Summary
GAO has documented many problems resulting from the fragmented nature of the federal food safety system and recommended fundamental restructuring to ensure the effective use of scarce government resources. In this report, GAO (1) identified overlaps in food safety activities at USDA, FDA, EPA, and NMFS; (2) analyzed the extent to which the agencies use interagency agreements to leverage resources; and (3) obtained the views of stakeholders.
Several statutes give responsibility for different segments of the food supply to different agencies to ensure that the food supply is safe. The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) have the primary responsibility for regulating food safety, with the Environmental Protection Agency (EPA) and the National Marine Fisheries Service (NMFS) also involved. In carrying out their responsibilities, with respect to both domestic and imported food, these agencies spend resources on a number of overlapping activities, such as inspection/enforcement, training, research, or rulemaking. For example, both USDA and FDA conduct similar inspections at 1,451 dual jurisdiction establishments--facilities that produce foods regulated by both agencies. Under authority granted by the Bioterrorism Act of 2002, FDA could authorize USDA inspectors to inspect these facilities, but it has not done so. Furthermore, USDA and FDA maintain separate training programs on similar topics for their inspectors that could be shared. Ultimately, inspection and training resources could be used more efficiently. GAO identified 71 interagency agreements that the agencies entered into to better protect public health and to coordinate their food safety activities. However, the agencies have weak mechanisms for tracking these agreements that, in some cases, lead to ineffective implementation. Specifically, USDA and FDA are not fully implementing an agreement to facilitate the exchange of information about dual jurisdiction establishments, which both agencies inspect. In addition, FDA and NMFS are not implementing an agreement designed to enable each agency to discharge its seafood responsibilities effectively. GAO spoke with selected industry associations, food companies, consumer groups, and academic experts, and they disagree on the extent of overlap and on how best to improve the food safety system. Most of these stakeholders agreed that laws and regulations should be modernized to more effectively and efficiently control food safety hazards, but they differed about whether to consolidate food safety functions into a single agency.
Recommendations
Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director:
Team:
Phone:
Lisa R. Shames
Government Accountability Office: Natural Resources and Environment
(202) 512-9894
Recommendations for Executive Action
Recommendation: The Secretary of Agriculture and the Commissioner of the Food and Drug Administration should work together to ensure the implementation of the interagency agreement that calls for, among other things, sharing inspection- and enforcement-related information at food-processing facilities that are under the jurisdiction of both agencies.
Agency Affected: Department of Agriculture
Status: Closed - implemented
Comments: According to USDA, USDA/FSIS and DHHS/FDA have significantly increased the effectiveness of communications between the two agencies, heightened awareness of each other's responsibilities and operations, initiated more frequent and more effective cooperative efforts. The FSIA Performance Based Inspection System has been modified to include a field for indicating that an establishment is under dual jurisdiction. In addition, FSIS Directive 5730.1, "Responsibilities in Dual Jurisdiction Establishments (DJE)," was issued on June 28, 2005, to provide instruction to FSIS inspection program personnel about their roles and responsibilities with regard to inspection, verification, documentation of findings, and enforcement actions in DJE. FSIS and FDA have agreed to communicate at the District Office level about findings of hazardous, contaminated, or mislabeled foods and about processes that may result in contamination, recalls, or evidence of tampering in DJE. The directive outlines District Office responsibilities including specific findings that should be reported to FDA.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Closed - implemented
Comments: FDA and USDA's FSIS have signed a Memorandum of Understanding (MOU) to facilitate the sharing of information between the agencies about establishments that are subject to the jurisdiction of both agencies. This exchange of information is to permit more efficient use of both agencies' resources and to contribute to improved public health protection. The primary application for this shared information is for enforcement collaboration when inspections find unsanitary conditions that cut across the regulatory authority of both agencies. FDA and FSIS coordinate these activities at the local level on a regular basis. FDA believes that this MOU has been productive and has been successful in enhancing collaborative activities to improve public health protection. For example, the sharing of information through this MOU led to a number of recalls of both FDA- and USDA-regulated products and has led to joint enforcement activities by the agencies. In addition, USDA and FDA have participated in a number of meetings and worked together to develop a web course, entitled, "Introduction to Food Security Awareness."
Recommendation: The Secretary of Agriculture and the Commissioner of the Food and Drug Administration should work together to examine the feasibility of establishing a joint training program for food inspectors.
