Raw Milk Redux (and Ken Redux for an Instant)

Our former colleague and still good friend Ken Odza was in our offices last week; I was in a meeting and just had the chance to say hello. 

By pure coincidence, one of Ken's favorite topics was in the news this week. Ken had written two big pieces on raw milk for this blog, which can be found here and here.  Tyler wrote about another development here

What happened in Oregon is sad:  20 people were apparently sickened in a single outbreak, including four children, and two of the victims may have long-term complications.  E.Coli O157:H7 is not fun for anyone. 

The real issue, as the article points out, is what the right level of regulation would be.  It's not easy to answer.  Drinking raw milk is simply dangerous; it's like playing Russian roulette without knowing how many chambers are in the gun or how many are filled.  Ban it and the users go underground.  Legalize it and yes, some bad batches will not be caught by inspectors (this happens with a lot of other foods, too, in case you hadn't noticed).  You can try to educate people about it, but if there's anything we know now it is that official education on almost any topic will lead to dissent.  There's no perfect solution in a free society. 

Arsenic in Apple Juice: Strong Poison or Much Ado About Nothing?

It's the battle of the network talking heads, M.D. division.  In this corner, Dr. Mehmet Oz, host of the Dr. Oz Show on FOX, and former Oprah Winfrey contributor.  In the other corner, Dr. Richard Besser, former head of the Centers for Disease Control and now chief health and medical director of ABC News.  The issue:  is there too much arsenic in apple juice marketed to consumers, including kids? 

Click on the links above to see the positions of the two sides.  Basically, Dr. Oz did a study of apple juice and found elevated levels of arsenic in excess of the amounts the FDA approves for simple bottled water.  Weighing in on the side of Dr. Besser (or perhaps vice versa), though, is the FDA itself, which rather loudly is proclaiming "tosh."  Or, rather, "Apple Juice is Safe to Drink." 

It's hard to wade through the rhetoric here to figure out who's "right", particularly when even Dr. Oz is not recommending anyone give up apple juice because of the risk of arsenic.  The FDA and the manufacturers all dispute both Dr. Oz's test results--they both tested juice from the same batches and came up with significantly lower levels of total arsenic--and criticize him for testing only for total arsenic, instead of distinguishing between inorganic arsenic, which is really bad, and organic arsenic, which the FDA says is generally safe and is ordinarily the kind of arsenic found in apple juice (but not in bottled water).  Dr. Oz's response doesn't seem to be all that persuasive; if the juice doesn't test for too much inorganic arsenic (or too much total arsenic), does it matter that it comes from countries that use arsenic as pesticides?  And arguments about whether apple juice is better for you than eating raw apples are neither made stronger nor weaker if the level of arsenic is insignificant. 

Although known to the ancients as a poison, arsenic has many benign uses, including being used in the first effective treatment of syphillis.  Along with other poisonous chemicals, it was used for centuries in makeup.  The plot of Dorothy L. Sayers novel Strong Poison centers on a murder by arsenic poisoning, where the murderer (SPOILER ALERT!) developed a resistance to arsenic over time, and thus survived while eating the exact meal as his victim.  The story was suggested by the tale of King Mithridates, as A.E. Housman wrote in "A Shropshire Lad,"

They put arsenic in his meat
And stared aghast to watch him eat;

Today, arsenic is used in semiconductors and light-emitting diodes.

It is not for this blog, of course, to weigh in on the actual merits of the controversy.  But we note that comments in the popular media about the safety of food can have a really strong, negative impact on purveyors of food items, whether they are true or not.  A strong debate about food safety is always welcome, but the use of sensationalist headlines and a failure to meet scientific arguments head on can leave misleading impressions that can have really significant impacts on real people.  Stay tuned.

Japan to World: Remember Me?

Way before Hurricane Irene, the earthquake in Richmond, the liberation of Libya, the death of Osama bin-Laden, the liberation of Egypt . . . way back in the mists of time, or, to be specific, March 11, 2011, there was an earthquake in Japan, and damage to nuclear power facilities that affected the safety of Japan's food supply.  We wrote about it here and here

I have to admit I didn't give a lot of thought to what was going on in Japan, what with all that other stuff going on, but this morning I saw this article in Slate.  What the article points out is that both the actual food safety situation, and the psychological food safety situation, in Japan will be issues for a long time to come:  years, not months. 

By coincidence, I received an email from Second Harvest Japan.  And that led to this link to a means of making a tax-deductible donation to provide food to people in the affected areas.  So I did that.  I'd ask you to consider doing it, too.

FDA's Right To Photograph In Your Plant

The FDA asserts in its inspection manual its right to photograph in your plant. Yet the FDA does not have statutory authority to photograph. The manual cites the following cases as authority for its right to photograph the inside of a plant: Dow Chem. Co. v. United States, 476 U.S. 227 (1986), and United States v. Acri Wholesale Grocery Co., 409 F. Supp. 529 (S.D. Iowa 1976). But these cases rely on the theory of implied consent or a minimal expectation of privacy. These cases do not hold that FDA has the right to photograph the interior of a food facility when the facility has a strict policy against photography and does not consent to the photography.

So, should you resist FDA's request to photograph?

The first thing you need to do is to ask yourself the following two questions:

  1. Do you have a policy against photography in your plant?
  2. If you do, is the policy strictly enforced?

If the answer to either question is no, then you're on shaky footing in resisting the FDA's request. By not having a policy or by not strictly enforcing the policy, FDA's legal authority based on implied consent is that much stronger.

Assuming your plant does have a no-photography policy that is strictly enforced, you need to assess whether the photography is worth the fight. It may be. Resisting the request for photos may be worthwhile to protect potential disclosure of trade secrets and to prevent out-of-context photographs from being used adversely by FDA. The problem is that the harder you push against FDA, the more likely that it will seek more information and the more likely that it will seek enforcement action.

In a future entry, we'll explore what legal remedies might be available to prevent the FDA from photographing the inside of  your plant.

3 New Ways FDA Will Access Your Records and 5 Things You Can Do About It

The Food Safety Modernization Act ("FSMA") significantly expands the FDA's ability to access a food company’s records.

The expanded authority is found in three places in the statute:

  1. FSMA § 101 amends 31 USC § 350c(a) and allows the FDA to obtain records related not only to a product that the FDA believes "will cause serious adverse health consequences or death to humans or animals" but also those related to "any other article of food" that the FDA believes is "likely to be affected in a similar manner."

This statute may allow FDA to "access and copy" all records in any format and at any location of products that are not known to be contaminated but that might share similar ingredients or be produced in a shared facility or that could otherwise be affected in a "similar manner" as products thought to be contaminated.

Section 101 was effective immediately on FSMA becoming law in January 2011.

  1. FSMA § 103 requires that FDA facilities (with certain exceptions) implement "Hazard Analysis and Risk-Based Preventative Controls." As part of this section, Congress requires the affected FDA facilities to keep "records documenting the monitoring of the preventative controls" and to keep a "written plan that documents and describes the procedures used by the facility to comply with the requirements of this section." Congress requires that these records "be made promptly available" to the FDA upon "oral or written request." The statute also requires that records be kept for at least two years.

Note that unlike in section 101, Congress did not use the term "copy" in section 103. This section instead says that records must "be made promptly available."

The question remains open whether the FDA interprets "be made promptly available" to mean copy and whether such a broad interpretation will be held up by the courts. Section 103 is effective in July 2012.

  1. FSMA § 202 requires the FDA by January 2013 to create a "program for the testing of food by accredited laboratories." By July 2013, section 202 will require testing by an "owner or consignee (i) in response to a specific testing requirement under this Act or implementing regulations, when applied to address an identified or suspected food safety problem; and (ii) as required by the Secretary, as the Secretary deems appropriate, to address an identified or suspected food safety problem.“

Test results from the FDA-accredited lab "shall be sent directly to the [FDA]" unless exempted by regulation.

The big questions under section 202 are whether:

a. Routine product and environmental testing accomplished for the purpose of a food safety plan under section 103 will be considered "in response to a specific testing requirement . . . when applied to address an identified or suspected food safety problem" and

b. The FDA will exempt certain testing records under this provision.

So, what should you do to prepare for the FDA's considerable expansion of its ability to access your records?

