Product Recalls Are A Complex Process

The Peanut Corporation of America closed its Plainview, Texas, plant on Feb. 9 after laboratory tests indicated possible salmonella contamination.

Three days later, the Texas Department of State Health Services ordered a recall of products shipped from the plant after inspectors found dead rodents, rodent excrement and bird feathers in a crawl space above a production area. The company must now recall all of its products ever shipped from that plant, which began operations in March 2005, and it cannot reopen without approval from the state.

In January, the Peanut Corp. expanded an earlier recall of products processed at its Blakely, Ga., plant due to the ongoing investigation that linked salmonella bacteria to the deaths of nine — and illnesses of at least 600 — people.

Just how does a recall work?

When consumer products such as toys, child seats or pesticides are defective — or food products like peanut butter or chicken are found to be potentially harmful to consumers — companies can issue voluntary recalls. And depending on the severity of the hazard, additional measures can be taken to reduce the risk to consumers.

Six government agencies are responsible for managing product recalls, and each works closest with the industries it regulates. The Consumer Product Safety Commission, the National Highway Traffic Safety Administration, the U.S. Coast Guard, the Food and Drug Administration, the U.S. Department of Agriculture's Food Safety and Inspection Service, and the Environmental Protection Agency each maintain a list of recalled products online at www.recalls.gov.

Contrary to popular belief, most recalls are not ordered by these agencies, but rather are voluntarily issued by the product manufacturer, according to the FDA. Most companies either identify a problem with a product independently and approach the regulatory agency with a recall notification or, as was the case with the recent salmonella outbreak in peanut products, work with the regulatory agency to issue a recall.

The Federal Food, Drug and Cosmetic Act, a set of laws that authorizes FDA-ordered recalls in cases when medical devices, human tissue products and infant formula products pose a threat to human health, may be invoked to force product recalls. Normally, a letter written by the FDA to the product manufacturer advising of a recall is enough to prompt a voluntary recall.

The FDA can, however, require mandatory recalls or seizures if experts determine "a recall wouldn't be effective or if a recall proves ineffective, or if the violation is continuing," according to an article in FDA Consumer magazine.

In the case of the Texas peanut processing plant, a news release issued by the Texas health department on Feb. 12 says the company voluntarily stopped operations the previous Monday night — but that state law authorized the department to shutter the plant because there was an "immediate and serious threat to human life or health."

The FDA has formal guidelines for recall processes that require companies to take responsibility for recalls, update the FDA on their status and ensure they are complete and successful.

The FDA asks for extensive paperwork when companies file recalls. This information includes: complete product descriptions, documentation, packaging, typical uses, reasons for the recall, potential health hazards associated with the product, volume and quantity of the recalled product, distribution methods, a list of everyone who bought or received the product and a detailed strategy to execute the recall.

The guidelines also advise companies on how to publicize the recall, including issuing press releases and written notification. If the FDA deems the product a significant enough public health hazard, as it has done with the salmonella outbreak, it will jointly issue a press release with the company.

Each week, the FDA issues an Enforcement Report, which lists all of the products being recalled at that time. Typically, dozens of products are recalled each week from across all sectors, ranging from chemicals to red blood cells to medical devices and food products.