Agency Affected: Department of Agriculture
Status: Closed - implemented
Comments: USDA and FDA have worked together to examine the feasibility of establishing a joint training program for food inspectors. While USDA agrees that there is merit in examining the feasibility of conducting joint training activities when workable commonalities can be found, it determined that it is not feasible to create one unified training program between FSIS and FDA that cover all food safety verification activities. FSIS and FDA have recently collaborated to provide joint training activities. Two retail meat and poultry processing teleconferences have been conducted, and the two agencies have developed, a retail meat and processing training curriculum.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Closed - implemented
Comments: HHS agrees that FDA and USDA should collaborate in developing training where both agencies can benefit. However, FDA has determined that that it is not feasible to create one unified training program between FSIS and FDA that cover all food safety verification activities. According to FDA, the two agencies enforce different laws and regulations using different procedures. Most of the foods regulated by the two agencies are different.
Recommendation: The Secretary of Agriculture and the Commissioner of the Food and Drug Administration should work together to consider the findings of USDA's foreign country equivalency evaluations when determining which countries to visit.
Agency Affected: Department of Agriculture
Status: Closed - implemented
Comments: USDA shares information obtained during its foreign country equivalence determinations with other Federal agencies and makes available a wealth of information on the FSIS website including foreign audit reports, export requirements for U.S. producers, import requirements for foreign countries, the equivalence process, port-of-entry procedures, re-inspection procedures, and labeling requirements.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Open
Comments: FDA has not provided the status of this recommendation.
Recommendation: To better use FDA's limited inspection resources and leverage USDA's resources and if appropriate and cost effective, the Commissioner of the Food and Drug Administration, as authorized under the Pubic Health Security and Bioterrorism Preparedness and Response Act of 2002, should enter into an agreement to commission USDA inspectors to carry out FDA's inspection responsibilities for food establishments that are under the jurisdiction of both agencies.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Open
Comments: FDA and FSIS jointly held a public meeting to discuss and solicit information on an approach for providing consistency and predictability with respect to which of the two agencies should have jurisdiction over certain types of food products that contain meat and poultry as ingredients. Among the types of products under consideration are bagel dogs, pizzas, natural casings, traditional closed-face sandwiches, bread products made with less than 50% meat or poultry, dried poultry soup mixes, and flavor bases/flavors. FDA and FSIS also opened a joint agency docket to receive written comments. Following the meeting, FDA and USDA reviewed materials submitted to the docket and are meeting to consider which products should be covered by each agency.
Recommendation: To better use FDA's limited inspection resources and leverage NMFS's resources, the Commissioner of the Food and Drug Administration and the Under Secretary of Commerce for Oceans and Atmosphere should ensure the implementation of the interagency agreement that calls for FDA to recognize the results of NMFS inspections when determining the frequency of its seafood inspections.
Agency Affected: Department of Commerce
Status: Open
Comments: FDA and NMFS have initiated discussions to update and revise the Memorandum of Understanding related to inspection activities.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Open
Comments: FDA and NMFS have initiated discussions to update and revise the Memorandum of Understanding related to inspection activities.
Recommendation: To strengthen management controls and maximize the effectiveness of interagency agreements that are designed to reduce overlap, increase coordination, and leverage resources, the Secretary of Agriculture, the Commissioner of the Food and Drug Administration, the Administrator of the Environmental Protection Agency, and the Under Secretary of Commerce for Oceans and Atmosphere should identify and inventory all active interagency food safety-related agreements.
Agency Affected: Department of Agriculture
Status: Open
Comments: According to USDA/FSIS, they will identify and inventory all active interagency food safety-related agreements.
Agency Affected: Department of Commerce
Status: Open
Comments: Waiting on status.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Closed - implemented
Comments: According to information received from Doris Tucker of FDA on December 2007, FDA has identified and inventoried all active interagency food safety-related agreements.
Agency Affected: Environmental Protection Agency
Status: Open
Comments: Waiting on status.
Recommendation: To strengthen management controls and maximize the effectiveness of interagency agreements that are designed to reduce overlap, increase coordination, and leverage resources, the Secretary of Agriculture, the Commissioner of the Food and Drug Administration, the Administrator of the Environmental Protection Agency, and the Under Secretary of Commerce for Oceans and Atmosphere should evaluate the need for these agreements and, where necessary, update the agreements to reflect recent legislative changes, new technological advances, and current needs.
Agency Affected: Department of Agriculture
Status: Open
Comments: According to USDA/FSIS, FSIS will review all active food safety agreements and updates will be made, as necessary.
Agency Affected: Department of Commerce
Status: Open
Comments: Waiting on status.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Closed - implemented
Comments: According to information received from Doris Tucker of FDA on December 2007, this activity is ongoing. FDA's joint public meeting to determine dual jurisdiction responsibilities is an example of this effort.
Agency Affected: Environmental Protection Agency
Status: Open
Comments: Waiting on status.