Here are five things that a food company should consider:

  1. Understand what records the FDA does not have the right to access (recipes, financial, pricing, research, personnel or certain sales data), and maintain these separate from records the FDA can access.
  2. Create and enforce a document destruction policy that conforms with FSMA.
  3. Create a standard FOIA letter to present to the FDA when it requests letters explaining that it considers information provided to be trade secrets, confidential and proprietary.
  4. Create and train employees on a confidential FDA inspection policy that involves legal counsel and therefore can be cloaked in the attorney-client privilege.
  5. Understand what finished product and environmental testing is needed and not needed for a section 103 food safety plan.

Food Companies Should Revisit Insurance Program and Other Risk Management in Light of Emerging Massive European Union E. coli Outbreak

The E. coli outbreak unraveling now in the European Union, centered primarily in Germany, is setting new records for both the number of affected persons and the number of persons diagnosed with Hemolytic Uremic Syndrome (HUS), a serious complication from E. coli infection (HUS can lead to kidney failure, brain damage and death). As of the writing of this blog, the latest news can be read here and here. To date, 17 people are believed to have died, 470 people have been diagnosed with HUS, and 1,534 people have been infected with E. coli.

The strain of E. coli is reported to be E. coli O104:H4, a previously rare strain of shiga toxin producing E. coli. The source is still a mystery, but many believe it to be associated with fresh produce.

How is this relevant for U.S. food businesses? At the very least, the European Union outbreak changes the equation for liability exposure. Previously, most food safety experts would opine that about 10% of those infected with a shiga toxin producing E. coli would be expected to develop HUS. In the European Union outbreak, the percentage of HUS cases now exceeds 30%. In even a small outbreak, a 30% HUS rate could increase exposure threefold.

Now is the time to:

  1. Convene your coverage team (brokers, risk management and legal) to reevaluate and audit coverage,
  2. Reevaluate your suppliers and food processing procedures,
  3. Revise and clarify your supply chain/co-packing agreements, and
  4. Rehearse your recall, RFR and crisis management plans.

UK Foot-and-mouth Disease Study: Impacts for the Future, Not the Past

A May 6 study in Science with the banal title of “Relationship Between Clinical Signs and Transmission of an Infectious Disease and the Implications for Control,” written by a number of scientists at the Institute for Animal Health in Surrey and the Centre for Immunity, Infection and Evolution at the University of Edinburgh, has garnered a lot of publicity. The study involved foot-and-mouth disease, a worldwide scourge for cattle which had had its most virulent outbreak in a developed country in the United Kingdom in 2001

What is revolutionary about the study may be surprising to non-scientists. What the scientists did with cattle was to study the interaction between infected animals and healthy ones in order to learn exactly when the infected animals were actually transmitting the disease. You may well think, "don't we know this already?  Was I coughing into my elbow for no reason at all?"  The answer is, we didn't know it at this level of detail, and when fashioning quarantines of people or animals, or mandatory culls of animals, knowing it at this level of detail can save lives and money.  As Mark Woolhouse, one of the scientists who co-authored the study, said as quoted in Science Daily,

 

If you do things like measure virus in the blood, you're taking no account of the clinical state of the animal. People might imagine that the clinical signs of a virus -- the symptoms, such as sneezing -- have something to do with its transmission. But, while there has been a lot of thoughtful speculation on the topic, there haven't been many actual studies.

 

As a result of the study, for these animals and with this one disease, they estimated that the actual period of transmission was much shorter than had been previously thought, and not necessarily related to the animal showing the outward signs of the disease. 

 

In reading this, I was reminded of a statement in Simon Winchester’s Atlantic, where he points out how much more we know about the surface of the moon than the undersea part of the surface of the earth. The same can be said for the way microorganisms operate in the environment as close as your nose or a cut on your skin. Although it is obviously a different thing to study foot-and-mouth disease for cows, who are unwitting subjects, than, say, influenza on humans, these techniques may be applicable in some ways to study a whole range of diseases, which can refine the public health reaction to a host of outbreaks. The study suggests that if diagnostic tools can be found to pinpoint the moment of contagion, quarantine can be more effective and possibly both shorter and involving fewer subjects, and more destructive means of prevention like culling may be avoided.  To quote further from Woolhouse's interview with Science Daily:

 

We now know that there is a window where, if affected cattle are detected and removed from the herd promptly, there may be no need for pre-emptive culling in the immediate area of an infected farm.  We have an opportunity now to develop new test systems which can detect infected animals earlier and reduce the spread of the disease.

This is a two-edged sword, and potentially both edges can be used for good.  If we can develop tools to find contagious subjects more exactly, we can take effective steps to quarantine them for just the right period of time.  And we would be able to rule out non-contagious subjects that are currently impacted out of an abundance of caution.

 

Which brings us back to the past.  Now that we know what we know, what of the thousands of British cows slaughtered in 2001, including those at farms where the cows showed no symptoms but were located next to the outbreaks? The study certainly suggests that this was unnecessary. But before any British cattle farmers consider calling in a solicitor, however, they need to understand a couple of things. First, public health officials have historically always been given a lot of leeway in terms of making decisions to promote the general welfare.  When the cows are showing signs of disease, no one has the time to do a ten-month study; you do what you can  right then.  Second, and most germane, liability, if any, would be based on the state of knowledge at the time of the incident. It could hardly be treated any other way. This both acknowledges the state of (or lack of) knowledge and encourages the advance of scientific learning. If you try one solution and it seems like it could be improved, you’re less likely to improve it if you might end up being liable for how your first attempt worked out. 

Take the "Cold" out of Cold Cuts and Put Back the "Hot" in Hot Dogs

We've blogged a lot about listeria and avoiding it is a good idea, in the neighborhood of "breathing is a good idea."  The CDC, in an article reported by Elizabeth Weise in USA Today Wednesday, is recommending a couple of things in connection with cold cuts, including hot dogs, for those over 50, and in particular those over 65, to avoid listeria:

  • Reheat them to 165 degrees Fahrenheit just before eating
  • Don't keep them in the refrigerator longer than five days after opening

Which kind of takes the "cold" out of cold cuts, doesn' t it? 

Ms. Weise's article then goes on to explain what a change this would be in the behavior of people who are often dependent on lunch meats as a relatively inexpensive source of protein, and to question where the source of this advice is coming from.  The CDC, for its part, notes that listeria doesn't go away when refrigerated and doesn't give either visual or olfactory clues to its presence.  The industry response is that consumers should look for products containing antimicrobials like sodium lactate or potassium lactate. 

As the article implies, this advice is counterintuitive for many people.  Moreover, as one person quoted in the article points out, the placing of the label of "risky" on such an ordinary item takes away some of life's enjoyment as well.  That is not to deny that the risk is real, but it is akin to a "Black Swan" event whose probability may be low but where the consequences of the event occurring are high and can change the way we think.  Pregnant women and people with weakened immune systems are at high risk, but constitute a more discrete part of the population that is generally more likely to consider itself in need of health information.  I'm 54 and don't think of myself as at extra risk of this kind of food-borne illness. 

On the other hand, I haven't eaten any cold cuts or hot dogs since I started getting a reaction to them while still in my 30s. 

FDA's Reportable Food Registry Makes a Profound Impact

Here is a link to my article, "FDA's Reportable Food Registry Profoundly Impacts Litigation and the Food Industry," posted this week by the American Bar Association's Litigation Section (Products Liability). The article is a follow-on to lively discussions over the litigation impacts of the federal Reportable Food Registry ("RFR") at the ABA’s recent Food & Supplements CLE at Coca-Cola World Headquarters in Atlanta. The RFR was created by Congress as part of the Food and Drug Administration ("FDA") Amendments Act of 2007 and requires that a company submit a report to the FDA within 24 hours of discovering reportable adulterated food.

Two hot-button issues discussed at the ABA CLE (and in the ABA article) were whether the FDA (1) intends to use the RFR as an enforcement as well as an informational tool, and (2) will move toward the concept of "control" and away from "possession" in interpreting one of the key exceptions to the reporting requirement.

