GAO 

United States Government Accountability Office

Report to Congressional Committees

FOOD SAFETY 

Agencies Need to 

Address Gaps in 

Enforcement and 

Collaboration to 

Enhance Safety of 

Imported Food 

September 2009 

GAO-09-873 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

September 2009

FOOD SAFETY

Agencies Need to Address Gaps in Enforcement and 

Collaboration to Enhance Safety of Imported Food 

Highlights of GAO-09-873, a report to 

congressional committees 

Imported food makes up a 

substantial and growing portion of 

the U.S. food supply. To ensure 

imported food safety, federal 

agencies must focus their 

resources on high risk foods and 

coordinate efforts. 

In this context, GAO was asked to 

(1) assess how Customs and 

Border Protection (CBP), the Food 

and Drug Administration (FDA), 

and the U.S. Department of 

Agriculture’s (USDA’s) Food Safety 

and Inspection Service (FSIS) are 

addressing challenges in 

overseeing the safety of imported 

food; (2) assess how FDA leverages 

resources by working with other 

entities, such as state and foreign 

governments; and (3) determine 

how FDA is using its Predictive 

Risk-Based Evaluation for Dynamic 

Import Compliance Targeting 

(PREDICT) system to oversee 

imported food safety. GAO 

analyzed CBP, FDA, and FSIS 

procedures, reports, and 

regulations and interviewed agency 

officials and key stakeholders. 

What GAO Recommends

GAO recommends, among other 

things, that FDA seek authority 

from the Congress to assess civil 

penalties on firms and persons who 

violate FDA laws, and that the FDA 

Commissioner explore ways to 

improve the agency’s ability to 

identify foreign firms with a unique 

identifier. CBP and FDA generally 

agreed with our recommendations. 

FSIS provided technical comments 

only. 

CBP, FDA, and FSIS have taken steps to address challenges in ensuring the 

safety of the increasing volume of imported food. For example, CBP maintains 

the system that importers use to provide information to FDA on food 

shipments; FDA electronically reviews food imports and inspects some 

foreign food production facilities to prevent violative food from reaching U.S. 

shores; and FSIS employs an equivalency system that requires countries to 

demonstrate that their food safety systems provide the same level of 

protection as the U.S. system. However, gaps in enforcement and 

collaboration undermine these efforts. First, CBP’s computer system does not 

currently notify FDA or FSIS when imported food shipments arrive at U.S. 

ports, although efforts are underway to provide this information to FDA for 

air and truck shipments. This lack of communication may potentially increase 

the risk that unsafe food could enter U.S. commerce without FDA review, 

particularly at truck ports. Second, FDA has limited authority to ensure 

importers’ compliance with its regulations. Third, CBP and FDA do not 

identify importers with a unique number; as a result, FDA cannot always 

target food shipments originating from high risk importers. Finally, CBP faces 

challenges in managing in-bond shipments—those that move within the 

United States without formally entering U.S. commerce—and such shipments 

possibly could be diverted into commerce. 

FDA generally collaborates with select states and foreign governments on 

imported food safety. FDA has entered into a contract, several cooperative 

agreements, and informal partnerships for imported food with certain states, 

and some state officials told GAO that they would like to collaborate further 

with FDA on food imports. However, citing legal restrictions, FDA does not 

fully share certain information, such as product distribution lists, with states 

during a recall. This impedes states’ efforts to quickly remove contaminated 

products from grocery stores and warehouses. FSIS has begun to make 

available to the public a list of retail establishments that have likely received 

food products that are subject to a serious recall. FDA is also expanding 

efforts to coordinate with other countries. In particular, through its Beyond 

Our Borders initiative, FDA intends to station investigators and technical 

experts in China, Europe, and India, to provide technical assistance and 

gather information about food manufacturing practices to improve risk-based 

screening at U.S. ports. 

According to FDA, PREDICT will analyze food shipments using criteria that 

include a product’s inherent food safety risk and the importer’s violative 

history, among other things, to estimate each shipment’s risk. A 2007 pilot test 

of PREDICT indicated that the system improved FDA’s ability to identify 

products it considers to be high risk while allowing a greater percentage of 

products it considers low risk to enter U.S. commerce without a manual 

review. However, FDA has not yet developed a plan to measure the system’s 

performance, and GAO previously identified shortcomings in FDA’s 

information technology modernization efforts. FDA plans to begin deploying 

PREDICT at all ports and for all FDA-regulated products in September 2009. 

View GAO-09-873 or key components.

For more information, contact Lisa Shames at 

(202) 512-3841 or shamesl@gao.gov. 
Page i GAO-09-873 

Contents 

Letter 1

Results in Brief 4 

Background 10 

Three Federal Agencies Are Taking Actions to Better Ensure the 

Safety of Imported Food, but Enforcement and Collaboration 

Gaps Undermine These Efforts 16 

FDA Collaborates with States and Foreign Governments, but Does 

Not Fully Share Information with States During a Recall 26 

PREDICT Testing Indicates that the System May Improve FDA’s 

Risk-Based Import Screening Efforts, but Further Actions Are 

Needed 34 

The EU Has Developed Some Practices That Could Inform CBP, 

FDA, and FSIS Practices 39 

Conclusions 41 

Recommendations for Executive Action 42 

Agency Comments and Our Evaluation 44 

Appendix I Objectives, Scope, and Methodology 47 

Appendix II FDA Field Examinations, Fiscal Years 2006 

through 2009 49 

Appendix III FSIS Inspections at Ports of Entry, Fiscal Years 

2006 through 2008 50 

Appendix IV Agencies’ Processes to Oversee Imported Food 51 

Appendix V FDA’s Overseas Inspections 61 

Appendix VI FDA’s Funding for Imported Food by Activity, 

Fiscal Years 2002 through 2009 62 

 Food Safety 
Appendix VII FSIS's Funding for Food Imports, Fiscal Years 2006 

through 2009 63 

Appendix VIII Comments from the Department of Homeland 

Security 64 

Appendix IX Comments from the Department of Health and 

Human Services 67 

Appendix X GAO Contact and Staff Acknowledgments 72 

Table 

Table 1: FDA’s Planned Staffing Levels for Foreign Posts (35 U.S. 

nationals) 32 

Figures 

Figure 1: FDA Staff Examining Food at the Port of Baltimore 14 

Figure 2: FDA’s Process for Electronically Screening Imported 

Food Shipments 53 

Figure 3: FDA’s Process for Examining Selected Imported Food 

Shipments Before Allowing Entry into U.S. Commerce 54 

Figure 4: FSIS’s Process for Reinspecting Imported Meat, Poultry, 

and Processed Egg Products 58 

Page ii GAO-09-873 Food Safety
Abbreviations 

ACE Automated Commercial Environment 

ACS Automated Commercial System 

AIIS Automated Import Information System 

CBP Customs and Border Protection 

EU European Union 

FDA Food and Drug Administration 

FSIS Food Safety and Inspection Service 

MDA Michigan Department of Agriculture 

NYSDAM New York State Department of Agriculture and Markets 

OASIS Operational and Administrative System for Import Support 

PREDICT Predictive Risk-Based Evaluation for Dynamic Import 

Compliance Targeting 

TRACES Trade Control and Expert System 

USDA U.S. Department of Agriculture 

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Page iii GAO-09-873 Food Safety
Page 1 GAO-09-873 

United States Government Accountability Office

Washington, DC 20548 

 

September 15, 2009 

The Honorable Henry A. Waxman 

Chairman 

The Honorable Joe Barton 

Ranking Member 

The Honorable John D. Dingell 

Chairman Emeritus 

Committee on Energy and Commerce 

House of Representatives 

The Honorable Bart Stupak 

Chairman 

The Honorable Greg Walden 

Ranking Member 

Subcommittee on Oversight and Investigations 

Committee on Energy and Commerce 

House of Representatives 

Food imported from more than 150 countries and territories constitutes a 

substantial and increasing percentage of the U.S. food supply. According 

to the Food and Drug Administration (FDA), the number of food entry 

lines has nearly doubled in the last 10 years. (An entry line is each portion 

of an import shipment that is listed as a separate item on an entry 

document. Items in an import entry having different tariff descriptions or 

FDA product codes must be listed separately.) According to U.S. 

Department of Agriculture (USDA) data, imported food comprises 15 

percent of the U.S. food supply, including 60 percent of fresh fruits and 

vegetables and 80 percent of seafood. Additionally, the volume of 

agricultural and seafood products imported for consumption increased 29 

percent between fiscal years 2003 and 2008, and the value of these 

products increased 65 percent. 

Imported foods have been associated with recent outbreaks of foodborne 

illnesses. For example, in 2008, more than 50 people became ill with 

Salmonella from Honduran cantaloupes, and more than 1,400 people 

became ill with Salmonella from Mexican peppers. Ensuring the safety of 

this large and growing volume of imported food challenges federal 

agencies to better target their resources on the foods posing the greatest 

risks to public health and to coordinate efforts so that unsafe food does 

not enter U.S. commerce. 

 Food Safety 
 

In the United States, two agencies—FDA, under the U.S. Department of 

Health and Human Services, and the Food Safety and Inspection Service 

(FSIS), under USDA—have primary responsibility for food safety. FSIS 

oversees the safety of meat, poultry, and processed egg products, both 

domestic and imported, and verifies that shipments of these products meet 

FSIS requirements. FDA is responsible for the safety of virtually all other 

foods, including milk, seafood, fruits, and vegetables. Owing in part to the 

volume of imported products it regulates, FDA physically examines only 

approximately 1 percent of imported food; however, the agency is 

developing the Predictive Risk-Based Evaluation for Dynamic Import 

Compliance Targeting (PREDICT) computer system to improve its 

targeted screening efforts. In addition, Customs and Border Protection 

(CBP), under the Department of Homeland Security, is responsible for 

enforcing FDA’s food safety regulations at the border, among other things. 

CBP’s computerized screening system processes all imported shipments, 

including food, and CBP requires importers to (1) give a manufacturer 

identification number for each imported shipment and (2) post a monetary 

bond for formal entries (i.e., all shipments exceeding $2,000 or certain 

shipments valued below that amount) to provide assurance that these 

shipments meet U.S. requirements, among other things. Sometimes, CBP 

may allow an imported food shipment to proceed from the U.S. port of 

arrival to another U.S. port without appraising the merchandise or 

requiring payment of duties until the product reaches the port where it is 

officially entered into U.S. commerce or exported. This movement of a 

product between ports is referred to as an in-bond movement. All three 

agencies—CBP, FDA, and FSIS—participate in the Interagency Working 

Group on Import Safety, which in 2007 recommended, among other things, 

that agencies harmonize federal procedures and requirements for 

processing import shipments. 

Food safety responsibility is further divided among the 50 states, which 

may have their own statutes, regulations, and agencies for regulating and 

inspecting the safety and quality of food products. Food safety concerns 

are not unique to the United States. As we reported in 2008, increased 

public concern about food safety recently led the European Union (EU) to 

reorganize its food safety system, including its procedures for overseeing 

food imports.1

 The procedures discussed in that report may provide 

 

1

GAO, Food Safety: Selected Countries’ Systems Can Offer Insights into Ensuring Import 

Safety and Responding to Foodborne Illness, GAO-08-794 (Washington, D.C.: June 10, 

2008). 

Page 2 GAO-09-873 Food Safety
 

insights into keeping food safe at the U.S. border. Specifically, in April 

2004, the EU adopted comprehensive food safety legislation to create a 

single, transparent set of EU food safety rules applicable to both animal 

and nonanimal products. 

In this context, you asked us to (1) assess how CBP, FDA, and FSIS are 

addressing challenges in overseeing the safety of imported food; (2) assess 

how FDA leverages resources in overseeing imported food safety by 

working with other entities, such as state and foreign governments; and 

(3) determine how FDA is using PREDICT to oversee the safety of 

imported food. In addition, to learn about leading practices in other 

countries, we examined how the EU screens and monitors food imports at 

two ports of entry. 

To assess how the agencies are addressing challenges in overseeing the 

safety of imported food, we collected documents, such as strategic plans 

and procedure manuals; interviewed officials from CBP, FDA, and FSIS; 

and spoke with industry representatives—including trade associations and 

customs brokers—as well as consumer advocacy groups and other food 

safety experts. We focused primarily on CBP and FDA because the USDA 

Inspector General has conducted several detailed reviews of FSIS’s import 

procedures in recent years. In addition, we visited five U.S. ports—

Baltimore, Maryland; Buffalo, New York; Laredo, Texas; Los Angeles/Long 

Beach, California; and Miami, Florida—and observed how agency officials 

examine incoming shipments. We selected these ports because they are 

located on different borders or coasts with different modes of 

transportation. To assess the extent to which FDA leverages resources for 

overseeing the safety of imported food by working with state 

governments, we spoke with officials from FDA, as well as with officials in 

Arizona, California, Florida, Illinois, Michigan, New Mexico, New York, 

Texas, and Washington. We selected Illinois because it is an inland state 

that receives a high volume of in-bond shipments, and the other states are 

border states and home to large, high-volume ports. To assess the extent 

to which FDA leverages resources with foreign governments on imported 

food issues, we reviewed agency documentation and spoke with a senior 

FDA official who is responsible for FDA’s international initiative. We 

focused primarily on FDA because it regulates roughly 80 percent of the 

food supply and because of our longstanding concerns regarding the 

agency’s need to better leverage its limited resources. To determine how 

FDA is using PREDICT to oversee the safety of imported food, we 

reviewed and summarized formal assessments of PREDICT, spoke with 

FDA officials responsible for managing and implementing the system to 

obtain their views, and observed the system’s use at the Los Angeles/Long 

Page 3 GAO-09-873 Food Safety
 

Beach and Buffalo ports. We also leveraged recent GAO work assessing 

FDA’s information technology modernization efforts. We did not review 

PREDICT’s hardware or software environments or testing activities. To 

learn about leading practices for screening food imports in the EU, we 

visited two EU ports—Antwerp, Belgium and Rotterdam, the 

Netherlands—which, according to EU officials, are known for using 

leading practices. Under the Federal Food, Drug, and Cosmetic Act, FDA’s 

authorizing legislation, the term “food” means (1) articles used for food or 

drink for man or other animals, (2) chewing gum, and (3) articles used for 

components of any such article. We use this definition, which also 

includes meat, poultry, and egg products, in this report. 

We conducted this performance audit from July 2008 to September 2009 in 

accordance with generally accepted government auditing standards. Those 

standards require that we plan and perform the audit to obtain sufficient, 

appropriate evidence to provide a reasonable basis for our findings and 

conclusions based on our audit objectives. We believe that the evidence 

obtained provides a reasonable basis for our findings and conclusions 

based on our audit objectives. More information on our objectives, scope, 

and methodology is presented in appendix I. 

While CBP, FDA, and FSIS have taken steps to address challenges in 

ensuring the safety of the increasing volume of imported food, gaps in 

enforcement and collaboration undermine these efforts. CBP addresses 

key challenges by maintaining the system that importers use to provide 

information to FDA on food shipments and using its authority to issue civil 

penalties against importers that fail to comply with food safety 

regulations, among other things. FDA electronically reviews all formal 

entries for food products and inspects some foreign food production 

facilities to prevent violative food from reaching U.S. shores. FSIS’s 

equivalency system requires that countries exporting meat and poultry and 

processed egg products to the United States demonstrate that their food 

safety standards are equivalent to those of the United States. The agency is 

also developing a new information technology initiative, called the Public 

Health Information System, which is a Web-based application. According 

to FSIS, this application will replace many of FSIS’s legacy systems and is 

expected to allow the agency to receive foreign health certificates 

electronically and provide secure and timely advance notice of a foreign 

shipment certified by a foreign government. Despite the actions these 

three agencies have taken, we identified the following four gaps in 

enforcement and collaboration that could allow high risk foods to enter 

domestic commerce without assurance that these products are examined. 

