Matters for Congressional Consideration

1. Status: Closed - Implemented

   Comments: The Public Health Security and Bioterrorism Preparedness Act of 2002 requires that facilities engaged in manufacturing, processing, and packaging of foods for consumption be registered with the Secretary.

   Matter: To strengthen FDA's ability to ensure that all domestic seafood products are processed under HAACP requirements, Congress should provide FDA with comprehensive authority to require the registration of all seafood-processing firms.

2. Status: Closed - Not Implemented

   Comments: Congress has not yet acted on this recommendation. We are closing it as not implemented.

   Matter: To strengthen FDA's ability to ensure the safety of imported seafood, Congress should amend the Federal Food Drug and Cosmetic Act to require FDA to certify that seafood eligible for importation into the United States is produced under equivalent food safety systems.

Recommendations for Executive Action

1. Status: Closed - Implemented

   Comments: FDA did not agree with GAO's recommendation, and does not plan to take direct action to ensure that vessels meeting FDA's hazard analysis critical control point (HACCP) criteria for land-based firms operate under HACCP requirements. However, in response to GAO's report, FDA conducted a mid-course review of its seafood program and, as part of this effort, developed guidance for vessel operators to address proper handling of histamine forming fish. This action addresses, in part, GAO's concern that seafood on board fishing vessels be maintained under safe conditions.

   Recommendation: To better ensure the safety of domestic and imported seafood consumed in the United States, the Commissioner of FDA should require that all seafood-processing firms, including vessels that meet FDA's HACCP criteria for land-based seafood firms, operate under HACCP requirements.

   Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

2. Status: Closed - Implemented

   Comments: In April 2001, FDA reissued its Compliance Program Guide to refocus inspection priorities in response to this report's recommendations. The guide now requires that FDA inspectors review hazard analysis critical control point (HACCP) plans for high risk products to determine if hazards reasonably likely to occur and critical control points are identified as required by the HACCP regulations.

   Recommendation: To better ensure the safety of domestic and imported seafood consumed in the United States, the Commissioner of FDA should conduct in-depth audits of seafood firms that operate HACCP systems to verify that they identify and control all hazards reasonably likely to occur.

   Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

3. Status: Closed - Implemented

   Comments: In April 2001, FDA reissued its Compliance Program Guide for seafood inspections to change the program's priorities in response to this report's recommendations. The modified Compliance Program now includes a section emphasizing the need for hazard analysis critical control point inspections to be planned for times when the firm is known to be in production, and states that every effort should be made to perform the inspection while the firm is producing product(s) selected for inspection. If this cannot be accomplished, a re-inspection of the product(s) selected must take place at the earliest opportunity.

   Recommendation: To better ensure the safety of domestic and imported seafood consumed in the United States, the Commissioner of FDA should emphasize to inspectors the need to revisit firms to observe the processing of seafood product(s) selected for inspection as required by FDA's compliance manual and establish a system to monitor inspections to ensure that such revisits occur.

   Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

4. Status: Closed - Implemented

   Comments: FDA has taken action and established milestones for evaluating methylmercury in seafood as GAO recommended.

   Recommendation: To better ensure the safety of domestic and imported seafood consumed in the United States, the Commissioner of FDA should develop milestones for completing the agency's ongoing evaluation of methylmercury and determine whether it is a seafood hazard reasonably likely to occur.

   Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

5. Status: Closed - Implemented

   Comments: In February 2003, FDA reported that the agency has succeeded in sharply reducing its review time for issuing warning letters from an average of 70 days, as GAO reported, to an average of 20 days during fiscal year 2001. The agency recently completed a review of the 15-day requirement and has reaffirmed its continued appropriateness. FDA further reports that it intends to make every effort to bring the average review time down to this timeframe. These actions are partially responsive to GAO's recommendation and, therefore, GAO is closing this recommendation as implemented.

   Recommendation: To better ensure the safety of domestic and imported seafood consumed in the United States, the Commissioner of FDA should issue warning letters within FDA's required time frames.

   Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

6. Status: Closed - Implemented

   Comments: FDA essentially agreed with this recommendation and indicated that the agency had already conducted a nation-wide survey of salmonella levels in a wide variety of commercial seafood. In April 2005, FDA reported that it is using results from the salmonella nationwide survey of seafood products to begin developing good aquaculture practices to be integrated into the HACCP program. This action indicates that the agency is beginning to use microbial testing results in conjunction with HACCP program implementation and represents a significant action in response to GAO's recommendation.

   Recommendation: To better ensure the safety of domestic and imported seafood consumed in the United States, the Commissioner of FDA should develop baseline information, such as regular microbial test results, and use it to assess the effectiveness of HACCP systems over time.

   Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

7. Status: Closed - Not Implemented

   Comments: FDA does not concur with this recommendation. FDA said that, while it considers equivalence determination to be an ongoing activity, the development of meaningful timetables has not proven possible, primarily because other countries are involved in the considerable amount of data on regulatory systems that must be exchanged in order to permit a determination. For fiscal year 2001, FDA plans to continue to make progress toward accomplishing foreign equivalence assessments and has listed it as one of its priorities.

   Recommendation: To better ensure the safety of domestic and imported seafood consumed in the United States, the Commissioner of FDA should develop specific goals and time frames for establishing equivalence agreements while Congress considers whether to mandate FDA's certification of other countries' equivalence before their seafood products are allowed entry into the United States.

   Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

8. Status: Closed - Implemented

   Comments: In 2001, GAO reported that FDA visited foreign seafood firms to determine their compliance with FDA's seafood safety regulations, including HACCP (Hazard Analysis and Critical Control Point. These visits identified many HACCP-related problems and FDA issued warning letters to 24 firms. FDA noted that, when such deficiencies occur, it can place the foreign firms under an import alert and detain their products at U.S. ports-of-entry. However, GAO found that the deficiencies identified were not being communicated to the Imports Office and, as a result, the import alert system was not being updated to ensure that seafood from such firms were subjected to increased scrutiny at U.S. ports-of-entry. GAO recommended that the FDA Commissioner communicate deficiencies identified during FDA's importer inspections and foreign country inspections to ports-of-entry personnel so that potentially contaminated imported seafood can be examined before being allowed into the United States. FDA agreed with this recommendation and took action after GAO brought this issue to its attention to communicate these deficiencies by placing nine firms on the import alert list. Products from firms placed on such detention may no longer be entered into the United States without the importer first demonstrating that the seafood was produced in compliance with the HACCP regulations. In April, 2005, FDA further reported that 45 foreign firms have been placed on detention. These actions are responsive to GAO's recommendation.

   Recommendation: To better ensure the safety of domestic and imported seafood consumed in the United States, the Commissioner of FDA should communicate HACCP system deficiencies identified during FDA's importer inspections and foreign country inspections to port of entry personnel so that potentially contaminated imported seafood is examined before being allowed to the United States.

   Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

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