • Persons with clotting factor disorders
  • Persons with chronic liver disease
  • Persons with occupational risk of infection
  • Children living in regions of the U.S. with increased rates of hepatitis A
  • Household members and other close personal contacts

The vaccine may also help protect household contacts of those persons infected with hepatitis A. Although generally not a legal requirement at this time, vaccination of food handlers would be expected to substantially diminish the incidence of hepatitis A outbreaks.

Although outbreaks continue to occur in the United States, no one should ever get infected if other preventive measures are taken. For example, food handlers must always wash their hands with soap and water after using the bathroom, changing a diaper, and certainly before preparing food. Food handlers should always wear gloves when handling or preparing ready-to-eat foods, although gloves are not a substitute for good hand washing. Ill food-handlers should be excluded from work.

Hepatitis A is a communicable (or contagious) disease that often spreads from person to person. Person-to-person transmission occurs via the “fecal-oral route,” while all other exposure is generally attributable to contaminated food or water. Food-related outbreaks are usually associated with contamination of food during preparation by a HAV-infected food handler. The food handler is generally not ill because the peak time of infectivity—that is, when the most virus is present in the stool of an infected individual—occurs two weeks before illness begins.

Fresh produce contaminated during cultivation, harvesting, processing, and distribution has also been a source of hepatitis A. In 1997, frozen strawberries were the source of a hepatitis A outbreak in five states. Six years later, in 2003, fresh green onions were identified as the source of a hepatitis A outbreak traced to consumption of food at a Pennsylvania restaurant. Other produce, such as blueberries and lettuce, has been associated with hepatitis A outbreaks in the U.S. as well as other developed countries.

HAV is relatively stable and can survive for several hours on fingertips and hands and up to two months on dry surfaces. The virus can be inactivated by heating to 185°F (85°C) or higher for one minute, or disinfecting surfaces with a 1:100 dilution of sodium hypochlorite (household bleach) in tap water. It must be noted, however, that HAV can still be spread from cooked food if it is contaminated after cooking.

So, for Goodness Sake, Vaccinate Against Hepatitis A

Islamic State leaders are reportedly asking its followers to carry out terror attacks by poisoning food in Western supermarkets.  It is not like poisoning our food has not happened before and we certainly have been warned.  In 2011 Secretary of State Hillary Clinton warned of infectious disease outbreaks caused by pathogens falling into the wrong hands and into our food. She said:

“Unfortunately the ability of terrorists and other non-state actors to develop and use these weapons is growing. Therefore this must be a renewed focus of our efforts.”

“Because there are warning signs and they are too serious to ignore.”

“Al Qaeda in the Arabian Peninsula had urged brothers with degrees in microbiology or chemistry to develop a weapon of mass destruction.”

Sound familiar? It should. In 2004 Health and Human Services Secretary Tommy Thompson warned of food-related terrorist attacks. He said:

“For the life of me, I cannot understand why the terrorists have not attacked our food supply because it is so easy to do.”

It reminded me of an Op-ed I did for Forbes a year or so ago:

Imagine this: At 10:00 PM, after yet another story about Donald Trump, a foreign TV network begins airing a video taken inside a facility showing someone treating wash water in a cucumber packing house with an unknown liquid. There is a claim that this was the terrorist act that has so far sickened 341 and killed 2 in 30 states with Salmonella.

In the next 15 minutes, every network news operation is playing the video. The broadcast networks break into regular programming to air it, and the cable news stations go nonstop with the video while talking heads dissect it. The Donald fades into the distance.

Coming on a Thursday evening on the East Coast, the food terrorism story catches the mainstream Media completely off guard. Other than to say the video is being analyzed by CIA experts, and is presumed to be authentic, there isn’t much coming out of the government.

Far-fetched? Don’t count on it. I have been saying for years that a foodborne illness outbreak will look just like the terrorist act described above, but without the video on FOX News.

Tell that to the 751 people in Wasco County, Oregon—including 45 who required hospital stays—who in 1984 ate at any one of ten salad bars in town and were poisoned with Salmonella by followers of Bhagwan Shree Rajneesh. The goal was to make people who were not followers of the cult too sick to vote in county elections.

Tell that to Chile, where in 1989, a shipment of grapes bound for the United States was found laced with cyanide, bringing trade suspension that cost the South American country $200 million. It was very much like a 1970s plot by Palestinian terrorists to inject Israel’s Jaffa oranges with mercury.