An Update on Japan from the Perishable Pundit

This really relates to the food situation generally as a result of the earthquake and tsunami, but it was so comprehensive and well-written about the food supply situation it seemed worth linking to.  And making a donation to Second Harvest Japan

The Japanese Nuclear Incident and Food Safety

We've been somewhat reluctant to post anything about this, mainly because the facts seem to change daily.  But today I found a very good website from WHO, the World Health Organization, Western Pacific Region, that is updated frequently and has a lot of good information that appears to be presented reasonably.  I was particularly impressed by this FAQ, which compares various levels of radioactivity to exposure humans might have in everyday life.

Although I suspect everyone has been exposed to opportunities to donate to relief in Japan, I thought I'd pass along my own favorite group, World Vision.  They're already on the ground in Miyagi prefecture. 

How Regulatory Changes Affect Litigation Risks

On February 24, 2011, Lee Smith and I presented "How Regulatory Changes Affect Litigation Risks" to the Grocery Manufacturers Association's food litigation conference. A link to the slide-deck can be found here.

We discussed ways that the Reportable Food Registry (RFR) and the Food Safety Modernization Act (FSMA) are affecting litigation now and can be expected to affect litigation in the near term.

In particular, we discussed:

  • Ongoing and pending changes to the RFR
  • FSMA’s grant of records access to FDA
  • Mandatory recall authority and how this may delay certain recalls
  • Suspension of FDA registration
  • Hazard analysis and preventative controls: What are they? How do they differ from HAACP? How they will be effective with or without FDA rulemaking
  • Regulation of chemicals under FSMA (and under proposed changes to TSCA and Proposition 65 in California)
  • Specific things that food sellers should consider now to reduce risk

Let me know if your business is interested in an in-house, customized presentation or training on the RFR and FSMA.

Beyond Statistics: What the FDA's RFR Report Means for Food Manufacturers

Last week, the FDA issued its first annual report on the Reportable Food Registry (RFR). The report provides statistics on the first year of the RFR (2240 entries, 229 "primary reports," a breakdown of the report by hazards, etc.).

Beyond the statistics, the FDA report should be noted by food companies for two reasons:

  1. Food Safety Plans

FDA Deputy Commissioner for Foods Michael Taylor says that “[s]everal key U.S. industries are already re-evaluating their hazard and preventive controls, core principles of the Food Safety Modernization Act recently passed by Congress. We also anticipate improved reporting as we continue our vigorous outreach to food facilities through federal, state, local and foreign agencies, to help us expand the positive effect of the RFR on the safety of the U.S. food supply.”

The new hazard analysis and preventative controls requirements in the Food Safety Modernization Act (FSMA) are not effective for 18 months following passage. Deputy Commissioner Taylor's comments suggest that industry standards may already be moving in that direction . To mitigate exposure and risk, FDA enforcement actions, product liability claims, supply chain contract claims and recalls, food manufacturers may want to consider updating and/or creating food safety plans that address the hazard analysis and preventative controls prescribed by the FSMA.

  1. Allergen Controls

The FDA reports undeclared allergens/intolerances accounted for 34.9 percent of the primary reports. Industry experts assert that the FDA believes that the industry does not in general have good control over the issue of undeclared allergens. These experts believe that the FDA will give special attention to the issue of undeclared allergens/intolerances in promulgating regulations under the FSMA's requirements for hazard analysis and preventative controls (see point 1 above). In anticipation of the FDA's concern, manufacturers should consider now how they can change manufacturing processes to address the undeclared allergen issue.

It's Official: The Food Safety Modernization Act Is Law. What Food Companies Need to Do Right Now

President Obama signed into law today the Food Safety Modernization Act (FSMA).

Companies with facilities subject to FDA jurisdiction should  take immediate steps to review and, where necessary, modify SOPs, policies and procedures.

For example, given the FDA's expanded access to business records, companies should set SOPs that anticipate (before a crisis occurs) what records they may have to turn over and what they may not. Food companies should take steps to protect confidential and proprietary information.

Companies also should anticipate now how they need to change their policies and approaches to mandatory recalls and whistleblower protections.

These parts of the legislation take effect today:

  • Stronger records access authority by FDA (FSMA § 101)
    • When FDA determines a "reasonable probability" of "serious adverse health consequences"
    • FDA can access records of other food affected in a similar manner
    • But FDA must show proper credentials and provide written notice
  • Mandatory recall authority (FSMA § 206)
    • FDA can order a recall if it finds a "reasonable probability" that
      1. food is adulterated or misbranded; and
      2. there may be serious adverse health consequences
    • FDA has to provide an opportunity for a voluntary recall
    • FDA will provide an informal hearing within two days of the order’s issuance
       
  • Increased frequency of inspections (FSMA § 201)
    • FDA will immediately increase the frequency of inspections
    • FDA will apply a risk-based approach to determine priorities
       
  • Whistleblower protection (FSMA § 402)
    • Protects employees who:
      • Provide information re violation of FDC Act ,
      • Testify, assist or participate in a proceeding re a violation, and/or
      • Object to "activity, policy, practice or assigned task" they "reasonably believe to be a violation"
         
  • Refused admission of imports if foreign facility refuses inspection (FSMA § 306)
    • Foreign establishments must allow entry to U.S. inspectors within 24 hours of requesting entry
    • Or imported food will be refused admission.

Future blog entries will discuss compliance with other provisions of the FSMA scheduled to be phased-in. If you are interested in a more detailed in-house discussion of the FSMA and its effect on your company, please let us know.

The Sally Jackson Cheese Recall: the Last Purely Voluntary Recall?

There are few places in the United States that have less in common than Oroville, Washington and Washington, D.C. Tucked against the Canadian border in the peaceful and beautiful Okanagan Valley, Oroville is easier to reach from Kelowna, B.C. than from Seattle. Yet events in Oroville last Friday combined with the unusual events in the other Washington beginning last Sunday to give an Oroville business an historical significance it undoubtedly would have preferred not to have.

Last Friday, the FDA Food Safety Modernization Act, then known as S. 510, was as dead as Don Van Vliet, a/k/a Captain Beefheart, the legendary musician who passed away that day. Thus, the FDA had no more than the same power it has always had: publicity and the right to shut down a facility, but no power to force a recall. That day, Sally Jackson Cheeses of Oroville, provided evidence that linked its artisanal cheeses to outbreaks of E. Coli O157:H7, agreed to a recall of all of its products

As we know, on Sunday, the food safety bill was resurrected in an unusual weekend session of the Senate and was passed today by the House and heads to President Obama’s desk for a certain signature. The new act contains a section, effective immediately upon the President’s signature, which gives the FDA mandatory recall authority for the first time in its history. While that section includes a provision (which will become Section 423(a) of the Federal Food, Drug & Cosmetic Act) calling on the FDA to give companies a chance to effect a voluntary recall before using its mandatory powers, the difference between wielding a velvet glove and a velvet fist is significant. 

Thus, a tiny cheese manufacturer in an isolated Washington town, through an unexpected chain of events occurring nearly 2700 miles away, may have become the last food manufacturer ever to agree to a voluntary recall without the FDA’s power to order it to do so looming in the background.

Food Safety Tools and Defenses for Cheesemakers

Cheesemakers have endured a string of bad publicity recently over food safety. Cheesemakers, especially raw milk cheesemakers, are in the cross hairs of the FDA, the media, retailers and plaintiffs’ lawyers such as Bill Marler. I was interviewed last week on FDA seizure issues by the Pacific Northwest Cheese Project. Click here for the PowerPoint slides from my presentation to the American Cheese Society's annual meeting last August entitled "Product Liability - Protect Yourself and Protect Your Business."

Multiple Occurrences in a Single E.Coli Outbreak: Double-Edged Sword for Insureds?

Marler Clark clients and the owners of the restaurant that sold MarlerClark's clients food they claim was contaminated with E.coli O111 joined forces against the restaurant's insurer. In the end, the peronsal injury plaintiffs and the restaurant insured convinced the United States District Court for the Northern District of Oklahoma  on a Rule 56 summary judgment motion that a single E.coli outbreak constituted at least two separate "occurrences" under a commercial general liability insurance policy ("CGL") issued to the restaurant. The result was another $1 million in coverage available to pay claims. A copy of the court's opinion can be linked here.

