Imported Seafood Safety: Actions Needed to Improve FDA Oversight of Import Alert Removal Decisions
Released: 2019-12-06T00:00:00

Letter

Background

Purposes and Scope of Import Alerts

According to FDA documents and officials, import alerts serve several purposes, including the following:

Prevent products that appear to violate FFDCA from being distributed in the United States.

Free up agency resources to examine other shipments by automatically detaining shipments on import alerts on a case-by-case basis without examining them.

Place the responsibility on the importer to ensure that the products being imported into the United States comply with federal laws and FDA regulations.

Import alerts may apply to (1) one or more products produced by all firms in a specific geographic area, (2) one or more products produced or shipped by a specific firm, or (3) a specific product because of concerns about the product regardless of what firm produces it or where. Import alerts covering a specific geographical area may apply to an area within a country, to one or more entire countries, or worldwide. For example, FDA established an import alert covering all firms processing shrimp in India because of the presence of filth, decomposition, and Salmonella.

For import alerts that apply to geographical areas, all firms in the area that produce the products specified in an import alert are initially placed on that alert, and the specified products are subject to detention without physical examination. If a firm presents evidence establishing that the conditions that gave rise to the appearance of the violation associated with the alert have been resolved and the agency has confidence that future entries will comply with FFDCA, FDA indicates that the firm may be removed from the alert by placing it on a “green list” that FDA creates for the alert. For import alerts that apply to products that a specific firm produces, FDA individually determines—for example, through testing or examination—whether a firm and its products are potentially violative and may be identified for potential detention without physical examination. If so, FDA places them on a “red list” that it creates for the alert. Import alerts that apply to a specific product of concern generally have neither a red list nor a green list because such products cannot be removed from the alerts. Products detained via import alerts may be (1) refused entry, in which case they must be exported to another country or destroyed, or (2) allowed to enter U.S. commerce if they can be shown to not violate FFDCA or can be reconditioned to be brought into compliance with the act.

Federal Agency Roles in Overseeing Seafood Imports

DHS, through CBP, is charged with facilitating international trade at the ports-of-entry for seafood and other imports, while FDA examines or inspects certain seafood imports.

CBP is responsible for, among other things, collecting the duties, taxes, and fees assessed on products, including seafood, and managing the import process. CBP collects import entry data through its Automated Commercial Environment/International Trade Data System. These entry data are submitted by a filer (typically, the product importer or a broker) and include a description of the product, manufacturer information, and the country of origin.

Generally, FDA electronically receives notification from CBP of all entries of products under FDA jurisdiction at ports of entry through the CBP system described above, which links to FDA’s OASIS. Once entry information is received in OASIS, FDA uses its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) screening tool to evaluate each entry line. PREDICT is a computerized tool designed to estimate the risk of imports using information such as the history of the importer or processing facility, inspection history, and country of origin. FDA staff use these risk estimates to target for examination shipments with high levels of risk. FDA cannot physically examine every shipment of such products, owing in part to the volume of imported products; we previously reported that the agency examines about 1 percent of entry lines annually. FDA uses PREDICT to electronically screen all imported food shipment information filed electronically to determine which imports to physically examine at the border. PREDICT uses a variety of data and analyzes data by applying rules—conditional statements that tell PREDICT how to react when encountering particular information—to generate risk scores for imported food.

The electronic screening process consists of two phases:

Prior notice screening is intended to protect against potential terrorist acts and other public health emergencies. Prior notice screening requires that an importer, broker, or other entity submit information to FDA on food being imported or offered for import into the United States before that food arrives at the port of entry. FDA targets, screens, and reviews the information to ensure that the information meets the prior notice requirements and to determine whether the food potentially poses a terrorism threat or other significant health risk.

Admissibility screening is intended to ensure that the food is admissible under FFDCA. As part of admissibility screening, FDA electronically screens entry lines using PREDICT to determine, among other things, whether the product on the entry line is on an import alert. If the product on an entry line is on an import alert, then the entry line may be detained without physical examination. If the product is not on an import alert, then the entry line goes through the typical admissibility screening process through which FDA uses PREDICT to calculate a risk score and determine whether the entry line is identified for potential examination or sampling.