Tell that to the 111 people, including 40 children, sickened in May 2003 when a Michigan supermarket employee intentionally tainted 200 pounds of ground beef with an insecticide containing nicotine.

Tell that to Mr. Litvenenko, the Russian spy poisoned in the UK with polonium-laced food.

Tell that to Stanford University researchers who modeled a nightmare scenario where a mere 4 grams of botulinum toxin dropped into a milk production facility could cause serious illness and even death to 400,000 people in the United States.

The reason I bring this up is not to mark another anniversary of 9/11. I raise the issue not because I actually think that food terrorism is the cause of this week’s Salmonella cucumber outbreak. However, I wonder if it would have made any difference in our government’s ability to figure out there was an outbreak, to figure out the cause, and to stop it before it sickened so many.

After 9/11, Health & Human Services Secretary Tommy G. Thompson said: “Public health is a national security issue. It must be treated as such. Therefore, we must not only make sure we can respond to a crisis, but we must make sure that we are secure in defending our stockpiles, our institutions and our products.”

Before Thompson’s early exit from the Bush Administration, he did get published the “Risk Assessment for Food Terrorism and Other Food Safety Concerns.” That document, now 5-years old, let the American public know that there is a “high likelihood” of food terrorism. It said

the “possible agents for food terrorism” are:

  • Biological and chemical agents
  • Naturally occurring, antibiotic-resistant, and genetically engineered substances
  • Deadly agents and those tending to cause gastrointestinal discomfort
  • Highly infectious agents and those that are not communicable
  • Substances readily available to any individual and those more difficult to acquire, and
  • Agents that must be weaponized and those accessible in a use able form.

After 9/11, Secretary Thompson said more inspectors and more traceability are keys to our food defense and safety. To date, we’ve made some, but not enough movement to ensure this.

Would the fact of terrorists operating from inside a manufacturing facility somewhere inside the United States bring more or effective resources to the search for the source of the Salmonella? If credit-taking terrorists were putting poison on our cucumbers, could we be certain Uncle Sam’s response would have been more robust or effective then if it was just a “regular” foodborne illness outbreak?

Absolutely not! The CDC publicly admits that it manages to count and track only one of every forty foodborne illness victims, and that FDA inspectors miss key evidence as outbreaks begin. The FDA is on record as referring to themselves as overburdened, underfunded, understaffed, and in possession of no real power to make a difference during recalls. If you are a food manufacturer, packer, or distributor, you are more likely to be hit by lightning than be inspected by the FDA. You are perfectly free to continue to sell and distribute your poisoned product, whether it has been poisoned accidentally or intentionally.

The reality is that the cucumber Salmonella outbreak is a brutal object lesson in the significant gaps in our ability to track and protect our food supply. We are ill prepared for a crisis, regardless of who poisons us.

So, what can we do?  Since we inspect only about 1% of imported food that food could be tainted with biological or chemical agents before entering the United States. Given, also the lack of inspections domestically, toxins could easily be introduced in food at the farm, in transit, at processing plant or in restaurants.

More and better inspections by FDA and FSIA inspectors at various points in our food supply are absolutely necessary, as is good intelligence work by those at the CDC and FBI. However, when a terrorist uses a biological or chemical weapon against the civilian population – in food or otherwise, how quickly the outbreak is detected, analyzed, understood and addressed would be the responsibility of state and local public health offices and the CDC. Surveillance would be the key to limiting the damage and bringing the terrorists to justice.

We need to invest in the science of epidemiology and the surveillance of biological and chemical illnesses. We need to increase our laboratory capacity for biological and chemical agents, and our ability to quickly track patterns of potential illnesses. And, we need to strengthen the teamwork between state, local and federal health officials so outbreaks are caught early.

Perhaps a foodborne bio-terrorism event cannot be stopped, but with investments in surveillance, the event can be minimized.

I’m not sure I will get through what I plan on saying today at Dave’s Memorial, so I thought I would put it here:

Funerals are painful, and our hearts go out to Jill and the entire Theno clan. We all share just a small part of your grief.

Funerals are also uncomfortable, because they remind us all of life’s fragile nature and of all the things we should have said too so many.  Especially as we grow older, we think of all the deeds that we have not done, and the ever – decreasing time to do them.

