Summary
Two large food recalls completed in 2003 were associated with 8 deaths and nearly 100 serious illnesses in at least 16 states. Manufacturers voluntarily recall potentially unsafe food by notifying their customers to return or destroy it. The U.S. Department of Agriculture (USDA), for meat, poultry, and egg products, and the Food and Drug Administration (FDA), for other food, have programs to monitor voluntary food recalls, verify that companies contact their customers, and maintain recall data. GAO (1) examined the recall programs and procedures USDA and FDA use to protect consumers from unsafe foods and (2) compared their food recall authority with the authority of agencies to recall other consumer products.
Weaknesses in USDA's and FDA's food recall programs heighten the risk that unsafe food will remain in the food supply and ultimately be consumed. Specifically, USDA and FDA do not know how promptly and completely the recalling companies and their distributors and other customers are carrying out recalls, and neither agency is using its data systems to effectively track and manage its recall programs. For these and other reasons, most recalled food is not recovered and therefore may be consumed. GAO's analysis of recalls in 2003 showed that about 38 percent and 36 percent of recalled food was ultimately recovered in recalls overseen by USDA and FDA, respectively. These agencies also told GAO of instances in which companies were slow to reveal where they had distributed the food or provided inaccurate customer lists. That distribution information is critical because USDA's and FDA's primary role in recalls is to monitor the effectiveness of a company's recall actions. To do so, the agencies contact a sample of the distribution chain from these lists to verify that customers in the food distribution chain received notice of the recall, and that they located the food and removed it from the marketplace. However, the methodology that the agencies use for selecting the customers to check can result in entire segments of complex distribution chains being overlooked. Moreover, GAO found that the agencies did not complete verification checks for some recalls before the shelf life of the food expired. In addition, consumer groups and others question the usefulness of USDA's and FDA's efforts to communicate with the public, suggesting alternatives such as posting notices in grocery stores and direct notification of consumers. Agencies responsible for the safety of products, such as toys, heart pacemakers, and automobiles, have specific recall authority not available to USDA and FDA for food. This includes the authority to (1) require a company to notify the agency when it has distributed a potentially unsafe product, (2) order a recall, (3) establish recall requirements, and (4) impose monetary penalties if a company violates recall requirements. For example, by law, companies must promptly notify the Consumer Product Safety Commission after learning that a product may pose an unreasonable risk of serious injury or death, or face penalties of up to $1.65 million. Likewise, FDA has recall authority for unsafe biological products, medical devices, radiation emitting electronic products, and infant formula. Moreover, in contrast to its inability to penalize a company that is slow to conduct a food recall, FDA can impose penalties of up to $100,000 per day for a company that fails to recall a defective biological product, such as a vaccine.
Recommendations
Our recommendations from this work are listed below with a Contact for more information. Status will change
from "In process" to "Implemented" or "Not implemented" based on our follow up work.
Director:
Team:
Phone:
Lawrence J. Dyckman
Government Accountability Office: Natural Resources and Environment
(202) 512-9692
Matters for Congressional Consideration
Recommendation: To ensure that USDA and FDA have information and authority so they can act quickly to remove potentially unsafe food from the marketplace and can better protect consumers, Congress may wish to consider legislation that would require a company to notify the responsible agency when it becomes aware that a food it has distributed is unsafe.
Status: In process
Comments: When we determine what steps the Congress has taken, we will provide updated information.
Recommendation: To ensure that USDA and FDA have information and authority so they can act quickly to remove potentially unsafe food from the marketplace and can better protect consumers, Congress may wish to consider legislation that would give USDA and FDA authority to (1) issue a mandatory recall order, (2) establish recall requirements, and (3) impose monetary penalties or seek fines or imprisonment for failing to follow food recall requirements.
Status: In process
Comments: When we determine what steps the Congress has taken, we will provide updated information.
Recommendations for Executive Action
Recommendation: To ensure that companies promptly and effectively recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should revise agency guidance to recalling companies to include specific time frames for notifying their customers, removing recalled food from the marketplace, and providing the agencies with the names and locations of customers that received the food.
Agency Affected: Department of Agriculture
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: To ensure that companies promptly and effectively recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should use agency data systems to routinely generate reports for recall program managers so that they may monitor ongoing recalls and oversee recall timeliness and effectiveness.
Agency Affected: Department of Agriculture
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: To ensure that companies promptly and effectively recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should track in their recall data systems the dates that companies (1) start and finish notifying their customers, (2) provide the agency with the lists of customers that received the food, and (3) start and finish recovering the recalled food.
Agency Affected: Department of Agriculture
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: To ensure that companies promptly and effectively recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should track in their data systems the dates that the agencies start and finish verification checks.
Agency Affected: Department of Agriculture
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: To ensure that companies promptly and effectively recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should work jointly to determine what, if any, additional approaches are needed for alerting consumers about recalls.
Agency Affected: Department of Agriculture
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: The Commissioner of FDA should revise guidance to agency staff to include risk-based time frames for completing verification checks promptly.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: The Commissioner of FDA should develop a sound methodology for district staff to verify that companies have quickly and effectively carried out recalls.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: The Commissioner of FDA, when tracking the amount of food recalled and recovered for individual recalls, should use the same units of measure to facilitate calculations of the recovery rate.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Recommendation: The Commissioner of FDA should direct the recall staff to use FDA's Recall Enterprise System as the sole data system to capture recall information, manage food recalls, and generate reports to Congress.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: In process
Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
