December 2015

CBS News just reported that the Department of Justice has started an investigation into Blue Bell after their ice cream was linked to a deadly Listeria outbreak earlier this year that killed three people. Sources told CBS News that the Department of Justice is trying to determine what Blue Bell management knew about potentially deadly hazards in their plants, and when they knew it.

Screen Shot 2015-12-30 at 6.12.22 AMLast May I wrote, “Paul Kruse, President and CEO of Blue Bell Ice Cream – My Advice, Get a Good Criminal Lawyer.” Seems like I was on the money.

After watching the Blue Bell Listeria Outbreak unfold over the last months – especially after reading the FDA’s 483’s, I think it is time for the President and CEO of Blue Bell to consult with criminal counsel.  True, perhaps he did not know that his Broken Arrow Plant had Listeria positives going back over years, but knowledge is not necessary for the FDA and a US Attorney to prosecute – just ask the Jensens and DeCosters.

Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands.  The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce.  Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “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.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health.  The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.

Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.

The legal jargon aside, if you are a producer of food and knowingly or not sell adulterated food, you can (and should) face fines and jail time.  Mr. Kruse, I know you are a lawyer, but you should get another one.

The inspection observations of the most recent completed FDA inspections at the Blue Bell production facilities in Brenham, Texas, Broken Arrow, Okla., and Sylacauga, Ala. are available:

151228_KDB_CHIPOTLE_005The Boston Globe reported that the head of Boston’s restaurant inspection program ate lunch at a Chipotle in Cleveland Circle on Monday afternoon to show he is confident that it is safe to dine at the location after more than 100 people got sick after eating there this month. Commissioner William Christopher, who was joined by his chief of staff, Indira Alvarez, ate at the Cleveland Circle location after the restaurant officially reopened over the weekend following an inspection. Christopher stuck to his current carb-free diet, ordering a bowl with steak, chicken, peppers, onions, and lettuce. “The food was wonderful,” he said. “There were no side effects or anything.”

Is it me, or do the rest of you feel a bit uncomfortable with those in charge of protecting the public from foodborne illness are being used (perhaps willingly or not) as PR shills for a company they are charged with inspecting? Perhaps leave it to elected officials or the agency in charge of promoting business?

bjcolorNews from Benin makes the rough and tumble of my world look a bit better today after this tragic event.

The police in Benin have confirmed the death of three persons who were allegedly shot dead by a middle-aged man identified as Onana Osua.

Osua who was said to have shot six persons over alleged food poison, was finally gunned down after he allegedly attacked a police patrol team.

The incident occurred at Uromi, Esan North East local government area of the state.‎

The late Osua who was admitted at an undisclosed hospital for food poisoning, reportedly left the hospital bed, went home, took his gun and went to the homes of people he suspected to be responsible for poisoning him and shot them dead.

Having the ability to take a grievance, such as food poisoning, to a neutral place – like a courtroom – certainly is a bit more civil than the alternative.

Mike-Adams-Health-Ranger-FitnessI think Mike Adams, the “Health Ranger,” thought he might be helping Chipotle with his recent post: “ANALYSIS: Chipotle is a victim of corporate sabotage… biotech industry food terrorists are planting e.coli (sic) in retaliation for restaurant’s anti-GMO menu.”

Although, I understand that people might want to deflect blame/responsibility away, however, blaming one, or six, foodborne illness outbreaks on the “biotech industry” does not seem to engender a sense of customer safety.

Here is some of the “best” of his conspiracy theory:

After observing recent events involving Chipotle and e.coli (sic), here’s my analysis of the situation: Chipotle’s e.coli (sic) outbreaks are not random chance. They are the result of the biotech industry unleashing bioterrorism (sic) attacks against the only fast food company that has publicly denounced GMOs.

How do we know? The CDC has already admitted that some of these e.coli (sic) outbreaks involve a “rare genetic strain” of e.coli (sic) not normally seen in foods. Furthermore, we also know the track record of the biotech industry engaging in the most criminal, dirty, sleazebag tactics imaginable against any person or company that speaks out against GMOs.

There is absolutely no question that the biotech industry will resort to ANY activity necessary to destroy food companies that oppose GMOs. And yes, this includes acts of bioterrorism (sic) against Chipotle — something that’s ridiculously easy for biotech industry operatives to carry out with simple, low-cost laboratory supplies sold online at places like Amazon.com.

… I am now openly encouraging Chipotle’s management to initiate a criminal investigation with the FBI to attempt to identify the sources of this corporate sabotage campaign.