Under Its Import Alert Process for Seafood Products, FDA Detains Affected Products and Removes Firms and Products from Alerts When Violations Are Resolved

Our review of FDA’s Regulatory Procedures Manual found that FDA’s import alert process for seafood products includes three key components: (1) establishing new import alerts to respond to human health risks, (2) placing firms and products on new or existing import alerts (placement decisions), and (3) removing firms and products from existing import alerts when violations are resolved (removal decisions).

FDA Establishes New Seafood Import Alerts to Respond to Human Health Hazards

According to FDA’s Regulatory Procedures Manual, FDA establishes new seafood import alerts to respond to human health hazards. FDA officials may recommend new import alerts for a variety of reasons, including the following:

FDA officials detain one or more products for a violation of FFDCA that poses a significant health hazard (e.g., the presence of Salmonella);

FDA officials notice a large number of violations affecting firms or products from a specific country or area (e.g., the presence of filth in canned crabmeat from Thailand);

FDA enforces regulatory requirements affecting importers that the agency decides could be implemented, in part, through the use of an import alert (e.g., HACCP requirements); or

FDA addresses concerns about the safety of specific products, including puffer fish, which contain a deadly neurotoxin, or products produced in geographic areas with known contamination, such as those from areas surrounding Fukushima, Japan, which are at risk of radionuclide contamination.

FDA officials in the field or at headquarters may recommend new import alerts. FDA’s Division of Import Operations reviews the recommendations and decides whether to approve them (called the clearance process). After approval, according to FDA officials, FDA revises its screening process at the ports of entry via PREDICT to screen for products, firms, or countries on the new alert.

According to FDA’s import alert data, as of July 3, 2018, FDA had 52 active import alerts affecting imported seafood that addressed a wide range of seafood products and violations of FFDCA. The range of violations that these alerts address included the presence of foodborne pathogens, such as Salmonella and E. coli; the presence of unapproved animal drug residues, such as chloramphenicol and nitrofurans; the presence of pesticide chemical residues that are not allowed or do not meet tolerance levels, such as diuron; the presence of decomposition or insect, rodent, or other filth; the presence of illegal or undeclared colors, undeclared food additives, such as high fructose corn syrup, or undeclared food allergens, such as milk; the failure of the firm to meet HACCP requirements; and the failure of the firm to operate in conformity with current good manufacturing practices.

According to FDA’s import alert data, overall, from October 1, 2011, through July 3, 2018, the 52 import alerts for imported seafood affected a total of 3,765 unique firms in 111 countries. (See app. I for information describing these 52 alerts.)

FDA Places Certain Seafood Firms and Products on Existing Import Alerts and Detains Affected Products

According to FDA’s Regulatory Procedures Manual, after an import alert has been established, FDA places certain seafood firms or products on the alert and may detain affected products at the port of entry to prevent them from entering U.S. commerce pending the importer of record’s response. The manual specifies that FDA may place firms or products on a new or existing import alert for the following violations of FFDCA: (1) products are manufactured, processed, or packed under insanitary conditions; (2) products are forbidden or restricted for sale in the country in which they were produced or from which they were exported; or (3) products appear to be adulterated or misbranded based on information such as the product’s history of violations, among other things. Examples of adulteration may include pathogens, such as Salmonella, and residues of drugs or pesticides above accepted levels.

FDA’s Regulatory Procedures Manual also specifies the following types of evidence that FDA generally may rely on to show that violative conditions exist: one violative sample from FDA’s examination of the product, if the product may have adverse health consequences; information and historical data, such as a firm showing a pattern of exporting violative products, if evidence indicates the product could pose a health hazard; multiple violative samples, for violations (such as decomposition, filth, or labeling) that do not pose a significant public health hazard; and violations identified during inspections of importers or foreign processing facilities.

