Food Safety
Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of Imported Food Gao ID: GAO-09-873 September 15, 2009Imported 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.
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.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-09-873, Food Safety: Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of Imported Food
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Report to Congressional Committees:
United States Government Accountability Office:
GAO:
September 2009:
Food Safety:
Agencies Need to Address Gaps in Enforcement and Collaboration to
Enhance Safety of Imported Food:
GAO-09-873:
GAO Highlights:
Highlights of GAO-09-873, a report to congressional committees.
Why GAO Did This Study:
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 Found:
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.
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.
View [hyperlink, http://www.gao.gov/products/GAO-09-873] or key
components. For more information, contact Lisa Shames at (202) 512-3841
or shamesl@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Three Federal Agencies Are Taking Actions to Better Ensure the Safety
of Imported Food, but Enforcement and Collaboration Gaps Undermine
These Efforts:
FDA Collaborates with States and Foreign Governments, but Does Not
Fully Share Information with States During a Recall:
PREDICT Testing Indicates that the System May Improve FDA's Risk-Based
Import Screening Efforts, but Further Actions Are Needed:
The EU Has Developed Some Practices That Could Inform CBP, FDA, and
FSIS Practices:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: FDA Field Examinations, Fiscal Years 2006 through 2009:
Appendix III: FSIS Inspections at Ports of Entry, Fiscal Years 2006
through 2008:
Appendix IV: Agencies' Processes to Oversee Imported Food:
Appendix V: FDA's Overseas Inspections:
Appendix VI: FDA's Funding for Imported Food by Activity, Fiscal Years
2002 through 2009:
Appendix VII: FSIS's Funding for Food Imports, Fiscal Years 2006
through 2009:
Appendix VIII: Comments from the Department of Homeland Security:
Appendix IX: Comments from the Department of Health and Human Services:
Appendix X: GAO Contact and Staff Acknowledgments:
Table:
Table 1: FDA's Planned Staffing Levels for Foreign Posts (35 U.S.
nationals):
Figures:
Figure 1: FDA Staff Examining Food at the Port of Baltimore:
Figure 2: FDA's Process for Electronically Screening Imported Food
Shipments:
Figure 3: FDA's Process for Examining Selected Imported Food Shipments
Before Allowing Entry into U.S. Commerce:
Figure 4: FSIS's Process for Reinspecting Imported Meat, Poultry, and
Processed Egg Products:
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:
[End of section]
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.
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.[Footnote 1] The procedures
discussed in that report may provide 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 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.
Results in Brief:
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.
* 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 data-sharing 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.[Footnote 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.
[Footnote 3] In a February 2009 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 in-bond.
We reported in the past that CBP does not effectively manage in-bond
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.[Footnote 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 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
federal-state 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 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
FDA-regulated 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.[Footnote 5] Additionally, we reported
in June 2009 that FDA lacks a comprehensive information technology
strategic plan for PREDICT and other modernization projects.[Footnote
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 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.
Background:
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.[Footnote 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.
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
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.[Footnote 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.[Footnote 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 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.
[Sidebar: 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. End of sidebar]
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.[Footnote 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 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.
[Footnote 11] Figure 1 shows an FDA staff person examining food
products at the Port of Baltimore.
Figure 1: FDA Staff Examining Food at the Port of Baltimore:
[Refer to PDF for image: photograph]
Source: GAO.
[End of figure]
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.
* 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
FSIS-approved 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
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 inspection may involve laboratory testing or additional
physical inspections. Additional detail on the processes FDA and FSIS
use to oversee imported food is presented in appendix IV.
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 grow.[Footnote 12] 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-related 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 manufacturing and processing
facilities, which they conduct under contract to FDA. Some states also
inspect retail and food service establishments.[Footnote 13] State
officials told us that their agencies are mainly concerned with food in
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 illnesses within their borders after it is
cleared for domestic consumption.
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 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.[Footnote 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.
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
information-sharing 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 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-
of-arrival 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 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.[Footnote 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.[Footnote 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.[Footnote 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.
FDA Has Limited Authority to Ensure Importers' Compliance:
Importers can retain possession of their food shipments until FDA
approves their release into U.S. commerce. 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.[Footnote 18] Indeed, as we
reported in 1998,[Footnote 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.
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.
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.[Footnote 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 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.[Footnote 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 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.[Footnote 22] For example, we reported that CBP did not
consistently reconcile the in-bond documents issued at the arrival port
with documents at the destination port to ensure that a shipment is
either officially entered into U.S. commerce--with appropriate duties
or quotas applied--or is re-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.