To be clear, what’s really happening at Chipotle is that biotech industry shills are deliberately contaminating Chipotle’s food with strains of e.coli (sic) in a malicious attempt to destroy both the reputation and finances of the Chipotle food chain.

Chipotle should step up and denounce Mike’s BS. Bio-terrorism is not something to take lightly.

unnamed-300x150Were I  the CEO of a 1,900-store restaurant chain with 45,000 employees (with a CEO-to-worker pay ratio of 1522:1), and just had six foodborne illness outbreaks in six months, what would I do this coming Monday morning?

Frankly, with my stock price in free fall – losing $6 billion in value in less than two months – just staying in bed in the fetal position might be welcome.   However, I did not get to be a multi-millionaire hiding in bed. So, here are the things you would see me doing starting  bright and early Monday morning.

  1. Park my large ego. Monetary success can and does breed a sense of otherness – especially when the core of your business culture is that your brand of “integrity” is better than your competitors. With a crisis of this proportion facing the company going humble is not a bad thing.
  2. It is time to be as open as possible. Why was the July E. coli outbreak in Seattle kept from the public by both public health and the company? What did I learn in the August Salmonella outbreak in Minnesota and the Norovirus outbreak in California? Could have being open and learning from these three outbreaks have prevented the next two E. coli outbreaks and the Norovirus outbreak that has nearly brought my company to its knees?
  3. It is time to have a culture of food safety added to the “integrity” of the food. I have now learned that bacteria and viruses do not care a whit if my food’s ingredients are organic, sustainable, non-GMO and humanely raised.
  4. I am going to make mandatory reading Benedict’s book “Poisoned” and Yannis’s book “Food Safety Culture.”
  5. I am going to hire a vice-president of Food Safety. That person will report directly to me and to the Board of Directors. Like Dave Theno being brought in to address the Jack-in-the-Box crisis of 1993, this person will have the resources and access to decision makers to create a culture of food safety from the top down.
  6. With input from the new vice-president, we will hire the consultants and experts necessary to create a sustainable food safety program that brings even more meaning to our core value of “food with integrity.”
  7. I would invite input from regulators, academics, pubic health officials, and yes, the public to add to and critic the new food safety program.
  8. The company’s new mantra – “Safe Food with Integrity” – will be completely transparent and shared with all – including our competitors.
  9. I am going to rehire the two Boston employees fired last week and instead fire someone in management that allowed the company to drift into a position that allowed these outbreaks to occur. I am likely not going to fire myself, but I certainly will take a cut in pay to $1 a year until the ship gets off the rocks – same with the existing top management.
  10. I will stop “shooting the messengers.” This crisis was not caused by public health announcements (one could argue in fact had the July outbreak been announced perhaps all others would have been avoided) or the coverage by the media. We like it when public health covers for us and when the press fawns, its time to grow up and take the good with the less so.
  11. Hit the reset button. Shut every store and open them only when each store is actually ready – not just “deep cleaned” – but ready from a structural and management (food safety culture) perspective.
  12. Invite the customers back with open arms – they will come back.

Merlin_1798961.  Keep hands clean. Cooks and bakers should wash their hands before, during and after preparing food. Proper hand hygiene can get rid of most germs that cause food poisoning. It’s important for people working in a kitchen to wash their hands between tasks, particularly if they’ve been handling raw meat.  Also, do not rinse your poultry in your sink – Salmonella Splatters.

2.  Clean all tools and surfaces. Kitchen appliances, counters, cutting boards, utensils and other cooking tools and surfaces should be washed with hot, soapy water throughout the cooking process.

3.  Use more than one cutting board. Raw meat, poultry and fish should always be separated from other foods, including fruits and vegetables. Be sure to prepare these foods on separate surfaces or cutting boards. It’s a good idea to use colored cutting boards so the ones used for raw meats, poultry and fish are easily identifiable.

4.  Don’t mix utensils. Different forks, spoons or other cooking tools should be used to taste, stir and serve food.

5.  Use a food thermometer. This is the only reliable way to know if your food is cooked thoroughly to the proper temperature. Never rely on “clear juices” to determine if a turkey is fully cooked.

6.  Don’t let food sit out. Food should be refrigerated within two hours of being served. This prevents harmful bacteria that can cause food poisoning from growing.

7.  Check the fridge temperature. It’s a good idea to use a refrigerator thermometer to ensure it’s set to a temperature below 40F.