According to FDA officials, about 90 percent of the recommendations to place firms or products on an import alert result from FDA analysis of imported seafood samples that identified product violations, such as drug residues above acceptable levels. Officials stated that the remaining 10 percent of the recommendations arise from FDA inspections of importers or processing facilities that identify firm violations, such as violations of FFDCA related to HACCP requirements.

According to FDA’s Regulatory Procedures Manual, once a firm or product has been placed on an import alert, future shipments may be detained without physical examination, and the importer of record must decide how to respond. The importer of record receives a notice stating that the associated entry line is being detained and subject to refusal. The importer of record may request that FDA immediately refuse entry of the product, in which case the product must either be exported or destroyed. Alternatively, the importer of record may (1) submit evidence showing that the product does not appear to be violative or (2) request to “recondition” the product—for example, relabel the product or convert the product into a type of product FDA does not regulate.

According to FDA’s Regulatory Procedures Manual, FDA will hold a hearing to determine whether the detained product should be released. If FDA determines that the importer of record has provided sufficient information to overcome the appearance of a violation, the importer of record receives a notice stating that the product is released. If FDA determines that the importer of record’s actions did not bring the product into compliance, the product would be refused and must be exported elsewhere or destroyed.

FDA May Remove Firms and Products from Existing Import Alerts When Violations Are Resolved

FDA may decide to remove a firm or product from an import alert if there is evidence that the conditions that led to placement on the alert have been resolved, according to FDA’s Regulatory Procedures Manual. Our review of the manual and interviews with FDA officials indicate that FDA sampling and inspections are key activities that support the agency’s removal decisions. Generally, firms petition FDA to remove one or more products or the firms themselves from seafood import alerts, and FDA’s Division of Import Operations reviews the petitions. FDA’s procedures specify the evidence that firms are to submit, which varies depending on the nature of the import alert and the violation of FFDCA.

FDA may require one or a combination of the following: a minimum of five consecutive nonviolative commercial shipments as determined by a private laboratory hired by the firm, an on-site inspection of the importer or foreign processing facility, or documentation showing that the cause of the violation has been fully corrected. For example, according to FDA’s procedures, firms or products placed on an import alert based on a violative facility inspection may generally be removed from the alert following a reinspection that shows that corrective actions to resolve the violation have been taken. Private laboratories usually collect and analyze the samples used as evidence to indicate that a commercial shipment does not violate FFDCA and provide support for FDA’s decisions to remove firms and products from import alerts. The procedures also call for the agency to have confidence that future shipments will comply with FFDCA, but they do not specify how FDA should ensure continued compliance. According to FDA officials, when the agency relies on documentation to support a removal decision, FDA generally relies on subsequent inspections of the importers or foreign processing facilities and sampling of their products to have confidence that the firms and their products continue to comply.

FDA’s Regulatory Procedures Manual, as supplemented by the ORA Laboratory Manual, specifies that the agency should conduct checks to review whether the work performed by such laboratories can be used as an appropriate basis for FDA’s removal decisions. These checks include the following:

Audit samples. FDA’s manuals specify the following two audit goals to ensure that the private laboratories’ analyses that FDA uses to support its removal decisions are valid: (1) to audit samples from at least one of the five nonviolative entries, as determined by a private laboratory that the firm hired, to support a removal decision to ensure the validity of the laboratory’s analysis and (2) to audit at least 10 percent of the work that a private laboratory performed to ensure that the laboratory submits scientifically sound data. In the course of its audits, FDA is to collect samples, called audit samples, to verify analytical results from a private laboratory that demonstrates a product complies with FFDCA. According to FDA, private laboratory analyses are a critical element in public health protection because they support FDA decisions to release detained goods. FDA’s collection of audit samples is intended to provide confidence in the laboratories’ analytical results.