The primary policy at issue limited the amount of insurance available to $1 million per occurrence ($2 million products-completed operations aggregrate). According to the court, the policy defined an "occurrence" as “an accident, including continuous or repeated exposure to substantially the same general harmful conditions.” According to court's summary of the state health department's findings, the outbreak at issue included 341 persons, 60 confirmed, and 94 probable. The "point source outbreak" was from the Country Cottage restaurant. Though 21 persons did not dine at the restaurant, they were believed to be exposed at a church tea catered by the restaurant.

The court concluded that under Oklahoma law there are "two distinct places of injury and thus, two separate occurrences." The court explained that:

Looking for “the same temporal and spatial parameters” of an occurrence, the Court finds that the undisputed facts at least establish two separate occurrences of E. coli-induced illness covered under the policies: that resulting from the negligent contamination of food prepared and served at the Country Cottage restaurant and that resulting from the negligent contamination of food prepared and served at the Church Tea. Regardless of any temporal overlap between these two occurrences, the geographical distinction between the physical location of Country Cottage restaurant in Locust Grove, Oklahoma, and that of the Free Will Baptist Church in Broken Arrow, Oklahoma where the Church Tea took place is appreciable and, appreciatively, concrete.

For MarlerClark clients and the injured plaintiffs, the end result is another $1 million available to settle their claims. But is this a good result for the restaurant owners? The answer is maybe. Insureds should understand that the result may be a double-edged sword. On the one hand, another $1 million in indemnity is available to protect the owners' personal assets. On the other hand, if the insured had a large deductible or self-insured retention ("SIR"), two occurrences could mean two deductibles or two SIRs that need to be paid by the insured.

So why would an insured ever have a high deductible or SIR? The answer is that many food manufacturers and retailers maintain a high deductible or SIR in order to control the defense and settlement of the case and not hand over control to the insurer at the outset. Often, the insured's objective is to resolve the case in a way that best protects the client’s business and brand going forward. A conflict with the insurer arises because the insurer's objective is to resolve the case for the fewest dollars possible (combined payment of defense costs plus indemnity paid to the allegedly injured consumer).

Listeria Recall Toolkit

The FDA recently took the relatively unusual step of obtaining a court-issued warrant to seize all cheese products at Estrella Family Creamery, a small, family-owned artisan cheese maker in Washington State. According to the United States Attorney's Office for the Western District of Washington, "the FDA asked Estrella to recall all cheese products. The company refused." The FDA requested the recall after both products and the manufacturing environment at Estrella tested positive for Listeria. A copy of the FDA form 483 report immediately pre-dating the recall request is here.

As the Estrella situation illustrates, the FDA is not just focused on large-scale manufacturing. As the FDA and USDA move to more risk-based allocation of resources, they are increasingly concerned about smaller operations and retail. Below are issues any food manufacturer must tackle when it comes to Listeria (much of this also applies to other food-borne pathogens).

What is Listeria?

Listeria monocytogenes is a bacterium that causes listeriosis, which primarily affects persons of advanced age, pregnant women, newborns, and adults with weakened immune systems. Though it affects only a small portion of the population, Listeria is the most deadly food-borne pathogen in the United States, killing 20-30% of all those who become seriously ill.

What should you do if your product tests positive for Listeria?

Assemble your well-rehearsed crisis management team immediately if a product tests positive (or if a regulator believes that your product may be contaminated). Members of the crisis management team; food safety personnel; company executives; and representatives from accounting, legal, supply chain, sales and customer service all are essential in the decision making process below.

Can you trace back and isolate contamination?

Quality assurance and food safety personnel need to answer trace-back issues as soon as possible. Can you determine the source of the contamination? Is it limited to one lot or a single day of production? How often are production facilities sanitized? How often are production surfaces swabbed for Listeria? Does the production facility re-use contaminated product from shift to shift?

Will you have to issue a recall?

Both the FDA and USDA lack mandatory recall authority. Though, as Estrella learned, the agencies do have the bully pulpit and the ability to get a court order to seize products. Because of the high mortality rate, regulators (federal and state) take any positive Listeria test result in food products extremely seriously.

If the food is considered a ready-to-eat product (RTE), a positive Listeria test will almost invariably lead to the FDA or USDA requesting a class I recall.

Even for a non-RTE food, a positive Listeria test will lead to a requested recall. If the agencies believe that the cooking instructions are clear, are easily followed by consumers and, if followed, will kill the bacterium, then the recall may be considered class II.

A primary difference between class I and II is that the class I recall will result in much greater publicity. For FDA-regulated facilities, a class I recall also triggers reporting and notification requirements under the Reportable Food Registry (RFR).

What does the Reportable Food Registry require?

RFR requires FDA-registered facilities to report to the FDA portal within 24 hours when there is a "reasonable probability that an article of food will cause serious adverse health consequences." As part of the report, information must be submitted "one step back and one step forward" in the supply chain. Once a report is submitted, the FDA will promptly alert your customers of the "reasonable probability" that your product will result in "adverse health consequences or death." If suppliers and customers are also FDA facilities, the FDA will also pressure those companies to report to the portal.

The ticking of the RFR's 24-hour reporting deadline forces a company to make snap decisions that might affect its entire business. While RFR reports can be amended or withdrawn based on new information, in the world of food products, the bell can almost never be unrung. A more lengthy discussion of the RFR can be found here.

How do you marshal your case with the regulators?

Assuming that you have information showing that contamination is limited (or non-existent), how do you convince the regulators? The FDA and USDA’s concern is public health (and politics). The regulators’ concern is not for your business.

Providing information to the regulators in a manner they perceive as credible, prompt and transparent is critical. Once the regulators lose confidence in your company's credibility and competence, the game may be over. In most cases, the most effective way to marshal your evidence is a well-prepared and credentialed crisis management team (e.g., food safety, quality assurance, supply chain, accounting, sales, legal, media, etc.).

The Great Egg Recall of 2010: Another Review of Lessons Already Taught

You have probably heard about the great egg recall of 2010, which has required Wright County Eggs of Galt, Iowa to recall an ever-growing number of shell eggs because of fears of salmonella enteriditis

An interesting issue here is the non-overlapping jurisdiction of USDA and FDA over eggs in the shell.  According to the FDA:

Generally, USDA is responsible for egg safety at what are called breaker plants or egg products processing facilities. In these facilities eggs are broken and pasteurized. FDA is responsible for shell egg safety and egg products once they leave the breaking facility.

Interestingly, while this outbreak is easily found on the FDA's website and at FoodSafety.gov, there is nary a word on the USDA home page.

The FoodSafety.gov page about safely handling and dealing with eggs is a good place to start for consumers worried about their own eggs. 

We also repeat the advice we have collected from previous outbreaks:

 

Jim Prevor's Traceability Answers

We recently asked for comments on Jim Prevor's story about traceability.  While there was a loud silence in our comments in box (still happy to take them), today we got a long response from Jim himself in his latest Perishable Pundit.  I commend it to you.  And feel free to comment to Jim directly or, of course, right here.

A Traceability Story: Request for Comments

Jim Prevor has an intriguing story in one of his latest Perishable Pundits, updated here and here, that frankly has me wondering.  According to Jim, Freshway Foods discovered E.Coil 0145 in some romaine and, using tracking numbers, was able to trace it to a specific lot supplied by a grower in Yuma, Arizona.  It then issued a recall limited to that specific lot. 

But the FDA decided to be more cautious and to advise Freshways to recall all the romaine from Yuma, not just the identified lot.  And the buyers of the product decided to pull anything they had on their shelves from Freshways, whether it was from Arizona,  and whether, apparently, it was romaine or not. 

This raises a number of questions and I am not going to purport to answer them.  Rather, I'd really like to solicit comments from our very knowledgeable and resourceful readership.  This is the age of Web 2.0 and beyond.  We'd love to hear from you.

  • Is the implication of Jim's article right, that spending money on good tracing systems may be futile because consumers and regulators will never trust the system?
  • What kind of public education might work to improve the acceptance of traceability? 
  • As a legal matter, it's unlikely that the buyer of the non-recalled products has any recourse against the seller; in the real world, however, is the seller likely to make good in order to assure future sales? 
  • Ken recently wrote about a similar insurance issue; is there any kind of insurance for something taken off the shelves because of an abundance of caution when the supplier says only to recall specific items?
  • In his updates, Jim suggests that the real issue is that perhaps we are providing more traceability than the market demands and others suggest that the issue is that upon discovery of an outbreak, the FDA doesn't either adequately communicate the perceived cause of the outbreak or ever issue an "all clear" after it is over.  Is either step either (a) practical when things are moving in real time, or (b) really the FDA's responsiblity or even power under current laws and regulations? 