However, we are here today to honor our friend Dave, who unlike most of us, left nothing undone and leaves this life a hero.  Dave was honored by so many.  Here are just a few:

  • NSF Lifetime achievement award
  • American Association of Food Hygiene Veterinarians
  • American Meat Science Association
  • International Association of Food Protection
  • International Meat & Poultry HACCP Alliance
  • Institute of Food Technologists
  • National Advisory Committee on Meat & Poultry Inspection
  • National Advisory Committee for Microbiological Criteria for Foods
  • National Cattlemen’s Beef Association’s Beef Industry Food Safety Council
  • National Meat Association
  • Black Pearl Award by the International Association of Food Protection
  • Innovator of the Year Award from Nation’s Restaurant News
  • California Environmental Health Association’s Mark Nottingham Award
  • Nation’s Restaurant News “Top 50 Players”
  • STOP’s Hero Award and Scholarship

And, this coming year Dave was due for even more deserved recognitions.

Of course, many in the food safety community’s most poignant visual, and most vivid memory, is of Dave asking a picture of Lauren what was the right thing to do.  However, Dave always knew what the right thing to do was, and Lauren was always beside him to confirm it.

In the end, Dave’s profile will not be etched into Mount Rushmore or on the Washington D.C. Mall – but it should be.  Why?  Because Dave’s life’s work saved countless lives and will continue to do so long after all of us have attended our own funerals.

Dave is and will be missed, but he will always be a hero remembered.

I dropped an Op-ed on the Hill this morning.  Here is an excerpt:

This week the CDC reported that at least 47 people were stricken with Salmonella, with one death, likely linked to papayas imported from Mexico. In the summer of 2016 came reports of hepatitis A tainted scallops sickening 292 in Hawaii. In that outbreak two died of liver failure complications. And, also in 2016, 143 people, mostly in Virginia, were also stricken with hepatitis A. This time the culprit was hepatitis A-tainted strawberries imported from Egypt.

While most food we consume is still produced in the United States, we rely on imports for some of our most nutritionally important but more risky commodities. And, imported food is increasingly taking a larger “bite” out of our food consumption. We now import over 90 percent of our seafood, 50 percent of our fresh fruit and 20 percent of our vegetables. Canada, Mexico, China and India are our top food trading partners. In 2014, we imported nearly $50 billion of food from just those four countries. Imports from all countries have increased, and that is especially true for China and India.

I am off to IAFP on Sunday.  I’m doing a “Point/Counterpoint” on what responsibility consumers have for food safety.

Who’s to Blame? Do Consumers own a Piece of Food Safety?

Lawyers Who Are Changing the World

By Jeff Tolman

I have great respect for people who take control of their lives and create a successful life and practice in the changing and evolving legal universe. That would be Bill Marler, Senior Partner at Marler Clark, The Food Safety Law Firm, in Seattle. Bill is considered the most prominent foodborne illness lawyer in America and a major force in food policy in the U.S. and around the world. Wondering if as a youngster he was innately interested in food and food poisoning – and, if not, how in the world he got into this niche practice – I gave Bill a call.

Bill grew up in Silverdale, WA, less than 10 miles from my office, the son of a Navy nurse and Marine Sergeant, both later teachers. After graduating from Olympic College in Bremerton, WA, Bill attended Washington State University. He graduated with three majors due to the fact he was elected to the Pullman City Council as a 19-year-old student and he was determined to fill out his term. After working as a paralegal in a Seattle law firm (Bog;e and Gates) for a year, Bill went to law school and received his J.D. from Seattle University School of Law in 1987. From 1987 to 1998 Bill worked in a variety of firms including Dick Krutch; McKay and Gaitan, Keller Rohrback; Perey Law Group; and Kargianis, Osborne, Watkins & Marler.

His first big civil case related to two children killed by Westley Allan Dodd. Bill decided to go right to the horse’s mouth and met with Dodd in the Washington State Penitentiary in Walla Walla, and for five hours heard about Dodd’s various contacts with the legal system. Determining the state of Washington had failed in its duty to monitor Dodd, resulting in the murders, a settlement was reached for the family of the victims.

Then came the 1993 E. coli outbreak at Jack-in-the-Box restaurants. Within a day Bill’s investigation led him to file a lawsuit and he became the face of that litigation. Sometime later, in two days of mediation, the plaintiffs received $23 million in settlements. Bill’s reputation as a foodborne illness go-to lawyer was cemented. Now, he said, there is not a significant outbreak of foodborne illness that isn’t touched by his firm.

In 1998 Marler Clark was formed, initially with four lawyers and four staff, now with six lawyers.