Results in Brief 

Page 4 GAO-09-873 Food Safety
 

• Agencies’ computer systems do not share key information. CBP’s import 

screening system does not notify FDA’s or FSIS’s systems when imported 

food shipments arrive at U.S. ports. Without access to time-of-arrival 

information, FDA and FSIS may not know when shipments that require 

examinations or reinspections arrive at the port, which could potentially 

increase the risk that unsafe food may enter U.S. commerce. This is of 

particular concern at truck ports. The agencies have begun to take steps to 

address this gap, but work remains. For example, FDA and CBP developed 

an interagency agreement under which CBP would modify its existing 

system to provide shipment time-of-arrival information to FDA. According 

to CBP officials, the agency has completed these modifications for air and 

truck ports. CBP does not have a similar agreement with FSIS. In addition, 

CBP is upgrading its import screening system in part to improve datasharing with other government agencies such as FDA and FSIS, but CBP 

officials told us that development of key system components has been 

delayed because of budget shortfalls and unforeseen difficulties in 

programming the system to meet agency requirements. Moreover, 

according to agency officials, it is unknown whether this new system will 

address the agency’s inability to routinely communicate time-of-arrival 

information. Effective practices for collaboration and internal controls call 

for agencies to address the compatibility of data systems and ensure 

adequate means of obtaining information from external stakeholders that 

have a significant impact on agency goals.2

 In addition, the Interagency 

Working Group on Import Safety recommended in 2007 that, among other 

things, agencies improve the interoperability of government and private 

sector computer systems to facilitate the exchange of information on 

imported products. 

• FDA has limited authority to ensure importer compliance. Importers can 

retain possession of their food shipments until FDA approves their release 

into U.S. commerce. FDA relies on a bond between CBP and the importer 

to discourage the premature release of FDA-regulated shipments. If 

importers do not comply with the requirements, they may be required to 

forfeit the amount of the bond. However, as we reported in 1998, the 

shipment’s maximum bond value is often not sufficient to deter the sale of 

imported goods that FDA has not yet released.3

 In a February 2009 

 

2

GAO, Standards for Internal Control in the Federal Government, GAO/AIMD-00-21.3.1. 

(Washington, D.C.: November 1999); and GAO, Results-Oriented Government: Practices 

That Can Help Sustain Collaboration Among Federal Agencies, GAO-06-15 (Washington, 

D.C.: Oct. 21, 2005). 

3

GAO, Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are 

Inconsistent and Unreliable, GAO/RCED-98-103 (Washington, D.C.: Apr. 30, 1998). 

Page 5 GAO-09-873 Food Safety
 

testimony, FDA requested several additional authorities, but did not 

include civil penalties authority in this request. However, FDA officials 

told us that if the agency had its own authority to impose civil penalties on 

importers, it might be possible to deter future violations. 

• CBP and FDA do not provide unique identification numbers to firms. 

The identification numbers FDA uses to target manufacturers that have 

violated FDA standards in the past are not unique. As a result, these 

manufacturers, and their shipments, may evade FDA review, which 

increases the possibility that high risk foods may enter the U.S. market. 

This occurs in part because FDA relies on entry-filer generated 

identification numbers to create FDA’s own identifiers for firms at the 

time of importation, a process that, over time, often results in multiple 

identifiers for a single firm. (An entry filer is the individual or firm 

responsible for filing an entry—usually the broker or importer.) CBP is 

responsible for validating the manufacturer identification numbers and 

ensuring they are unique, but FDA officials told us that some foreign food 

facilities have multiple identification numbers. 

• CBP faces challenges in managing in-bond shipments. According to 

CBP, food is one of the most common types of products to be shipped inbond. We reported in the past that CBP does not effectively manage inbond shipments. In 2007, for example, we recommended, among other 

things, that CBP amend a regulation to reduce the time allowed for 

transporting cargo and to limit importers’ ability to change the final 

destination of in-bond shipments without the agency’s knowledge.4

 CBP 

has taken steps to address some of our recommendations, and CBP 

officials told us they had drafted the amendments to the regulation, but as 

of July 2009, the agency had not issued a final regulation. Until it does so, 

concerns remain that imports of violative food—food that does not meet 

U.S. safety standards or labeling requirements—could be shipped in-bond 

and enter U.S. commerce undetected. 

Although the agencies face multiple challenges in improving their 

oversight of food safety imports, FDA and CBP officials at the ports of 

Buffalo and Miami have developed practices that could improve agency 

collaboration at other ports. At both ports, the two agencies employ joint 

initiatives to better coordinate actions when a food shipment violates or 

 

4

GAO, International Trade: Persistent Weaknesses in the In-Bond Cargo System Impede 

Customs and Border Protection’s Ability to Address Revenue, Trade, and Security 

Concerns, GAO-07-561 (Washington, D.C.: Apr. 17, 2007). 

Page 6 GAO-09-873 Food Safety
 

appears to violate FDA regulations. These initiatives have simplified 

agency procedures and, according to FDA and CBP officials, have 

improved importers’ compliance with regulations for destroying or 

returning to the importer food products that violate FDA’s safety 

standards. 

FDA has formal and informal mechanisms to work with states on imported 

food safety. FDA generally leverages resources by collaborating with 

select states but does not fully share information with the states during a 

recall, whether of imported or domestic food. According to the 

Interagency Working Group on Import Safety, federal and state 

governments’ roles and resources for ensuring the safety of imported food 

are complementary. That is, the federal government can interdict unsafe 

imported goods at ports of entry, and states can address unsafe imported 

food products within their borders. We also found that FDA collaborates 

with foreign governments on certain food safety issues. Specifically: 

• FDA collaborates with some states to leverage resources. For imported 

foods, FDA has entered into a contract, several cooperative agreements, 

and informal partnerships with some states. Specifically, FDA has 

contracted with Michigan to fund state inspectors to sample and test 

imported food. FDA also uses cooperative agreements—in which FDA 

provides funding for state services that primarily benefit the state as a 

proxy for the “public,” rather than the federal government—to leverage 

state resources for imported food safety. For example, FDA has 

agreements with six states to establish rapid response teams to address 

emergencies, including incidents associated with imported food. FDA also 

has several informal partnerships for food imports to facilitate federalstate cooperation, although the partnerships are not legally binding and do 

not involve federal funding. For example, at FDA’s request, New York 

State food inspectors will enter warehouses specializing in food from a 

particular country to look for violative imported products in domestic 

commerce. Some state officials told us that they would like to collaborate 

further with FDA on food imports, and they can act more quickly than 

FDA when contaminated food is initially identified. 

• FDA does not always share certain information during a recall. 

According to officials from several states, during food recalls, FDA is 

reluctant to share certain information, such as product distribution lists. 

This lack of information-sharing impedes states’ efforts to quickly remove 

contaminated products from grocery stores and warehouses. FDA believes 

that product distribution lists are confidential commercial information and 

cannot be shared with states except as allowed by law. FSIS discloses 

certain information to the public during a recall—specifically, the names 

Page 7 GAO-09-873 Food Safety
 

Page 8 GAO-09-873 Food Safety 

and locations of retail consignees of meat and poultry products that have 

been recalled by a federally inspected meat or poultry establishment—if 

the product has been recalled at the retail level. 

• FDA is expanding its efforts to coordinate with other countries in a 

number of ways. According to a senior agency official, FDA initiated its 

Beyond Our Borders program in an effort to prevent food that fails to meet 

U.S. standards from reaching the United States. Under this program, FDA 

intends to station food investigators and technical experts in China, 

Europe, and India to provide technical assistance and conduct inspections, 

among other things. Furthermore, FDA expects to get direct access to 

information about foreign facilities’ food manufacturing practices so that 

its staff at U.S. ports of entry can make informed decisions on which food 

imports to examine. FDA also holds yearly meetings with officials in other 

countries, such as Australia, Canada, and New Zealand, to share 

information and strategize over food safety and other public health issues. 

According to FDA, the PREDICT system is intended to improve the 

agency’s ability to target shipments for inspection that are more likely to 

violate FDA’s regulations. PREDICT is to estimate the risk of FDAregulated imports (e.g., food, drugs, and medical devices) using criteria 

such as the violative histories of the product, importer, and country of 

origin. FDA entry reviewers are to use these risk estimates to target for 

examination shipments the agency considers to be high risk while the 

system allows shipments the agency considers to be low risk to enter U.S. 

commerce without further review. A 2007 pilot test of PREDICT at one 

location for seafood products indicated that the system improved FDA’s 

ability to (1) identify products that were more likely to violate FDA 

regulations, (2) identify product violations that posed more severe public 

health risks, and (3) allow a greater percentage of products the agency 

considers to be low risk to enter U.S. commerce without requiring an entry 

reviewer’s intervention. However, FDA has not yet developed a plan to 

monitor and assess the system’s ability to identify high risk products once 

it is deployed. Under federal standards on internal controls, agencies are 

to engage in the ongoing monitoring of programs to assess performance 

over time, including establishing policies and procedures to ensure that 

findings of reviews are promptly resolved.5

 Additionally, we reported in 

June 2009 that FDA lacks a comprehensive information technology 

 

5

GAO/AIMD-00-21.3.1. 
 

strategic plan for PREDICT and other modernization projects.6 Without 

such a plan, FDA’s modernization efforts, including PREDICT, may not 

adequately meet the agency’s urgent mission needs. We also identified 

shortcomings in the agency’s enterprise architecture (i.e., modernization 

blueprints that describe an organization’s operation in terms of business 

and technology) and information technology human capital management. 

These shortcomings reduce FDA’s assurance that it will be able to 

effectively modernize its systems and have the appropriate staff to 

implement and support its modernization efforts. FDA generally agreed 

with our recommendations in the June 2009 report and, while recognizing 

the need for further agency actions, plans to begin deploying PREDICT on 

a district-by-district basis at all ports and for all FDA-regulated products in 

September 2009. 

The EU takes a comprehensive, risk-based approach to screening and 

monitoring food imports to ensure the safety of these foods by targeting 

products that are more likely to present risk, and taking steps to ensure 

that violative products do not enter EU countries. Because the EU 

considers live animals and products of animal origin to be particularly high 

risk, owing to past problems with bovine spongiform encephalopathy

(“mad cow disease”), all such imports must enter the EU through 

approved border inspection posts, where veterinarians are present, and 

cannot leave the port without veterinary approval. The EU’s new computer 

system, which automatically updates information about products of 

animal origin entering the EU, is linked to the EU’s Rapid Alert System for 

Food and Feed (which covers all types of food) in order to communicate 

alerts to all border inspection posts. If port officials reject a food 

shipment, whether of animal or nonanimal origin, the shipment cannot 

leave government custody for exportation to another, non-EU country 

until that country’s counterpart agency officially accepts the shipment in 

writing. 

To better ensure the safety of imported food, we are making several 

recommendations. For example, we are recommending that the FDA 

Commissioner seek authority from the Congress to assess civil penalties on 

firms and persons who violate FDA’s food safety laws. We further 

recommend that the Commissioner determine what violations should be 

subject to this new FDA civil penalties authority, as well as the appropriate 

 

6

GAO, Information Technology: FDA Needs to Establish Key Plans and Processes for 

Guiding Systems Modernizations Efforts, GAO-09-523 (Washington, D.C.: June 2, 2009). 

Page 9 GAO-09-873 Food Safety
 

nature and magnitude of the penalties. In addition, we are recommending 

that the CBP Commissioner ensure that the agency’s new import screening 

system, the Automated Commercial Environment (ACE), is able to accept a 

unique identification number for foreign firms that export FDA-regulated 

foods, and that the FDA Commissioner explore ways to improve the 

agency’s ability to identify foreign firms with a unique identifier. 

We provided a draft of this report to CBP, FDA, and FSIS for their review 

and comment. CBP agreed with our recommendations, but disagreed that 

the in-bond entry process is a gap in the enforcement of food imports. 

FDA also generally agreed with our recommendations. Although the 

agency agreed in principle with our recommendation on developing a joint 

refusal/redelivery process, it does not believe that a study is warranted, 

noting that discussions with CBP on this topic have already begun. FSIS 

did not provide formal comments. All three agencies provided technical 

comments, which we incorporated into the report as appropriate. CBP’s 

and FDA’s comments are included in appendixes VIII and IX, respectively. 

We have been concerned about ensuring the safety of imported food for 

many years. In 1998, we assessed the federal government’s efforts to 

ensure the safety of imported foods and determined that federal agencies 

could not be certain that the growing volume of imported food was safe 

for consumers.7

 For example, we found that (1) the agencies’ import 

screening systems did not take advantage of available data in order to 

target imported foods that posed the greatest health risks, (2) FDA did not 

maintain effective control over the violative products it detained and did 

not have adequate measures to ensure the integrity of sampling and testing 

procedures for suspect food shipments, and (3) the evasion of safety 

requirements was seldom punished effectively. The agencies relied on the 

penalties the importer would incur if the importer violated the terms of the 

bond as the principal mechanism to ensure compliance with laws; 

however, these penalties did not represent an effective deterrent. 

Background 

Over the past 30 years, we have detailed problems with the current 

fragmented federal food safety system. A total of about 15 federal 

agencies, including FDA and FSIS, share some responsibility for food 

 

7

GAO/RCED-98-103. 

Page 10 GAO-09-873 Food Safety
 

safety, and we have reported that the system has caused inconsistent 

oversight, ineffective coordination, and inefficient use of resources. This 

fragmentation is the key reason that we added federal oversight of food 

safety to our high risk series in January 2007 and called for a 

governmentwide examination of the food safety system.8

Furthermore, as we have reported, when an issue, such as imported food 

safety, cuts across federal agency jurisdictions, the agencies involved must 

collaborate to deliver results more efficiently and effectively. Our previous 

work indicates that federal agencies can efficiently and effectively 

collaborate when they establish (1) joint strategies to achieve goals and 

(2) procedures and policies for working together systematically across 

agency lines, among other things.9

CBP, FDA, and FSIS each uses its own processes to screen imports, and all 

three share certain information with each other to enhance their efforts. 

CBP and FDA rely to a large extent on information that brokers and 

importers provide; FSIS reviews a health certificate, as well as an 

application of import inspection that an importer or broker is required to 

present with an incoming shipment. More specifically: 

• CBP seeks to interdict shipments of contraband and the illegal importation 

of food and other products. CBP requires importers to notify it about all 

shipments in advance. Specifically, importers or their brokers 

electronically submit information on the shipment to either CBP’s legacy 

computer system, the Automated Commercial System (ACS), or ACE, the 

agency’s new system that is operating in conjunction with ACS at some 

ports. CBP tracks each shipment throughout the importation process and 

determines whether it needs to conduct a more detailed examination. 

Once CBP clears a food shipment for U.S. commerce, it requires the 

importer to agree to return the goods to the port of entry upon a CBP 

demand for redelivery within 30 days. 

CBP also requires importers shipping formal entries to post a monetary 

bond to provide assurance that the importer will meet the obligations 

imposed by law or regulation. For example, an importer’s bond obligations 

require the importer to pay duties and submit entry summary 

documentation at the times required by law, and to redeliver merchandise 

 

8

GAO, High-Risk Series: An Update, GAO-07-310 (Washington, D.C.: January 2007). 

9

GAO-06-15. 

Page 11 GAO-09-873 Food Safety
 

to CBP upon a lawful demand. A bond is thus like an insurance policy that 

guarantees payment to CBP if a required act is not performed. 

• Under the Federal Food, Drug, and Cosmetic Act—the primary legislation 

governing FDA’s activities—any foreign company can export food 

products to the United States provided, among other things, that it first 

registers with the agency, if registration is required. FDA’s approach to 

overseeing imported food safety encompasses (1) preventing food safety 

problems by promoting corporate responsibility; (2) intervening through 

targeted inspections, sampling, and surveillance; and (3) responding to 

food safety emergencies when they occur. 

The Public Health Security and Bioterrorism Preparedness and Response 

Act of 2002 (also called the Bioterrorism Act), directs FDA to, by 

regulation, require Prior Notice for food imported or offered for import 

into the United States. The purpose of Prior Notice is to enable such food 

to be inspected at the ports of entry. To meet the requirements of FDA’s 

regulation, filers are to submit electronically to FDA, among other things, 

the (1) submitter’s name, phone number, and e-mail address; (2) identity of 

the article of food, including the FDA product code and the estimated 

quantity; (3) name and address of the manufacturer, grower (if known), 

and shipper; (4) country from which the product is shipped; and (5) 

anticipated port of arrival. Filers can submit Prior Notice either through 

FDA directly or through CBP’s Automated Broker Interface, which is 

linked to ACS.10 An article of food that arrives at the port of entry with 

inadequate Prior Notice is subject to refusal and may not be delivered to 

the importer, owner, or consignee. 

