4/4/2008

Bad Bugs on the Rise?

Recent food recalls and the likelihood of more to come demand we know more to protect our clients

By Meg Weist, J.D.

The topic of food contamination is a top news story these days. The consolidation of the food production system and the rapid distribution methods currently available have exposed our food supply to greater opportunities for potential contamination. In 2007, the news headlines were dominated by recalls of spinach, lettuce, peanut butter and pet food. It appears that the trend will continue in 2008. Recently, in what has been billed as the largest beef recall in the United States, the U.S. Department of Agriculture ordered the recall of 143 million pounds of frozen beef. Publicized recalls have raised public awareness of food liability issues, and have increased the likelihood that a food contamination claim may cross your desk.

While the process appears complicated and multi syllable terms seem ominous, the fundamentals of the claims investigation are easier if you know where to begin. Like any claims investigation, the earlier you start and the more prepared you are, the more manageable the claim handling can be.

The first two things to master in a food contamination inquiry are the myriad of acronyms involved as well as the roles of particular federal agencies. The federal agencies that are involved in food safety regulatory activities are: the Food and Drug Administration (FDA), which is part of the Department of Health and Human Services (DHHS); the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA); the Environmental Protection Agency (EPA); and the National Marine Fisheries Service (NMFS). Each of these agencies has different resources, management controls and regulations. Each of the 50 states also has its own regulatory agencies whose guidelines should be reviewed since they have some autonomy and concurrent jurisdiction with federal agencies.

The NMFS conducts voluntary, fee-for-service inspections of seafood safety and quality. The EPA regulates the use of pesticides and maximum allowable residue levels on food commodities and animal feed. The USDA, through FSIS, oversees the inspection of meat, poultry, and processed egg products, while the FDA is charged with ensuring the safety and purity of all other food products. The FDA also has regulatory oversight of animal feed and would be the lead agency in a recall. The FSIS is the public health agency in the USDA that is responsible for ensuring that its regulated products are safe, wholesome, and correctly labeled and packaged. Incredibly, under USDA regulations, companies may sell E. coli infected meat as long as it is labeled as “cook only,” based on the premise that thorough cooking to at least 160 degrees can destroy bacteria. This practice has been referred to by some commentators as E-coli Loophole.”

The FDA and the USDA also have some overlapping oversight. For example, the inspection of a ready-to-eat sandwich depends on how the sandwich is presented. The USDA inspects manufacturers of packaged open-face meat sandwiches (e.g., those with one slice of bread), and the FDA inspects manufacturers of packaged closed-face meat sandwiches (e.g., those with two slices of bread). The USDA inspects wholesale manufacturers of open-face sandwiches sold in interstate commerce on a daily basis, while the FDA inspects closed-face sandwiches about once every five years. (Government Accountability Office (GAO) High Risk Report 2007).

Once you have a basic understanding of the federal agencies that might be involved, it is necessary to determine whether or not you are analyzing an illness caused by a food contaminant. Essentially, food borne illness is caused by eating or drinking food that contains disease-causing agents. Contamination can come from a sick food handler, unhygienic equipment, or from an outside source such as tainted irrigation water or soil. Improper packaging, unsanitary transport or improper storage of food can also cause food borne illnesses. The contamination can be in the form of bacteria, virus, toxin or parasite.

In order to confirm a claim of food borne illness, a causal connection must be established between the ingestion of the allegedly contaminated food and the illness claimed. The best proof, unquestionably, is a human specimen (a stool or blood sample) that matches a contaminant found in a product. In order to assess whether or not a causal connection exists, you can start with the symptoms. Many different kinds of illnesses can cause diarrhea, fever or abdominal cramps. The incubation period is also an important factor to consider. Food borne illnesses from chemical contaminants or allergic reactions can occur within minutes, while other food borne infections may occur within a few hours to a few weeks after consumption of the contaminated food.

The FDA Web site (www.usda.org) contains the Food Borne Pathogenic Microorganisms and Natural Toxins Handbook which is commonly known as the “Bad Bug Book.” This is an excellent source for specific information on various illnesses, their incubation periods and potential sources of contamination. Common types of food borne illnesses are Salmonella, Campylobacter, E.coli, Shigella, Listeria, Norovirus, Hepatitis A and Staphylococcus. At one end of the spectrum symptoms can include nausea, vomiting, stomach pain, diarrhea or fever. At the other end of the range more severe disorders can be triggered by food borne illnesses. Hemolytic uremic syndrome (HUS) occurs when an E. coli toxin destroys large numbers of red blood cells, leading to kidney failure as blood platelets clog the organ. Reactive arthritis can occur when salmonella poisoning leads to a painful, chronic and potentially debilitating condition that causes joint inflammation. Infections involving Campylobacter jejuni significantly increase the risk of Guillain-Barre syndrome (GB), a disease of the peripheral nerves.