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 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.[Footnote 23] Such
mutually reinforcing strategies help in aligning activities, core
processes, and resources to accomplish a common outcome.
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.
[Sidebar: 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. End of sidebar]
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.
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 may
accept state results as the basis of a class I or class II recall.
[Footnote 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.
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 "stop-
sale" 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.
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;
* 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 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 in-country 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: China (Beijing, Guangzhou, and
Shanghai);
Number of staff (current as of 8/20/09):
4 (at post in Beijing);
2 (at post in Guangzhou);
2 (at post in Shanghai);
Date first US national FDA employee arrived at post:
November 8, 2008 (Beijing);
July 3, 2009 (Guangzhou);
May 29, 2009 (Shanghai).
Geographic region and staff category: Foods;
Number of staff (current as of 8/20/09): 3 (including 2 inspectors).
Geographic region and staff category: Medical products;
Number of staff (current as of 8/20/09): 4 (including 2 inspectors).
Geographic region and staff category: Both;
Number of staff (current as of 8/20/09): 1 (office director).
Geographic region and staff category: EU (Belgium, Italy, and United
Kingdom);
Number of staff (current as of 8/20/09):
1 (at post in Brussels);
1 (at post in London);
1 (not yet at foreign post);
Date first US national FDA employee arrived at 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.
Geographic region and staff category: Foods;
Number of staff (current as of 8/20/09): 1.
Geographic region and staff category: Medical products;
Number of staff (current as of 8/20/09): 1.
Geographic region and staff category: Both;
Number of staff (current as of 8/20/09): 1 (office director).
Geographic region and staff category: India (Mumbai and New Delhi);
Number of staff (current as of 8/20/09):
5 (at post in New Delhi);
2 (at post in Mumbai);
5 (not yet at foreign post)[B];
Date first US national FDA employee arrived at post:
December 9, 2008 (New Delhi);
June 20, 2009 (Mumbai).
Geographic region and staff category: Foods;
Number of staff (current as of 8/20/09): 5 (including 3 inspectors).
Geographic region and staff category: Medical products;
Number of staff (current as of 8/20/09): 6 (including 2 inspectors).
Geographic region and staff category: Both;
Number of staff (current as of 8/20/09): 1 (office director).
Geographic region and staff category: Latin America (Chile, Costa Rica,
and Mexico)[C];
Number of staff (current as of 8/20/09):
4 (at post in San José);
1 (at post in Santiago);
3 (not yet at foreign post)[D];
Date first US national FDA employee arrived at post:
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.
Geographic region and staff category: Foods;
Number of staff (current as of 8/20/09): 5; .
Geographic region and staff category: Medical products;
Number of staff (current as of 8/20/09): 2; .
Geographic region and staff category: Both;
Number of staff (current as of 8/20/09): 1 (office director).
Geographic region and staff category: Middle East (Israel and Jordan);
Number of staff (current as of 8/20/09):
0 (at post in Amman);
0 (at post in Tel Aviv);
4 (not yet at foreign post)[E];
Date first US national FDA employee arrived at post:
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.
Geographic region and staff category: Foods;
Number of staff (current as of 8/20/09): 1.
Geographic region and staff category: Medical products;
Number of staff (current as of 8/20/09): 1.
Geographic region and staff category: Both;
Number of staff (current as of 8/20/09): 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) in-country. 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.
[End of table]
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 Testing Indicates that the System May Improve FDA's Risk-Based
Import Screening Efforts, but Further Actions Are Needed:
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 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.
PREDICT is to generate a numerical risk score for all FDA-regulated
products by analyzing importers' shipment information using sets of FDA-
developed 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 bulletins[Footnote 25]--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.[Footnote
26] For some 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 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.
[Footnote 27]
We recently identified information technology management concerns that
might hinder the rollout of FDA modernization projects such as PREDICT.
[Footnote 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,[Footnote 29] and (2) strategically
manage information technology human capital to 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.
The EU Has Developed Some Practices That Could Inform CBP, FDA, and
FSIS Practices:
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.[Footnote 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, risk-based 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.
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.[Footnote 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 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.[Footnote 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.
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.
Conclusions:
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.
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-of-arrival 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 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.
Recommendations for Executive Action:
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:
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.
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.
Agency Comments and Our Evaluation:
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.
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-of-arrival 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.