On-site assessments. FDA’s ORA Laboratory Manual states that, at times, FDA visits a private laboratory to ascertain that it has the capability or capacity to perform analyses that FDA often relies on to support removal decisions. The manual also states that on-site assessments provide the opportunity to observe that equipment and standards, among other things, needed to conduct the proposed analyses are present and in good order; to review the adequacy of the laboratory’s quality assurance and record-keeping programs; and to observe the techniques and practices of the analysts. Furthermore, the manual states that the on-site assessments are voluntary and that a private laboratory may decline to participate.

FDA’s Oversight of Key Activities to Support Import Alert Removal Decisions Is Limited

FDA has established audit goals, requirements, and expectations related to sampling and inspections—key activities to support import alert removal decisions—but does not monitor the extent to which it is meeting them.

In our review of FDA’s CMS data for 274 removal decisions from a nongeneralizeable selection of seven import alerts from October 1, 2011, through July 3, 2018, we found that FDA conducted audit sampling and inspections to support removal decisions and subsequent sampling and inspections to ensure continued compliance for a small percentage of the decisions. Specifically:

Audit samples prior to removal decisions. For almost all of the 274 removal decisions we reviewed, FDA did not meet its first audit goal— to audit samples from at least one of the nonviolative shipments used to support a removal decision to ensure the validity of the analysis of the private laboratory hired by the firm. All seven of the import alerts we reviewed were established for violations of FFDCA for which FDA’s Regulatory Procedures Manual specifies that firms should enter into U.S. commerce at least five consecutive nonviolative commercial shipments, as determined by a private laboratory hired by the firm, before FDA may consider a removal. Therefore, FDA should have audited samples from at least one nonviolative shipment for all 274 removal decisions related to these seven import alerts. As described earlier, FDA collects audit samples from shipments of imported seafood to conduct such audits. However, we found that FDA did not conduct any sampling, including audit sampling, within 1 year prior to removal for 260 (or 95 percent) of the 274 removal decisions we reviewed. FDA officials told us that they do not monitor the extent to which the agency is meeting its audit goal, such as through analyzing CMS sampling data across all firms and products affected by the alerts and therefore were not aware that the agency had not met the audit goal.

Conversely, FDA officials told us that they were aware that the agency historically had not met its second audit goal specified in its procedures—to audit at least 10 percent of each private laboratory’s work to support removal decisions to ensure that each laboratory submits scientifically sound data. While FDA does not regularly monitor whether it is meeting its 10 percent audit goal, in 2014, the agency analyzed data on the audit samples it collected during its audits of shipments covering fiscal years 2003 through 2013. FDA conducted this analysis in response to concerns that district staff raised about the quality of the analyses performed by private laboratories for one of its districts. These concerns included the following:

Failure to obtain representative samples from throughout a shipment.

Failure to obtain samples randomly from throughout the shipment.

Failure to ensure an unbroken chain of custody from the site of collection of a sample to the private laboratory as necessary to ensure the integrity of the sample.

Use of untrained temporary employees to collect samples and representing these individuals as employees of the private laboratory.

FDA’s 2014 analysis showed that the agency did not achieve its 10 percent audit goal during the 11-year period. According to the analysis, FDA audited about 1 to 2 percent of work performed by private laboratories to support removal decisions.

In response to our request, FDA updated its analysis through fiscal year 2018. The updated analysis shows that this percentage has improved in recent years, with FDA auditing about 3 percent of the work that private laboratories performed for fiscal year 2018. However, this level of auditing remains far below the goal of at least 10 percent, as shown in figure 1. According to FDA officials, the agency has not met this audit goal largely because it has limited resources.

