What Is the Utility of Microbiological Testing Data in Litigation?
As microbiological testing of products in the field or in processing plants becomes more frequent (even ubiquitous), there are questions about its usefulness. Microbiologists say that the utility of microbiological sampling as it is currently done is marginal at best. Current testing looks at only a small sample of a product for a small range of bacteria, meaning a contaminated product easily can test negative.
Testing is done largely because it can be, and because some testing is better than none. For meat and poultry plants, FSIS has announced that testing data will be posted on its Web site. In the event of a positive test result, food can be recalled or prevented from entering the marketplace.
Because a negative test result proves nothing, it is usually irrelevant in litigation (especially at trial). The negative result, therefore, is nothing more than a red herring.
Recent breakthroughs in technology may dramatically increase the utility of testing. These breakthrough technologies can be combined with methods that do not rely on actual culturing of the organisms, allowing microbiologists to examine the entire population of microorganisms present in an ecosystem. This “community profiling” concept entirely changes how microbiologists would interpret testing data. Microbiology promises us the ability to conduct “community profiling” of bacteria on food products. Dr. Andrew Benson of the University of Nebraska offered fascinating insight into this emerging technology at the April 11-12 food law conference at Seattle University Law School. While the approach cannot yet get around the limited sample size, the ability to examine the content of the entire community of microorganisms in a sample may offer industry more reliable information and the chance to use microbiological testing to reduce risk in a meaningful way. Stay tuned as technologies develop. . .
"Shotgun Questionnaire"--An Important Tool in Food Liability Defense
Food-borne illness cases generally involve strict liability. If a plaintiff can show illness and a causational link between the illness and adulterated food produced by the defendant, the defendant generally will be liable for damages proven by the plaintiff. In defense of first-party injured-plaintiff claims, negligence and the standard of care employed by the defendant is frequently irrelevant to issues of liability.
Because the defendant food seller’s actions may not be relevant, litigated issues frequently center on “causation” (i.e. was the plaintiff’s alleged illness caused by the defendant’s product). From the defense perspective, the plaintiff’s deposition and discovery of plaintiff’s food history and other possible sources of exposure are often key to assessing causation. Oregon’s “shotgun questionnaire” used by its public health investigators provides a great outline.
FSIS to Begin Testing for Non-O157 E. Coli
Dr. Richard Raymond, Under Secretary for Food Safety at the USDA, dropped a bombshell this week. As reported in the Des Moines Register, Dr. Raymond explained at the Seattle University food law symposium that his agency will begin testing for at least six different non-O157 E. coli strains in meat, poultry, and eggs. This is an important development because currently only E. coli O157:H7 is classified as an adulterant.
The USDA’s primary enforcement mechanism (as it has no mandatory recall authority) is to pull its inspectors from food processing plants, effectively shutting the plants down (a meat processing plant cannot operate by law without USDA inspectors). The USDA has no authority to remove its inspectors unless products are adulterated, so it cannot shut down a plant if it finds non-O157 E. coli.
Dr. Raymond’s announcement, therefore, raises the question of what USDA intends to do with its testing results for non-0157 E. coli. If USDA intends to request voluntary recalls for non-0157 E. coli, this is certain to generate controversy and crisis. For example, what is a food producer to do when the USDA (or another state or federal agency) asks for a large-scale recall or destruction of a product but cannot provide a sufficient scientific basis? What if the public health agency is wrong about the public health concern, and the recall threatens the viability of a business? As discussed previously on this blog, uncertainty prevails about the science, behavior, and public health effects of non-O157 shiga toxin-producing E. coli. Research (which by all means should be accelerated) may show that non-O157 E. coli justifies classification as an adulterant, but putting enforcement ahead of science is a risky business. How much confidence will the public or industry have in our public health officials when their decisions are made without scientific rationale?
Stay Tuned for More Non-O157 Information
Tomorrow FSIS will hold a meeting to discuss “challenges and proposed solutions in moving forward to address recalls and illnesses related to E. coli O157:H7.” The meeting will “explore proposed next steps as a means to make progress in the challenge of addressing E. coli O157:H7 and non-O157:H7 STECs.”. FSIS is also planning a “short term study to determine the extent to which non-O157 STECs may be present in FSIS-regulated products.”
Non-O157 Shiga toxin-producing E. Coli. is an important issue for food producers and sellers. Although non-O157 bugs have been implicated in food-borne outbreaks in recent years, serious questions exist concerning the scientific basis for implicating non-O157 bugs.
