What happens when Shiga toxin-producing E. coli (STEC) is detected in food?
In 1994, the USDA declared E. coli O157:H7 an adulterant in ground beef. In 2012, USDA declared the six additional most common non-O157 STECs (O26, O45, O103, O11, O121, and O145) as adulterants in raw ground beef as well. Being labeled an adulterant means that there is zero tolerance for bacterial contamination in food; whenever the adulterant is found in a product, that product cannot enter commerce or must be removed from the marketplace if it has already entered commerce. Today, if one of the STEC adulterants is detected in ground beef, ground beef components, or other non-intact beef products, recalls are initiated by the manufacturer or distributor of the meat, sometimes at the request of USDA FSIS.
In addition to the circumstances specified above, when a FDA- or USDA- regulated product is deemed to be potentially harmful to consumers, recalling that product (i.e. removing it from the market) is the most effective means for protecting the public (https://www.fda.gov/consumers/...). Recalls are almost always voluntary; however, if a company refuses to recall its products, FDA and USDA FSIS have the legal authority to either mandate a recall or to seize and detain a food product in commerce. Sometimes, a company discovers STEC contamination in their product and recalls a product on its own. Other times, a company recalls a product after testing by a local, state, or federal public health or regulatory agency identifies STEC in food, or if an outbreak investigation implicates a product as the vehicle of that outbreak. Whatever the reason, it is the role of FDA or USDA, often along with state food safety regulatory partners, to oversee a company's strategy and assess the adequacy of the recall, through a process known as recall effectiveness checks.
FDA and USDA FSIS STEC Recall Management
In the case of FDA-regulated products (all foods except meat, poultry, and processed egg products), FDA’s role is to oversee a company’s STEC recall strategy and to assess the adequacy of the recall. For USDA-regulated products, the USDA Food Safety and Inspection Service’s (FSIS) role is well integrated into the STEC recall process. A Recall Committee, which is housed within the USDA FSIS Recall Management Division, makes recommendations to the company about the need for a recall if STEC contamination is found.
Food Recall Classifications have been established for both FDA and USDA FSIS. Guidelines are used to categorize food recalls into one of three classes, according to the level of hazard involved. In the event that STEC is found in a food product, a Class I recall is initiated.
FDA Recall Classifications for all food products except meat, poultry, and eggs
- Class I: Dangerous or defective products that predictably could cause serious health problems or death. Examples include food found to contain botulinum toxin or food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.
- Class II: Products that might cause a temporary health problem or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.
- Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.
Public health and regulatory agencies seek publicity about a recall when they believe the public can benefit from the information. For example, when a recalled product has been widely distributed and could still be on store shelves or in people’s homes, the news media is a very effective way to reach large numbers of people. These agencies can hold press conferences, issue press releases, and post updates to their websites.
Not all recalls are announced in the media. But all recalls are posted to FDA or USDA FSIS website recall pages: