Food Safety: FDA Could Strengthen Oversight of Imported Food by Improving Enforcement and Seeking Additional Authorities
Released: 2010-05-06T00:00:00

Letter

While the Number of FDA Overseas Inspections Has Fluctuated, the Agency Has Opened Overseas Offices, and Has Piloted PREDICT

In 2008, FDA inspected 153 foreign food facilities out of an estimated 189,000 such facilities registered with FDA and estimated that it would conduct 200 inspections in 2009 and 600 in 2010. In 2007, FDA inspected 95 facilities. Table 1 shows the number of FDA inspections of foreign food facilities, by country, from fiscal years 2001 through 2008. As the table shows, FDA conducted 1,186 inspections in 56 countries from fiscal years 2001 through 2008; the majority of FDA inspections were in Mexico, followed by Ecuador, Thailand, and Chile. FDA conducted a total of 46 inspections in China during this period.

For fiscal year 2009, FDA allocated 272 full-time employees to examine imported food shipments at U.S. ports of entry and estimated a budget of approximately $93.1 million for field import activities. The total estimated 2009 FDA budget for all FDA products and programs, including food, drugs, medical devices, and other products, was $2.7 billion. In 2008, we testified that if FDA were to inspect each of the 189,000 registered foreign facilities—at the FDA Commissioner’s estimated cost of $16,700 per inspection—it would cost FDA approximately $3.2 billion to inspect all of these facilities once.

Since November 2008, FDA has opened overseas offices to help prevent food that violates U.S. standards from reaching the United States. These offices are expected to provide FDA with direct access to information about foreign facilities’ food manufacturing practices so that its staff at U.S. ports of entry can make more informed decisions about which food imports to examine. For example, FDA’s overseas staff are working with staff at counterpart regulatory agencies overseas, as well as with other stakeholders who may be knowledgeable about certain industries. Overseas staff are also educating local exporters to make sure they understand U.S. food safety laws and regulations and FDA expectations. FDA opened offices in China (Beijing, Guangzhou, and Shanghai); in Europe (Brussels, London, and soon in Parma, Italy); in Latin America (San Jose, Costa Rica; Santiago, Chile; and Mexico City, Mexico); and in India (New Delhi and Mumbai). The FDA Middle East Office is operating out of FDA headquarters because the Department of State denied its request to locate in Amman, Jordan, due to security concerns.

In addition to having overseas offices assist FDA’s oversight of imported food, the agency is developing PREDICT. PREDICT is intended to assist FDA’s oversight of imported food and uses FDA-developed criteria to estimate the risk of imported food shipments. These criteria are to incorporate, among other things, the violative histories of the product, importer, manufacturer, consignee, and country of origin; the results of laboratory analyses and foreign facility inspections; and general intelligence on recent world events—such as natural disasters, foreign recalls, and disease outbreaks—that may affect the safety of a particular imported food product. In addition, agency officials stated that PREDICT will assign higher risk scores to firms for which the system does not have historical data.

PREDICT generates a numerical risk score for all FDA-regulated products. According to FDA, PREDICT is to present the shipment’s risk score to FDA reviewers if the score is above an FDA-specified threshold. Shipments that are below the threshold are to receive a system “may proceed” (cleared) message unless other conditions are present, such as an FDA import alert. FDA intends that reviewers using PREDICT will also be able to view the specific risk factors that contributed to the shipment’s risk score, such as whether the product or importer has a history of FDA violations. FDA expects reviewers to use PREDICT to supplement, rather than replace, their professional judgment when deciding what food products to inspect.

A 2007 pilot test of PREDICT in Los Angeles for seafood products indicated that the system could enhance FDA’s risk-based import screening efforts. When compared with baseline data from FDA’s existing import screening system, the Operational and Administrative System for Import Support (OASIS), PREDICT improved FDA’s ability to target imports that the agency considers to be high risk for further examinations and allowed a greater percentage of products the agency considers to be low risk to enter U.S. commerce without requiring a reviewer’s intervention. Specifically, PREDICT nearly doubled the percentage of field examinations—and increased by approximately one-third the percentage of laboratory examinations—that resulted in violations, relative to baseline OASIS data. In addition, according to FDA, the violations in shipments that reviewers targeted using PREDICT, on average, posed a greater risk to human health than the violations that OASIS detected.

FDA told us on April 12, 2010, that PREDICT is fully operational in the Los Angeles and New York districts, but due to technical problems, FDA has not determined when the system will be deployed in the Seattle district. In addition, FDA officials stated that a scheduled nationwide rollout of PREDICT this summer has been delayed, primarily because of technical problems, such as server crashes and overloads, which are affecting FDA’s field data systems nationwide.

Although the PREDICT pilot produced positive results and demonstrated the system’s potential to improve import screening efforts, we reported that further agency actions were needed to help ensure that the system is effective. For example, FDA had not yet developed a performance measurement plan to evaluate, among other things, PREDICT’s ability to identify high-risk shipments for manual review while simultaneously returning “may proceed” messages for low-risk shipments and enabling them to enter U.S. commerce. We recommended FDA develop such a plan. According to agency officials, since our report was issued in September 2009, FDA had completed a draft performance measurement plan. However, we have not reviewed this draft plan.

FDA and Other Agencies Face Gaps in Enforcement That Undermine Efforts to Ensure the Safety of Imported Food

We identified specific gaps in enforcement that could allow violative food products to enter U.S. commerce: (1) FDA’s limited authority to assess civil penalties on certain violators; (2) lack of unique identifiers for firms exporting FDA-regulated products; (3) lack of information-sharing between agencies’ computer systems and (4) FDA’s not sharing product distribution information during a recall.

FDA Has Limited Authority to Ensure Importers’ Compliance

Importers can retain possession of their food shipments until FDA approves their release into U.S. commerce. However, FDA and CBP officials do not believe that CBP’s current bonding procedures for FDA- regulated food effectively deter importers from introducing violative food products into U.S. commerce. Specifically, importers post a monetary bond for formal entries (i.e., all shipments exceeding $2,000 and certain shipments valued below that amount) to provide assurance that these shipments meet U.S. requirements. According to these officials, many importers still consider the occasional payment of forfeited bonds as part of the cost of doing business. Indeed, as we reported in 1998, forfeiture of the shipment’s maximum bond value is often not sufficient to deter the sale of imported goods that FDA has not yet released. In its response to our September 2009 report, FDA agreed with this finding. According to FDA’s regulatory procedures manual, the bond penalty is intended to make the unauthorized distribution of articles unprofitable, but liquidated damages incurred by importers are often so small that they, in effect, encourage future illegal distribution of imported shipments. Even though the bond may be up to three times the value of the shipment, for a large importer, this sum may be negligible, especially when the importer successfully petitions CBP to reduce the amount.

We recommended that the FDA Commissioner seek authority from Congress to assess civil penalties on firms and persons who violate FDA’s food safety laws and that the Commissioner determine what violations should be subject to this new FDA civil penalties authority, as well as the appropriate nature and magnitude of the penalties. FDA agreed with this recommendation and was working with Congress to include civil penalty authority in food safety legislation. FDA officials also told us that if the agency had the authority to impose civil penalties on importers, which is also provided for in H.R. 2749, FDA might be better able to deter violations.

FDA and CBP Do Not Provide Unique Identification Numbers to Firms

High-risk foods may enter U.S. commerce because the identification numbers that FDA uses to target manufacturers that have violated FDA standards in the past are not unique, and therefore these manufacturers and their shipments, may evade FDA review. Importers generate a manufacturer identification number at the time of import, when, among other things, they electronically file entry information with CBP. (CBP is responsible for validating the manufacturer identification numbers and ensuring they are unique.) CBP electronically sends this information to FDA’s computer system. From this new manufacturer identification number, FDA’s computer system automatically creates an FDA firm identification number—called the FDA establishment identifier. Officials told us that a single firm may often have multiple CBP manufacturer identification numbers—and therefore multiple FDA establishment identifiers. FDA officials told us that because CBP has multiple identification numbers for many firms, FDA has an average of three “unique” identifiers per firm, and one firm had 75 identifiers.

The creation of multiple identifiers can happen in a number of ways. For example, if information about an establishment—such as its name—is entered by importers incorrectly at the time of filing with CBP, a new manufacturer identification number, and therefore a new FDA establishment identifier, could be created for an establishment that already has an FDA number. In this scenario, an importer may— intentionally or unintentionally—enter a firm’s name or address slightly differently from the way it is displayed in FDA’s computer system. This entry would lead to the creation of an additional FDA number for that firm. If an import alert was set using the original FDA establishment identifier, a shipment that should be subject to the import alert may be overlooked because the new number does not match the one identified in the alert.

In addition, foreign facilities that manufacture, process, pack, or hold food for consumption in the United States, with some exceptions, are required to register with FDA. Upon registration, FDA assigns a registration number. FDA calculated that in 2008, 189,000 foreign firms were registered under this requirement. However, some of the firms included in that total may be duplicates because the facility may have been reregistered without the cancellation of the original registration; consequently FDA may not know the precise number of foreign firms registered. As we previously reported, FDA officials told us they are working to address the unique identifier problem by establishing an interactive process in which FDA’s systems recognize when a product’s identifier does not match its manufacturer’s registration number.

As we reported, FDA could consider requiring food manufacturers to use a unique identification number that FDA or a designated private sector firm provides at the time of import. However, the use of this unique number would necessitate collaboration with CBP, since importers would use such a number each time they file with CBP to ship goods to the United States. That is, CBP’s computer system would need to be programmed to accept an FDA unique identification number. According to CBP officials, it is unknown if or when CBP’s system will have this capability. To improve FDA’s and CBP’s ability to identify foreign firms with violative histories, we recommended that the FDA Commissioner explore ways to improve the agency’s ability to identify foreign firms with a unique identifier and that the CBP Commissioner ensure that its computer system is able to accept a unique identification number for foreign firms that export FDA- regulated foods. Both FDA and CBP agreed with our recommendation, and CBP officials told us that the agency has developed a plan for implementing a unique identifier. However, we have not reviewed this plan. We observe that H.R. 2749 contains a provision that may allow the Secretary of Health and Human Services, in consultation with the Commissioner of CBP, to specify the unique numerical identifier system to be used, taking into account compatibility with CBP’s automated systems. Such actions would help prevent high-risk foods from entering U.S. commerce.

Information Is Not Shared between Computer Systems

When we issued our report in September 2009, we reported that CBP’s computer system did not notify FDA’s or FSIS’s systems when imported food shipments arrive at U.S. ports, which increases the risk that potentially unsafe food may enter U.S. commerce, particularly at truck ports. If FDA chooses to examine a shipment as part of its admissibility review, the agency notifies both CBP and the importer through its computer system, OASIS. However, once the shipment arrives at the port and clears CBP’s inspection process, the importer is not required to wait at the port for FDA to conduct its examination. Instead, the importer may choose to transport the shipment to the consignee’s warehouse or other facility within the United States. The importer might choose to do so because, for example, CBP and FDA do not have the same hours of operation at some ports, and FDA’s port office may be closed when the shipment arrives. In such cases, as a condition of the bond with CBP, the importer agrees to hold the shipment intact and not distribute any portion of it into U.S. commerce until FDA has examined it.

CBP and FDA officials told us that, occasionally, an importer will transport the shipment to the consignee’s warehouse without first notifying FDA. If this occurs, FDA will not quickly know that the shipment has arrived and been transported to a U.S. warehouse because CBP’s computer system does not notify FDA’s OASIS computer system when the shipment arrives at the port. Instead, from the perspective of an FDA reviewer using OASIS, it will appear as if the shipment’s arrival is still pending. FDA port officials told us that it could be 2 or 3 days before FDA reviewers become suspicious and contact CBP to inquire about the shipment’s arrival status. By this time, an unscrupulous importer could have distributed the shipment’s contents into U.S. commerce without FDA’s approval. As we reported, if CBP communicated time-of-arrival information directly to OASIS, then FDA would be able to quickly identify shipments that are transported into the United States without agency notification and arrange to examine them before they are distributed to U.S. markets. Since our report was issued in September 2009, CBP told us that it had modified its software to notify FDA of a shipment’s time of arrival. However, we have not reviewed the effectiveness of these modifications. We are still waiting to see whether CBP has an agreement with FSIS regarding time of arrival modifications.

FDA Does Not Always Share Product Distribution Information During a Recall

One key issue of concern, according to officials we spoke with from several states, is that FDA does not always share with states certain distribution-related information, such as a recalling firm’s product distribution lists, which impedes the states’ efforts to quickly remove contaminated products from grocery stores and warehouses. According to one state official, because FDA does not provide this information, the state has to spend time tracking it down on its own. Public health may be at risk during the time it takes for the states to independently track distribution information when a product is found to be contaminated. FDA told us that it usually considers such information to be confidential commercial information, the disclosure of which is subject to statutory restrictions, such as the Trade Secrets Act. However, FDA’s regulations allow for sharing of confidential commercial information with state and local government officials if, for example, the state has provided a written statement that it has the authority to protect the information from public disclosure and that it will not further disclose the information without FDA’s permission, and FDA has determined that disclosure would be in the interest of public health, if such sharing is necessary to effectuate a recall, or the information is shared only with state and local officials who are duly commissioned to conduct examinations or investigations under the Federal Food, Drug, and Cosmetic Act. In certain circumstances, FDA may also seek a firm’s consent to disclose its market distribution information.

Statutory Authorities We Identified Could Help FDA Oversee Food Safety

In our past work, we have pointed out that mandatory recall—the authority to require a food company to recall a contaminated product— would help ensure that unsafe food does not remain in the food supply. We also reported that FDA should strengthen its oversight of food ingredients determined to be generally recognized as safe for their intended use and to seek the authority if the agency deems necessary. Likewise, we reported that FDA has identified a need for explicit authority from Congress to issue regulations to require preventive measures by firms producing foods that have been associated with repeated instances of serious health problems or death.

FDA Lacks Mandatory Recall Authority

We have reported that food recalls are largely voluntary and that federal agencies responsible for food safety, including FDA, have no authority to compel companies to recall contaminated foods, with the exception of FDA’s authority to require a recall for infant formula. FDA does have authority, through the courts, to seize, condemn, and destroy adulterated or misbranded food under its jurisdiction and to disseminate information about foods that are believed to present a danger to public health. However, government agencies that regulate the safety of other products, such as toys and automobile tires, have recall authority not available to FDA for food and have had to use their authority to ensure that recalls were conducted when companies did not cooperate.

We have noted that limitations in the FDA’s food recall authorities heighten the risk that unsafe food will remain in the food supply and have proposed that Congress consider giving FDA similar authorities. H.R. 2749 authorizes the Secretary of Health and Human Services to request that a person recall an article of food if the Secretary has reason to believe it is adulterated, misbranded, or otherwise in violation of the Federal Food, Drug, and Cosmetic Act and to require a person to cease distribution if the Secretary has reason to believe the article of food “may cause serious adverse health consequences or death to humans or animals.” It also requires the Secretary to order a recall of such an article of food if the Secretary determines (after an informal hearing opportunity) it is necessary. Finally, it authorizes the Secretary to proceed directly to a mandatory recall order if the Secretary has credible evidence that an article of food subject to an order to cease distribution presents an imminent threat of serious adverse health consequences or death to humans or animals. As our previous work has shown, mandatory recall authority would allow FDA to ensure that unsafe food does not remain in the food supply.

FDA Has Limited Oversight of Food Ingredients Determined to be Generally Recognized as Safe

We have reported that FDA should strengthen its oversight of food ingredients determined to be generally recognized as safe (GRAS) for their intended use. Manufacturers add these substances—hundreds of spices and artificial flavors, emulsifiers and binders, vitamins and minerals, and preservatives—to enhance a food’s taste, texture, nutritional content, or shelf life. Currently, companies may conclude a substance is GRAS without FDA’s approval or knowledge. We reported that FDA only reviews those GRAS determinations that companies submit to the agency’s voluntary notification program. The agency generally does not have information about other GRAS determinations companies have made because companies are not required to inform FDA of them. Among other things, we recommended to FDA that it develop a strategy to require any company that conducts a GRAS determination to provide the agency with basic information about this determination, and to incorporate such information into its public Web site.

We also reported that FDA is not systematically ensuring the continued safety of current GRAS substances. According to FDA regulations, the GRAS status of a substance must be reconsidered as new scientific information emerges, but the agency has not systematically reconsidered GRAS substances since the 1980s. Rather, FDA officials said, they keep up with new developments in the scientific literature and, on a case-by-case basis, information brought to the agency’s attention could prompt them to reconsider the safety of a GRAS substance. We recommended that FDA develop a strategy to conduct reconsiderations of the safety of GRAS substances in a more systematic manner. We also recommended that, if FDA determines that it does not have the authority to implement one or more of our recommendations, the agency should seek the authority from Congress. FDA generally agreed with the report’s findings and recommendations.

In addition, we reported that FDA has taken steps to make information about its GRAS notification program available to the public by posting its inventory of all GRAS notices FDA has received on its Web site. By placing information about the GRAS notice and its response on its Web site, FDA enhances the ability of Congress, stakeholders, and the general public to be better informed about GRAS substances. H.R. 2749 contains provisions on GRAS substances, including a requirement that the Secretary post on FDA’s Web site information about GRAS notices submitted to FDA within 60 days of receipt of the notice.

FDA Lacks Explicit Authority to Issue Regulations Requiring Food-Producing Firms to Institute Preventive Measures

We have also reported that FDA should strengthen its oversight of fresh produce. For example, we noted that FDA has identified a need for explicit authority from Congress to issue regulations requiring preventive controls (risk-based safety regulations) by firms producing foods that have been associated with repeated instances of serious health problems or death. FDA already has preventive regulations for seafood and juice, which require firms to analyze safety hazards and implement plans to address those hazards. According to FDA, such authority would strengthen the agency’s ability to implement risk-based processes to reduce illnesses from high-risk foods. FDA officials told us that issuing preventive regulations may be one of the most important things they can do to enhance their oversight of fresh produce. We therefore recommended that the Commissioner of FDA seek authority from Congress to make explicit FDA’s authority to adopt preventive controls for high-risk foods. FDA agreed with this recommendation and has sought authority to issue additional preventive controls for high-risk foods. Furthermore, H.R. 2749 requires FDA to create preventive controls for produce and certain raw agricultural commodities. Such measures could help the agency reduce illnesses from these high-risk foods.

In conclusion, food imports from around the world constitute a substantial and increasing volume of imported foods. Our work has shown that FDA could strengthen its oversight of imported food by improving its enforcement, such as by assessing civil penalties and providing unique identification numbers to firms. Additional statutory authorities, such as mandatory recall authority, could also help FDA oversee food safety. FDA generally agreed with our recommendations and has some taken actions to address them.

Mr. Chairman, this concludes my statement. I would be pleased to answer any questions that you or other Members of this Subcommittee may have.

Contact and Staff Acknowledgments

For further information about this testimony, please contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this statement.

Key contributors to this statement were José Alfredo Gómez, Assistant Director; Kevin Bray; Candace Carpenter; Anne Johnson; Carol Herrnstadt Shulman; Nico Sloss; and Rebecca Yurman.

Appendix IV: GAO-08-1047 (Fresh Produce)

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