In case you should come across some romaine tainted with E Coli 0145, the answer is to heat it, not wash it.  Salon.com has a recipe.

The Great HVP Recall of 2010: A Review of Lessons Already Taught

As Ken noted last week, there has been a widespread recall of products containing hydrolized vegetable protein (HVP), a flavor enhancer, after salmonella Tennessee was discovered in product manufactured by Basic Food Flavors of North Las Vegas, Nevada.  Consumers, who may have been unaware of the existence of HVP, are starting to learn how pervasive an ingredient it is in packaged and processed foods.  The FDA has a handy list of products so far affected by the recall.  There's a widget, too.   

So far, no one has been reported to have been made sick or died as a result of this outbreak. 

The FDA warns consumers "Remember to follow cooking instructions on all foods", except that many of the foods that contain HVP are not ones consumers cook.  Included are salad dressings, ready to eat meal products, sauce and marinade mixes and snacks.  I don't think there's a way for a consumer to cook a pretzel. 

This outbreak is a good excuse to reiterate some of our advice from prior outbreaks, like the 2008 tomato outbreak and the 2009 peanut and pistachio outbreaks. 

As Professor Moody would say, "Constant vigilance."

 

Where to Eat in Dodgy Places: Advice from a Real World Traveller

Joel Putnam is a world traveller in his early 20's.  He recently reached Africa, his seventh continent in his travels around the world.  As is typical of  his generation (he is, in the interests of full disclosure, a friend of my son), he is blogging about it.  His blog is very well-written, and the captions on his photographs are always witty and often downright hilarious. 

Joel has apparently been reflecting more broadly on his experiences, and he penned an entry entitled "Travel Tip:  Street Food Primer" that includes some excellent advice on how to select a place to eat anywhere in the world. 

Here are some excerpts:

  • Lesson number one: In the developing world, street food is often safer than restaurant food. Yes, you read that correctly. Street food. The food that has made me the most sick while traveling has almost all come from restaurants. The reason why, is that with street food, you see it get cooked right in front of you, and you see who is cooking it. In restaurants, you see neither.

This is an important insight, although as readers of this blog know, you can get sick at the most sanitary of street stalls, or in the best restaurant on earth

  • Lesson number two: usually, if the tap water isn't safe, neither is the ice. This is seems obvious when written, but it's one a lot of of people forget in practice. There are a few countries, mostly in Asia, where ice is actually factory made from safe water. But please take the extra step and check that that's the kind of ice floating in your drink.
     
  • Lesson number three: what's safe for the locals isn't necessarily safe for you, yet. . . . We all have  little local beneficial bacteria running around our digestive tracts that helps us handle the local food. This differs from place to place. So take it easy for the first few days in a new place to develop your own. Legend has it local yogurt helps with this (though beware, yogurt that hasn't been refrigerated properly or that has expired is a fast way to making you sick). After you've been eating tame food (like vegetarian dishes) in a place for a bit, then try moving on to the more interesting stuff.
     
  • Lesson number four (this one is important): if the place is crowded, the food is probably good, and it's almost definitely being cooked fresh. This is an excellent way to pick street food vendors and restaurants. We'll call it the sheep method. The reason is that deserted restaurants and vendors are much more likely to leave things like meat lying around in temperatures that let nasty things start growing in it. Then when you order it, it'll get quickly reheated and served. Popular vendors, on the other hand, are having to constantly cook fresh batches to meet demand. And if it's in that much demand from the locals, it's probably because the food is especially good.

From the introduction to his blog entry, I might add a lesson number five:  avoid hubris.  He recounts the tale where he bragged to some fellow travellers that he had eaten so many different things in China that he should have no trouble in Mongolia.  The natural result of that was that he had 12 hours of indigestion from his first Mongolian street food.  But fortune follows the brave, since one of those fellow travellers from Wales was a doctor.

Joel's common sense advice can be used anywhere.  We all have internal sensors that tell us when it's good to eat or drink something--our eyes, our noses, our taste buds, our ears.  This is good supplementary information for how to deploy them in unfamiliar places.

I commend Joel's blog to you and not just for the travel insights.  If you care to do so, vote for his blog as Travel Blog of the Year in the Blogger's Choice Awards.  I also thank him for the delicious photograph accompanying this entry.  I think we may safely assume he didn't get sick from that meal.

FDA's Searchable Widget for Fraudulent H1N1 (Swine) Flu Products

Ken has previously blogged about liability issues relating to H1N1 flu, also known as swine flu.  Today, the FDA has issued a widget to allow employers, consumers and others to browse and search fraudulent H1N1 influenza products and report suspected fraud. The widget can be copied onto any other Web site or blog.  The FDA had previously issued a similar widget for the peanut butter recall.  Additional information can be obtained from the FDA's swine flu page or flu.gov

This is the widget:

 

Jim Prevor Deconstructs CSPI's List of "Ten Riskiest Foods"

The Center for Science in the Public Interest has released its list of "Ten Riskiest Foods Regulated by the FDA."  The list has gotten a lot of publicity, particularly because some unexpected foods like potatoes made the list. 

Our friend Jim Prevor, the Perishable Pundit, has written a Special Edition of his newsletter that pretty much says everything about the list that we would say, so I'm just linking to his article.  The only thing I'd add is that Stoel Rives were co-sponsors of the conference he mentions in the article, along with Bill Marler.  Otherwise, thanks for doing the good work, Jim. 

UPDATE:  Being the total gentleman that he is, within hours of Friday's post Jim emailed me that he would add a credit to Stoel Rives on his entry.  And of course he did. 

Tool For Food Companies and Litigators - New Guidelines for Foodborne Disease Outbreak Response

Council to Improve Foodborne Outbreak Response (“CIFOR”) has published new guidelines designed to help local, state and federal agencies to improve their response to outbreaks. I became aware of this (again) through Ricardo Carvajal, who was a reviewer for the guidelines, and his firm’s FDA Law Blog. I agree with Ricardo that while the guidelines are designed for public agencies they have value for food businesses.

According to CIFOR, “[t]he guidelines are intended to give all agencies a common foundation from which to work and to provide examples of the key activities that should occur during the response to outbreaks of foodborne disease.”

Anticipating how the public health agency will behave will not only assist in crisis management, but it may also prevent the crisis. As discussed previously in this blog, one of the benefits of good crisis management is the ability to reach out and offer assistance to the investigating public health agencies. Keeping current on protocols that we can expect agencies to follow is a good practice.

The guidelines are also of some value to litigators. In the face of an outbreak investigation, they provide tools to assess the merits of the agency investigation. While it is always difficult to challenge a public health agency’s findings (no matter how flawed), the guidelines may help.

Video From Governor's Conference on Ensuring Food Safety

University of Nebraska has posted video on its website from the entire three days of the 2009 Governor’s Conference on Ensuring Food Safety. You can view my presentation on Defending Liability in Foodborne Illness Outbreaks. More important, you view the presentations of Dr. Andrew Benson and the other scientists who offer fascinating insights into the latest developments driving the science of food safety.

Tort Damages Not the Only Exposure from Food-Borne Illness Outbreaks

For lawyers and insurance adjustors, compartmentalizing food-borne illness claims is easy. They often see their jobs solely as minimizing the tort liability and legal fees. In my experience, attorneys and adjustors often fail to appreciate how outbreaks can affect a client’s (or even a whole industry’s) business going forward. Often, the long-term business losses of a food-borne illness outbreak, recall, or government alert are not insured.

There is no better example of how a nationally reported food-borne illness outbreak can affect an entire industry (or even an entire category of food products) than the 2006 E. coli spinach outbreak. Two new studies published by the Agriculture & Applied Economics Association (AAEA) in its Choices magazine analyze consumer information and studies in the wake of the spinach outbreak. 

Among the highlights from the first study, “Public Response to Large-Scale Produce Contamination” by Carra Cuite and William K. Hallman, were findings that Americans were more aware of advisories beginning than ending. For example, 87% of spinach consumers knew about the outbreak, but more than six weeks after the FDA had lifted its spinach warnings “almost half (45%) of people who were aware of the spinach recall were not confident that the recall had ended.”