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 time-of-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 [hyperlink, http://www.gao.gov].
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.
Signed by:
Lisa Shames:
Director, Natural Resources and Environment:
[End of section]
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 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.
[End of section]
Appendix II: FDA Field Examinations, Fiscal Years 2006 through 2009:
Import lines[A]:
2006: 8,883,999;
2007: 9,356,074;
2008: 9,441,024;
2009 (estimated): 9,526,745.
Import field exams and tests[B]:
2006: 94,545;
2007: 94,743;
2008: 100,718;
2009 (estimated): 120,000.
Import laboratory samples analyzed:
2006: 20,662;
2007: 24,558;
2008: 23,052;
2009 (estimated): 26,200.
Import physical exam subtotal:
2006: 115,207;
2007: 119,301;
2008: 123,770;
2009 (estimated): 146,200.
Percent of import lines physically examined:
2006: 1.30%;
2007: 1.28%;
2008: 1.31%;
2009 (estimated): 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.
[End of table]
[End of section]
Appendix III: FSIS Inspections at Ports of Entry, Fiscal Years 2006
through 2008A:
Shipments presented:
2006: 219,979;
2007: 217,634;
2008: 208,409.
"Skipped" shipments[B]:
2006: 188,820;
2007: 195,532;
2008: 188,854.
"Inspected" shipments[C]:
2006: 31,159;
2007: 22,102;
2008: 19,555.
Percent of shipments inspected:
2006: 14.2%;
2007: 10.2%;
2008: 9.4%.
Total pounds presented;
2006: 3,888,188,159;
2007: 3,896,425,509;
2008: 3,278,956,513.
Total pounds refused[D](percentage):
2006: 177,034 (0.005%);
2007: 149,173 (0.004%);
2008: 93,731 (0.003%).
Total pounds rejected[E](percentage):
2006: 12,124,451 (0.312%);
2007: 9,124,547 (0.234%);
2008: 2,715,089 (0.083%).
Total pounds accepted (percentage):
2006: 3,875,876,497 (99.683%);
2007: 3,887,151,789 (99.762%);
2008: 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 FSIS-approved 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.
[End of table]
[End of section]
Appendix IV: Agencies' Processes to Oversee 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,[Footnote 33] 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 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.
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:
[Refer to PDF for image: complex process chart]
1) Importer, broker or other entity submits Prior Notice to FDA (using
either of the following systems;
2A) Prior Notice System Interface (FDA); or;
2B) ACS/ACE(CBP).
3) OASIS Prior Notice screening (FDA).
4) Prior Notice Center(FDA).
5) Prior Notice requirements met?
If no, proceed to step 15.
If yes, continue.
6) Examine for bioterriorism or significant health risk?
If yes, go to step 7;
If no, go to step 8.
7) Results of exam?
If fail, proceed to step 15.
If pass, go to step 8.
8) OASIS/PREDICT electronic admissibility screening (FDA).
9) Review for admissibility?
If no, got to step 10;
If yes, go to step 11.
10) ACS/ACEFDA ’may proceed."
11) FDA entry reviewer.
12) Initial action?
May proceed message; and;
13) Slated field exam; Slated lab exam; Detain without physical exam.
14) ACS/ACEFDA review(see figure 3).
15) FDA refused entry.
Source: GAO.
[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.
[End of figure]
Figure 3: FDA's Process for Examining Selected Imported Food Shipments
Before Allowing Entry into U.S. Commerce:
[Refer to PDF for image: complex process chart]
1) ACS/ACEFDA review (CBP)(from figure 2).
2) CBP officer refers shipment to FDA inspector.
3A) Field exam;
Results OK? Go to step 10.
Violation or appearance of a violation? Go to step 4.
3B) Sample and lab analysis;
Go to step 4.
3C) Detain without physical exam;
Go to step 4.
4) FDA compliance officer.
5) Compliance action?
Release message[A].
6) Notice of detention and hearing.
7) Importer decision?
8A) Importer re-labels or reconditions product;
Successful: go to step 10;
Not successful: go to step 9.
8B) Importer waives right to hearing;
Go to step 9.
8C) FDA hearing on product‘s admissibility;
Violation or appearance of a violation? Go to step 9.
Product okay: go to step 10.
9) Notice of FDA refusal[B].
10) FDA release.
Source: GAO.
[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.
[End of figure]
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
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 re-export 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 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.
