Actions Needed by USDA and FDA to Ensure That Companies Promptly Carry Out Recalls
RCED-00-195, Aug 17, 2000
Pursuant to a congressional request, GAO provided information on voluntary food recall programs, focusing on: (1) the number of food recalls documented by the Department of Agriculture (USDA) and the Food and Drug Administration (FDA) since 1984, and of those, the number associated with outbreaks of foodborne illnesses; (2) for recalls associated with such outbreaks, the extent to which USDA and FDA identified the cause of the outbreak and how the product became contaminated; (3) the extent to which companies delayed or did not comply with USDA- or FDA-requested recalls; and (4) the economic impact of recalls on affected companies, to the extent identifiable.
GAO noted that: (1) USDA and FDA documented more than 3,700 food recalls from the mid-1980s through 1999; (2) USDA, which generally maintains its data by calendar year, identified 515 recalls of fresh and processed meat and poultry from calendar year 1984 through 1999; (3) FDA, which began compiling such data electronically in 1986, identified 3,248 recalls of other foods from fiscal year (FY) 1986 through FY 1999; (4) neither agency has tracked whether recalls were associated with outbreaks of foodborne illnesses over those time periods; (5) however, USDA, according to its electronic recall files since 1992 and its staff's recollections, identified 12 recalls from 1988 through 1999 that were associated with outbreaks of foodborne illnesses; (6) likewise, FDA, according to its staff's recollections and data on illness outbreaks that it has collected since FY 1997, identified 49 recalls for 1997 through 1999 that were associated with outbreaks of foodborne illnesses; (7) USDA and FDA were able to identify a specific contaminant for each of the 61 recalls they considered to be associated with an outbreak--in total, the agencies believe strains of five bacteria and two viruses were responsible; (8) however, the agencies generally were unable to determine how the food became contaminated; (9) according to USDA and FDA officials, efforts to determine the cause of contamination are generally not successful because so much time passes--up to several weeks or months--before an illness is linked to a specific food; (10) recently implemented systems by the Centers for Disease Control and Prevention (CDC) to track foodborne illnesses could reduce that lag time and may improve the agencies' ability to determine points of contamination; (11) both agencies believe that companies have generally initiated recalls without delays--either on their own initiative or in response to requests to voluntarily do so; (12) neither USDA nor FDA compiles information on the economic impact of recalls on affected companies; (13) similarly, the food industry associations GAO contacted do not collect this information; (14) however, according to food industry officials, recalls can have a significant economic impact on affected companies through lost sales and food retrieval costs; (15) the extent of this impact depends on such factors as the amount and value of the food recalled, its location in the distribution process, and the severity of the health risk; and (16) in addition, following a recall, consumers may stop buying a company's products or switch to another company's brand for future purchases.
- Closed - implemented
- Closed - not implemented
Recommendations for Executive Action
Recommendation: To ensure that companies initiate and carry out recall without delays, particularly of foods that may cause serious adverse health consequences, the Secretaries of Agriculture and Health and Human Services should direct the Food Safety and Inspection Service and FDA, respectively, to provide specific guidance to companies on time frames for quickly initiating and carrying out food recalls that involve potentially serious adverse health risks, including procedures to expeditiously notify their distribution chains and alert the public.
Agency Affected: Department of Agriculture
Status: Closed - Implemented
Comments: FDA revised its recall guidance in November 2003. That guidance addresses in part this recommendation.
Recommendation: To ensure that companies initiate and carry out recall without delays, particularly of foods that may cause serious adverse health consequences, the Secretaries of Agriculture and Health and Human Services should direct the Food Safety and Inspection Service and FDA, respectively, to modify existing recall databases, as necessary, to include information on the timeliness of companies' recall activities to determine whether companies delay in initiating and carrying out recalls. The information should, at a minimum, include the dates a company: (1) finds out about the problem warranting a recall; (2) initiates the recall; (3) notifies the distribution chain; (4) notifies the public; and (5) completes the recall. In addition, the database should track the methods the company used to notify its distributors and the public, and the date(s) on which the agencies requested the company to initiate the recall.
Agency Affected: Department of Health and Human Services
Status: Closed - Implemented
Comments: FSIS enhanced its recall database to include additional information to allow it to more effectively track and verify companies' recall activities.