Once a food shipment has passed Prior Notice screening, it undergoes a 

second, separate assessment, called admissibility review, in which the 

shipment is screened for regulatory standards and requirements, 

misbranding, adulteration, and safety. During the admissibility process, 

FDA electronically screens information about food and other products it 

regulates using data that the broker provides on behalf of the importer and 

automatically transmits its screening decisions to CBP. When deciding on 

FDA Relies on Importers to Supply 

Accurate Information

FDA relies on information that importers or 

brokers provide when determining the risk a

food product may pose to human health. It is

therefore critical that importers provide 

accurate information. However, in 1998 we 

found that some importers had an incentive to 

misrepresent their goods in order to avoid 

FDA inspections, and FDA officials indicated 

that the agency is still concerned about 

information quality.

To evaluate the accuracy of the information 

that importers and brokers provide, FDA 

conducts “filer evaluations” (filers are 

generally importers and brokers). If filers

electronically submit information that is not at 

least 90 percent accurate, FDA will require 

the filers to submit subsequent shipment 

information on paper entry forms in order to 

import products into the United States. 

According to agency officials, the use of 

paper entries is disadvantageous for filers

because it triggers an FDA examination of the 

shipment at the port of entry before the 

shipment is allowed to enter U.S. commerce. 

Therefore, according to these officials, the 

filer evaluations serve as an incentive for 

compliance. 

 

10Generally, Prior Notice must be filed at least 2 hours before a food shipment arrives by 

road, at least 4 hours before arriving by rail or air, and at least 8 hours before arriving by 

water. However, there are certain exemptions from Prior Notice requirements (e.g., food 

that is imported and exported without leaving the port of arrival until export). CBP also 

generally requires advance notification for all shipments, including FDA- and FSISregulated foods; this notification is independent of the Bioterrorism Act requirements. 

Page 12 GAO-09-873 Food Safety
 

whether a food shipment’s documents should be reviewed or the shipment 

physically examined, FDA reviewers consider, among other data, the 

product type as well as the manufacturer, based in part on the facility’s 

identification number, which is automatically generated from information 

that CBP maintains. 

FDA reviewers analyze information about food shipments and use their 

professional judgment to select shipments—approximately 1 percent—for 

physical examination. In addition, some shipments may be detained on the 

basis of information other than a physical examination at any time (for 

example, on the basis of a company’s past compliance information). 

Appendix II provides detailed information on FDA’s field examination 

activities for 2006 to 2008. According to a 2008 USDA Economic Research 

Service study on FDA data on shipments that had been refused entry 

between 1998 and 2004, FDA’s data on refusals highlights recurring food 

safety problems found in imports, as well as where FDA focuses its import 

screening. However, the report noted that the data do not necessarily 

reflect the full distribution of risk, since the data are in part a reflection of 

FDA’s particular screening criteria.11 Figure 1 shows an FDA staff person 

examining food products at the Port of Baltimore. 

 

11Buzby, Jean C.; Laurian J. Unnevehr; and Donna Roberts. Food Safety and Imports: An 

Analysis of FDA Food-Related Import Refusal Reports, EIB-39, U.S. Department of 

Agriculture, Economic Research Service (September 2008). 

Page 13 GAO-09-873 Food Safety
 

Figure 1: FDA Staff Examining Food at the Port of Baltimore 

FDA is developing PREDICT, which it expects will improve its electronic 

screening process by calculating a detailed risk score for food shipments. 

FDA reviewers will use this risk score, in addition to their professional 

judgment, to determine which imports should be physically examined 

before entering U.S. commerce. FDA uses PREDICT to screen certain 

seafood shipments at two locations. 

Source: GAO.

• FSIS uses a three-part approach to overseeing the safety of imported food: 

an equivalency system, whereby countries that wish to export meat and 

poultry products to the United States must demonstrate that their food 

safety systems meet standards that are equivalent to those of the U.S. 

system; audits to verify that their system remains equivalent; and 

reinspection of all imported shipments arriving at approximately 150 FSISapproved import facilities located near about 30 U.S. ports of entry. 

Appendix III provides detailed information on FSIS’s inspections at U.S. 

ports of entry for 2006 to 2008. 

FSIS’s computer system does not share information with CBP about food 

shipments, although the agency does notify CBP officials manually in 

certain circumstances, such as when a noncompliant product must be sent 

Page 14 GAO-09-873 Food Safety
 

back to its country of origin. Although FSIS physically inspects all food 

imports that it regulates, it occasionally targets a shipment for a higher 

level of inspection, primarily on the basis of the foreign country’s recent

track record and the risk of the product. This higher level of inspec

may involve laboratory testing or additional physical inspections. 

Additional detail on the processes

tion 

 FDA and FSIS use to oversee imported 

food is presented in appendix IV. 

w.12 

-related 

g 

in 

nesses within their borders after it is cleared 

for domestic consumption. 

 

As food safety problems increasingly cut across jurisdictional lines and 

have national consequences, experts anticipate that the role of state and 

local agencies in the national food safety system will continue to gro

Most state governments are involved in food safety prevention and 

response functions, generally through both their health departments and 

agriculture departments or other agencies that play food safety regulatory 

roles in some states. States conduct the majority of all food safety

laboratory testing and more than 80 percent of all nonretail food 

establishment inspections (excluding FSIS-inspected meat and poultry 

establishments). These include many inspections of food manufacturin

and processing facilities, which they conduct under contract to FDA. 

Some states also inspect retail and food service establishments.13 State

officials told us that their agencies are mainly concerned with food 

domestic commerce; they do not have any formal jurisdiction over 

imports. However, these officials told us that they are concerned with 

imported food if it causes ill

12Taylor, Michael R. and Stephanie D. David, Stronger Partnerships for Safer Food. 

Department of Health Policy, School of Public Health and Health Services, The George 

Washington University. (Washington, D.C.: April 2009). 

13Taylor et al. 2009. 

Page 15 GAO-09-873 Food Safety
 

Three Federal 

Agencies Are Taking 

Actions to Better 

Ensure the Safety of 

Imported Food, but 

Enforcement and 

Collaboration Gaps 

Undermine These 

Efforts 

Federal Agencies Have 

Taken Actions to Prevent 

Potentially Violative Food 

Products from Entering 

U.S. Commerce 

CBP, FDA, and FSIS have each taken actions to better oversee the growing 

volume of imported foods. CBP addresses key challenges by maintaining 

the system that importers use to provide information to FDA on food 

shipments and has the authority to issue civil penalties against importers 

that fail to comply with regulations, among other things. CBP has also 

developed a national trade strategy, which is based upon six priority trade 

initiatives. One of the initiatives is an import safety strategy, which is a 

broad category that includes several general food safety provisions and 

goals, such as the detection and prevention of the unintentional 

introduction of unsafe food into the country. Furthermore, CBP has taken 

on a leadership role throughout the government on certain import-related 

issues. For example, CBP coordinates communication within government 

agencies to ensure that harmonized government procedures and 

requirements exist for shipments arriving by sea. The agency has also 

contributed to a special interagency effort called Operation Guardian, 

aimed at investigating imports of substandard, tainted, and dangerous 

products. 

FDA electronically reviews all formal entries and inspects some foreign 

food production facilities to prevent violative food from reaching U.S. 

shores. For example, in 2008, FDA inspected 153 foreign food facilities out 

of an estimated 189,000 foreign food facilities registered with FDA; the 

agency estimates that it will conduct 200 inspections in 2009 and 600 in 

2010. Inspections may entail reviewing documentation of adherence to 

safety controls, such as seafood Hazard Analysis and Critical Control Point 

procedures. (These procedures are designed to improve the safety of food 

by having industry identify and control biological, chemical, and physical 

hazards in products before they enter the market.) FDA officials told us 

Page 16 GAO-09-873 Food Safety
 

that they face logistical challenges in conducting foreign inspections, and 

to some extent must rely on the cooperation of manufacturers in advance 

of the inspection. During these visits, FDA may offer information to firms 

on how to bring their facilities into compliance with applicable FDA 

requirements. 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 $3.16 

billion to inspect all of these facilities once.14 Appendix V provides data on 

FDA’s overseas facility inspections, while appendixes VI and VII present 

data on FDA’s and FSIS’s funding for food imports. 

FSIS’s equivalency system requires that countries exporting meat, poultry, 

and processed egg products to the United States demonstrate that their 

food safety standards are equivalent to those of the United States. In 

addition, FSIS annually audits the food regulatory system in every country 

that exports meat or poultry products to the United States and physically 

examines 100 percent of the imported food shipments it regulates. FSIS is 

also developing the Public Health Information System, a new, Web-based 

computer system that will replace the agency’s current import screening 

system, the Automated Import Information System (AIIS). According to 

FSIS officials, the new system, which GAO has not reviewed, will allow 

FSIS to receive foreign health certificates electronically and will provide 

secure and timely advance notice of a foreign shipment certified by a 

foreign government. Once the new Public Health Information System 

becomes operational, FSIS officials expect that it will also streamline 

import processing procedures and enable the agency to electronically send 

and receive information on imported food shipments to and from CBP’s 

ACE system. However, CBP noted that its deployment of ACE has been 

significantly delayed. 

 

14GAO, Federal Oversight of Food Safety: FDA has Provided Few Details on the Resources 

and Strategies Needed to Implement its Food Protection Plan, GAO-08-909T (Washington, 

D.C.: June 12, 2008).

Page 17 GAO-09-873 Food Safety
 

Federal Agencies Face 

Gaps in Enforcement and 

Collaboration That 

Undermine Efforts to 

Ensure the Safety of 

Imported Food 

We identified four gaps in enforcement and collaboration that could allow 

violative food products to enter U.S. commerce: (1) lack of informationsharing between agencies’ computer systems, (2) FDA’s limited authority 

to assess civil penalties on certain violators, (3) lack of unique identifiers 

for firms exporting FDA-regulated products, and (4) CBP’s challenges in 

overseeing in-bond shipments. However, at two of the ports we visited, 

CBP and FDA officials are working together to overcome these problems. 

Information-sharing 

between Computer 

Systems 

CBP’s computer system does not notify FDA or FSIS 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 or broker. FDA communicates 

this decision to CBP through its import screening system—the Operational 

and Administrative System for Import Support (OASIS)—informing CBP 

of FDA’s intent to examine a product when it arrives at the port. 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 importer’s or consignee’s warehouse or other facility within the 

United States. This may occur because 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 commerce until FDA has examined it. 

CBP and FDA officials told us that, occasionally, an importer will 

transport the shipment to the consignee’s facility 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 or facility because 

CBP’s ACS system does not notify OASIS when the shipment arrives at the 

port. Instead, from the perspective of an FDA entry reviewer using OASIS, 

it will appear as if the shipment’s arrival is still pending. FDA port officials 

told us that it could be two or three days before FDA entry 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. 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 make 

arrangements to examine them before they are distributed to U.S. markets. 

Similarly, CBP’s ACS system does not communicate with FSIS’s AIIS 

Page 18 GAO-09-873 Food Safety
 

system to notify the agency when a shipment arrives at a port. This is 

problematic because FSIS-regulated shipments that clear CBP’s inspection 

process must be transported to an FSIS-approved import facility near the 

port for reinspection. Since FSIS does not know when a shipment arrives, 

it cannot detect importers or brokers that fail to report to an import 

facility and present for reinspection imported meat, poultry, or processed 

egg products. 

FDA officials at several ports told us that they have developed informal 

workaround solutions to alleviate the challenges posed by insufficient 

information-sharing between FDA’s and CBP’s computer systems. For 

example, at one port, officials told us that FDA entry reviewers contact 

CBP by phone or in person if they notice that a shipment designated in 

OASIS for examination does not appear to have arrived after several days. 

In this way, FDA can determine whether a shipment is still in transit to the 

port or whether the shipment has already arrived and the importer failed 

to notify FDA. At another port, FDA officials stated that when a shipment 

designated for FDA review arrives at the port, a CBP port official usually 

will notify FDA via telephone. However, agency officials also told us that 

successful informal collaboration depends on positive interagency 

working relationships between FDA and CBP port officials. These positive 

working relationships may be lacking at other ports. 

The agencies have taken steps to address the lack of systematic time-ofarrival information. For example, FDA and CBP developed an interagency 

agreement that calls for CBP to modify its existing software to provide 

FDA with time-of-arrival information for air and land shipments. CBP 

stated that it had completed these software modifications and is working 

with FDA to test the system, in accordance with the interagency 

agreement. However, CBP has not developed a similar interagency 

agreement with FSIS. 

In addition, CBP is in the process of updating its computer systems from 

ACS to ACE as part of its ongoing modernization efforts. One component 

of ACE is Cargo Control and Release, which comprises several modules 

and is intended to provide FDA, FSIS, and other agencies with a single, 

integrated system to more efficiently control and evaluate shipments for 

security and commercial compliance. However, it is unclear whether the 

addition of Cargo Control and Release modules to the ACE system would 

address the lack of timely notification of arrival. According to CBP, 

communicating time-of-arrival information to FDA and FSIS through ACE 

would require “a significant amount of work.” Moreover, CBP has not 

scheduled a completion date for Cargo Control and Release and has not 

Page 19 GAO-09-873 Food Safety
 

even begun to develop this system. The Department of Homeland 

Security’s Office of Inspector General reported in 2008 that the agency had 

scheduled Cargo Control and Release to be fully operational by July 2010.15

Since then, CBP has encountered delays in completing Cargo Control and 

Release owing to budget shortfalls and unforeseen difficulties in 

programming the system to meet agency requirements, according to CBP 

officials. We anticipated these problems in a prior report on ACE. 

Specifically, we reported in 2005 that, although the Department of 

Homeland Security had taken actions to help address ACE’s cost and 

schedule overruns, these actions likely would not prevent similar 

problems in the future. We also found that the department had met its 

revised cost and schedule commitments in part by relaxing system quality 

standards, which we predicted would likely affect future system 

deployments.16

To its credit, CBP has developed ACE “portals” that grant FDA and FSIS 

staff “read-only” access to ACE data at ports where ACE is already 

operating in conjunction with ACS. After FSIS gained access to the ACE 

portal in 2006, for example, the agency’s detection of illegally imported 

meat and poultry products increased sixty-fold. Nonetheless, these portals 

do not communicate time-of-arrival information to FDA’s or FSIS’s 

computer systems. Effective practices for collaboration and internal 

controls call for agencies to address the compatibility of data systems to 

ensure adequate means of obtaining information from external 

stakeholders that have a significant impact on agency goals.17 Moreover, in 

2007, the Interagency Working Group on Import Safety recommended, 

among other things, that agencies improve the interoperability of 

government and private sector computer systems, to the extent allowable 

by law, to facilitate the exchange of information on imported products. 

 

15Department of Homeland Security, Office of Inspector General, Additional Controls Can 

Enhance the Security of the Automated Commercial Environment System (Redacted), 

OIG-08-64 (June 2008). 

16GAO, Information Technology: Customs Automated Commercial Environment Program 

Progressing, but Need for Management Improvements Continues, GAO-05-267 

(Washington, D.C.: Mar. 14, 2005). 

17GAO-06-15 and GAO/AIMD-00-21.3.1. 

Page 20 GAO-09-873 Food Safety
 

Importers can retain possession of their food shipments until FDA 

approves their release into U.S. commerce. 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. According to these officials, many brokers and importers 

still consider the occasional payment of liquidated damages as part of the 

cost of doing business.18 Indeed, as we reported in 1998,19 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 written response to 

our 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. FDA officials told us that if the 

agency had the authority to impose penalties on importers, it might be 

possible to better deter violations. 

FDA Has Limited Authority 

to Ensure Importers’ 

Compliance 

CBP and FDA 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. Brokers or 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 a 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. 

 

18CBP refers to the amount of the forfeited bond as liquidated damages; FDA sometimes 

refers to this amount as a bond penalty. 

19GAO/RCED-98-103. 

Page 21 GAO-09-873 Food Safety
 

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 brokers 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, a broker 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 FD 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.20

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 original registration being canceled, and consequently FDA may not 

know the precise number of foreign firms registered. 

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. In the interim, FDA officials told us that they have 

developed informal workarounds to address the problem. For example, 

they can identify and merge duplicate records, a process that is done 

manually, or, to some extent, can be done electronically. Furthermore, 

officials told us that the new PREDICT screening system has a feature that 

will assign higher risk scores to firms perceived by the system to be new, 

which may also include firms with multiple identifiers in FDA’s system. 

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 

 

20Import alerts communicate information and policy to FDA field staff. Usually, they 

provide information that products covered by the alert are subject to detention. If 

detained, the importer can prove that the imported product is compliant, such as by 

providing FDA with the results of third-party laboratory analysis of the product. 

Page 22 GAO-09-873 Food Safety
 

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. 

CBP Faces Challenges in 

Overseeing In-Bond 

Shipments 

To facilitate trade, CBP allows imported cargo intended for either U.S. or 

foreign markets to move from one U.S. port to another without duties or 

appraisement of the cargo and without entering U.S. commerce. This 

cargo—referred to as an in-bond shipment—requires a responsible party 

to obtain a CBP-approved bond and agree to comply with applicable 

regulations. Some CBP port officials have estimated that in-bond 

shipments represent from 30 percent to 60 percent of goods received at 

their ports. CBP officials told us that food is one of the most common 

types of products shipped using the in-bond system; other products 

include auto parts, textiles, and machinery. 

Importers and shipping agents can use three types of in-bonds. First, the 

Immediate Transportation in-bond allows a shipment arriving at a U.S. port 

to be transported to another U.S. port, where it is entered into commerce. 

Alternatively, these types of in-bond shipments can be admitted to a bonded 

warehouse or foreign trade zone.21 Second, Transportation and Exportation 

in-bonds cover shipments that are in transit through the United States. For 

example, a shipment may arrive at a U.S. port and be transported through 

the United States and exported from another U.S. port. Finally, Immediate 

Exportation in-bonds are used for shipments that arrive and are unloaded at 

the U.S. port but are to be exported from that same port. FDA neither 

distinguishes between these various types of in-bonds, nor does the agency 

differentiate between in-bonds and other types of imported shipments. 

(Since FDA generally does not review or examine shipments for 

admissibility until the broker files entry, the agency is not concerned with 

the status of shipments prior to that stage). According to a CBP official, 

even though the agency does not examine in-bond shipments at the port of 

arrival, it can still deny an in-bond movement if it has reason to believe a 

given shipment contains a high risk product. However, some CBP, FDA, and 

FSIS officials expressed concern that in-bond cargo, including some 

 

21For merchandise that is admitted into a foreign trade zone or bonded warehouse, duties 

and taxes are deferred until the goods are withdrawn for consumption. Goods may also be 

withdrawn from a bonded warehouse for export, thereby avoiding the payment of U.S. 

duties and taxes. Goods admitted to a foreign trade zone may be further processed and 

incorporated into new products, such as automobiles or refined petroleum products. 

Page 23 GAO-09-873 Food Safety
 

potentially violative food products, may be diverted from their final 

destination and illegally sold in the U.S. market. 

We reported in 2007 that CBP did not effectively track in-bond 

shipments.22 For example, we reported that CBP did not consistently 

reconcile the in-bond documents issued at the arrival port with do

at the destination port to ensure that a shipment is either officially entered

into U.S. commerce—with appropriate duties or quotas applied—or i

exported. We made several recommendations to improve CBP’s oversight 

of in-bonds that the agency has since addressed. For example, CBP has 

implemented our recommendation to use certain shipment-related 

information to ensure that the agency can adequately track in-bond 

shipments between the arrival and destination ports. In addition, CBP told 

us that they have provided guidance to field personnel on measuring 

importers’ compliance with in-bond regulations. However, CBP has not yet 

finalized one of our key recommendations. Specifically, CBP agreed to 

amend a regulation to reduce the time allowed for transporting cargo and 

to limit importers’ ability to change the final destination of in-bond 

shipments without the agency’s knowledge. We found in 2007 that in-bond 

regulations provide unusual flexibility for the trade community, but create 

challenges for CBP. The regulations currently allow bonded carriers 15 to 

60 days, depending on the mode of shipment, to reach their final 

destination and allow them to change a shipment’s final destination 

without notifying CBP. According to agency officials, CBP has drafted 

amendments to the regulation, but as of July 2009, CBP had not issued a 

final regulation and was awaiting the Department of Homeland Security’s 

approval for these amendments. Although it is commendable that CBP has 

taken this step, until the agency finalizes the regulation, concerns remain 

that potentially violative food imports could be shipped in-bond and enter 

U.S. commerce undetected. 

cuments 

s re-

 

CBP and FDA Officials Are 

Working to Overcome 

Enforcement and 

Collaboration Issues 

Although the agencies have gaps in enforcement and collaboration, FDA 

and CBP have implemented joint initiatives at two ports we visited that, 

according to officials from both agencies, have improved interagency 

coordination. At the ports of Buffalo and Miami, FDA and CBP coordinate 

their efforts to issue a joint notice of action to the importer or broker 

when FDA identifies a food shipment that is violative or appears to be 

violative. This joint notice—which is issued through a unified arrangement 

22GAO-07-561. 

Page 24 GAO-09-873 Food Safety
 

at the Buffalo port and by a formal joint operations team at the Miami 

port—combines FDA’s notice of refusal and CBP’s notice of redelivery, 

which are typically issued separately. According to agency officials, these 

separate notices can confuse importers and brokers because each agency 

has different (1) documentation requirements for the importer’s response 

to its notice, (2) procedures and deadlines with which the importer must 

comply, and (3) points of contact for responding to importer inquiries. 

Although the same information is communicated to the importer 

regardless of whether the notices are issued separately or jointly as a 

single notice, agency officials in Buffalo and Miami told us that the joint 

notice simplifies the import refusal process for CBP and FDA and is also 

less confusing to importers. The formal joint operations team in Miami 

provides a single point of contact for importers, which further simplifies 

the process. FDA and CBP officials, as well as a customs broker 

representative, told us that lack of coordination between agencies also 

occurs at other ports and results in confusion for industry. According to 

FDA and CBP officials, the joint notice of action appears to benefit both 

agencies; officials from both ports told us that (1) importer compliance 

with FDA’s refusal procedures and CBP’s redelivery procedures has 

improved and (2) FDA and CBP can better ensure that violative food 

products are either exported or destroyed. FDA’s guidance for imports 

recognizes that some FDA districts have developed joint notices of action 

and encourages districts to “follow local procedures” in this regard, but it 

also states that the use of joint notices of action has not been approved 

nationally. 

Agency officials noted that to successfully develop a joint team, the two 

agencies should ideally be co-located, and managers must have good 

relationships. Moreover, effective practices for agency coordination call 

for agencies to establish strategies that work in concert with those of their 

partners or are joint in nature.23 Such mutually reinforcing strategies help 

in aligning activities, core processes, and resources to accomplish a 

common outcome. 

 

23GAO-06-15. 

Page 25 GAO-09-873 Food Safety
 

FDA Collaborates 

with States and 

Foreign Governments, 

but Does Not Fully 

Share Information 

with States During a 

Recall 

FDA has formal and informal mechanisms to work with the states on 

imported food safety. However, FDA does not always share market 

distribution information with states in the event of a recall, which makes it 

difficult for states to find and remove contaminated products from store 

shelves within state borders. According to the Interagency Working Group 

on Import Safety, federal and state governments have complementary 

roles and resources for ensuring the safety of imported food. 

Internationally, FDA has started opening offices overseas to collect 

information, collaborating with foreign counterparts, and educating 

exporters on U.S. food safety laws and regulations. FDA also exchanges 

food safety information with officials in counterpart agencies in several 

countries. 

FDA Collaborates with 

Some States to Leverage 

Resources 

As the Interagency Working Group on Import Safety noted in 2007, federal 

and state government can take complementary actions to ensure the safety 

of imported food. While the federal government can interdict unsafe 

imported goods at ports of entry, states can address unsafe imported 

products within their borders. The federal or state governments may have 

access to information relevant to protecting consumers that the other does 

not possess. For example, the federal government may have relevant 

information about the foreign source of the imported product and about 

the importer. This information can help state officials track down an 

unsafe imported product within their jurisdiction. On the other hand, state 

officials may identify an unsafe imported product during transport or at 

the point-of-sale, if the product does get into the country, and can tip off 

federal officials to prevent future shipments from entering domestic 

commerce. Therefore, FDA has entered into one contract, several 

cooperative agreements, and several informal partnership agreements with 

various states. In general, FDA uses a contract when it believes that it will 

benefit directly from the contract. It has such a contract with Michigan. 

Under this contract, the Michigan Department of Agriculture (MDA), the 

state’s food safety body, has added imported products to its routine food 

inspections. An FDA employee in the Detroit district office determines the 

type of food to be inspected. As part of the 2008 through 2009 contract, for 

example, MDA sampled baked goods (turnovers), canned products 

(maraschino cherries), flour, bottled water, bulk cherries in drums, and 

fresh produce (peppers). MDA approached FDA about adding imports to 

its FDA contract because it recognized that Detroit was a major port for 

imported food. In addition, after melamine was found to have 

contaminated U.S. human and pet food products in 2007, Michigan focused 

more attention on imports. FDA concurred and added imports to the 

Michigan contract. 

Page 26 GAO-09-873 Food Safety
 

According to an FDA official, FDA also enters into cooperative agreements 

with states. Cooperative agreements are appropriate when the principal 

purpose of the transaction is the transfer of money, property, services, or 

anything of value to accomplish a public purpose of support authorized by 

federal statute. Moreover, under a cooperative agreement, substantial 

involvement is anticipated between FDA and the recipient during 

performance of the funded activity. For example, FDA has 3-year 

cooperative agreements with six states to establish Food Hazard Rapid 

Response Teams to address emergencies, which may include incidents 

associated with imported food. The six states participating in these rapid 

response cooperative agreements are California, Florida, Massachusetts, 

Michigan, Minnesota, and North Carolina. The goal of these agreements is 

to develop, implement, exercise, and integrate an all-hazards food and 

foodborne illness response capability to rapidly react to potential threats 

to the U.S. food supply. To support these state efforts, FDA provides 

funding for program assessment, additional equipment, supplies, funding 

for personnel, training, and the development and coordination of the rapid 

response teams’ exercises. 

Under FDA’s contract with the state of 

Michigan, if a violative situation is determined 

with an imported ingredient or an imported 

finished product, the state agrees to, in 

addition to its routine procedures, do the 

following:

 Conduct field examination so imported foods

while in either import or domestic status at the 

establishment being inspected.

 Collect samples of imported goods while in 

either import or domestic status if indicated.

 Analyze samples of imported goods using

FDA-approved methods and procedures.

 Supervise destruction or exportation,

including marking activities, of imported

products refused entry by FDA.

 Conduct traceback investigations of

imported goods related to consumer

complaints, adverse events, recalls, or other

reports indicating significant health and safety

problems associated with the products. The

tracebacks will attempt to identify the foreign

source or origin of the implicated product. The

tracebacks will consist only of paper review at

establishments.

Finally, FDA enters into informal partnerships with states when both 

benefit. FDA has several informal partnerships for food imports; these 

partnerships facilitate federal-state cooperation but do not involve federal 

funding. The New York State Department of Agriculture and Markets 

(NYSDAM) and FDA’s New York district office, for example, have 

partnerships for a joint inspection protocol and a joint sampling protocol. 

As part of the joint inspection protocol, NYSDAM food inspectors will 

enter warehouses specializing in food from a particular country or culture 

to look for violative imported products in domestic commerce. The state 

has the ability to immediately seize the product. (In exercising its food 

seizure authority, NYSDAM may prohibit the movement of food anywhere 

within the state.) A NYSDAM official told us that the joint inspection 

protocol has helped FDA generate a number of import alerts since it 

began. However, if NYSDAM finds that a sample tests positive for 

contamination, it must still send the sample to FDA for verification before 

FDA will take regulatory or enforcement actions, such as voluntary recalls 

or import alerts. FDA does not accept the results of states’ laboratory tests 

at face value without further review or verification as the basis for an 

import alert because states typically use their own sampling, testing, and 

reporting standards, rather than FDA’s generally stricter standards. FDA 

Page 27 GAO-09-873 Food Safety
 

may accept state results as the basis of a class I or class II recall.24 At this 

time, FDA reviews the data, and then a decision is made on a case-by-case 

basis to either use the data or to verify the results before taking action. 

FDA can also adjust OASIS to target future shipments of the violative 

product type at the border. 

Under the joint sampling initiative, NYSDAM collects food samples in the 

marketplace for analysis and sends them to a state laboratory for testing. 

If the product is imported, and if the state laboratory finds the sample to 

be violative, NYSDAM personnel will inform FDA and conduct a risk 

assessment. If FDA agrees, when NYSDAM staff go back to seize the 

product (if still present) they will collect a sample and send it to an FDA 

laboratory. FDA will process the sample in its computer system and 

submit it for laboratory analysis. If the FDA laboratory confirms that the 

sample is violative, the agency will issue an import alert. 

In addition to the joint inspection and sampling initiatives, NYSDAM helps 

FDA track down a product in the marketplace if a food safety violation is 

detected after the product has entered commerce. In 2004 for example, 

according to New York state officials, a Chinese infant formula 

manufacturer produced a formula that was found to be deficient in several 

key ingredients and hence could not provide adequate nutrition for an 

infant. Although FDA had advised NYSDAM that there had been no entries 

listed in FDA’s OASIS system for this imported infant formula, NYSDAM 

sent inspectors into Chinese-American neighborhoods, where they found 

the smuggled product for sale in an Asian market. NYSDAM seized, 

sampled, and tested the product and supervised its destruction after 

receiving confirmation from the state food laboratory that the product 

lacked appropriate nutritional value. 

 

24FDA categorizes all recalls into one of three classes, according to the level of hazard 

involved. Class I recalls are for dangerous or defective products that predictably could 

cause serious health problems or death, such as food found to contain botulinum toxin or 

food with undeclared allergens. Class II recalls are for products that might cause a 

temporary health problem or pose only a slight threat of a serious nature, such as the 

presence of dry milk—an allergen—as an ingredient in sausage without mention of the dry 

milk on the label. Class III recalls are for products that are unlikely to cause any adverse 

health reaction, but that violate FDA labeling or manufacturing regulations, such as a minor 

container defect or lack of English labeling in a retail food. However, with the exception of 

infant formula, FDA does not have the authority to order a recall of a food product. In most 

cases, food manufacturers voluntarily recall the product when there is a problem. 

Page 28 GAO-09-873 Food Safety
 

Other states also have informal partnerships with FDA on imports. For 

example: 

• At FDA’s request, some states, including California, Illinois, New Mexico, 

and Washington, sometimes embargo imported foods that are found to be 

contaminated or violative and have already entered U.S. commerce. 

• Florida’s Department of Agriculture and Consumer Services has “stopsale” authority, granted under state law, which it can use if it determines 

that a food product is imminently dangerous or in violation of state public 

health law. FDA can ask the department to issue a stop-sale notice if 

circumstances warrant. An embargo or stop-sale action prevents the 

product from being sold to consumers, which allows FDA enough time to 

sample and test the product to determine whether, for example, a 

voluntary recall notice is warranted. 

• New Mexico’s Environment Department performs surveillance of local 

grocery stores, looking for illegal imports from Mexico, such as queso 

fresco, a type of cheese often made from unpastuerized milk. 

• The Texas Department of State Health Services has a Partnership 

Agreement with FDA’s Southwest Import District, based in Dallas, to 

coordinate surveillance of imported items in domestic commerce, 

including queso fresco and candies from Mexico. In addition, because the 

department has the authority to detain a product as soon as it detects a 

suspected violation, it can issue a food recall more quickly than FDA, 

which must conduct extensive, often time-consuming analysis to classify a 

food recall. (Recalls made by the state of Texas are independent of those 

made by FDA.) Once it confirms the violation, the state notifies FDA of its 

laboratory results and its intent to issue a recall letter or require the 

importer or wholesaler to do so. FDA may then notify its staff at the 

border to watch for the violative product and may also issue an import 

alert—but only after conducting the appropriate reviews. In some 

instances—particularly if the product is distributed nationally—FDA may 

request that a producer initiate a recall at the national level. 

• Illinois has participated informally in a joint initiative with FDA in which 

state inspectors visited warehouses that were known to store imported 

products and performed checks for specific types of products from 

targeted companies. A state official told us that when FDA has requested 

this assistance, Illinois uses FDA forms and provides FDA with copies of 

inspection and laboratory results. 