Inspections prior to removal decisions. For the 274 removal decisions we reviewed, FDA conducted inspections of importers or foreign processing facilities for 28 (about 10 percent) of the removal decisions in the 6 months prior. According to FDA’s procedures, firms or products placed on an import alert based on a violative facility inspection may generally be removed from the alert following a reinspection of the importer or foreign processing facility. In some instances, a firm may present information or documentation sufficient to demonstrate that appropriate corrections are in place to overcome the appearance of a violation and, with appropriate concurrence, may be removed from the import alert. FDA officials added that, regardless of the basis for placement on an import alert, FDA could require an on-site inspection prior to removal, depending on the hazard the violation posed. For example, certain violations may result in a finding of “official action indicated” (OAI), which indicates that an establishment failed to meet regulatory or administrative requirements and may pose a hazard to public health. FDA’s Field Management Directive 86 establishes a goal for FDA staff to conduct a follow-up inspection within 6 months after an OAI finding to verify that the facility has corrected violations. In our review of the 274 removal decisions, we found that for 32 firms that received an OAI inspection finding after FDA issued the directive in December 2011, FDA did not conduct a follow-up inspection for 31 of these firms before removing them from an import alert. According to FDA officials, the agency did not monitor whether its staff decided that inspections would be expected for the 274 removal decisions or whether the facilities that received an OAI inspection finding were reinspected. FDA officials told us that the agency relied on reviewing data on removal decisions individually to ensure that expected inspections had been conducted. Consequently, FDA was not aware of the extent to which the facilities associated with the removal decisions were actually inspected.

Sampling or inspections following removal decisions. As shown in figure 2, for the 274 removal decisions we reviewed, FDA subsequently conducted sampling for 6 percent of the products at ports of entry and inspections for 13 percent of the importers or foreign processing facilities within 1 year after removal. FDA does not have a goal for the amount of sampling or inspections that should be conducted following removal decisions; however, as described above, FDA’s procedures call for the agency to base removal decisions on evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved and that the agency has confidence that future shipments will comply with FFDCA.

FDA officials said that when the agency does not inspect a facility and relies on documentation describing the actions the firm has taken to address the appearance of a violation to support a removal decision, the agency relies on subsequent sampling and inspections to have confidence in continued compliance. According to FDA, the past violative history of a firm is reflected in the PREDICT screening rules for the examination of future shipments and in the process of prioritizing inspections of foreign facilities. It was unclear from the CMS data that FDA provided the extent to which the agency relied on documentation to support the remainder of its removal decisions. However, based on FDA officials’ statements about subsequent sampling or inspections, we would expect to see a larger percentage of products sampled and firms inspected after their removal from import alerts for FDA to have confidence in continued compliance given the low percentage of inspections we found before removal decisions. FDA officials said they were not monitoring whether staff decided that subsequent sampling and inspections would be expected for these removals, and staff do not continuously monitor post- removal activities. Consequently, FDA officials were not aware of the extent to which the products and foreign processing facilities associated with removal decisions were subsequently sampled and inspected.

FDA officials told us that they were generally aware that FDA had conducted limited sampling and inspections to support removal decisions and have confidence in continued compliance. They attributed this limited sampling and inspections to their belief that many import alert removal decisions can be supported by reviewing documentary evidence that FDA requested and the firms provided that describes the actions the firms have taken to address the appearance of a violation. According to FDA officials, such reliance on firm-provided documentation to support removal decisions is, in part, how FDA prioritizes its use of limited laboratory and inspection resources.

FDA officials stated that the agency can check the basis of its removal decisions by looking up individual import alert cases in CMS and the agency’s sampling and inspection data in FACTS and OASIS to determine whether the agency would conclude that sampling and inspections to support these decisions would be appropriate, and if so, whether they were done. These officials said that they believed that checking the data on the basis of removal decisions individually and when questions arise from sources internal or external to FDA, instead of regularly analyzing sampling and inspections data, was sufficient to ensure the appropriate level of oversight. However, as discussed above, this approach has not informed them of the extent to which the agency is meeting its audit goals and expectations.

Standards for internal control in the federal government state that management should design control activities to achieve objectives and respond to risks. An example of such control activities includes management comparing actual performance with planned or expected results. Such a comparison could include FDA comparing audits conducted with its audit goal (e.g., auditing at least 10 percent of a private laboratory’s work) to ensure that its goal was met. Monitoring the extent to which the agency is meeting its audit goals and expectations for conducting sampling and inspections to support its import alert decisions would enhance its oversight of these activities to better protect U.S. consumers from imported seafood that is not safe and wholesome.

