What Are the Primary Causes of Recalls, and What Are the FDA/USDA Requirements for Them?
When firms or government agencies discover likely violations of food safety standards, their best recourse is generally in the form of a recall. Recalls for human food fall under the authority the Food and Drug Administration, which regulates most food – except for meat, poultry, and processed egg products, which fall under the purview of the USDA’s Food Safety and Inspection Service (FSIS).
The FDA defines a recall as “a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action.”1 Most often, FDA-related recalls are conducted by the firms themselves, under guidance by the FDA. Under the 2011 Food Safety Modernization Act, the FDA was granted the legal authority to recall any food in a situation where there is “a reasonable probability that an article of food is adulterated or misbranded and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.”2When firms discover such serious risks, they are obligated to divulge them to the FDA within 24 hours. Whether recalls are of this magnitude (Class I), of a “remote” possibility of serious consequences (Class II), or unlikely to cause such consequences (Class III), firms should report their recalls to the FDA so that the agency may advise the firm on public warnings, evaluate the risks associated, and monitor or audit the firm throughout the recall process. If products are of Class I, this information must be reported.
The USDA defines a recall as “a voluntary action by a manufacturer or distributor to protect the public from products that may cause health problems or possible death.”3 FSIS has the authority to request such recalls but are unable to require them. If firms do not comply with a request for recall, FSIS may seize and destroy the relevant products in commerce. FSIS bases its requests off of the results of its own testing as well as that of other agencies, and begins investigations as a result of those tips or Under the same classification system as above, FSIS publicly reports all Class I and II recalls.
Recalls are unpleasant but necessary – and they’re surely preferable to the consequences of legal action, and more importantly, the public consequences of illness, injury, or even death. The only way to avoid recalls is to avoid the dangerous circumstances which make them a necessity. According to the FDA’s Fifth Annual Reportable Food Registry Report4, in 2014, three hazards comprised over 90% of total recall reports: Salmonella, Listeria monocytogenes, and undeclared allergens. The balance of the reports was the result of nutrient imbalance, undeclared sulfites, E. coli, drug contamination, and lead.
2 Above; slide 9.