Figure 4: FSIS's Process for Reinspecting Imported Meat, Poultry, and
Processed Egg Products:
[Refer to PDF for image: complex process chart]
1) Importing firm or broker submits shipment information to CBP and
FSIS.
2) CBP conditionally releases the shipment to FSIS.
3) FSIS manually enters shipment information into AIIS system.
4) AIIS.
5) Verify equivalence of country, firm, and product?
Not equivalent: USDA denies entry.
Equivalent: go to step 6.
6) Generate reinspection assignment;
If no, go to step 7;
If yes, go to step 11.
7) Skipped.
8) Examine general condition, labeling, proper certification, and
accurate count.
9) Is the entry in violation?
Okay: go to step 10;
Violation: go to step 16.
10) USDA approval.
11) Inspect (physical, lab, or both).
12) Examine general condition, labeling, proper certification,and
accurate count.
13) Level of inspection?
14A) ’Normal“ (random);
14B) ’Increased“ (based on FSIS intelligence);
14C) ’Intensified“ (recent failed inspection).
15) Results of inspection? (physical and/or laboratory);
Okay: go to step 10.
Violation: go to step 16.
16) USDA denies entry, firm put on ’intensified“ inspection status[A].
17) Firm has 45 days to turn into animal feed, re-export, or destroy.
Source: GAO.
[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).
[End of figure]
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
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 Web-
based 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 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.
[End of section]
Appendix V: FDA's Overseas Inspections:
FDA Inspections of Food Firms in Foreign Countries, Fiscal Years 2001
through 2008:
Mexico:
2001: 17;
2002: 15;
2003: 8;
2004: 15;
2005: 7;
2006: 16;
2007: 26;
2008: 29;
Total: 133.
Ecuador:
2001: 8;
2002: 0;
2003: 11;
2004: 24;
2005: 0;
2006: 11;
2007: 10;
2008: 0;
Total: 64.
Thailand:
2001: 4;
2002: 10;
2003: 0;
2004: 10;
2005: 0;
2006: 22;
2007: 0;
2008: 12;
Total: 58.
Chile:
2001: 13;
2002: 0;
2003: 15;
2004: 6;
2005: 7;
2006: 11;
2007: 0;
2008: 5;
Total: 57.
Peru:
2001: 13;
2002: 0;
2003: 0;
2004: 18;
2005: 1;
2006: 9;
2007: 9;
2008: 4;
Total: 54.
Brazil:
2001: 0;
2002: 12;
2003: 6;
2004: 7;
2005: 21;
2006: 0;
2007: 0;
2008: 7;
Total: 53.
China:
2001: 0;
2002: 9;
2003: 2;
2004: 6;
2005: 16;
2006: 0;
2007: 0;
2008: 13;
Total: 46.
Taiwan:
2001: 9;
2002: 7;
2003: 0;
2004: 9;
2005: 0;
2006: 7;
2007: 0;
2008: 7;
Total: 39.
Canada:
2001: 13;
2002: 0;
2003: 13;
2004: 1;
2005: 0;
2006: 7;
2007: 4;
2008: 0;
Total: 38.
Costa Rica:
2001: 0;
2002: 11;
2003: 0;
2004: 4;
2005: 5;
2006: 7;
2007: 0;
2008: 7;
Total: 34.
Honduras:
2001: 9;
2002: 8;
2003: 0;
2004: 0;
2005: 7;
2006: 0;
2007: 0;
2008: 8;
Total: 32.
Vietnam:
2001: 0;
2002: 9;
2003: 0;
2004: 10;
2005: 8;
2006: 0;
2007: 0;
2008: 4;
Total: 31.
Argentina:
2001: 7;
2002: 5;
2003: 0;
2004: 0;
2005: 0;
2006: 0;
2007: 19;
2008: 0;
Total: 31.
India:
2001: 6;
2002: 0;
2003: 10;
2004: 0;
2005: 7;
2006: 7;
2007: 0;
2008: 0;
Total: 30.
South Korea:
2001: 14;
2002: 0;
2003: 0;
2004: 1;
2005: 7;
2006: 0;
2007: 6;
2008: 0;
Total: 28.
Australia:
2001: 12;
2002: 0;
2003: 6;
2004: 0;
2005: 0;
2006: 9;
2007: 0;
2008: 0;
Total: 27.
Jamaica:
2001: 2;
2002: 6;
2003: 0;
2004: 3;
2005: 0;
2006: 3;
2007: 0;
2008: 8;
Total: 22.