FDA Generally Has Not Coordinated with DHS to Help Ensure Firms Comply with Seafood Import Alerts

FDA and DHS have established a mechanism for coordinating the use of certain resources, but they generally have not coordinated to help ensure that firms comply with seafood import alerts by identifying potential instances of evasion of alerts, according to agency officials. FDA officials stated that the agency can coordinate with CBP in situations that could involve evasion of import alerts, but the agency does not have a formal mechanism for regularly and proactively coordinating to identify evasion. FDA officials said that such coordination could include CBP sharing information that could help FDA identify instances of evasion.

As previously noted, CBP is responsible for collecting customs duties on imports, including seafood, and seeks to prevent the evasion of customs duties. As we reported in 2012, CBP personnel are to analyze trends in import data, among other things, to look for anomalies that may indicate evasion and also follow up on allegations from external sources. Once CBP identifies a potential instance of evasion, it can use a variety of techniques at different points in the import process to determine whether evasion is actually occurring. These techniques include collecting samples from shipments of products at U.S. ports of entry and conducting laboratory analyses of these samples to identify their true country of origin. Through its efforts, CBP has identified illegal transshipments—a scheme to conceal the country of origin and thereby evade applicable duties or FDA’s import alerts. For example, CBP reported that in 2016, customs officers seized about 42 tons of Chinese honey that had been transshipped through Taiwan to evade U.S. duties applicable to Chinese honey. According to FDA documents, at the same time, FDA had an import alert for honey because of unsafe drug residues. This alert included Chinese firms, but did not include any firms from Taiwan.

In February 2009, we reported on CBP’s expertise in detecting illegal transshipment that could enhance FDA’s ability to detect import alert evasion. We stated that FDA and CBP could work together to help ensure that importers were not attempting to evade duties or import alerts.

However, we found that the agencies had not identified ways to maximize and leverage their resources or established processes and policies for working together systematically across agency lines. We recommended, among other things, that FDA and CBP develop mechanisms to share information related to the evasion of import alerts. FDA and CBP agreed with our recommendation, but as of July 2019, the agencies had not fully implemented it.

Specifically, FDA and CBP signed a memorandum of understanding (MOU), effective May 2013, to set forth terms for CBP to coordinate with FDA on staffing, space, and equipment requirements for the National Targeting Center. However, the MOU does not address CBP sharing information on potential evasion of import alerts with FDA regularly or the agencies working proactively to identify such evasion. According to CBP officials, FDA and CBP do not coordinate specifically on targeting to detect evasion, but CBP would be willing to coordinate with FDA and provide any applicable expertise in this area.

While a collaborative mechanism such as an MOU is not needed to share information, we continue to believe that FDA and CBP should develop a mechanism to help the agencies formally coordinate to identify potential evasion of seafood import alerts. Until these agencies develop such a mechanism, they may be missing opportunities to share information regularly that could benefit each agency’s efforts to detect illegal transshipment and help FDA proactively identify and prevent evasion of seafood import alerts.

FDA Has Not Assessed the Effectiveness of Its Seafood Import Alerts in Achieving Its Food Safety Mission

FDA has not assessed the effectiveness of its seafood import alerts in helping to achieve its food safety mission. Specifically, FDA has not established performance goals and measures for seafood import alerts— key elements of assessing the effectiveness of programs. Performance goals explain the purpose of agency programs and the results—including outcomes—that they intend to achieve. Performance measures provide organizations with the ability to track the progress they are making toward their mission and goals and provide managers with information on which to base their organizational and management decisions. Under GPRAMA, agencies are required to develop long-term strategic plans and establish results-oriented goals in alignment with their missions and identify objectives and strategies needed to achieve those goals. GPRAMA also requires agencies to use performance information to assess their progress toward achieving their goals.