Page 29 GAO-09-873 Food Safety
 

Given the range of possibilities for working with FDA, some state officials 

told us that they would like to collaborate further with FDA on food 

imports. For example, one state official told us that there could be value in 

having states inspect warehouses where imported goods are stored before 

entering into commerce. Another state official said that, budgets 

permitting, her agency would like to coordinate more on surveillance of 

imports in retail establishments. A third state official expressed interest in 

collaborating with FDA on testing for pesticide residues on imports. FDA 

has pointed out the need to work quickly when food contamination occurs 

and to coordinate a rapid response among FDA, state, and local 

governments. Because some states can issue recalls more quickly than 

FDA, a state official said it might be advantageous for FDA to leverage 

state resources so that violative products can be more quickly detained 

while FDA takes the legal steps necessary to ask the company to recall the 

product. 

Although some state officials see opportunities for more collaboration 

with FDA, other state officials told us that, with limited resources, it is 

likely to be burdensome for them to divert resources to working with FDA 

on imports. These states prefer to focus their work on the domestic food 

supply, leaving FDA to focus on imported food. 

FDA Does Not Always 

Share Product Distribution 

Information During a 

Recall 

According to officials from several states, during food recalls, FDA 

generally does not share 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 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; 

• such sharing is necessary to effectuate a recall; 

Page 30 GAO-09-873 Food Safety
 

• 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. 

FSIS discloses certain distribution-related information to the public during 

a recall—specifically, the names and locations of the retail consignees of 

meat and poultry products that have been recalled by a federally inspected 

meat or poultry establishment if the recalled product has been distributed 

to the retail level. According to FSIS, the agency discloses information 

only when there is a reasonable probability that the use of the recalled 

product will cause serious adverse health consequences or death (class I 

recalls). FSIS officials stated that they do not consider this a release of 

business confidential or proprietary information because it is not releasing 

a firm’s distribution list to the public. FSIS also does not post the names 

and locations of any of the intermediate consignees that received the 

recalled product or that routinely receive product from that firm. Rather, 

FSIS is making public a list that FSIS personnel compile only of the retail 

consignees that received recalled products. FSIS officials believe this 

information helps consumers reduce their risk of foodborne illness by 

providing more information that may assist them in identifying recalled 

products. 

FDA Is Expanding Its 

Efforts to Coordinate with 

Other Countries in a 

Number of Ways 

According to FDA, the agency initiated its Beyond Our Borders program in 

an effort to help prevent food that violates U.S. standards from reaching 

the United States. Under this program, FDA intends to open offices in 

China, Europe, India, Latin America, and the Middle East to provide 

technical assistance and conduct inspections, among other things. FDA 

will station investigators in some of the overseas locations, although FDA 

has decided not to station investigators in Latin American countries 

because of the region’s close proximity to the United States. The program 

is also 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 informed decisions on which food imports to 

examine. For example, FDA expects that its overseas staff will be able to 

work with staff at counterpart regulatory agencies overseas, as well as 

with U.S. expatriates who may be knowledgeable about certain industries. 

Overseas staff will also educate local exporters to make sure they 

understand U.S. food safety laws and regulations. The offices in China 

(Beijing, Guangzhou, and Shanghai) opened in November 2008. FDA plans 

to post staff at the U.S. Mission to the EU in Brussels, Belgium; in the 

European Medicines Agency in London, England; and at the European 

Page 31 GAO-09-873 Food Safety
 

Food Safety Authority in Parma, Italy. The office in New Delhi, India, 

opened in January 2009; a second office in Mumbai, India, is expected to 

open later in 2009. FDA opened an office in San, José, Costa Rica, in 

January 2009 and also intends to open offices in Mexico City, Mexico, and 

Santiago, Chile. FDA has not opened offices in the Middle East because its 

request to do so was denied by the Department of State owing to security 

concerns. See table 1 for an overview of the locations and staffing of these 

planned offices. While it is too early to evaluate the program, an FDA 

official told us that the information the agency will acquire through its incountry presence may enable FDA staff at U.S. ports of entry to make 

more informed, risk-based decisions about which food imports to 

examine. 

Table 1: FDA’s Planned Staffing Levels for Foreign Posts (35 U.S. nationals)

a

Geographic region and staff category 

Number of staff (current as of 

8/20/09) 

Date first US national FDA employee arrived 

at post 

China (Beijing, Guangzhou, and Shanghai) 4 (at post in Beijing) 

2 (at post in Guangzhou) 

2 (at post in Shanghai) 

November 8, 2008 (Beijing) 

July 3, 2009 (Guangzhou) 

May 29, 2009 (Shanghai) 

Foods 3 (including 2 inspectors) 

Medical products 4 (including 2 inspectors) 

Both 1 (office director) 

EU (Belgium, Italy, and United Kingdom) 1 (at post in Brussels) 

1 (at post in London) 

1 (not yet at foreign post) 

May 11, 2009 (U.S. Mission to the EU in 

Brussels) 

June 25, 2009, FDA liaison at the European 

Medicines Agency (London) 

Plan is to have FDA liaison at the European Food 

Safety Agency (Parma) in early 2010 

Foods 1 

Medical products 1 

Both 1 (office director) 

India (Mumbai and New Delhi) 5 (at post in New Delhi) 

2 (at post in Mumbai) 

5 (not yet at foreign post)b

December 9, 2008 (New Delhi) 

June 20, 2009 (Mumbai) 

Foods 5 (including 3 inspectors) 

Medical products 6 (including 2 inspectors) 

Both 1 (office director) 

Page 32 GAO-09-873 Food Safety
 

Page 33 GAO-09-873 Food Safety 

Geographic region and staff category 

Number of staff (current as of 

8/20/09) 

Date first US national FDA employee arrived 

at post 

Latin America (Chile, Costa Rica, and 

Mexico)c

 

4 (at post in San José) 

1 (at post in Santiago) 

3 (not yet at foreign post)d

April 29, 2009 (San José, Costa Rica) 

August 13, 2009 (Santiago, Chile) 

Plan is to have U.S. nationals at post in Mexico 

City on or around November 1, 2009 

Foods 5 

Medical products 2 

Both 1 (office director) 

Middle East (Israel and Jordan) 0 (at post in Amman) 

0 (at post in Tel Aviv) 

4 (not yet at foreign post)e

Deployment date to Amman and Tel Aviv is 

uncertain at this time; FDA is still in discussions 

with the Department of State over site and timing 

of any deployments to the Middle East 

Foods 1 

Medical products 1 

Both 2 (office director and 1 inspector) 

Source: FDA. 

a

These numbers include only U.S. nationals and only staff that are located (or to be located) incountry. Using these funds, FDA will also employ foreign nationals to assist with administrative and 

other support. 

b

One additional employee, an inspector, is scheduled to be at the post by the end of December 2009. 

FDA is in the process of filling the remaining four positions. 

c

An FDA official stated that it is not necessary to permanently station inspectors in Latin America 

because of the region’s geographic proximity to the southern United States. 

d

Of the three remaining positions, one has been hired for Mexico City and is expected to deploy on or 

around November 1, 2009. The second Mexico City position will be filled with a detailee also starting 

in Mexico on or around November 1, 2009. The third position is the second person FDA had hoped to 

post to Santiago, Chile. Owing to space considerations, however, the embassy in Santiago agreed to 

only one U.S. national. That position will be filled and posted in Rockville, Maryland until an 

alternative site can be agreed on or until the embassy agrees to the posting there. 

e

For now, FDA has established the Middle East Office in the Office of International Programs in 

Rockville, Maryland. The Director and the Medical Products Specialist are on board, and FDA is in 

the process of hiring the remaining two positions. 

Furthermore, according to an FDA official, the agency works with its 

counterpart regulatory agencies in countries such as Australia, Canada, 

and New Zealand. High-level officials from the United States and these 

three countries hold a formal meeting every year and a teleconference 

every 3 months to strategize over food safety; exchange information, such 

as laboratory findings; and set public health limits on certain substances, 

such as pesticides. FDA also maintains confidentiality agreements with 

counterpart agencies in Canada, the EU, and the United Kingdom that 

allow FDA to share nonpublic information—with the exception of trade 

secret information. Routine information-sharing also occurs at the desk 

officer level in the event of an outbreak. For example, the Canadian Food 

Inspection Agency informally notified FDA when it detected a shipment of 
 

caviar with dangerously low salt concentrations. (Salt is needed to prevent 

the growth of Botulism bacteria.) The Canadian agency ordered the 

product out of the country, so the importer attempted to return it to the 

United States. However, when FDA examined the returning shipment at 

the border, they found that not all of the caviar was accounted for, and 

some unlabeled cans were actually tuna. They notified counterparts in 

Canada, and Canadian officials were able to locate some of the product. 

Since the caviar was mislabeled, CBP treated the case as a smuggling 

incident, and the importer pled guilty to a misdemeanor FDA violation. 

Information also flows in the other direction. For example, in 2009, when 

peanuts from an American firm were found to be contaminated with 

Salmonella, FDA staff coordinated with their counterparts at the Canadian 

Food Inspection Agency. During the outbreak, FDA staff told their 

Canadian counterparts about the problem so Canadian officials could be 

on the alert for products from the Georgia company and remove them 

from the market. 

PREDICT, which uses FDA-developed criteria to estimate the risk of 

imported food shipments, reflects FDA’s planned strategy of identifying 

food vulnerabilities and assessing risks, focusing inspections and sampling 

based on risk, and using science and modern technology systems. A 2007 

pilot test of PREDICT in Los Angeles for seafood products indicated that 

the system, compared with baseline OASIS data, improved FDA’s ability to 

target imports that the agency considers to be high risk for field or 

laboratory examinations. It also allowed a greater percentage of products 

the agency considers to be low risk to enter U.S. commerce without 

requiring an entry reviewer’s intervention. Further actions are needed, 

however, to help ensure the system’s success. 

PREDICT Testing 

Indicates that the 

System May Improve 

FDA’s Risk-Based 

Import Screening 

Efforts, but Further 

Actions Are Needed 

PREDICT Is a Risk-Based 

Screening System that 

Quantifies the Risk of 

Imported Food Shipments 

According to FDA, it is developing PREDICT to improve its ability to 

target shipments for inspection that are more likely to violate FDA’s 

regulations. The agency pilot-tested the system at several ports in the 

metropolitan Los Angeles area—including Los Angeles/Long Beach, the 

nation’s busiest ports for seafood as ocean cargo, and Los Angeles 

International Airport, one of the busiest ports for seafood as air cargo—

from June through September 2007 for seafood imports. FDA plans to 

begin deploying PREDICT on a district-by-district basis at all ports and for 

all FDA-regulated products (e.g., food, drugs, and medical devices) in 

September 2009 over a 6-week period. 

Page 34 GAO-09-873 Food Safety
 

PREDICT is to generate a numerical risk score for all FDA-regulated 

products by analyzing importers’ shipment information using sets of FDAdeveloped risk criteria. 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. According 

to FDA, PREDICT will also randomly select a small number of shipments 

for examination and incorporate criteria—such as certain import alerts 

and import bulletins25—historically used in OASIS to screen imports. In 

addition, agency officials stated that PREDICT will assign higher risk 

scores to firms for which the system does not have historical data. FDA 

believes that in some cases, these firms are new importers that do not 

have established track records with the agency, while in other cases these 

firms may be intentionally using multiple manufacturer identifiers to 

circumvent FDA’s targeting screening criteria, including import alerts. 

According to FDA, after PREDICT estimates the risk that an imported food 

shipment poses, the system is to present to entry reviewers the shipment’s 

risk score 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 

that flags the products for examination or detention without physical 

examination. FDA intends for entry reviewers using PREDICT to 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 entry reviewers to use PREDICT to supplement, 

rather than replace, their professional judgment when deciding what food 

products to inspect. 

PREDICT is also designed to improve screening efficiency by automating 

certain “data lookup” activities that entry reviewers currently must 

perform manually in several other systems, according to FDA.26 For some 

 

25Import bulletins are generally informational only. While some import bulletins may 

identify potential problems with a product, unlike some import alerts, they do not provide 

information regarding detention without physical examination or other FDA action, 

although in some cases they may advise sample collections. 

26For example, according to agency officials, for low-acid canned food imports, entry 

reviewers must manually determine whether the importer’s manufacturing facility is 

certified in additional FDA-required safeguards. 

Page 35 GAO-09-873 Food Safety
 

entries, the results of these data lookups may provide evidence that the 

product is low risk and does not require further FDA review. In such 

cases, an automated data lookup process would enable the system to “may 

proceed” these low risk entries—that is, automatically clear these 

shipments for U.S. commerce without a manual review. According to 

agency officials, FDA entry reviewers spend a significant amount of time 

performing these manual data lookups. The agency expects that PREDICT 

will substantially increase the system “may proceed” rate; as a result, entry 

reviewers will have more time to spend on higher-risk products. 

Preliminary Data Suggest 

that PREDICT Could 

Improve FDA’s Screening 

Efforts 

FDA’s PREDICT pilot test suggests that the system could enhance FDA’s 

risk-based import screening efforts. First, PREDICT improved the agency’s 

ability to identify imports that were more likely to violate FDA regulations. 

Specifically, PREDICT nearly doubled the percentage of field 

examinations—and increased by approximately one-third the percentage 

of laboratory examinations—that resulted in violative findings, relative to 

baseline OASIS data. Second, according to FDA, the violations in 

shipments that entry reviewers targeted using PREDICT, on average, 

posed a greater risk to human health than the violations that OASIS 

detected. In particular, the severity of the violations that FDA detected in 

field and laboratory examinations during the pilot increased by 

approximately 47 and 43 percent, respectively. Finally, PREDICT allowed 

a greater percentage of shipments the agency considers to be low risk to 

enter U.S. commerce without requiring manual review. The effective 

system “may proceed” rate for seafood imports increased from 6 percent 

to 39 percent during the pilot, which improved screening effectiveness and 

allowed entry reviewers to spend more time reviewing shipments FDA 

considers to be higher-risk. 

FDA officials acknowledged a methodological limitation in the PREDICT 

pilot. Specifically, during the pilot FDA excluded all aquaculture-produced 

Chinese seafood from the comparison between OASIS and PREDICT. 

According to these officials, these products accounted for approximately 

30 percent of the total volume of seafood shipments FDA screened during 

the pilot. According to agency officials, FDA excluded these products 

because it had previously issued an import alert during the pilot under 

which several types of seafood produced in China were subject to 

detention without physical examination because they appeared to violate 

applicable requirements, such as the presence of unsafe new drugs or food 

additives. Since these shipments were subject to detention without 

physical examination at the border, entry reviewers could not use 

PREDICT’s risk assessments to guide their decision to “may proceed” or 

Page 36 GAO-09-873 Food Safety
 

review the shipments. Agency officials stated that they do not believe that 

excluding these products significantly affected PREDICT’s results, and the 

agency concluded that the pilot demonstrated PREDICT’s benefits to 

import screening compared with the OASIS system. 

Further Agency Action Is 

Needed to Help Ensure 

PREDICT’s Success 

Although the PREDICT pilot produced positive results and demonstrated 

the system’s potential to improve import screening efforts, further agency 

actions are needed to help ensure that the system is effective. For 

example, FDA has 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. According to officials, a working group charged with 

developing an evaluation plan has met, but has not yet completed a plan. 

FDA officials told us that they intend to evaluate PREDICT after it has 

been in operation long enough to permit officials to collect and analyze a 

sufficient amount of data—officials provided a rough estimate of 3 

months—but as of June 2009, the agency had not yet developed a plan to 

do so. Under federal standards for internal controls, agencies are to 

engage in the ongoing monitoring of programs to assess performance over 

time, including establishing policies and procedures to ensure that 

findings of reviews are promptly resolved.27

We recently identified information technology management concerns that 

might hinder the rollout of FDA modernization projects such as 

PREDICT.28 Specifically, we reported in June 2009 that FDA does not have 

a comprehensive information technology strategic plan to guide its efforts 

to modernize its information technology initiatives. Until it develops such 

a plan, FDA’s efforts to modernize its information technology may not 

adequately meet the agency’s urgent mission needs. We also found that 

FDA does not (1) have a well-defined enterprise architecture to efficiently 

and effectively guide and constrain the agency’s modernization efforts,29

and (2) strategically manage information technology human capital to 

 

27GAO/AIMD-00-21.3.1. 