A second study entitled “E. coli Outbreaks Affect Demand for Salad Vegetables” was authored by Faysal Fahs, Ron C. Mittelhammer, and Jill J. McCluskey. It examines the cumulative effects that sequential outbreaks can have on consumer demand and concludes that “the empirical results suggest that the subsequent outbreaks had a greater impact on the consumption of salad vegetables than the first.”

For food companies the lesson is this:

A lawyer’s role in responding to a food product crisis is important. But the roles of others, such as public relations experts, may be as important or more important in preserving the business. Make sure your lawyer (and your insurer) understands that the world may not revolve around simply resolving the tort claims as economically as possible.

The Fuller Monty and Lady Godiva: More on the Plainview Problem

As I predicted last week, more and more companies are discovering that they had incorporated products from Plainview Milk Products Cooperative into what they sold.  The full FDA database, which is constantly being updated, is here.

While there have now been recalls of products as widely different as frosting and diet mixes, I was most struck by Godiva's recall.  As others have noted, as of the time of this post this doesn't appear anywhere in the Godiva website, either. 

Godiva's recall related to a special collection that was available only for Valentine's Day and Mother's Day. The "consume by" date for the Valentine's Day candy has passed and the "consume by" date for the Mother's Day collection has nearly passed.  Exactly one candy in the box, a praline crunch, included product from Plainview.  No one has complained of any symptoms from eating this candy.  So, if you, your mom, your grandma, your spouse or your sweetheart (a) got this box for Valentine's Day or Mother's Day, (b) haven't finished it yet, even though it has a short "consume by" window that has more likely passed; and (c) didn't eat that praline crunch, then you are supposed to discard the product and call 1-800-9GODIVA for a refund. 

The Godiva recall is being taken as a superabundance of caution, given the unlikelihood anyone meets all those criteria.  However, it does indicate that not all Plainview products were shelf-stable.  This may go on for awhile.

Monty Python and the Food Recalls

One of Monty Python's most imitated sketches was "The Four Yorkshiremen."  Even if you've never seen it, it will be instantly recognizable to you.  It's the one where four men sit around talking about how tough they had it as kids, compared to how kids have it today.  One starts by complaining about how small his house was, and another exclaims, "You had a house?"  Eventually, the last one claims to have been roused from bed half an hour before he went  to bed, worked 27 hours a day and paid for the privilege and then was murdered every night when he got home. 

I was thinking about this sketch as I was contemplating how different from the last food recall about which I blogged, involving tuna in New England, was from the painfully slow recalls involving the salmonella finding that has led Plainview Milk Products Cooperative to recall the last two years of its products.  As you might recall, the last recall involved fresh tuna steaks sold to three New England supermarket chains over four days before the problems were identified.  By this time, most of the food subject to the recall had probably been consumed and the recall required only publicity in a limited area for those who might have frozen the steaks rather than eaten them fresh.  Without denying the difficulties that North Coast Sea-Foods might have encountered in that recall, or the suffering of anyone who got scombroid poisoning, as a recall goes, they, in the words of Monty Python, had it easy.

The Plainview Milk Products Cooperative and everyone who bought from them, on the other hand, have it anything but easy, and the fact that almost every day new products are added to the recalled list demonstrates this. 

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Another Recall From a Company That Does the Right Thing

The FDA announced a recall of fresh tuna steaks distributed to Shaw's, Star Market and Big Y grocery stores by North Coast Sea-Foods Corp. of Boston and New Bedford.  The alleged problem was increased levels of histamine that might cause scombroid poisoning.  The tuna was removed from sale on June 24, but consumers who might have frozen the steaks were told to return them to the stores for a full refund.  We again assume that North Coast (and its insurers) will be funding the refunds.

What made me write about this recall was a rather silly poll in DailyKos.  The question was whether the increase in recalls was due to the food supply becoming less safe or that the FDA was getting better.  Like many online polls, this so oversimplified the situation that I thought I should write about it, and the North Coast tuna recall seemed as good a vehicle as any.

The three reported cases of scombroid poisoning associated with this tuna would presumably have been reported to local public health officials in New England, not the FDA.  Or they might have been reported to the markets, which in turn would have easily been able to identify the source of the tuna and reported to North Coast (scombroid poisoning occurs almost immediately, so there isn't the usual problem of figuring out what food might have caused a delayed reaction).  Both the markets and North Coast will have significant food safety programs.  Some of this will be the result of government action, and some of it the result of simply caring about their customers.  There is no indication that this outbreak was the result of anyone's inattention or failure. 

It took me awhile to identify that I had the right North Coast Sea-Foods Corp., because their name is spelled differently in the release.  In doing my research, I discovered some nice things about them, such as that they had argued strenuously against a Department of Defense initiative to buy cheaper, and potentially more hazardous fish for our troops, on the grounds of food safety.  Another thing I learned was that they had installed solar power at their Boston facility, and considered wind power at their New Bedford facility.  We at Stoel are not just committed to renewable energy, we literally wrote the book on it.  So, similar to the Fat Duck and Nestle, even those committed to doing the right thing can sometimes be the subject of a food recall. 

Why Are Food-borne Organisms Associated with Beef?

 USDA’s Be Food Safe Twitter Feed circulated its Fact Sheet titled “Beef . . . from Farm to Table.” First published a few years ago, this might be of interest to businesses involved in the sale, marketing, labeling, and/or packaging of beef. The article is a helpful primer on the history of beef, current industry practices, USDA’s role in inspection, consumer trends, cooking times, storage times, and food-borne illnesses associated with beef.

Tracking the Food Safety Working Group - More or Less Legal Exposure For Food Sellers?

This week the Obama administration announced the launch of a new website for the recently formed food safety working group. Obama announced the formation of this group in March in the wake of the high-profile food safety issues surrounding PCA peanut products

This website will assist in tracking the efforts of the working group. As discussed previously on this blog, this group is expected to make recommendations aimed at detection, awareness and government reorganization. Possible examples include increasing funding to states to monitor food-borne illness, combining FDA and USDA food safety efforts, reexamining mandatory recall authority, increasing retail enforcement and implementing more aggressive consumer warnings.

What is not clear is whether the working group will look beyond just detection, awareness and reorganization to bolder initiatives that may result in less consumer illness and less legal exposure for food sellers. Bolder initiatives could include funding for irradiation, consumer food safety education, and fast-track development and implementation of technology that can sample food products for whole colonies of microorganisms

 

How Not to Feed Airport Guards

An Interesting news item out of Kathmandu40 airport guards were taken sick with what appears to be dysentery all at the same time.  The cause appears to be eating the same tainted food in the same employee cafeteria.  According to the Malaysian national news agency:

All the police personnel used to share a cafeteria. Probably, they had eaten pumpkin curry and pickle of radish and potato unfit for human consumption which caused them food poisoning,

35 of the guards had been released from the hospital, and the airport, the only international airport in Nepal, employs 323 guards, but the question remains:  can you allow all the guards on a single shift to eat the same food at the same time without knowing that it is absolutely, positively, safe?  Otherwise, you're taking the risk that the bad pickle of radish can lead to more dire consequences. 

We've all, I presume, seen Airplane!  You'll be hoping that someone picked the right day to give up pumpkin curry. 

Secretary of Agriculture Emphasizes Safety of U.S. Pork

Secretary of Agriculture Tom Vilsack issued a statement today emphasizing that U.S. pork products are safe and that there is no evidence that U.S. swine have been infected with the swine flu virus.

Calling trade restrictions on pork or pork products unnecessary, Vilsack said any such restrictions would be inconsistent with World Organization for Animal Health guidelines. “[I]t is not necessary to introduce specific measures for international trade in swine or their products, nor are consumers of pork products at risk of infection,” Vilsack said. The complete statement is available here.

A report in The New York Times notes that pork producers are questioning whether it is appropriate to call the virus “swine flu” given that there is no evidence of swine infection. The report states that officials in Thailand, one of the world’s largest meat exporters, have started calling the virus “Mexican flu.”  An Israeli deputy health minister reportedly said Israel would follow suit to keep Jews from having to say the word “swine.”

FDA and CDC Warn of Salmonella in Raw Sprouts

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are recommending against eating raw alfalfa sprouts because of potential salmonella contamination.