Fiji:
2001: 0;
2002: 0;
2003: 8;
2004: 0;
2005: 0;
2006: 0;
2007: 13;
2008: 0;
Total: 21.
Guatemala:
2001: 0;
2002: 10;
2003: 0;
2004: 0;
2005: 6;
2006: 0;
2007: 0;
2008: 5;
Total: 21.
Singapore:
2001: 10;
2002: 0;
2003: 0;
2004: 8;
2005: 0;
2006: 0;
2007: 0;
2008: 3;
Total: 21.
Nicaragua:
2001: 0;
2002: 8;
2003: 0;
2004: 0;
2005: 0;
2006: 7;
2007: 0;
2008: 4;
Total: 19.
El Salvador:
2001: 0;
2002: 0;
2003: 8;
2004: 0;
2005: 6;
2006: 0;
2007: 0;
2008: 4;
Total: 18.
Germany:
2001: 5;
2002: 4;
2003: 4;
2004: 0;
2005: 0;
2006: 1;
2007: 1;
2008: 2;
Total: 17.
Estonia:
2001: 8;
2002: 0;
2003: 0;
2004: 8;
2005: 0;
2006: 0;
2007: 0;
2008: 0;
Total: 16.
Panama:
2001: 0;
2002: 0;
2003: 7;
2004: 0;
2005: 0;
2006: 0;
2007: 0;
2008: 9;
Total: 16.
South Africa:
2001: 5;
2002: 0;
2003: 11;
2004: 0;
2005: 0;
2006: 0;
2007: 0;
2008: 0;
Total: 16.
Malaysia:
2001: 0;
2002: 0;
2003: 0;
2004: 0;
2005: 9;
2006: 0;
2007: 0;
2008: 6;
Total: 15.
28 additional countries[A]:
Total number of countries that had firms inspected by FDA during the
specific fiscal year listed above:
2001: 26;
2002: 22;
2003: 22;
2004: 20;
2005: 16;
2006: 15;
2007: 11;
2008: 24;
Total: 56.
Total inspections:
2001: 211;
2002: 169;
2003: 148;
2004: 153;
2005: 132;
2006: 125;
2007: 95;
2008: 153;
Total: 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).
[End of table]
[End of section]
Appendix VI: FDA Funding for Imported Food by Activity, Fiscal Years
2002 through 2009:
FDA Funding and Full-Time Equivalents (FTEs), Fiscal Years 2002 through
2009 (Dollars in thousands):
Fiscal years: 2002;
Field laboratory analyses: Dollars: $39,763;
Field laboratory analyses: FTE: 286;
Field foreign inspections: Dollars: $4,152;
Field foreign inspections: FTE[A]: 30;
Field import activities[B]: Dollars: $30,142;
Field import activities[B]: FTE[C]: 217;
Field activities: Dollars: $74,057;
Field activities: FTE: 533;
Field and center food activities (imports and domestic)[D]: Dollars:
$393,256;
Field and center food activities (imports and domestic)[D]: FTE: 2,734;
All FDA (all products and programs)[E]: Dollars: $1,537,000;
All FDA (all products and programs)[E]: FTE: 9,468.
Fiscal years: 2003;
Field laboratory analyses: Dollars: $46,940;
Field laboratory analyses: FTE: 400;
Field foreign inspections: Dollars: $2,552;
Field foreign inspections: FTE[A]: 22;
Field import activities[B]: Dollars: $63,103;
Field import activities[B]: FTE[C]: 536;
Field activities: Dollars: 112,595; Field activities: FTE: 958;
Field and center food activities (imports and domestic)[D]: Dollars:
$406,824;
Field and center food activities (imports and domestic)[D]: FTE: 3,167;
All FDA (all products and programs)[E]: Dollars: $1,627,700;
All FDA (all products and programs)[E]: FTE: 10,257.
Fiscal years: 2004;
Field laboratory analyses: Dollars: $46,687;
Field laboratory analyses: FTE: 395;
Field foreign inspections: Dollars: $2,538;
Field foreign inspections: FTE[A]: 21;
Field import activities[B]: Dollars: $69,040;
Field import activities[B]: FTE[C]: 530;
Field activities: Dollars: 118,265; Field activities: FTE: 946;
Field and center food activities (imports and domestic)[D]: Dollars:
$407,052;
Field and center food activities (imports and domestic)[D]: FTE: 3,082;
All FDA (all products and programs)[E]: Dollars: $1,678,900;
All FDA (all products and programs)[E]: FTE: 10,141.