Bill is an enthusiastic, charming, ebullient, charismatic speaker. I wish we could have spoken for another hour or two. He was in Houston, speaking to a conference of food safety agencies. His schedule a week before and after our conversation took him all over America as a lawyer, speaker and advocate for food safety.  His next stop was Utah where he is representing a group of victims of food poisoning from a store’s chicken salad, including a 20-year-old woman who became brain injured, unable to work and unable to bear children as the result of the poisoning.

Bill indicated that the foodborne illness litigation is a small community of plaintiff and defense specialists where collegiality and professionalism still reign. He would recommend becoming a lawyer (he has a daughter who plans to take the LSAT) if you go in with your eyes open. Ask yourself: What do you want to do in your career? Can you afford to get a law degree?

Describing his life, he says, “I travel all over the world trying to convince companies that it’s a really bad idea to poison people.”

Not a bad goal to have. Not a bad way to spend a professional life.

I have been thinking about Dave Theno a lot today.  I recall that several time before I wrote the below, Dave an I shared a few glasses of good wine.  I am not sure what I’m going to do without Dave.

Food Safety is the crazy uncle of corporate food production – everyone has one, but no one really wants to talk about it.

Corporate management on average is far more interested in sales and profits and would just as soon ignore those people who talk incessantly about a “culture of food safety,” or “food safety from farm to fork.”

Management is most interested in getting food from the farm to your grocery cart in exchange for as much cash as possible and for as little corporate cost as necessary.  Food safety is overhead, as are the audits that slow the chain of distribution from revealing bad food safety behavior.

True, safe food becomes important when a foodborne illness outbreak happens and the corporate brand is put at risk.  However, on a day-to-day basis, food safety is at best, and most often, simply ignored.

That is why food – most produced here in the U.S. – sickens 48,000,000, hospitalizes 125,000 and kills 3,000 of us yearly.

What if the corporate management of a food manufacturer or retailer was required to personally certify to the public that he or she had established “internal controls” over food safety, and in fact the food produced and sold was safe?

What if an auditor was required to “issue an opinion” as to the accuracy of those controls over food safety, and that in fact the audit was truthful?

Stunning ideas?  Not really!

There is a somewhat recent and apt model for increasing corporate and auditing responsibility that would work quite well to focus attention on good food safety behavior.

Fact – good food safety behavior in the long run protects consumers, which protects the corporate brand.  Not poisoning your customers is actually good for business.

The Sarbanes–Oxley Act known as the “Corporate and Auditing Accountability and Responsibility Act” has set increased standards for all corporate management and auditing firms.  The bill was enacted in 2002 in reaction to corporate and auditing scandals in the 1990’s, which cost investors billions of dollars when share prices of public companies collapsed.

As a result of Sarbanes–Oxley, top corporate management must now personally certify the accuracy of financial information. Management must certify that they are “responsible for establishing and maintaining internal controls” and “have designed such internal controls to ensure that material information relating to the company” is made known.

Sarbanes–Oxley has also increased the responsibility of outside auditors who review the accuracy of corporate financial data. External auditors are now required to issue an opinion on whether management maintained effective internal control over financial reporting and that the financial statements are in fact accurate.

How can the Sarbanes–Oxley Act relate to safer food?

Can you imagine if the president of a food company was actually required to sign off yearly on the company’s food safety “internal controls?’  If that were the case, perhaps food safety would have a direct line of communications to corporate leadership instead of lagging behind marketing and short-term profits.

It would be truly revolutionary to have a food company focused on producing and selling safe food as its core mission.  That would be a “culture of food safety.”

And, what about audits?  What if an auditor had to sign his or her name that the audit was in fact truthful and was not simply a mechanism to move product speedily, not necessarily safely, along the chain of distribution?

An honest audit would be “food safety from farm to fork.”

Does it not seem at least equally important that the food manufacturers or retailers ask our children to put in their bodies have some of the safeguards that investors have in the same corporation?

Thanks Dave

In 2013, I wrote a piece on my blog about “Why I Love my Job.”  Its ironic how much of my job and my life over they last 25 years has been intertwined with Dave Theno.  I will miss the occasions we shared a good meal – Dave with a rare steak and mine well-done – with always a very good bottle of wine.  We will all miss his humanity and leadership.

Here is the piece I wrote:

A few months ago I was asked to write something by WSBA about my practice and life as a lawyer.  The ask was something like this:

Mr. Marler, I noted that you are a (“the” – I must admit I added that) preeminent litigator in food poisoning cases in our state (well, actually the “world” – I must admit I added that too). Our members would love an article from you describing a significant case or client that resonated with you, or a description of what it is like to practice in your area of law.

