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Highlights

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.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Agriculture 1. 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.
Closed - Implemented
FSIS revised recall guidelines to companies to include specific timeframes for notifying the agency, initiating recalls, and carrying out recalls expeditiously.
Department of Health and Human Services 2. 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.
Closed - Implemented
FDA revised its recall guidance in November 2003. That guidance addresses in part this recommendation.
Department of Agriculture 3. 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.
Closed - Implemented
FSIS enhanced its recall database to include additional information to allow it to more effectively track and verify companies' recall activities.
Department of Health and Human Services 4. 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.
Closed - Implemented
FDA implemented a new Recall Enterprise System database for recall tracking, which addresses GAO's recommendation.

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