Header graphic for print

Food Safety News

Breaking news for everyone's consumption

Understanding Food Recalls: The Recall Process Explained

This article was originally published by Food Sentry on July 25.

Food recalls are very common. In the U.S. and Canada in the past 12 months, there have been more than 600 recalls. With disconcerting frequency, foods enter the market with problems that have the potential to cause serious adverse health effects. When this happens, food companies and U.S. federal regulatory agencies must take steps to ensure that consumers are kept safe. Food recalls are the method by which companies and government regulators try to improve food safety by removing products from distributor inventories, store shelves and consumers’ kitchens.

Regulatory agencies involved

The U.S. Food and Drug Administration (FDA) is responsible for the regulation and safety standards of approximately 80 percent of the food supply in the U.S., both domestic and imported foods. The FDA is also responsible for overseeing the safety of pet foods. The remaining 20 percent, primarily meat, poultry and some egg products, is regulated by a branch of the U.S. Department of Agriculture (USDA) known as the Food Safety and Inspection Service (FSIS).

These agencies can become aware of a problem in the food supply in one of several ways:

  • A food manufacturer or distributor discovers a food safety issue and contacts FDA or FSIS directly.
  • Inspection of a manufacturing facility or importer by FDA or FSIS reveals a potential cause for recall.
  • A food product or manufacturer fails testing carried out through FDA or FSIS sampling programs.
  • In the case of illness associated with a specific food product, individual state health departments will contact the Centers for Disease Control and Prevention (CDC), which in turn contacts FDA or FSIS.

Typically, recalls are voluntary and initiated by manufacturers and distributors. If FDA or FSIS requests that a product be recalled, the responsibility to take action falls on the company which manufactures the product. In the event that the company does not respond to FDA/FSIS requests for recall, legal action can be taken.

Under new authorities granted to it in the Food Safety Modernization Act (FSMA) of January 2011, FDA now has authority to actually shut down operations at food production facilities if it deems that there is a significant threat to public health. It exercised this authority for the first time in September 2012 when it shut down the Sunland, Inc., peanut-processing facility in Portales, NM, when Salmonella contamination was discovered.

Once a company initiates a food recall, it is the responsibility of either FDA or FSIS to evaluate the potential severity of the recall and make sure that all reasonable efforts to remove or correct the problem are being made. These regulatory agencies will also seek media publicity when the situation warrants widespread and rapid public awareness. In most cases, FDA and FSIS do not deem it necessary to alert the media to recalls; however, every recall is posted to agency Websites for consumers to seek out at their convenience.

Finally, FDA or FSIS determines when to terminate a recall. Recalling companies can request a recall termination by submitting a written request or wait on the agency to determine recall termination. Once a reasonably expected amount of the offending food product has been recovered or corrected, the product can be classified as safe. Written notification that the recall has ended is then sent to the recalling company by the responsible agency.

Recalling company

Many manufacturers work tirelessly to prevent recalls in the first place. Good Manufacturing Practices (GMP) and Hazard Analysis and Critical Control Points (HACCP) plans are used to ensure quality and safety during the manufacturing process; however, mistakes can and do occur. When such mistakes occur, it is ultimately the manufacturer’s responsibility to remove the product from the market quickly and before harm is caused. These events are typically planned for through contingency and crisis management strategies, facilitating the speed with which a recall can be completed.

Once a recall is initiated, the recalling company submits their recall strategy to be reviewed by FDA or FSIS. This strategy includes the depth of the recall (Does the recall effect wholesalers, retailers, consumers?), the type of press release to be issued and proposed effectiveness checks. Recall strategies are always executed immediately, even as they are under review. If FDA or FSIS finds issues that need correcting, they prompt the recalling company to make those changes.

Reasons for food recalls

Contamination, adulteration and misbranding comprise the major reasons for which food products can be recalled. Some examples of these include:

  • Contamination with a pathogen such as E. coli, Listeria monocytogenes or Salmonella
  • Foreign object contamination such as plastic, glass or metal fragments
  • Nutrient imbalance (often seen in pet food recalls)
  • Undeclared allergens such as peanut, tree nut, milk, egg, soy, shellfish, etc.
  • Undeclared sulfites
  • Uneviscerated fish

According to Food Sentry’s data, between July 2012 and July 2013, there were 610 food recalls. The primary reason for recall during this period was Salmonella contamination, accounting for 37.6 percent of all recalls.

This year was unusual because of the massive peanut butter recall that originated with Salmonella contamination at a primary producer’s plant in Portales, NM. Sunland, Inc., was the nation’s largest organic peanut processor. More than 300 separate products were recalled over a period of months.  The plant was shut down in September 2012 until May 2013 while it regained certification and permission to resume operations.

Other causes for food recalls were undeclared allergens (21.6 percent) and contamination with Listeria monocytogenes (20.2 percent). Typically, these three pathogens account for the majority of food recalls.

Recall classification

Recalls are classified according to their potential seriousness. This classification is given to a recall by the government agency responsible for overseeing the recall.

Both FDA and FSIS classify recalls according to this system:

  • Class I - A Class I recall involves a health hazard situation in which there is a reasonable probability that eating the food will cause health problems or death.
  • Class II - A Class II recall involves a potential health hazard situation in which there is a remote probability of adverse health consequences from eating the food.
  • Class III - A Class III recall involves a situation in which eating the food will not cause adverse health consequences.

The bottom line

Because food recalls are expensive and stigmatizing for the recalling companies, they are usually highly motivated to clean up their mess as quickly as possible. It is in the manufacturer’s best interest to do everything in their power to maintain and regain consumer confidence during recall events. The only way to ensure this is through coordination with federal agencies to achieve a rapid and efficient recall of potentially harmful products. Most companies will post updates and information on the recall on their company Websites. See Sunland’s Website for a good example of how companies keep interested parties informed and updated on food recall issues.

Food Sentry tracks and reports all recalls from the U.S. and Canada in a user-friendly format within hours of their posting.

© Food Safety News
  • Mike_Mychajlonka_PhD

    I have tried to make this point before on Food Safety News and I think it is worthwhile to revisit this question. The various segments of the food industry all need to have a good idea of what the eventual costs of a recall might be. On the other hand, companies undergoing a recall quite rightly consider themselves under a threat to their profitability (or worse) and are not interested in sharing information about the costs (i.e., losses) they are incurring. This is important because the costs associated with prevention (or at least risk-sharing) cannot be properly appreciated without a knowledge of how much it will cost a producer if the risks she runs catch up with her. A fairly recent (October, 2011) report jointly put out by the Grocery Manufacturers Association, Covington & Burling, LLP and Ernst & Young, LLP entitled: “Capturing Recall Costs – Measuring and Recovering the Losses” (http://www.ey.com/Publication/vwLUAssets/Capturing_Recall_Costs/$FILE/Capturing_recall_costs.pdf) appears to be the best treatment of this subject I have found to date. There, the majority (roughly 3/4) of recalls end up costing the responsible company between 10 and 49 million dollars per recall. We often hear the statement that ” . . . you can’t test your way to food safety.” True, if what is meant is that one cannot rigorously “prove” a negative (i.e., absence contamination) without testing so much of the product that there is nothing left to sell. Risk management, however, is an entirely different proposition. If anyone has better information on this topic, I am all ears.