28GAO-09-523. 

29An enterprise architecture is a set of descriptive models (e.g., diagrams and tables) that 

define, in business and technology terms, how an organization operates today, how it 

intends to operate in the future, and how it intends to invest in technology to transition 

from today’s operational environment to tomorrow’s. 

Page 37 GAO-09-873 Food Safety
 

identify existing gaps between skills on hand and future needs. Without an 

effective enterprise architecture and information technology human 

capital management that is based on a strategic vision for the agency’s 

information technology systems, FDA has less assurance that it will be 

able to modernize effectively and have the appropriate staff to implement 

and support its efforts to modernize. FDA generally agreed with our 

recommendations, stating that it is drafting a strategic plan for information 

management and has set a goal to complete the draft plan by the end of 

fiscal year 2009. FDA intends to include PREDICT in this plan. FDA also 

commented that it has made significant progress in developing an 

enterprise architecture program management plan and is assessing its 

workforce needs and developing hiring plans and priorities that will be 

used to recruit skilled personnel to the agency. However, FDA could not 

provide documentation to demonstrate its progress in developing the 

enterprise architecture program management plan, which we 

recommended should include a detailed work breakdown of the tasks, 

activities, and timeframes associated with developing the architecture, as 

well as the funding and staff resources needed. 

According to agency officials, FDA intends to deploy PREDICT on a 

district-by-district basis for all FDA-regulated products beginning in 

September 2009. The agency previously intended to implement PREDICT 

in April 2009 but postponed the deployment because of unexpected delays 

in developing a system interface between PREDICT and OASIS. These 

delays, in turn, postponed necessary system testing and user training. 

Since 2005, FDA has spent approximately $9 million on PREDICT. The 

agency estimates that PREDICT will cost an additional $12.7 million over 

the next 5 years, plus additional funding for three or four full-time 

equivalent staff per year to manage the program once it is fully 

operational. 

Page 38 GAO-09-873 Food Safety
 

We reported in 2008 that increased public concern about food safety 

recently led the EU to reorganize its food safety system, including its 

procedures for overseeing food imports.30 These procedures may provide 

insights into keeping food safe at the U.S. border. According to EU 

officials, the EU and the United States are facing many of the same 

challenges and have many of the same concerns related to food safety and 

imported food safety in particular. The EU takes a comprehensive, riskbased approach to ensure the safety of imported food by targeting 

products that are more likely to present risk, and taking steps to ensure 

that violative products do not enter EU countries. 

The EU Has 

Developed Some 

Practices That Could 

Inform CBP, FDA, and 

FSIS Practices 

Because the EU considers live animals and products of animal origin to be 

particularly high risk, mainly owing to past problems with bovine 

spongiform encephalopathy (mad cow disease), all such imports must 

enter the EU through approved border inspection posts, where 

government veterinarians are present. Imports are only permitted from 

approved third countries—non-EU countries intending to export to the 

EU—and approved establishments in these countries and must be 

accompanied by official certification of their compliance with EU animal 

health and food safety requirements. These shipments cannot leave the 

port without veterinary approval. Like FDA and FSIS, which are 

developing new computer systems to better manage risks associated with 

imported foods, the EU has implemented a new computer system, called 

the Trade Control and Expert System (TRACES). According to officials, 

nearly all member states already use TRACES. The system automatically 

updates information about live animals and products of animal origin 

entering the EU and is linked to the EU’s Rapid Alert System for Food and 

Feed (which covers all types of food) in order to automatically 

communicate alerts to all border inspection posts.31 The link between 

TRACES and the Rapid Alert System makes it easier to quickly see if 

products arriving at the border have been flagged for closer inspection. 

According to EU officials we spoke with, the creation of this computer 

system was largely motivated by the need for EU policymakers to have a 

more complete, centralized view of the entire supply chain for high risk 

products and to facilitate greater traceability. As such, TRACES provides a 

 

30GAO-08-794.

31For information on the U.S. animal identification system, see GAO, National Animal 

Identification System: USDA Needs to Resolve Several Key Implementation Issues to 

Achieve Rapid and Effective Disease Traceback, GAO-07-592 (Washington, D.C.: July 6, 

2007). 

Page 39 GAO-09-873 Food Safety
 

single window for all points of trade and government regulatory actions 

related to public health and animal health for all imported products of 

animal origin and live animals—tracking these products before they enter 

the EU, during the entry process at ports, and once they are released by 

the veterinary authority. EU officials told us this system will enhance their 

ability to track products throughout the supply chain—“trace back” and 

“trace forward”—during outbreaks of foodborne illness or other 

emergencies, which is a goal that FDA has stated it is pursuing for the 

products it regulates. In addition, when products are rejected for entry, all 

border inspection posts are automatically notified about this rejection 

through TRACES. This practice is intended to prevent importers from 

attempting to have rejected goods enter the EU through a different port, 

that is, “port-shopping,” which is also a concern in the United States. 

In addition to concerns about port-shopping, the EU has concerns 

regarding “transshipment” violations, in which goods intended for export 

to non-EU countries illegally enter the EU market while in transit to those 

countries through the EU.32 In order to be allowed to transship products of 

animal origin through the EU, the products must meet all EU animal health 

requirements—according to officials, this is an important way of lowering 

risks in the event that these products are sold in the EU rather than 

exported as intended. Additionally, the EU has implemented a monitoring 

system to ensure that these products leave the EU through an exit border 

inspection post, which has to confirm to the entry border inspection post 

that the shipment in fact left the EU. 

Unlike products of animal origin, foods of nonanimal origin—except for 

certain high risk foods (including, for example, certain nuts and spices)—

may enter the EU through any port, as they do in the United States, and 

screening systems vary somewhat from country to country. To inspect 

these types of food products, the EU allows member states to use their 

own sampling methodologies and their own national laboratories, which 

are most often accredited by a nongovernmental body, the International 

Standards Organization. This approach may be of interest to U.S. agencies 

as they seek to leverage their resources, where appropriate, by using data 

from state agencies and third parties. 

 

32For more information on transshipment involving seafood, see GAO, Seafood Fraud: FDA 

Program Changes and Better Collaboration among Key Federal Agencies Could Improve 

Detection and Prevention, GAO-09-258 (Washington, D.C.: Feb. 19, 2009). 

Page 40 GAO-09-873 Food Safety
 

If veterinary or port officials reject a food shipment, whether of animal or 

nonanimal origin, the shipment cannot leave government custody for 

exportation to another, non-EU country until that country’s counterpart 

agency officially accepts the shipment in writing. Officials told us that this 

requirement increases their confidence that such goods will not re-enter 

the EU through another port. Furthermore, EU laws place the primary 

responsibility for food safety on producers and other private sector 

entities, recognizing the important role industry plays in food safety, as it 

does in the United States. In the EU, for example, importers bear the cost 

of mandatory inspections and mandatory laboratory tests. In addition, the 

monetary burden for noncompliance with government regulations (for 

example, the cost of destroying rejected goods) is placed on importers or 

the next private sector entity involved in the importation process, such as 

a port terminal operator or warehouse owner. Because of the financial 

responsibilities noncompliance entails, officials told us that there is a 

climate of peer pressure among industry actors to adhere to government 

regulations. This approach may be of interest to U.S. agencies in light of 

concerns about the insufficiency of present measures to deter importer 

noncompliance. 

Increasing amounts of fresh produce, fish, and other food products from 

around the world have enriched U.S. diets and allowed Americans to enjoy 

certain foods in all seasons. But these benefits also carry with them the 

increased risk of foodborne illnesses, some of which can damage health 

over the long-term and even cause death. While CBP, FDA, and FSIS have 

taken steps to address food safety challenges, gaps in enforcement and 

collaboration limit confidence in CBP’s, FDA’s, and FSIS’s efforts to 

prevent potentially unsafe imported food from entering U.S. commerce. 

Conclusions 

Problems in identifying and tracking food shipments can begin at the port 

of entry. Effective communication between CBP’s computer system and 

those FDA and FSIS use to track shipments is essential so that potentially 

violative food products can be screened as expeditiously as possible. CBP 

and FDA have developed an interagency agreement to provide time-ofarrival information to FDA using CBP’s ACS system. However, it is unclear 

whether CBP’s new system (ACE), as currently planned, will keep either 

FDA or FSIS informed about the arrival times of incoming food shipments, 

particularly in light of delays in this system’s development and 

deployment. We believe that this lack of communication among the 

agencies is problematic because it may allow potentially violative food to 

enter U.S. commerce without FDA’s or FSIS’s knowledge or approval. 

Equally problematic is FDA’s lack of authority to assess civil penalties to 

Page 41 GAO-09-873 Food Safety
 

deter importers from bringing violative goods into the country. According 

to FDA’s regulatory procedures manual, liquidated damages that importers 

incur are often so small that they, in effect, encourage future illegal 

distribution of imported shipments. Finally, the importer’s ability to appeal 

CBP’s decisions on the bond amount further limits the bond’s 

effectiveness as a deterrent. Even if these first two problems were 

effectively addressed, FDA is still hampered in its efforts to target 

potentially unsafe shipments of imported food because of the multiple 

CBP identifiers that may be associated with a single foreign firm. As a 

result, importers may circumvent FDA’s systems for targeting higher-risk 

imported food products. 

To their credit, FDA and CBP officials at some ports have worked together 

to facilitate the redelivery of food shipments that FDA has identified as 

violating food safety standards. As these officials told us, this approach 

has facilitated importer compliance with refusal and redelivery procedures 

and therefore better ensures that violative food products are either 

exported or destroyed. We believe that such a joint initiative could be 

feasible at other ports. 

FDA also cooperates to some extent with state governments to inspect 

and sample imported products, although states have identified additional 

opportunities for federal-state collaboration on import safety. For 

example, states can quickly remove violative food from stores while FDA 

goes through the often time-consuming legal process required to ask the 

company to recall its product. Furthermore, we believe that it is in the 

public’s interest that FDA share with states as much information as 

possible under the law on product distribution to facilitate the recall of 

violative imported food in order to minimize potential harm to public 

health. 

Finally, FDA’s PREDICT system, which could improve the agency’s ability 

to screen imported food products on the basis of risk, is a step in the right 

direction, but some actions have not yet been taken to ensure that the 

program will fully succeed. For example, without a plan to measure the 

system’s performance, FDA cannot assess PREDICT’s effectiveness or 

determine whether additional actions are needed. 

To help ensure that CBP, FDA, and FSIS are able to effectively oversee the 

safety of imported food, we are making the following ten 

recommendations: 

Recommendations for 

Executive Action 

Page 42 GAO-09-873 Food Safety
 

To ensure that FDA and FSIS receive the information they need to 

adequately oversee imported food safety, we recommend that the CBP 

Commissioner ensure that CBP’s new screening system communicates 

time-of-arrival information to FDA’s and FSIS’s screening systems. 

Furthermore, until this new system is capable of communicating this 

information, we recommend that CBP implement its interagency 

agreement with FDA to provide time-of-arrival information and explore 

opportunities to implement a similar agreement with FSIS. 

To enhance FDA’s authority to oversee the safety of imported food, we 

recommend that the FDA Commissioner seek authority from the Congress 

to assess civil penalties on firms and persons who violate FDA’s food 

safety laws. We further recommend 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. 

To improve CBP’s and FDA’s ability to identify foreign firms with violative 

histories, we recommend the following actions: 

• The CBP Commissioner should ensure that ACE is able to accept a unique 

identification number for foreign firms that export FDA-regulated foods. 

• The FDA Commissioner should explore ways to improve the agency’s 

ability to identify foreign firms with a unique identifier. 

To enhance agency coordination and to streamline FDA’s refusal process 

with CBP’s redelivery process, we recommend that the FDA 

Commissioner and the CBP Commissioner jointly study, with input from 

agency field officials, ports where a joint initiative would be feasible. 

To better leverage state resources for protecting the safety of imported 

food, we recommend that the FDA Commissioner reach out to states to 

find opportunities for additional collaboration through contracts, 

cooperative agreements, and informal partnerships. 

To enhance public safety, we recommend that the FDA Commissioner find 

ways to share with states product distribution lists, to the extent permitted 

by law, while also protecting confidential commercial information, and if 

necessary, consider what regulatory or legislative changes may be needed 

to allow FDA to share otherwise protected information with states while 

preventing public disclosure. 

Page 43 GAO-09-873 Food Safety
 

To help ensure that PREDICT is effectively targeting high risk imported 

food shipments for field and laboratory examinations, we recommend that 

the FDA Commissioner develop a performance measurement plan prior to 

deploying the system at additional U.S. ports. 

We provided a draft of this report to CBP, FDA, and FSIS for their review 

and comment. CBP agreed with our recommendations but disagreed with 

some of our conclusions. Specifically, CBP stated that we provided no 

evidence that in-bond shipments are (1) riskier than other shipments, or 

(2) unlawfully diverted into commerce because of CBP’s failure to update 

its regulations on reducing the time allowed for transporting cargo and 

limiting the ability of carriers to change the final destination for cargo 

without CBP knowledge. However, as we described in our 2007 report, we 

found that CBP’s in-bond regulations provide unusual flexibility for the 

trade community but create challenges for CBP. One regulation currently 

allows in-bond shipments 15 to 60 days, depending on the mode of 

shipment, to reach their final destination and allow importers to change a 

shipment’s final destination without notifying CBP. In response to our 

recommendation, CBP agreed to amend this regulation, but as of July 

2009, CBP had not yet finalized it; we continue to believe that the agency 

should do so. 

Agency Comments 

and Our Evaluation 

In addition, while CBP acknowledged that its computer system is unable 

to communicate time-of-arrival information at this time, the agency noted 

that this has a limited impact on FDA’s enforcement. Specifically, CBP 

stated that (1) FDA is made aware that products of interest are about to 

arrive or have arrived in the United States via other communication 

mechanisms, and (2) FDA can assess the risk of incoming shipments 

through its Prior Notice requirement and the transmission of data through 

the CBP entry process. However, as we have pointed out, other 

communication mechanisms, such as informal workarounds between the 

agencies, may not be effective at all ports. Moreover, Prior Notice only 

provides a general time frame for arrival of goods and may not be specific 

enough for FDA to know precisely when a given shipment that it has 

designated for examination will arrive at the port. Similarly, information 

submitted through the CBP entry process does not include precise time-ofarrival information. 

Finally, CBP provided an update of its efforts to modify ACS to convey 

time-of-arrival information for FDA-regulated air and truck shipments. We 

have incorporated this information in the report. 

Page 44 GAO-09-873 Food Safety
 

FDA also generally agreed with our recommendations. Although the 

agency agreed in principle with our recommendation on developing a joint 

refusal/redelivery process, FDA does not believe that a study is warranted, 

noting that discussions with CBP on this topic have already begun. We 

continue to believe that a study is valuable because (1) it would document 

best practices and lessons learned at ports where joint initiatives are 

currently underway and would identify potential obstacles to joint 

initiatives, and (2) it would provide evidence of collaborative efforts. In its 

technical comments, FDA noted that the lack of time-of-arrival 

information does not increase the risk that potentially unsafe food may 

enter U.S. commerce without FDA review. Rather, FDA pointed out that 

the bond between CBP and the importer, not the FDA examination, is the 

deterrent to the distribution of the cargo without release. However, FDA’s 

Import Procedures Manual states that “very often penalties are so small 

that [they] in effect encourage the illegal distribution of future imported 

[shipments].” In addition, FDA agreed with our recommendation that the 

agency seek authority from the Congress to assess civil penalties on firms 

and persons who violate FDA’s food safety laws. Moreover, although timeof-arrival information would not prevent importers from distributing food 

shipments prior to FDA review, it would represent additional information 

the agency could use to enhance its review process. 

FSIS only provided technical comments, which we included as 

appropriate. 

As agreed with your offices, unless you publicly announce the contents of 

this report earlier, we plan no further distribution until 30 days from the 

report date. At that time, we will send copies to CBP, FDA, FSIS, and other 

interested parties. The report will also be available at no charge on the 

GAO Web site at http://www.gao.gov. 

Page 45 GAO-09-873 Food Safety
 

If you or your staff members have any questions about this report, please 

contact me 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 report. GAO staff who made major contributions to this 

report are listed in appendix X. 