According to the FDA, the salmonella contamination appears to be in seeds for alfalfa sprouts. As of yesterday, 31 cases of illness with Salmonella Saintpaul have been reported to the CDC. The reported cases are in Michigan, Minnesota, Pennsylvania, South Dakota, Utah, and West Virginia. The FDA cautions that the number of infected people may rise because some illnesses have not yet been confirmed with laboratory testing.

The FDA believes this outbreak may be linked to an outbreak from earlier this year. Its initial investigation traces the contaminated raw alfalfa sprouts to multiple sprout growers in multiple states. Additional details are available here.

Update on the Rojak Case

The rojak-related outbreak in Singapore happened only on April 3, but the Singapore health officials have already issued their official report

The report links the illnesses to Vibrio parahaemolyticus, which in turn got into the rojak by having raw cuttlefish on an upper shelf of a refrigerator, which dripped into the gravy on the lower shelf of the refrigerator.  Needless to say, this is a poor food handling practice.  The stall remains closed and prosecution is likely. 

The question that has not been answered is why the deaths occurred.  According to the FDA, cases linked to vibrio are usually "mild or moderate" and only in rare cases even require hospitalization.  Here, there were not only significant numbers of hospitalizations, but two deaths and an apparent miscarriage.  The Singapore officials await the coroner's report on the deaths to find out why  Ordinarily, vibrio causes death (about 7 a year in the US) only when there are other medical conditions present

Food-Borne Illness: Glass Half-Empty or Half-Full?

The Centers for Disease Control has issued a study of the incidence of food-borne illness in ten states.  The study, by the Foodborne Diseases Active Surveillance Network, known as "FoodNet", in general concludes that food-borne illness has not significantly either increased or decreased in the United States since 2004, after substantial gains in food safety from 1996 to 2004. 

The Associated Press article on this, by Mike Stobbe, is entitled, "CDC: US food poisoning cases held steady in 2008."  This is an appropriately neutral headline.  What is interesting is how different media outlets have dealt with the story

Reuters, in an article by Julie Steenhuysen, uses the headline, "U.S. making little progress on food safety."  She emphasizes in the lede the use in the study of the word "plateaued."  Lyndsey Layton's Washington Post article is headed, "CDC Study Finds Some Food-Borne Illnesses Rising in U.S."  The article's lede actually says that the rate has "remained stagnant", and nowhere in the article is any mention made of any specific diseases whose rates have risen (the article instead clumps together some where rates have either risen or remained constant, without distinguishing which are which).  The UPI headline is "Little Progress in U.S. food safety", similar to the New York Times's "U.S. Food Safety No Longer Improving, Data Show". 

On the rosier side, the Wall Street Journal's Jacob Goldstein blogged with the headline, "Reality Check on Foodborne Illness Rate." Goldstein takes the position that the lack of an increase given the wide publicity to certain outbreaks is an indication that things are doing well.  It is not clear, however, whether Goldstein understood, as the Washington Post article reported,

The data did not include the ongoing national outbreak of salmonella illness linked to peanut products that began in late 2008 but peaked in the early months of 2009, with nearly 700 people sickened and nine killed.

So what does the report actually say?

 

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The High Cost of Loving Rojak

Rojak is an important Singaporean dish.  To the Indonesian rudjek, basically a salad, is added (for the Indian version most popular in Singapore) yu tiao, sort of a doughnut; ju her, a cuttlefish salad; taupok, which are tofu puffs; or pei tan, which are preserved duck eggs.  What is usually not added is something--still unidentified--that has sickened over a hundred Singaporeans, may have caused a spontaneous miscarriage by a 38-year old pregnant woman and killed at least two people.  Unfortunately, this is exactly what has happened at Sheik Allaudin Mohideen's stall at the Geyland Serai temporary market in Singapore.

When we think of Singapore, we think of clean.  We also think of an amazing health care system, which costs one-third the per capita cost of U.S. healthcare

So when food poisoning occurs in Singapore, you get a Singaporean response.  Emergency rooms in three Singapore hospitals began filling overnight Friday with people vomiting who had all eaten food from the stall.  Mr. Allaudin, whose stand has been in business for over 20 years, arrived at his stand at 8am Saturday morning to find health officials who shut the stand down.  The remaining stands were inspected and found clean and allowed to open. 

One possible causeVibrio parahaemolyticus.  Its presence has been confirmed in two cases, but it has not been positively identified as the cause of the illnesses and deaths.

There is one lesson to be learned already, and it comes, unfortunately, from the sad story of the woman who miscarried, who was excited to be carrying a child by her new, second husband.  She had had a yearning for rojak, and her husband had brought her some on Friday from her favorite stand.  According to a report in Channel NewsAsia, "She noticed the Rojak smelled unusual [but] carried on eating it." 

I suspect she won't do that again.  And I imagine she wishes she had followed the basic advice not to eat food that smells off.

(The image is provided by the Creative Commons: http://creativecommons.org/licenses/by/2.5/)

A Bad Week for Grapefruit

The Lancet reported last week that a "constellation of potential risk factors" had almost cost a woman in Olympia, Washington her leg.  Dr. Lucinda Grande reported that the woman had started a "grapefruit diet", while taking birth control pills and having a previously undiagnosed genetic condition, while remaining immobile in her car for an extended period.  The result of this "perfect storm" of bad facts was a blood clot that eventually turned her left leg purple.  Not just an ordinary blood clot, according to the BBC:

When doctors examined her, an ultrasound scan confirmed the woman had a large blood clot within the veins of her left leg, which stretched from her hip down to her calf and she was deemed to be at risk of losing her leg because of gangrene.

The culprit, according to the Lancet article, is apparently the grapefruit.  The woman had not previously eaten much grapefruit, but had eaten about a half pound a day for three days.  Whatever the weight-loss advantages of the grapefruit diet, one of the effects of eating a lot of grapefruit is that is changes the effects of certain drugs.  In this case, it may have stopped a key enzyme from breaking down the estrogen from her birth control pills.  Combined with her genetic predisposition, the clot may have resulted.

It has been reported previously that grapefruit or grapefruit juice has an effect on other drugs.  It apparently enhances the effects of some, like certain antihistamines, and diminshes the effects of others, like Viagra.  The Mayo Clinic has a specific list:  Other studies have indicated no effect despite indications from others, such as with caffeine.  The evidence in many cases is inconsequential and subject to interpretation

I happen to love grapefruit and have drunk grapefruit juice for breakfast for years.  I don't drink caffeine with breakfast, but I do take over-the-counter antihistamines.  My doctor has told me not to worry about any side effects.  She did warn that if I took statins, we might have to rethink this.  Grapefruit is a good source of Vitamin C

Grapefruit growers should not have to worry about liability from the natural effects of grapefruit or the interactions between it and drugs.  This is quite similar to the naturally occurring mercury in tuna; courts are not eager to find liability for someone growing or selling an unadulterated, legal product in a safe manner. 

In other news, a horse named The Pamplemousse was scratched from the Santa Anita Derby over the weekend.  He won't be competing in the Kentucky Derby, either.  What does "Pamplemousse" mean in French?  Grapefruit. 

California Lawmakers Announce Proposed Food-Safety Reforms in Wake of Pistachio Recalls

As pistachio recalls continue to be announced in the wake of salmonella-tainted pistachios from Setton Farms, two California lawmakers this week announced legislation that is expected to strengthen food-safety standards in that state.

The bill to be introduced in the California State Assembly by Assembly Speaker Karen Bass and Assemblyman Mike Feuer is expected to require detailed safety plans from food processors, periodic testing of food at California food processing facilities, and requirements for food processors to report to state authorities any positive tests for a dangerous contaminant within 24 hours.

A video of Assemblyman Mike Feuer’s announcement is available below.  Meanwhile, the FDA continues to update its list of recalled products.

 

The Pistachio Recall: More Salmonella

The FDA and the California Department of Public Health announced on March 30 the recall of pistachios from Setton Farms, which have been linked to a discovery of salmonella originally identified by Kraft Foods in Back to Nature Trail Mix.  The FDA has a list of recalled products, but that may grow. 

Obviously, we have been through this drill before.  It is interesting to note the reactions of different involved parties.