I thought a lot about the ask and my 20 plus years of practice, and the fact that I may well be at the downslope of a job that I truly love.  In a not so often-quite moment, I thought about the beginning of what became both my passion and my job.  Honestly, it has had very little to do with being a lawyer.

I had just turned 35-years-old and was only five years out of Law School, I was a young lawyer in a job that seemed quite dead-end, and then my world changed.

Lauren Beth Rudolph died on December 28, 1992 in her mother’s arms due to complications of an E. coliO157:H7 infection – Hemolytic Uremic Syndrome – also know as acute kidney failure.  She was only 6 years, 10 months, and 10 days old when she died. The autopsy described her perforated bowel as being the consistency of “jelly.”  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 undercooked at Jack in the Box restaurants on the West Coast during late 1992 and January 1993.  I pushed myself to the front of the pack of lawyers.  Roni Rudolph, Lauren’s mom, I have known for nearly 20 years.

Dave Theno became head of Jack in the Box’s food safety shortly after the 1992-1993 outbreak. I too have known Dave for 20 years, mostly because I spent several days deposing (he would say – grilling/torturing) him over the course of the multi-year, multi-state litigation.  However, a decade after spending such quality time (for me anyway) with him, I only recently learned a significant fact about Dave – one that made me admire him even more – one that I think, that all leaders in corporate food safety, or any position of authority, should emulate.

Last year Dave and I shared the stage at the Nation Meat Association (NMA) annual “Meating” in Tampa as an odd pair of keynote speakers. 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 in a physical way.

Dave told the quiet audience about Lauren’s death. He too knew the same autopsy report.  Dave told the audience that the death of Lauren and his friendship with Roni had changed him also in a physical way. He told us all that he had carried a picture of Lauren in his briefcase 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 of any corporation holding the picture of a dead child seeking guidance to avoid the next possible illness or death is stunning, but completely appropriate.

I hugged Dave and we promised to get together again – sometime, someday.

Shortly after leaving Tampa, I spent time with a family in South Carolina whose 4 year old ate cookie dough tainted with E. coli O157:H7 and suffered months of hospitalizations, weeks of dialysis and seizures. She faces a lifetime of complications despite oversight by the Food and Drug Administration of the food she consumed.

After leaving South Carolina I headed to Cleveland, Ohio where I sat across the kitchen table with a family who lost their only daughter, Abby, because she died from an E. coli O157:H7 infection from meat inspected by the United States Department of Agriculture Food Safety Inspection Services.

Neither head of either agency, nor the president of either corporation, whose product took the life of one and nearly the life of the other, ever visited either family, and, that is a shame.

In 20 years of litigation, in 20 years of spending time with Lauren’s or Abby’s family, I am changed.  I see the world far differently than most do now.

If I had any advice to offer to corporate or governmental leaders – run your departments like Dave ran food safety at Jack in the Box. Go meet the families that Dave and I have met.  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 and to love it.

I got up early this AM and was checking emails when one landed in my inbox alerting me of the passing of a real hero and friend.  I was just with him a few weeks ago when he got the NSF Lifetime Achievement Award at the Food Safety Summit.

I do not have it in me yet to process it, so I’m borrowing an article from another source and going for a walk.

Reprinted from 2014 Meat and Poultry News article:

Food safety expert David Theno became “the man who saved Jack in the Box” after he revolutionized food safety at the fast-food company and across the meat-supply chain.

When exceptional people retire, it’s often less an ending and more often a new beginning. Derek Jeter retired a few months ago from the New York Yankees and his on-field baseball career, but already he’s involved in several new baseball projects. When Jimmy Carter was voted out of office in 1980, he invented an entirely new job: active post-president. And though David Theno, Ph.D., retired from his food-safety position at Jack in the Box in the fall of 2008, he hasn’t stopped following his passion to make meat, and food, in general, safer.

But he had every intention of truly retiring, he says. He bought a small American bison calf, named it Cheyenne and planned to spend a lot of afternoons watching Cheyenne graze peacefully on acreage Theno owns in southern California.