Lisa Shames 

Director, Natural Resources 

 and Environment 

Page 46 GAO-09-873 Food Safety
Appendix I: Objectives, Scope, and 

Methodology 

Page 47 GAO-09-873 

Appendix I: Objectives, Scope, and 

Methodology 

To respond to the question of how the agencies address challenges in 

overseeing the safety of imported food, we collected documents, such as 

strategic plans and procedure manuals, analyzed the procedures agencies 

follow to screen imported food, and interviewed officials from Customs 

and Border Protection (CBP), the Food and Drug Administration (FDA), 

and the Food Safety and Inspection Service (FSIS). However, we focused 

primarily on CBP and FDA because the U.S. Department of Agriculture 

Office of Inspector General has conducted several detailed reviews of 

FSIS’s import procedures in recent years. We also spoke with 

representatives of industry—including trade associations and customs 

brokers—as well as consumer advocacy groups and other food safety 

experts. In addition, we visited five U.S. ports on different borders or 

coasts where differing modes of transportation—ship, airplane, and 

truck—are used to bring products into the country. These ports were at 

Baltimore, Maryland; Buffalo, New York; Laredo, Texas; Los Angeles/Long 

Beach, California; and Miami, Florida. At each port, we interviewed agency 

officials and observed agency officials physically examining incoming 

shipments to determine whether the shipments met U.S. food safety 

standards and labeling requirements. In four of the five ports, we observed 

staff reviewing imports electronically. We assessed the agencies’ 

collaboration efforts using criteria that we have developed in prior work 

on agency collaboration and coordination. 

To determine the extent to which FDA leverages resources for overseeing 

the safety of imported food by working with state governments, we spoke 

with officials from FDA, as well as officials in Arizona, California, Florida, 

Michigan, New Mexico, New York, Texas, and Washington; all of these 

states are border states, and are also home to large, high-volume ports. We 

also interviewed officials in one inland state—Illinois—because Chicago’s 

O’Hare International Airport receives a high volume of in-bond shipments 

from other ports. To determine the extent to which FDA leverages 

resources with foreign governments for imported food safety, we reviewed 

agency documentation and spoke with a senior FDA official who is 

responsible for FDA’s international initiative. We focused primarily on 

FDA because it regulates roughly 80 percent of the food supply and 

because of our longstanding concerns regarding the agency’s need to 

better leverage its limited resources. 

To describe how the Predictive Risk-Based Evaluation for Dynamic Import 

Compliance Targeting (PREDICT) is being used to oversee the safety of 

imported food, we reviewed and summarized formal assessments of 

PREDICT that both FDA and one of its contractors had conducted. We 

also spoke with FDA officials responsible for managing and implementing 

 Food Safety 
Appendix I: Objectives, Scope, and 

Methodology 

PREDICT, as well as several FDA contractors charged with developing the 

system, and we observed its use at the Los Angeles/Long Beach and 

Buffalo ports. In addition, we leveraged recent GAO work assessing FDA’s 

information technology modernization efforts. We did not review 

PREDICT’s hardware or software environments and testing activities or 

assess the quality of the criteria the system will use to quantify risk. 

To learn about leading practices at EU ports, we visited two EU ports, 

Antwerp, Belgium and Rotterdam, the Netherlands. We selected these 

ports because they are two of the largest in the EU and accept shipments 

of high risk products. Moreover, according to EU officials, these ports are 

known for using leading practices in screening food imports. We did not 

independently verify statements of EU law. 

Under the Federal Food, Drug, and Cosmetic Act, FDA’s authorizing 

legislation, the term “food” means (1) articles used for food or drink for 

man or other animals, (2) chewing gum, and (3) articles used for 

components of any such article. We use this definition, which also 

includes meat, poultry, and egg products, in this report. 

We conducted this performance audit from July 2008 to September 2009 in 

accordance with generally accepted government auditing standards. Those 

standards require that we plan and perform the audit to obtain sufficient, 

appropriate evidence to provide a reasonable basis for our findings and 

conclusions based on our audit objectives. We believe that the evidence 

obtained provides a reasonable basis for our findings and conclusions 

based on our audit objectives. 

Page 48 GAO-09-873 Food Safety
Appendix II: FDA Field Examinations, Fiscal Appendix II: FDA Field Examinations, Fiscal Years 2006 through 2009 

Years 2006 through 2009 

2006 2007 2008 2009 (estimated)

Import linesa8,883,999 9,356,074 9,441,024 9,526,745

Import field exams and testsb 94,545 94,743 100,718 120,000

Import laboratory samples analyzed 20,662 24,558 23,052 26,200

Import physical exam subtotal 115,207 119,301 123,770 146,200

Percent of import lines physically examined 1.30% 1.28% 1.31% 1.53%

Source: FDA. 

a

All imported food entry lines, each of which represents a separate FDA decision under Section 

801(a) of the Federal Food, Drug, and Cosmetic Act. An entry line is each portion of a shipment that 

is listed as a separate item on an entry document. 

b

Includes import sample collections, import label exams, import entry reviews, and other import 

investigations. 

Page 49 GAO-09-873 Food Safety 
Appendix III: FSIS Inspections at Ports of Appendix III: FSIS Inspections at Ports of Entry, Fiscal Years 2006 through 2008a 

Entry, Fiscal Years 2006 through 2008a

2006 2007 2008

Shipments presented 219,979 217,634 208,409

“Skipped” shipmentsb 188,820 195,532 188,854

“Inspected” shipmentsc 31,159 22,102 19,555

Percent of shipments inspected 14.2 % 10.2 % 9.4 %

Total pounds presented 3,888,188,159 3,896,425,509 3,278,956,513

Total pounds refusedd 

(percentage) 

177,034

(0.005%)

149,173 

(0.004%) 

93,731

(0.003%)

Total pounds rejectede 

(percentage) 

12,124,451

(0.312%)

9,124,547 

(0.234%) 

2,715,089

(0.083%)

Total pounds accepted 

(percentage) 

3,875,876,497

(99.683%)

3,887,151,789 

(99.762%) 

3,276,147,693

(99.914%)

Source: FSIS. 

a

After an incoming shipment has met CBP and other requirements, it must be reinspected at an FSISapproved import inspection facility. 

b

For “skipped” shipments, an FSIS inspector examines the shipment’s general condition and ensures 

that it is labeled correctly and has proper documentation. 

c

For “inspected” shipments, an FSIS inspector may physically examine the shipment for visible 

defects, collect samples for laboratory analysis, or both. As with “skipped” shipments, FSIS inspectors 

examine “inspected” shipments’ general condition and ensure they are labeled correctly and have 

proper documentation. See appendix IV for more detail on FSIS screening processes. 

d

Products are refused reinspection if (1) the foreign country is not eligible; (2) the foreign 

establishment is not listed; (3) USDA’s Animal and Plant Health Inspection Service has placed animal 

disease restrictions on the country; (4) the product presented for reinspection is not eligible; or (5) 

there are duplicate shipping marks. 

e

Products are rejected if they fail to meet U.S. import requirements. 

Page 50 GAO-09-873 Food Safety
Appendix IV: Agencies’ Processes to Oversee Appendix IV: Agencies’ Processes to Oversee Imported Food 

Imported Food 

CBP, FDA, and FSIS have unique responsibilities for implementing federal 

laws on imported food products, and they work together to ensure the 

safety of these products. 

CBP CBP enforces the import regulations of 46 federal agencies. If an agency, 

such as FDA or FSIS, detects a problem with a particular shipment, CBP 

will levy the appropriate fines and penalties and oversee exportation or 

destruction of the violative goods. 

Importers or their brokers must notify CBP of an incoming shipment, 

whether food or other products, by electronically submitting information 

on the shipment to either CBP’s legacy computer system, the Automated 

Commercial System (ACS), or the Automated Commercial Environment 

(ACE), the agency’s replacement system, depending on which system 

operates at the port. CBP screens the incoming information primarily for 

national security purposes and potential terrorism threats. With respect to 

high risk imports, CBP uses ACS or ACE to determine whether to inspect 

incoming shipments using multiple criteria. 

In addition to Prior Notice information,1

 brokers, acting on behalf of 

importers, generally must submit an invoice to CBP that describes the 

merchandise, quantity, value, country of origin and Harmonized Tariff 

Schedule classification, which is a schedule of tariffs associated with 

individual products. Collectively, these documents are referred to as 

“entry documents.” All entry documents must be filed before the imported 

goods are allowed to be released (“entered”) into U.S. commerce, and 

entry must occur within 15 days after the shipment arrives in the United 

States. (“Arrival” occurs when a shipment physically comes within port 

limits. “Entry” occurs when the documentation on the shipment is filed 

and a CBP officer authorizes the shipment’s release.) CBP has the 

authority to conditionally release goods and may demand redelivery of the 

merchandise within 30 days if problems are discovered. If the importer 

does not redeliver the goods to CBP once a notice for redelivery has been 

issued, the importer is subject to liquidated damages. CBP is also 

authorized to detain merchandise upon arrival in order to determine 

 

1

Under FDA regulations promulgated in response to the Public Health, Security, and 

Bioterrorism Preparedness and Response Act of 2002, FDA must receive Prior Notice 

information in advance of the food shipment’s arrival. This information includes the names 

and addresses of the importer, owner, and consignee; FDA product code for the food; and 

country of production. 

Page 51 GAO-09-873 Food Safety
Appendix IV: Agencies’ Processes to Oversee 

Imported Food 

whether the goods are admissible into the United States and may seize the 

merchandise if warranted. 

All formal entries (i.e., those valued at more than $2,000, as well as certain 

other entries under that amount) must be covered by a bond, which 

guarantees payment to CBP if the importer violates a condition of the 

bond. Importers may use two types of bonds: (1) a single transaction bond, 

which covers a one-time transaction, or (2) a continuous bond, which 

covers multiple transactions (i.e., if the importer frequently imports to the 

United States). A bond may be secured by a surety (corporation or 

individual) or by the deposit of U.S. government obligations or cash. After 

the shipment has been released, the importer must file an “entry 

summary,” the final step in the import process, and pay the appropriate 

duties and taxes within 10 working days after the release. The entry 

summary is closed out, usually within a period of 314 days—that is, CBP 

determines that the shipments are admissible and closes the books on 

them, collecting any outstanding taxes or duties that were estimated at 

entry. At any point prior to this, if the importer fails to pay any additional 

duty determined to be due on liquidation or violates a condition of the 

bond, CBP will issue a bill for payment of any duty owed or may issue a 

claim for liquidated damages amounting to up to three times the value of 

the shipment. However, the importer can request administrative review of 

such actions within 180 days after the entry summary is closed out. Based 

on this review, for which there are strict guidelines, CBP may mitigate 

(i.e., reduce) the amount of liquidated damages assessed. 

Page 52 GAO-09-873 Food Safety
Appendix IV: Agencies’ Processes to Oversee 

Imported Food 

FDA Figures 2 and 3 show the processes that FDA follows for shipments. 

Figure 2 shows the initial process FDA follows to review all shipments, 

while figure 3 shows the procedures that are followed when FDA decides 

further review is necessary. 

Figure 2: FDA’s Process for Electronically Screening Imported Food Shipments

Examine for

bioterriorism

or significant

health risk?

Results

of

exam?

Importer, broker or

other entity submits

Prior Notice to FDA

Prior Notice

System

Interface

(FDA)

ACS/ACE

(CBP)

OASIS

Prior Notice 

screening (FDA)

OASIS/PREDICT

electronic admissibility

screening (FDA)

Prior Notice

Center

(FDA)

Prior Notice

requirements

met?a

Yes

Yes

Pass Fail

No No

No Yes Review

for

admissibility?

FDA entry

reviewer

“May proceed”

message

Initial

action?

Slated field

exam

Slated lab

exam

Detain without

physical exam

1

2

3

“May proceed”

message

ACS/ACE

FDA “may proceed”

ACS/ACE

FDA review

(see figure 3)

FDA refused

entry

Source: GAO.

Dashed line indicates Prior Notice

may be submitted to FDA using

either system.

a

FDA officials told us that in certain cases when Prior Notice information requirements are not met, 

the agency will notify the submitter and allow the information to be amended if the problem is easily 

corrected. In such cases, FDA would allow the shipment to proceed to admissibility screening, 

provided the amended Prior Notice satisfied FDA requirements. 

Page 53 GAO-09-873 Food Safety
Appendix IV: Agencies’ Processes to Oversee 

Imported Food 

Figure 3: FDA’s Process for Examining Selected Imported Food Shipments Before Allowing Entry into U.S. Commerce 

Release message

FDA release

ACS/ACE

FDA review

(CBP)

(from figure 2)

Field exam

Sample and

lab analysis

Okay

Violation or

appearance

of a violation

Yes

No

Violation

or appearance

of a violation

Importer re-labels

or reconditions

product

FDA hearing

on product’s

admissibility

Notice of

FDA refusalb

Source: GAO.

Detain without

physical exam

Compliance

action?

Importer

decision?

Result of

hearing?

CBP officer

refers shipment

to FDA inspector

Results?

FDA compliance

officer

Notice of

detention

and hearing

Release messagea

Importer waives

right to hearing

Product okay

Successful?

1

2

3

a

In some cases, a shipment may not fully comply with FDA requirements, but the violation is not 

sufficient to warrant an FDA detention. In such cases, the shipment may receive a “released with 

comment” message. 

b

If FDA issues a notice of refusal, the importer must decide whether to re-export or destroy the 

refused product. Some unscrupulous importers may choose to distribute the product and pay 

liquidated damages under the terms of the CBP bond. 

Page 54 GAO-09-873 Food Safety
Appendix IV: Agencies’ Processes to Oversee 

Imported Food 

Under FDA regulations promulgated in response to the Public Health 

Security and Bioterrorism Preparedness and Response Act of 2002, (1) 

food facilities must be registered with FDA and (2) FDA must receive Prior 

Notice information in advance of the food shipment’s arrival. Prior Notice 

information—which includes the names and addresses of the importer, 

owner, and consignee; FDA product code for the food; and country of 

production—can be submitted to CBP or directly to FDA. In either case, 

Prior Notice information is automatically transmitted to the Operational 

and Administrative System for Import Support (OASIS), FDA’s 

computerized food import screening system. FDA reviews the information 

to ensure that the Prior Notice requirements have been met and to 

determine whether the food potentially poses a bioterrorism or other 

significant health risk such that FDA should deploy resources to the port 

of arrival so that an inspection can be conducted before the product enters 

the United States. If the Prior Notice requirements are not met, the food is 

subject to refusal and, if refused, must be held until adequate Prior Notice 

is submitted. 

Once FDA has verified that the Prior Notice requirements have been met 

and the results of FDA’s Prior Notice screening indicate that the shipment 

does not appear to be a potential bioterrorism or significant public health 

threat, the shipment is allowed to proceed for further processing, 

including FDA’s admissibility review. For the admissibility review, the 

agency electronically screens the product using OASIS to determine 

whether it should be automatically “may proceeded” (i.e., allowed to 

proceed into U.S. commerce without further FDA action). A product is 

automatically “may proceeded” by OASIS if the system can determine that 

it is not covered by an existing rule in the system, such as an import alert, 

import bulletin, or other agency regulation (e.g., FDA’s requirement that 

facilities that manufacture low-acid canned foods must be certified in 

applicable safeguards). If the product is not automatically “may 

proceeded” after this initial electronic screening, it is referred to an FDA 

entry reviewer at the district office for a manual “on-screen” review. 

During manual reviews, entry reviewers use their professional judgment—

as well as available FDA intelligence, such as import alerts and import 

bulletins—to determine whether FDA should take further action on a 

shipment or if the shipment should be manually “may proceeded” and 

released into U.S. commerce. For example, if the entry reviewer 

determined that a particular shipment was high risk, the entry reviewer 

could select it for an FDA examination at the port or another location, flag 

it for a laboratory analysis at one of FDA’s 11 (out of 13 total) regional 

laboratories that perform testing on food, or if the food appears to be 

noncompliant, detain it without physical examination. Once the entry 

Page 55 GAO-09-873 Food Safety
Appendix IV: Agencies’ Processes to Oversee 

Imported Food 

reviewer decides whether to “may proceed” the shipment or take further 

action, FDA transmits this information to CBP’s ACS or ACE system. 

FDA’s new PREDICT system is intended to replace OASIS for both 

electronic admissibility screening and manual review. 