As discussed last October at the USDA’s conference on non-O157 E. coli, scientific challenges abound and uncertainties prevail in identifying and dealing with non-O157 Shiga toxin-producing E. coli. Little research currently exists. Often epidemiologists assume that non-O157 bugs behave and appear like E. coli O157:H7, and microbiologists looking for PFGE or genetic links between bugs apply the same run parameters and criteria. Yet many believe that comparing O157 bugs to non-O157 bugs may be like comparing apples to oranges.
Fortunately, I will have the opportunity to question many of the participants in this Friday’s FSIS meeting at Seattle University School of Law’s food law symposium. I’m looking forward to an update on the progress of non-O157 research.
Registration Filling Fast For April 11-12 Food Law Symposium
Next week’s food law symposium at Seattle University School of Law, cosponsored by my law firm, Stoel Rives is approaching quickly (I will be one of the moderators). In attendance will be Governor Christine Gregoire, top officials from the CDC and the USDA, representatives of the food industry, scientists, consumer advocates, food lawyers (both plaintiff and defense), and other stakeholders.
With the largest meat recall in U.S. history just a few weeks behind us, an uptick in large-scale food-borne outbreaks in the last 18 months, and the current focus on these issues by the media and the U.S. Congress, the symposium could not be more timely. I expect a lively debate about the trends in food safety, upcoming legislation, imports, and the responsibilities of consumers and the food industry, among other things. Anyone (not just lawyers) involved in food safety or food liability should attend. Registration is limited and filling up fast.
CDC Believes That Risks Associated with Leafy Greens Have Been on the Rise
Following the high-profile leafy greens E. coli outbreaks in 2006, CDC started studying the trends. It concluded that “during 1996 2005 leafy green consumption increased 9% and leafy green-associated outbreaks increased 39%,” according to a recent article on ScienceDaily. Therefore even taking into account the increase in leafy greens consumption, associated food-borne outbreaks are on the rise. This is consistent with general trends, as indicated in my recent magazine article in Cooperative Grocers.
Although there is no way to eliminate risk, grocers, restaurants, and produce suppliers should conduct ongoing reviews of their food safety, audit, supplier, and insurance programs to ensure that everything that can be done is being done to mitigate or shift risk.
Importance of Experts At Outset of Outbreak
A few weeks ago, I gave a presentation at a CLE seminar about how to use and challenge expert witnesses in a food case. One of the interesting discussions that occurred during my talk was about the importance of retention of experts at an early stage, even before health department officials finalize their findings.
Given the limited resources of most state and local health departments, I have always believed there is little to lose by offering the assistance of credible and known epidemiologists, microbiologists, etc. Additional resources in an outbreak investigation (and, therefore, additional investigation) can mean the difference between the health department pointing at your client and the health department pointing at another source. Several other defense lawyers, and, surprisingly, state health department officials, agreed. Examples of successful early intervention were elicited.
FSIS to Start Posting Plant Testing Data
I wrote earlier about Dr. David Goldman's talk at the ACI Food-Borne Illness Litigation conference and his comments regarding supermarkets. Another significant issue concerns posting by FSIS of microbiological testing results from meat and poultry plants on its Web site.
Continue Reading...Mitigating Supermarket Liability
Last week I had the privilege of attending and speaking at the American Conference Institute’s foodborne illness conference in Scottsdale, Arizona. One of the other speakers was David Goldman, M.D., Ph.D., Assistant Administrator of the Office of Public Health Science, Food Safety and Inspection Service (“FSIS”), United States Department of Agriculture (“USDA”). Dr. Goldman provided some interesting information about foodborne contamination from supermarkets.
Continue Reading...USDA to Study Distillers Grains
We recently published an email alert concerning studies allegedly linking distillers grains and E. coli O157:H7. The Des Moines Register ran a recent article on the subject. The article mentions the ongoing study by the USDA. The USDA study “will collect hide and feces samples from 300 control and 300 cattle fed diets supplemented with distillers grains. Cattle will be sampled every 28 days for ten months. These samples will be tested for the prevalence and level of E. coli O157:H7.”
Results from this study will not be released until at least the end of 2008 and more likely in 2009. However, the lack of definitive information may not insulate the biofuels industry from claims by plaintiffs relying on the results of the study. Strict liability, not negligence, will be the standard of liability. What defendant industries knew and when they knew it may not be relevant. In many states, the statute of limitations gives plaintiffs three or more years to bring suit. As we advised in our original alert, biofuels manufacturers should review both their vendor contracts and their insurance coverage now, in order to mitigate and shift risk against future claims of liability.