8.  Defrost safely. Foods should not defrost at room temperature or in a bath of warm water. Instead, defrost food in the microwave or in the refrigerator. While food like raw meat is thawing in the fridge, be sure to cover it and place it on a low shelf so juices won’t drip onto other foods. Foods defrosted in the microwave should be cooked immediately.

9.  Plan ahead. If food needs to be transported to a party, be sure to cook it thoroughly at home first and make sure it remains refrigerated as long as possible.

10.  Don’t sample batter. If you’re baking holiday treats, don’t eat cookie and cake batters that contain raw eggs. These can cause food poisoning.

11.  Don’t Forget Leftovers. It’s also important to be mindful about leftovers. Uneaten foods should be properly stored in shallow containers no more than 2 inches deep. Leftovers should be refrigerated or frozen after two hours.

bill-keene-is-oregons-top-food-borne-illness-detective-252b75975fa6fb17As the Chipotle E. coli O26 outbreak(s) creep(s) into its second month, I found myself thinking and talking today about Bill Keene, former Epidemiologist Extraordinaire at the Oregon Department of Public Health.  Somehow, I have to think that with the use of his “shotgun” questionnaire, we would have figured out by now what the what is that has caused this outbreak.  My hope is that CDC, et al are utilizing Bill Keene’s Keys to Interviewing Success and Ten Cardinal Rules for Conducting Interviews:

Bill Keene’s Keys to Interviewing Success

• Keep the interview as conversational and as natural as possible while staying in the confines of the questionnaire.
• Show empathy to the interviewee.
• Explain what you’re doing and why you’re doing it.

Ten Cardinal Rules for Conducting Interviews

1. Do a practice run until you’re comfortable with the questionnaire
2. Find a quiet place to conduct your interviews
3. Be non-judgmental
4. Avoid leading the witness
5. Accurately record what people say
6. Ensure confidentiality, beginning with conducting interviews in a private location
7. Gently re-direct, as needed
8. Probe if answers are vague, particularly about time of symptom onset
9. Work with epidemiology staff to provide language interpretation, if needed
10. Thank interviewee at closing and explain how info will be used

Bill, you are missed.

The local Boston CBS station reports that the Boston Chipotle linked to over 150 cases of Norovirus will likely open again within days. However, a public health official said the Chipotle manager has been fired from the restaurant as a result of the outbreak.

Chipotle has had six foodborne illness outbreaks in the last six months and it has seen its high-flying stock fall below $500 and see $6,000,000,000 in stock value disappear in the last sixty days.

It does make you wonder if they are firing the wrong guy(s)?

What do you say Mr. Steve Ells and Mr. Montgomery Moran?

cels-e1426531984919

821429b5480dbd8485b3b63cbf833a5fSince the last CDC update on December 4, one more ill person has been reported from Pennsylvania bringing the total to 53 in nine states.

Fifty-three people infected with the outbreak strain of E. coli O26 have been reported from nine states. The majority of illnesses have been reported from Washington and Oregon during October 2015. The number of ill people reported from each state is as follows: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (2), and Washington (27). Among people for whom information is available, illnesses started on dates ranging from October 19, 2015 to November 14, 2015. Ill people range in age from 1 year to 94, with a median age of 21. Fifty-nine percent of ill people are female. Twenty (38%) people reported being hospitalized. There have been no reports of hemolytic uremic syndrome and no deaths.

CDC is investigating another, more recent outbreak of a different, rare DNA fingerprint of Shiga toxin-producing E. coli O26 linked to Chipotle Mexican Grill. Because it is not known if these infections are related to the larger, previously reported outbreak of E. coli O26 infections, these illnesses are not being included in the case count for that outbreak. This investigation is ongoing.

5 ill people have been identified in Kansas (1), North Dakota (1), and Oklahoma (3).

The illnesses started on dates ranging from November 18, 2015 to November 26, 2015.

All five (100%) reported eating at a Chipotle Mexican Grill in the week before illness started.

Sound familiar?

Seattle

When: July 2015

Sickened: 5 people

Culprit: E. coli O157:H7

Source: Unknown

Simi Valley, CA

When: August 2015

Sickened: At least 234

Culprit: Norovirus

Source: Ill worker

Minnesota

When: August and September 2015

Sickened: 64 people

Culprit: Salmonella Newport

Source: Tomatoes

CA, IL, MD, MN, NY, OH, OR, PA, WA

When: Began October 2015

Sickened: 53 people

Culprit: E. coli O26

Source: Unknown

Boston

When: December 2015

Sickened: At least 136 people

Culprit: Norovirus

Source: Ill worker