If FDA determines that a shipment should be physically examined in the 

field—either at the port of entry or at another location, such as the 

importer’s or consignee’s warehouse or a cold storage facility—this 

examination must occur before the shipment can enter U.S. commerce. An 

FDA official would examine the product for such things as rodent or insect 

activity, inadequate refrigeration, and label compliance, and may take 

samples from the product for a laboratory analysis to test for pesticide 

residues, suspected microbiological contamination, and other toxic 

elements. If the examination and analysis indicate that the product is in 

compliance, FDA releases the shipment into U.S. commerce. However, if 

FDA finds a violation or an appearance of a violation, it will issue a notice of 

detention and hearing to the importer or consignee. FDA may also detain a 

product without physical examination, if, for example, a food product is on 

a certain type of import alert. The owner or consignee may control the 

shipment pending the results of FDA’s examination, but the shipment must 

be held intact and not distributed until FDA clears it. If the owner or 

consignee distributes the shipment’s merchandise without FDA’s approval, 

FDA can ask CBP to take action against the shipment’s entry bond. 

If a product is detained, the owner or consignee is given the opportunity at 

a hearing to provide evidence that the shipment complies with FDA 

standards or, in some situations, can request authorization to relabel or 

recondition the shipment to bring it into compliance. If the owner or 

consignee fails to recondition the shipment or provide sufficient evidence 

that it already complies with FDA standards, or waives the right to a 

hearing, FDA issues a notice of refusal. The importer can then either reexport the product or destroy it. FDA and CBP coordinate with each other 

to verify that one of these two outcomes has occurred; if the importer fails 

to comply and instead releases the product into commerce despite FDA’s 

refusal notice, FDA will report the incident to CBP, which issues the 

redelivery notice. Ultimately, CBP has the authority to issue a claim for 

liquidated damages if the importer fails to redeliver the shipment, as 

required by the terms of the bond. 

FSIS FSIS evaluates foreign meat and poultry and processed egg product food 

regulatory systems through an equivalency process that determines 

whether a foreign country’s food safety system provides the same level of 

Page 56 GAO-09-873 Food Safety
Appendix IV: Agencies’ Processes to Oversee 

Imported Food 

protection from food safety hazards as the U.S. system. A foreign country 

must receive a determination of equivalency before it can export meat and 

poultry or processed egg product products to the United States. To make 

this determination, FSIS reviews the documentation provided by the 

country and conducts an initial equivalency audit of the country’s meat or 

poultry food regulatory system. After FSIS determines that a country has 

an equivalent system and is eligible to export to the United States, FSIS 

relies on the country to effectively oversee food inspection activities and 

enforce U.S. requirements. 

Once FSIS designates a foreign country as having equivalent food safety 

standards, it ensures that the country maintains this designation using a 

three-part process. First, FSIS conducts a document analysis of the foreign 

country’s food regulatory system to (1) verify that it has adequate 

authority and funding, (2) determine whether it requires U.S.-equivalent 

sanitary measures for industry, and (3) evaluate written procedures for 

overseeing industry and enforcing requirements. Second, FSIS conducts 

routine systems audits at least once a year. It uses this systems audit to 

evaluate the foreign country’s inspection program and verify equivalence, 

not to inspect individual foreign establishments. Systems audits focus on, 

among other things, industry practices—including standard operating 

procedures, quality assurance systems, and laboratory testing programs—

and the foreign government’s capacity to monitor and verify the 

effectiveness of industry practices. Finally, FSIS conducts port-of-entry 

reinspections for all meat, poultry, and processed egg products imported 

into the United States before they enter domestic commerce, as depicted 

in Figure 4. 

Page 57 GAO-09-873 Food Safety
Appendix IV: Agencies’ Processes to Oversee 

Imported Food 

Figure 4: FSIS’s Process for Reinspecting Imported Meat, Poultry, and Processed Egg Products

Generate

reinspection

assignment?

Skipped Inspect

(physical, lab,

or both)

Examine general condition,

labeling, proper certification,

and accurate count

Is

the entry in

violation?

USDA

denies entry

Level of

inspection?

Importing firm or

broker submits

shipment information

to CBP and FSIS

CBP conditionally

releases the

shipment to FSIS

FSIS

manually enters

shipment information

into AIIS system

Verify

equivalence of

country, firm,

and product?

Equivalent Not equivalent

Okay

No

Okay Violation

Yes

Violation

“Normal”

(random)

“Increased”

(based on FSIS

intelligence)

“Intensified”

(recent failed

inspection)

1 2 3

USDA denies entry,

firm put on “intensified”

inspection statusa USDA approved

Source: GAO.

AIIS

Results of

inspection?

(physical and/or 

laboratory)

Firm has

45 days to turn into

animal feed, re-export,

or destroy

Examine general

condition, labeling,

proper certification,

and accurate count

a

If a product fails a physical reinspection, AIIS generates an “intensified” reinspection assignment for 

the importing firm’s next 10 shipments. If a product fails a laboratory inspection, AIIS generates an 

“intensified” reinspection assignment for either (1) the firm’s next 15 shipments, or (2) until FSIS has 

tested enough subsequent shipments from that firm to comprise 15 times the weight of the failed 

shipment without another positive laboratory test result (whichever comes first). 

Before an FSIS-regulated shipment arrives at a port, the importer or 

broker must submit information about the shipment, such as product type 

and country of origin, to both CBP and FSIS. FSIS’s import screening 

system, the Automated Import Information System (AIIS), is unable to 

Page 58 GAO-09-873 Food Safety
Appendix IV: Agencies’ Processes to Oversee 

Imported Food 

receive information electronically, so the foreign establishment typically 

faxes it to the agency. Once the shipment clears CBP’s screening, a CBP 

officer refers the shipment to an FSIS facility, where FSIS personnel 

manually enter the shipment’s information into FSIS’s AIIS import 

screening system. After verifying the eligibility of the foreign country and 

foreign establishment, AIIS assigns a type of inspection of either “skipped” 

or “inspection.” In either case, an FSIS inspector examines the shipment’s 

general condition and ensures that it is labeled correctly and has proper 

documentation. If AIIS generates an “inspection” assignment, however, the 

system also dictates whether FSIS should conduct a physical, laboratory, 

or combination inspection. AIIS also designates shipments at different 

inspection “levels.” For example, some shipments are inspected at random 

(called “normal” inspections), while other inspections are the result of an 

FSIS management decision to increase inspection rates for a specific 

product or country of origin. If a shipment fails reinspection, AIIS 

automatically designates the foreign establishment for intensified 

inspection status, which means that FSIS will inspect the establishment’s 

next 10 or 15 shipments, depending on the nature of the failed test. If a 

shipment passes reinspection, it is marked accordingly and allowed to 

enter U.S. commerce. However, if a product fails reinspection, FSIS 

refuses it entry and the product must be turned into animal feed, exported, 

or destroyed within 45 days. Foreign countries or establishments that 

repeatedly fail port-of-entry reinspections may forfeit their eligibility to 

export FSIS-regulated products to the United States. 

FSIS is replacing AIIS with the Public Health Information System, a Webbased application. According to agency officials, FSIS will deploy this new 

system in 2010. FSIS officials told us that the Public Health Information 

System will enable FSIS to receive foreign health certificates 

electronically, thereby providing a secure and timely advance notice of a 

foreign shipment certified by a foreign government. This certification will 

then be verified upon arrival in the United States. The Public Health 

Information System, according to FSIS, will be able to communicate with 

CBP’s ACE system, enhancing FSIS’s ability to track (1) the receipt of 

certain import shipments at official import inspection establishments and 

(2) the rejection of ineligible shipments at ports of entry. In addition, the 

Public Health Information System is expected to allow FSIS to 

systematically verify the effectiveness of foreign food safety systems by 

providing an automated audit planning process for foreign countries, 

which includes expanded information collection from the foreign 

governments. While awaiting deployment of the new system, FSIS has 

instituted a number of steps to fill the communication and coordination 

gap with CBP. According to FSIS, these interim steps have largely 

Page 59 GAO-09-873 Food Safety
Appendix IV: Agencies’ Processes to Oversee 

Imported Food 

succeeded in closing that gap, although agency officials believe that the 

permanent solution offered by the Public Health Information System is 

still needed. GAO has not reviewed the development of the Public Health 

Information System. 

Page 60 GAO-09-873 Food Safety
Appendix V: FDA’s Overseas Inspections Appendix V: FDA’s Overseas Inspections 

FDA Inspections of Food Firms in Foreign Countries, Fiscal Years 2001 through 2008 

2001 2002 2003 2004 2005 2006 2007 2008 Total

Mexico 17 15 8 15 7 16 26 29 133

Ecuador 8 0 11 24 0 11 10 0 64

Thailand 4 10 0 10 0 22 0 12 58

Chile 13 0 15 6 7 11 0 5 57

Peru 13 0 0 18 1 9 9 4 54

Brazil 0 12 6 7 21 0 0 7 53

China 0 9 2 6 16 0 0 13 46

Taiwan 9 7 0 9 0 7 0 7 39

Canada 13 0 13 1 0 7 4 0 38

Costa Rica 0 11 0 4 5 7 0 7 34

Honduras 9 8 0 0 7 0 0 8 32

Vietnam 0 9 0 10 8 0 0 4 31

Argentina 7 5 0 0 0 0 19 0 31

India 6 0 10 0 7 7 0 0 30

South Korea 14 0 0 1 7 0 6 0 28

Australia 12 0 6 0 0 9 0 0 27

Jamaica 2 6 0 3 0 3 0 8 22

Fiji 0 0 8 0 0 0 13 0 21

Guatemala 0 10 0 0 6 0 0 5 21

Singapore 10 0 0 8 0 0 0 3 21

Nicaragua 0 8 0 0 0 7 0 4 19

El Salvador 0 0 8 0 6 0 0 4 18

Germany 5 4 4 0 0 1 1 2 17

Estonia 8 0 0 8 0 0 0 0 16

Panama 0 0 7 0 0 0 0 9 16

South Africa 5 0 11 0 0 0 0 0 16

Malaysia 0 0 0 0 9 0 0 6 15

28 additional countriesa

Total number of countries that had firms inspected by 

FDA during the specific fiscal year listed above 

26 22 22 20 16 15 11 24 56

Total inspections 211 169 148 153 132 125 95 153 1186

Source: GAO analysis of FDA data. 

a

Countries with a total of 14 or fewer inspections between 2001 and 2008 are not listed in the table. 

These countries include: Italy (14 inspections), Latvia (14), Uruguay (14), Venezuela (14), Morocco 

(13), New Zealand (13), Poland (13), Trinidad and Tobago (12), France (11), Norway (11), Romania 

(10), Surinam (10), Iceland (9), Bulgaria (8), Colombia (8), United Kingdom (8), Cyprus (7), Turkey 

(5), Belize (4), Spain (4), Belgium (3), Greece (3), Hungary (3), Indonesia (3), Finland (2), Haiti (2), 

Japan (2), and the Netherlands (2). 

Page 61 GAO-09-873 Food Safety 
Appendix VI: FDA Funding for Imported Food Appendix VI: FDA Funding for Imported by Activity, Fiscal Years 2002 through 2009 

Food by Activity, Fiscal Years 2002 through 

2009 

FDA Funding and Full-Time Equivalents (FTEs), Fiscal Years 2002 through 2009 

(Dollars in thousands) 

Field 

laboratory 

analyses

Field foreign 

inspections

Field import 

activitiesb

Field activities

Field and 

center food 

activities

(imports and 

domestic)d 

All FDA (all 

products and 

programs)

e

Fiscal 

years Dollars FTE Dollars FTEa Dollars FTEc Dollars FTE Dollars FTE Dollars FTE

2002 $39,763 286 $4,152 30 $30,142 217 $74,057 533 $393,256 2,734 $1,537,000 9,468

2003 46,940 400 2,552 22 63,103 536 112,595 958 406,824 3,167 1,627,700 10,257

2004 46,687 395 2,538 21 69,040 530 118,265 946 407,052 3,082 1,678,900 10,141

2005 46,792 359 2,544 20 72,887 524 122,223 903 435,517 2,943 1,777,500 9,910

2006 51,573 353 1,540 11 67,547 463 120,660 827 438,721 2,774 1,862,700 9,698

2007 48,720 316 904 6 66,444 431 116,068 753 457,104 2,569 1,974,100 9,569

2008 57,080 324 2,867 16 79,974 438 139,921 778 507,797 2,614 2,245,000 9,811

2009 

(est.) 

70,600 364 18,440 82 93,111 493 182,151 939 648,722 3,019 2,668,000 10,953

Source: GAO analysis of FDA data. 

Note: The funding and FTEs include all infrastructure support. This support includes investigator 

salary and benefits, import sample collections, import label exams, import entry review functions, the 

Prior Notice Center, compliance officers, information technology, training, and equipment, as well as 

management and information technology support for the field. The funding also includes rent and 

other facility costs. 

a

Of the 82 FTEs estimated for fiscal year 2009, FDA has allocated six to conduct inspections of 

foreign food establishments. 

b

This category includes all nonlaboratory activities, such as field examinations and tests, import 

sample collections, import label exams, Prior Notice Center security reviews, import entry reviews, 

and other import investigations. 

c

FDA has allocated 272 FTEs to conduct examinations of imported foods at U.S. ports of entry for 

fiscal year 2009.

d

The Center for Food Safety and Applied Nutrition is the only FDA center included in this total, since it 

has primary responsibility for food safety-related work concerning human foods. Other FDA centers 

conduct some food safety-related work. 

e

Total FDA dollars include user fees. 

Page 62 GAO-09-873 Food Safety
Appendix VII: FSIS’s Funding for Food Appendix VII: FSIS’s Funding for Food Imports, Fiscal Years 2006 through 2009 

Imports, Fiscal Years 2006 through 2009 

FSIS Funding for Food Imports, Fiscal Years 2006 through 2009 

(Dollars in thousands) 

Import inspectionaInternational equivalenceb

Total import inspection 

activities

Dollars FTE Dollars FTE Dollars FTE

2006 $7,947 104 $1,378 11 $9,325 115

2007 7,632 88 1,248 10 8,880 98

2008 8,771 99 1,229 8 10,000 107

2009 (est.) 9,034 99 1,266 8 10,300 107

Source: FSIS. 

a

Includes funding for the process of reinspecting FSIS-regulated shipments imported into the U.S. at 

approved import inspection facilities. 

b

Includes funding for the process of determining equivalence, which involves foreign program 

document reviews, on-site audits, and activities to verify ongoing equivalence. 

Page 63 GAO-09-873 Food Safety
Appendix VIII: Comments from the Appendix VIII: Comments from the Department of Homeland Security 

Department of Homeland Security 

Page 64 GAO-09-873 Food Safety
Appendix VIII: Comments from the 

Department of Homeland Security 

Page 65 GAO-09-873 Food Safety
Appendix VIII: Comments from the 

Department of Homeland Security 

Page 66 GAO-09-873 Food Safety
Appendix IX: Comments from the Department Appendix IX: Comments from the of Health and Human Services 

Department of Health and Human Services 

Page 67 GAO-09-873 Food Safety 
Appendix IX: Comments from the Department 

of Health and Human Services 

Page 68 GAO-09-873 Food Safety
Appendix IX: Comments from the Department 

of Health and Human Services 

Page 69 GAO-09-873 Food Safety
Appendix IX: Comments from the Department 

of Health and Human Services 

Page 70 GAO-09-873 Food Safety
Appendix IX: Comments from the Department 

of Health and Human Services 

Page 71 GAO-09-873 Food Safety
Appendix X: 

S

GAO Contact and 

taff Acknowledgments

Page 72 GAO-09-873 

Appendix X: GAO Contact and Staff 

Acknowledgments 

Lisa Shames (202) 512-3841 or shamesl@gao.gov

Other key contributors to this report were Jóse Alfredo Gómez (Assistant 

Director), Anne K. Johnson (Analyst-in-Charge), Brenna Guarneros, Jeff C. 

Jensen, Carol Herrnstadt Shulman, John Wheeler, and Rebecca Yurman. 

Important contributions were also made by Kevin Bray, Michele Fejfar, 

Kim Raheb, and Kiki Theodoropoulos. 

 Food Safety 

GAO Contact: 

Staff 

Acknowledgments: 

(360984) 
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