Federal Agencies involved in Regulating Food Safety

FDA — Food and Drug Administration
The FDA is charged with ensuring the safety and purity of all food products not covered by FSIS. The FDA also has regulatory oversight of animal feed and would be the lead agency in a recall. They inspect manufacturers of packaged, closed-face meat or poultry sandwiches once every five years. The FDA is accountable for the inspection of eggs still in their shells.

DHHS — Department of Health and Human Services
The agency under which the FDA and CDC operate.

FSIS — Food Safety and Inspection Service
The public health agency in the USDA responsible for ensuring its regulated products are safe, wholesome, and correctly labeled and packaged.

USDA — US Department of Agriculture
Through FSIS, has oversight of inspection of meat, poultry, and processed egg products. They inspect manufacturers of packaged open-face meat or poultry sandwiches sold in interstate commerce daily. The USDA is accountable for the inspection of eggs once the shells are broken.

EPA — Environmental Protection Agency
The EPA regulates the use of pesticides and maximum allowable residue levels on food commodities and animal feed.

NMFS — National Marine Fisheries Service
The NMFS conducts voluntary, fee-for-service inspections of seafood safety and quality.
Any independent food contamination investigation requires the acquisition of health department reports. Each state health department reports food borne illnesses to the Centers for Disease Control (CDC). The CDC is one of the major operating components of the DHHS. The CDC utilizes Pulse Field Gel Electrophoresis (PFGE) to distinguish strains of organisms such as Escherichia coli 0157:H7, Salmonella, Shigella, Listeria or Campylobacter at the DNA level. This is called DNA fingerprinting. Any results of the fingerprinting are reported to PulseNet, a national network of public health laboratories coordinated by the CDC. The purpose of PulseNet is to detect food borne disease case clusters by utilizing PFGE. OutbreakNet can be credited with the discovery of many of the nationwide food recall cases. It is a network of public health epidemiologists at the local, state, and federal levels who investigate food borne and diarrheal disease outbreaks.

A quality food contamination investigation is also dependent upon finding the right specialists. A consultant who is an expert in the area of quality control issues as well as federal safety compliance issues is invaluable—for example, a local professor who has an expertise in food safety and can discuss pertinent regulations and industry practices. An epidemiologist will need to assess the causation evidence. An expert in infectious diseases may also be necessary. This could be a gastroenterologist who is able to review the medical records, conduct an independent medical examination identifying alternative explanations for asserted ailments, and address the plaintiffs’ claimed damages, including the likelihood of long-term complications. A consult with a microbiologist or bacteriologist who has an expertise in the food contamination at issue will be helpful to identify potential alternative sources of the particular contaminant. Finally, review all contracts and specifications to identify any potentially involved downstream or upstream vendors where the contamination may have occurred.

Food borne illness investigations rarely pinpoint the actual point of origin of the contamination. Consequently, causation is usually established through circumstantial evidence, and many states allow causation to be inferred from circumstantial evidence. As such, the investigation will include records and documents for the entity from which the alleged contamination originated. This will include prior health department records showing results from previous inspections, quality control measures and steps utilized by the company from the purchase of raw ingredients through the mixing process, to testing, packaging and shipping. Quality control steps utilized by the company should be reviewed.

Find out who is in charge of food safety. Are there employee training programs? Believe it or not, you have to remind people to wash their hands before handling food. The Occupational Safety Health Act (OSHA) provides standards for the minimum requirements for hand washing facilities in food handling operations (29 CFR 1910).

Finally, review all documentation for regulatory and code compliance. Most states have a food code modeled after the FDA model code. They usually contain two categories of regulations: critical regulations (priority items that are more likely to contribute to a food borne illness or injury, food contamination, or environmental health hazard if not under managerial control) and non-critical regulations (good retail practices). The key is not only to look for bad practices but good ones as well.
Meg Weist, J.D. is a claim superintendent with EMC Insurance Companies in the Home Office Claims Department. She has responsibility for the oversight of casualty branch claims operations, and provides advice and counsel to EMC branches regarding claim handling. Ms. Weist may be reached at meg.m.weist@emcins.com.



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