His had been a singular, remarkable career, one of the most distinguished and consequential in meat-industry history. In the mid-1980s, while working for California-based poultry processor Foster Farms, Theno installed the first Hazard Analysis and Critical Control Point (HACCP) program in an animal protein production plant, an accomplishment so revolutionary that then-director of the Food Safety and Inspection Service, the legendary Dr. Donald Houston, took the highly unusual step of flying to California to see HACCP up close and in operation for the first time. He was among the first in the industry to recognize that line workers are key to product integrity, and at Foster he took the unprecedented step of giving every employee, regardless of job title or job description, authority to remove any product or package from the production line if they thought it didn’t look or otherwise seem right.

Later, Theno became “the man who saved Jack in the Box,” as the media dubbed him, after he revolutionized food safety, not just at the fast-food company but across Jack in the Box’s entire meat-supply chain following the tragic deaths of four children who ate E. coli O157:H7-adulterated hamburgers at Jack in the Box outlets. Just one of the fundamental changes he instituted at Jack in the Box is finished-product testing, a protocol that was wildly controversial at first – Theno remembers it being called “heresy” by some well-known industry leaders – until its proven results made finished-product testing the industry standard.

Theno and Jack in the Box were crucial first supporters of the test-and-hold protocol for ground beef that Dr. Dell Allen had developed at Excel, which was also resisted by much of the ground-beef industry until the evidence of its effectiveness was too overwhelming to ignore. And the advice and counsel he gave as a member of the US Dept. of Agriculture’s National Advisory Committee on Microbiology Criteria for Foods changed the way the department, as well as the industry, looked at food safety.

An illustrious career

A graduate of the Univ. of Illinois, where he trained under Dr. Glenn Schmidt, Theno’s career began when “food safety” at some meat plants meant sweeping out the sawdust on the floor at the end of the day. When he retired as an industry executive 30 years later, producing microbiologically safe products had become the first priority of virtually every leading meat company in the world. So, after he packed up his belongings and left his Jack in the Box office for the last time six years ago, Theno breathed a sigh of relief and prepared to take his wife, Jill, on a long-overdue six-week vacation to Europe. “It wasn’t a head fake. I really meant to retire,” he says.

Before he left for the Continent, he got a few requests from food companies to assess their food-safety plans, nothing unusual. “So, I looked over their operations, wrote reports and left it at that. I wasn’t feeling sucked in or anything,” he comments.

Theno has become a proponent of creating a law that makes food safety a fiduciary responsibility.

He came home from vacation to three Federal Express envelopes on his desk, all from people he knew who wanted his help. “I talked to Jill, we discussed what it would mean if I got back into it and she said, ‘Go for it,’” he says. “And, you know, there was also this long vacation to pay for.”

Five years later, Theno’s Gray Dog Partners, based in Theno’s home in Del Mar, Calif., is one of the leading food-safety consultancies in the business. It manages Subway’s food-safety program all over the world. It partners with Costco to develop new methodologies for protecting produce. Gray Dog, which has 20 consultants out in the field, is developing an in-restaurant HACCP program for Outback Steakhouse, and more partnerships like this are in the works.

“These are the kind of people I enjoy partnering with. They are committed to what I’m committed to – producing safer food,” he says. He notes change doesn’t have to occur overnight and adds, “You can make fundamental, effective change in increments, and you can save yourselves a whole lot of money and trouble in the process.”

Future of food safety

He has become a proponent of creating a law that makes food safety a fiduciary responsibility in the way the Sarbanes-Oxley Act set standards for corporate financial responsibility. “You should treat food safety just like you do your fiscal responsibility,” he says.

At Subway and other chains, Theno and Gray Dog have been focusing on improving the safety of fresh produce. He is also working with Costco and Taco Bell, helping develop supplier initiatives to improve fresh produce safety. “The produce business is where the beef industry was 25 years ago in terms of food safety,” Theno comments. “You’ve got a lot of variables you have to get under control and a lot of points where things can go wrong. But it’s doable.”

If he has a disappointment in his second career as a freelance food-safety guru, it’s that USDA is less of a partner in food safety than it used to be. “It’s a resource problem for them. They just don’t have the manpower like they used to have,” he says. “I hope that changes because the department has a very important role in all this. In the past, they helped lead the pack in developing food-safety methodology and technologies. Without Dr. Houston’s support in the early days, I’m not sure HACCP would have ever become what it is now.”

Theno has lost none of his enthusiasm for finding the best way to produce the safest food. His passion and expertise have changed the course of food safety. “It’s been fun,” he says.

Meanwhile, Cheyenne, who still grazes peacefully on Theno’s property, now weighs 2,800 lbs.

Thanks to Rich Jochum of BPI for the email.