According to FDA officials, the agency is implementing a program, which it refers to as an import alert effectiveness program, to review its import alerts. FDA documents note that the focus of this program includes (1) determining if FDA identified the firms on import alerts during its admissibility screening and took the appropriate action, (2) ensuring the accuracy of data FDA maintains in CMS on firms on import alerts, and (3) determining whether the reasons for the alerts are still relevant, and ensuring that the import alerts are accurately posted for clear communication to industry and FDA field staff. We commend FDA for these efforts. However, according to our review of FDA documents describing the activities planned for this program, the program does not include performance goals and measures for import alerts. FDA officials stated that this is because the program is new.

Additionally, in February 2019, FDA published a broad plan for the safety of imported food that includes a goal, objective, and strategy related to import alerts. Under its goal to detect and refuse entry of unsafe foods at the border, FDA has an objective to strategically use import alerts and import certifications by using data and information from oversight activities, regulatory cooperation, and other reliable sources to enhance the effectiveness and efficiency of import alerts. However, FDA’s strategy for achieving this objective does not include performance goals or measures that would allow the agency to assess the effectiveness of its seafood import alerts in helping to achieve FDA’s food safety mission. In its 2019 plan for the safety of imported food, FDA states that it intends to develop performance goals and measures for imported food safety.

However, FDA has not established a time frame for doing so. Once FDA has developed goals and measures for imported food safety, FDA would be able to establish corresponding performance goals and measures specific to seafood import alerts. By developing such goals and measures, FDA would be better positioned to assess how well its seafood import alert activities are supporting the agency in achieving its food safety mission.

Conclusions

Import alerts play an important role in keeping the U.S. food supply—as well as other FDA-regulated products—safe, and FDA has numerous active import alerts affecting imported seafood that address a wide range of seafood products and violations of FFDCA. However, FDA does not have a process to monitor the extent to which it is conducting key activities to support its removal decisions—sampling and inspections. Establishing such a process would provide greater assurance that FDA is conducting its expected level of sampling and inspections to support its removal decisions and have confidence in continued compliance.

Additionally, FDA and CBP have yet to develop mechanisms to share information regularly and proactively that can help detect noncompliance with import alerts through evasion. We continue to believe that doing so, as we previously recommended, would enhance the agencies’ efforts to identify potential evasion of seafood import alerts.

Further, by establishing a time frame for developing goals and measures for assessing the effectiveness of its imported food safety efforts and also developing such goals and measures specific to seafood import alerts, FDA would be better positioned to assess how well its import alert activities are supporting the agency in achieving its food safety mission.

Recommendations for Executive Action

We are making the following three recommendations to FDA:

The Commissioner of FDA should establish a process to monitor whether the agency is meeting its audit goals and expectations for sampling and inspections to support its removal decisions for seafood import alerts. This could be done through regularly analyzing data that FDA collects, such as those in CMS, FACTS, and OASIS. (Recommendation 1)

The Commissioner of FDA should establish a time frame for developing performance goals and measures for its imported food safety program. (Recommendation 2)

The Commissioner of FDA should, as the agency develops goals and measures for its imported food safety program, develop performance goals and corresponding performance measures specific to seafood import alerts. (Recommendation 3)

Agency Comments and Our Evaluation

We provided a draft of this report to HHS and DHS for comment. In its comments, reproduced in appendix II, HHS’s FDA agreed with all three of our recommendations. FDA also provided technical comments, which we incorporated as appropriate. DHS provided technical comments, which we incorporated as appropriate.

More specifically, FDA agreed with our recommendation that it establish a process to monitor whether the agency is meeting its audit goals and expectations for sampling and inspections to support its removal decisions for seafood import alerts. FDA stated that it agrees that developing metrics and monitoring the import alert removal process is necessary and that these efforts should be guided by the analysis of available data. FDA also stated that it plans to develop goals for its auditing process to ensure audit sampling targets products of higher public health concern and provides the agency support to guide decisions to release individual shipments that have been detained as a result of an import alert. FDA further stated that it intends to enhance its case management system to include checklists for FDA reviewers who process petitions for removal from import alerts to better document that all necessary information is present and has been evaluated to support the removal decision.