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Nestle's Makes the Very Best Peanut Decision

On Thursday, March 19, the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee held another hearing on Peanut Corporation of America and the Salmonella outbreak.  A focus of the hearing was the different choices made by Nestle USA, which had refused to buy PCA peanuts, and the companies testifying at the hearing, including Kellogg and King Nut, which had. 

Nestle, when considering buying peanuts from PCA, had sent its own inspectors to PCA's plants.  They found, according to a report of the hearing in the Washington Post, some rather damaging items:

rat droppings, live beetles, dead insects and the potential for microbial contamination

Nestle, not surprisingly, declined to buy from PCA. 

At the hearing, witnesses from Kellogg and King Nut were questioned as to why they had not done their own inspections, instead relying on inspections by AIB, the American Institute of Baking, which were paid for by PCA, and which apparently tipped PCA about when it was coming

The question nobody seemed to ask--and no one from Nestle was at the hearing--was why Nestle could not have made the results of its inspection public at the time?  If there are "rodent droppings in the break room cabinets", and the company is selling peanuts to other members of the general public, just not through Nestle, isn't this something that should be made known to someone?

One answer lies in the fear of the various torts that come under the heading of "trade libel."  Nestle is a big company, and even though it presumably trusts its inspectors (and makes important business decisions based on their reports), it must recognize that it is a potential "deep pocket" for lawsuits.  Thus, to report publicly what its inspectors found, or even to make that information avaiable to others in the food industry, is to risk a major lawsuit. 

The flip side should also be considered.  If you are PCA, and someone broadcasts to the world that you have rat droppings in your break room cabinets, you are likely to experience significant losses, regardless of whether the report is true, and whether the presence of rat droppings in your cabinets affects the actual safety of your food.  What we do know is that in 2008 PCA began shipping peanuts that killed people.  The rat droppings found in the 2002 Nestle inspection presumably had nothing to do with those deaths, nor are we aware of any deaths or illnesses from PCA peanuts in the interim.  Finally, we do not of course know whether there are other suppliers Nestle or others who conducted their own inspections rejected, and what they did with the news of rejection.  Nestle, for instance, didn't write off PCA when it rejected it in 2002; it checked out another PCA facility in 2006 (and came to similar conclusions). 

Then there is the question of what contractual rights and obligations existed between PCA and Nestle.  Did PCA require Nestle to sign a non-disclosure agreement when it allowed it into the plants?  Any well-advised company would require such an agreement at the very least to protect proprietary technology.  Thus, Nestle may have been contractually bound not to reveal the results of its inspections.

As food safety legislation is being considered, the issue of tort liability and the right to use contracts to silence someone who knows about your dirty facility should be faced.  It is not as simple as "all inspections should be public", but it is also unlikely to remain as business as usual.  We publicize the results of government restaurant inspections without putting all restaurants that fail to pass inspection out of business.   

Georgia House Unanimously Passes Food Safety Bill; Kellogg CEO Calls for Food Safety Reforms

Update to today’s earlier post: the Georgia House of Representatives unanimously passed a bill today that would strengthen food safety laws in Georgia. The Georgia House and Senate now will resolve minor differences in the proposed legislation and send a final version to Georgia Gov. Sonny Perdue for his signature.

Also today, the AP reports that the chief executive of Kellogg Co. is urging food safety reforms, including written safety plans for all food companies and annual inspections of facilities that make “high-risk foods.” The AP article notes Kellogg lost $70 million worth of peanut products in the recent salmonella outbreak linked to Peanut Corporation of America.

Maple Leaf Foods: A Case Study in the Persistence of Memory

Maple Leaf Foods is Canada's largest food processor, and as the name implies, it traces its history a long way with our neighbor to the north.  It has always prided itself on its food safety procedures

Last year, as was widely reported, more than 20 people all across Canada died from listeriosis traced to one of Maple Leaf's processing plants in Toronto.  A huge recall of Maple Leaf products was ordered.  Recently, the company settled class action cases for a reported $27 million. 

Perhaps Maple Leaf thought that put it all behind them.  Hardly.  A Thomson-Reuters article described how Maple Leaf considers itself well-placed in the current economic environment.  The story is 11 paragraphs long.  Five of the paragraphs tell the company's story.  Six of the paragraphs, including the lead paragraph and the final five, are concerned in whole or in part with the listeriosis outbreak, plus a new recall of frankfurters and hot dogs

People have long memories.  The article in today's Wall Street Journal that peanut butter sales in the four weeks ending February 21 dropped 13.3% compared to the same period last year is just another indication of that.

The Best Restaurant on Earth Closed Due to Food Poisoning

The Fat Duck, Heston Blumenthal's three-Michelin star restaurant which was once named the best restaurant in the world (it is currently second), was closed temporarily because of reports of food poisoning.  Nothing has been found in a thorough search, leading to speculation that there may have been some form of sabotage, or simply a non-specific virus passed along not by the food but by a contagious member of the staff. 

In an interview in the Guardian, Blumenthal detailed all the efforts that had been made to isolate the problems, which appeared as stomach ailments in customers, which--unusually for food poisoning--appeared four to five days after diners ate at the restauarant.  The closure was voluntary and he plans to reopen Wednesday and compensate not only those who were affected with free meals, but give those whose bookings were cancelled something special upon their return. 

UPDATE:  It appears now more and more that the cause of the customers' illnesses was an unspecified airborne virus, and neither sabotage nor food poisoning.  Restaurants are, after all, gathering places, and the lessons of winter viruses apply as much to a restaurant, for all the efforts a place like the Fat Duck may take to remain clean, as to any other indoor place. 

Two Stories from China on the Same Day (with an update)

The curious juxtaposition of these two stories from China on the same day is striking.

In the first story, two men were sentenced to death for purposely poisoning the food in a snack bar in Shenzhen City with sodium nitrite.  It appears that a deal to develop a skating rink was contingent on removing a popular marketplace, and the ringleaders decided the best way to do that was to poison people at the marketplace, which they did in February 2008.  Two people died and 61 others were poisoned.  Those sentenced to die were the ones who administered the poison.  The manager who masterminded the plan was sentenced to life in prison and the developer of the skating rink was sentenced to fifteen years in prison.

Meanwhile, just yesterday, in Harbin, 57 people at a shopping center got food poisoning from eating a popular Chinese snack food called malatang.  The verdict:  poisoning from nitrite.  It makes you wonder if someone wanted to put a skating rink in there, too.

UPDATE 2/26/09:  Make that three stories.  Today CNN is reporting that 14 people in Guangzhou were poisoned from a dish of stir-fried pig's liver.

FDA's Searchable Widget for Peanut Product Recall

UPDATE to the Salmonella-driven peanut product recall: as the number of peanut products recalled continues to rise, the U.S. Food and Drug Administration has created a Web widget that allows users to search for peanut-containing product recalls (see below).  The FDA updates the list as it receives new information from companies that have recalled products. As discussed in an earlier article, a list of products that are unaffected by the recall is also available.

 FDA Salmonella Typhimurium Outbreak 2009. Flash Player 9 is required.

Developing A Strategy For Crisis Management

An upcoming panel discussion at the Nutritional Law Symposium in Utah and a call from a reporter about the Maple Leaf Foods issue in Canada have me thinking a lot about crisis management. How a business responds at the outset of an alleged food-borne outbreak determines its fate in many ways.
 

Implementing a strategy from the start is a must to minimize the impact of a crisis. Yet the million- or billion-dollar question is, how do you develop the right save-the-business strategy when events are overwhelming and occurring at light speed? You need to bring together quality assurance, legal and food safety personnel (epidemiologists, microbiologists and other food safety experts) who can respond immediately to find the source of the outbreak and work with public health officials. A business must ascertain at the earliest possible moment the source and scope of the crisis. Once a business understands whether an outbreak is limited to a particular outlet or product line, and how many people might be affected, it can formulate a public relations, recall and legal strategy to limit exposure.

The key is execution. Everyone on the crisis management team must work in sync and understand their roles. And the secret to execution is preparation. Long before a crisis, a team (usually a combination of personnel from outside and inside the business) should be in place, rehearsed and ready. History is full of lessons: Some businesses executed crisis management well and emerged from dire crises stronger than before; others were unprepared, and their brands have long been forgotten.

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