Food Safety:

USDA and FDA Need to Better Ensure Prompt and Complete Recalls of Potentially Unsafe Food

GAO-05-51: Published: Oct 7, 2004. Publicly Released: Oct 20, 2004.

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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.

Matters for Congressional Consideration

  1. Status: Closed - Implemented

    Comments: The 110th Congress passed the Food and Drug Administration Amendments Act of 2007 (P.L. 110-85), which requires persons who register a food facility with the FDA (registration is required of facilities that manufacture, process, pack, or hold food for consumption in the United States) to report to the FDA, within 24 hours after they have determined that "there is a reasonable probability that the use of, or exposure to, [an] article of food will cause serious adverse health consequences or death to humans or animals." With respect to USDA, the 2008 Farm Bill (P.L. 110-234; reenacted as P.L. 110-246) amends both the Federal Meat Inspection Act and Poultry Products Inspection Act to require any establishment subject to USDA inspection to promptly notify USDA if it believes, or has reason to believe, that an adulterated or misbranded meat or poultry product has entered commerce.

    Matter: 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.

  2. Status: Closed - Implemented

    Comments: The 110th and 111th Congresses have considered legislation to give USDA and FDA authority to issue mandatory recall orders, establish recall requirements, and impose monetary penalties for failing to follow recall requirements; various House and Senate committees have held oversight hearings; and a number of bills were introduced. Pending bills in the 111th Congress would provide mandatory recall authority for products currently regulated by USDA's Food Safety Inspection Service (FSIS). The Safe and Fair Enforcement and Recall for Meat, Poultry, and Food Act of 2009 (H.R. 815, 111th Cong.) would amend the Federal Meat Inspection Act to give appropriate persons the opportunity to cease distribution of a potentially unsafe meat, recall it, and to notify all others in the marketing chain including consumers, and state and local health officials. The bill would direct FSIS to mandate such actions if voluntary actions are not undertaken in a timely fashion; the bill also includes a provision for a pre-mandatory recall hearing opportunity. Comparable Poultry Products Inspection Act provisions in the bill would cover distribution of a potentially unsafe poultry and poultry products. The Food Safety and Tracking Improvement Act (S. 425, 111th Congress), contains language similar to H.R. 815, for foods regulated by FDA.

    Matter: 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.

Recommendations for Executive Action

  1. Status: Closed - Not Implemented

    Comments: FDA does not expect to establish target timeframes for recalling companies in its guidance to food-industry firms. According to FDA, it expects companies to immediately notify FDA when they discover the need to conduct a recall, and that they quickly remove and dispose of recalled food. FDA noted that companies are to issue a press release within 24 hours from the time the company decides to conduct a recall and if the company does not, FDA issues the press release.

    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

  2. Status: Closed - Implemented

    Comments: On November 17, 2008, USDA issued a revised Food Safety Inspection Service (FSIS) Directive 8080.1, Recall of Meat and Poultry Products, to issue new procedures and incorporate all previous, interim changes to the department's recall policies and procedures. GAO evaluated USDA's recall procedures and recommended that USDA address weaknesses in its recall guidance. The new directive substantially addressed GAO's recommendation that USDA revise agency guidance to provide clear expectations to recalling companies.

    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 Health and Human Services: Public Health Service: Food and Drug Administration

  3. Status: Closed - Implemented

    Comments: USDA is now using data from the Food Safety and Inspection Service (FSIS) recall data system, called Recall Web, to generate quarterly reports on recalls for senior FSIS management. The quarterly report calculates the dates for initiating and reporting verification activities as specified in the November 2008 FSIS Directive 8080.1, Rev. 5 so that managers will be able to readily determine which recalls are still active beyond the target date by which FSIS verification activities should be substantially completed.

    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 Health and Human Services: Public Health Service: Food and Drug Administration

  4. Status: Closed - Implemented

    Comments: FDA's Online Reporting Analysis Decision Support System (ORADSS)was developed in 2006 as a tool to generate routine and ad hoc reports from information in the Recall Enterprise System (RES), to help recall managers and coordinators monitor recalls. However, FDA continued to maintain a second recall database that contained recalls that were not in RES. Because FDA agreed in September 2008 to maintain all recalls in RES, the RES data will be more complete, and the reports generated from ORADSS using RES data will be more reliable for managers to use for overseeing recall timeliness and effectiveness.