FDA agreed with our recommendation that it should establish a time frame for developing performance goals and measures for its imported food safety program. FDA stated that the agency is developing performance measures and outcome indicators for imported food safety to help support the agency’s overall goal of reducing the incidence of illness and death attributable to preventable contamination of FDA- regulated foods.

Finally, FDA agreed with our recommendation that it should, as it develops goals and measures for its imported food safety program, develop performance goals and corresponding performance measures specific to seafood import alerts. FDA stated that the agency will use the results of its import alert effectiveness program to develop metrics to demonstrate the effectiveness of the program and its use of import alerts. The extent to which FDA’s planned actions will satisfy our recommendations will depend on how FDA implements those actions.

As agreed with your offices, unless you publicly announce the contents earlier, we plan no further distribution of this report until 30 days from the report date. At that time, we will send copies to the appropriate congressional committees, the Secretary of Health and Human Services, the Secretary of Homeland Security, and other interested parties. In addition, the report will be available at no charge on the GAO website at http://www.gao.gov.

If you or your staff members have any questions regarding this report, please contact me at (202) 512-3841 or morriss@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix III.

Appendix I: Food and Drug Administration Import Alerts Affecting Seafood Products

Table 1 includes information posted on the Food and Drug Administration’s website describing the 52 import alerts affecting seafood that were active as of July 3, 2018.

Appendix II: Comments from the Department of Health and Human Services

Appendix III: GAO Contact and Staff Acknowledgments

GAO Contact

Staff Acknowledgments

In addition to the contact named above, Anne K. Johnson (Assistant Director), David Moreno (Analyst in Charge), Kevin Bray, Steven Campbell, Stephen Cleary, Michele Fejfar, Ellen Fried, Juan Garay, Caitlyn Leiter-Mason, Ying Long, Cynthia Norris, Dan Royer, and Kiki Theodoropoulos made key contributions to this report.

Related GAO Products

Food Safety and Nutrition: FDA Can Build on Existing Efforts to Measure Progress and Implement Key Activities. GAO-18-174. Washington, D.C.: January 31, 2018.

Imported Seafood Safety: FDA and USDA Could Strengthen Efforts to Prevent Unsafe Drug Residues. GAO-17-443. Washington, D.C.: September 15, 2017.

Seafood Safety: Status of Issues Related to Catfish Inspection. GAO-17- 289T. Washington, D.C.: December 7, 2016.

Imported Food Safety: FDA’s Targeting Tool Has Enhanced Screening, but Further Improvements Are Possible. GAO-16-399. Washington, D.C.: May 26, 2016. 2015 Annual Report: Additional Opportunities to Reduce Fragmentation, Overlap, and Duplication and Achieve Other Financial Benefits. GAO-15- 404SP. Washington, D.C.: April 14, 2015.

Food Safety: FDA Can Better Oversee Food Imports by Assessing and Leveraging Other Countries’ Oversight Resources. GAO-12-933. Washington, D.C.: September 28, 2012.

Managing for Results: Key Considerations for Implementing Interagency Collaborative Mechanisms. GAO-12-1022. Washington, D.C.: September 27, 2012.

Seafood Safety: Responsibility for Inspecting Catfish Should Not Be Assigned to USDA. GAO-12-411. Washington, D.C.: May 10, 2012.

Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources. GAO-11-286. Washington, D.C.: April 14, 2011.

Seafood Fraud: FDA Program Changes and Better Collaboration among Key Federal Agencies Could Improve Detection and Prevention. GAO-09- 258. Washington, D.C.: February 19, 2009.

Results-Oriented Government: Practices That Can Help Enhance and Sustain Collaboration among Federal Agencies. GAO-06-15. Washington, D.C.: October 21, 2005.