    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

  5. Status: Closed - Implemented

    Comments: USDA tracks data relating to the initiation and completion dates for recalls on the revised Food Safety Inspection Service (FSIS) Form 8400-4, Report of Recall Effectiveness. A separate report is completed for every recall effectiveness check and product disposition verification conducted. Beginning in January 2006, FSIS activated TRECS (Tracking Recall Effectiveness Checks System), which provides the department with a central system for tracking effectiveness checks from initiation through completion, and provides management with timely status reports. Data from FSIS Forms 8400-4 are now compiled in TRECS.

    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

  6. Status: Closed - Implemented

    Comments: FDA added fields to its Recall Enterprise System (RES) for documenting key dates and information that would potentially allow for better tracking. However, because FDA continued to maintain a second recall data system that contained additional recalls, RES could not be relied upon for tracking recalls. Because FDA agreed in September 2008 to put all recall data into RES, the system will now allow for better tracking.

    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 Health and Human Services: Public Health Service: Food and Drug Administration

  7. Status: Closed - Implemented

    Comments: In November 2008, USDA issued a revised recall directive with new instructions intended to ensure that effectiveness checks are conducted in a manner that verifies that a recalled product is removed from commerce during a recall. When a District Recall Officer (DRO) determines the effectiveness of the recall, he/she sends a Final Recall Effectiveness Report (FRER) to the Director of the Recall Management Staff summarizing the findings of the recall effectiveness and product disposition verification check and any supporting documentation provided by the firm. Key dates from the FRER are reported in FSIS?s recall data system, including start and finish dates for the verification checks. In addition, FSIS?s Tracking Recall Effectiveness Checks System (TRECS), an enhancement to Recall Web, captures on-line documentation by FSIS personnel assigned to monitor the effectiveness checks and to verify product disposition of a company's recall activities. TRECS provides recall program managers with a central mechanism for tracking effectiveness checks from initiation through completion, and provides management with status reports.

    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 Health and Human Services: Public Health Service: Food and Drug Administration

  8. Status: Closed - Not Implemented

    Comments: In a June 3, 2008 Federal Register notice (Vol 73; # 107; pp31696-7], FDA asked the public to comment on a proposal to collect information on recalls including information on quantity recalled. It did not address FDA's actions, the subject of this recommendation.

    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 Health and Human Services: Public Health Service: Food and Drug Administration

  9. Status: Closed - Not Implemented

    Comments: Section 1005 of the FDA Amendments Act of 2007 establishes a reportable food registry within FDA for foods for which there is a reasonable probability that exposure will cause serious adverse health consequences or death to humans or animals. However, FDA issued a Request for Comments on an Announcement of Delay in Implementation of the Reportable Food Registry on May 27, 2008; comments were due on August 11, 2008. No further actions have been taken or coordination with USDA on the registry.

    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

  10. Status: Closed - Implemented

    Comments: USDA's Food Safety Inspection Service (FSIS) has taken actions to help alert consumers about food recalls. For example, FSIS now notifies the public of recalls through a single document posted on its Web site. A Recall Release is issued for the most hazardous recalls (Class I and Class II recalls) and is issued to media outlets in the areas where the product was distributed. For Class III Recalls, a Recall Notification Report (RNR) is issued. USDA also distributes press releases and RNRs through an email listserv, including pictures of the recalled product and a link to the recalling company's Web site, when possible. USDA also posts Recall Releases and RNRs on the Open Federal Cases area of the FSIS Web site. In its November 2008 revision to FSIS Directive on Recall of Meat and Poultry Products (8080.1, Revision 5), USDA highlighted the need to coordinate with FDA and other federal and state agencies.

    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: Congress

  11. Status: Closed - Not Implemented

    Comments: As part of its Food Protection Plan, FDA is implementing risk-based strategies for allocating resources, including recall-related activities. FDA began a project to improve recalls in 2005 that has recommendations in the final preparation and review stages, FDA is still developing recommendations for incorporating risk analysis into its recall verification check processes. FDA has not taken sufficient action on this recommendation.

    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

  12. Status: Closed - Not Implemented

    Comments: FDA anticipates that recommendations for verifying effective recalls will come from an ongoing quality management system review of its recall activities and a related request for public comments on recall issues. However, FDA has not yet taken sufficient action on this recommendation.

    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 Agriculture

  13. Status: Closed - Not Implemented

    Comments: FDA believes it does not have the means to currently implement the recommendation.

    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

  14. Status: Closed - Implemented

    Comments: In commenting on the recommendation, FDA told GAO that it would immediately stop using the second recall database and use only RES. However, we found the second system still in use by recall staff and the second system had recalls that were not in RES. After GAO reported this again in September 2008, FDA agreed to use RES as its sole recall data system.

    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 Agriculture

 

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