Fiscal years: 2005;
Field laboratory analyses: Dollars: $46,792;
Field laboratory analyses: FTE: 359;
Field foreign inspections: Dollars: $2,544;
Field foreign inspections: FTE[A]: 20;
Field import activities[B]: Dollars: $72,887;
Field import activities[B]: FTE[C]: 524;
Field activities: Dollars: 122,223;
Field activities: FTE: 903;
Field and center food activities (imports and domestic)[D]: Dollars:
$435,517;
Field and center food activities (imports and domestic)[D]: FTE: 2,943;
All FDA (all products and programs)[E]: Dollars: $1,777,500;
All FDA (all products and programs)[E]: FTE: 9,910.
Fiscal years: 2006;
Field laboratory analyses: Dollars: $51,573;
Field laboratory analyses: FTE: 353;
Field foreign inspections: Dollars: $1,540;
Field foreign inspections: FTE[A]: 11;
Field import activities[B]: Dollars: $67,547;
Field import activities[B]: FTE[C]: 463;
Field activities: Dollars: $120,660;
Field activities: FTE: 827;
Field and center food activities (imports and domestic)[D]: Dollars:
$438,721;
Field and center food activities (imports and domestic)[D]: FTE: 2,774;
All FDA (all products and programs)[E]: Dollars: $1,862,700;
All FDA (all products and programs)[E]: FTE: 9,698.
Fiscal years: 2007;
Field laboratory analyses: Dollars: $48,720;
Field laboratory analyses: FTE: 316;
Field foreign inspections: Dollars: $904;
Field foreign inspections: FTE[A]: 6;
Field import activities[B]: Dollars: $66,444;
Field import activities[B]: FTE[C]: 431;
Field activities: Dollars: $116,068;
Field activities: FTE: 753;
Field and center food activities (imports and domestic)[D]: Dollars:
$457,104;
Field and center food activities (imports and domestic)[D]: FTE: 2,569;
All FDA (all products and programs)[E]: Dollars: $1,974,100;
All FDA (all products and programs)[E]: FTE: 9,569.
Fiscal years: 2008;
Field laboratory analyses: Dollars: $57,080;
Field laboratory analyses: FTE: 324;
Field foreign inspections: Dollars: $2,867;
Field foreign inspections: FTE[A]: 16;
Field import activities[B]: Dollars: $79,974;
Field import activities[B]: FTE[C]: 438;
Field activities: Dollars: $139,921;
Field activities: FTE: 778;
Field and center food activities (imports and domestic)[D]: Dollars:
$507,797;
Field and center food activities (imports and domestic)[D]: FTE: 2,614;
All FDA (all products and programs)[E]: Dollars: $2,245,000;
All FDA (all products and programs)[E]: FTE: 9,811.
Fiscal years: 2009 (est.):
Field laboratory analyses: Dollars: $70,600;
Field laboratory analyses: FTE: 364;
Field foreign inspections: Dollars: $18,440;
Field foreign inspections: FTE[A]: 82;
Field import activities[B]: Dollars: $93,111;
Field import activities[B]: FTE[C]: 493;
Field activities: Dollars: $182,151;
Field activities: FTE: 939;
Field and center food activities (imports and domestic)[D]: Dollars:
$648,722;
Field and center food activities (imports and domestic)[D]: FTE: 3,019;
All FDA (all products and programs)[E]: Dollars: $2,668,000;
All FDA (all products and programs)[E]: FTE: 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.
[End of table]
[End of section]
Appendix VII: FSIS's Funding for Food Imports, Fiscal Years 2006
through 2009:
FSIS Funding for Food Imports, Fiscal Years 2006 through 2009 (Dollars
in thousands):
2006:
Import inspection[A]: Dollars: $7,947;
Import inspection[A]: FTE: 104;
International equivalence[B]: Dollars: $1,378;
International equivalence[B]: FTE: 11;
Total import inspection activities: Dollars: $9,325;
Total import inspection activities: FTE: 115.
2007:
Import inspection[A]: Dollars: $7,632;
Import inspection[A]: FTE: 88;
International equivalence[B]: Dollars: $1,248;
International equivalence[B]: FTE: 10;
Total import inspection activities: Dollars: $8,880;
Total import inspection activities: FTE: 98.
2008:
Import inspection[A]: Dollars: $8,771;
Import inspection[A]: FTE: 99;
International equivalence[B]: Dollars: $1,229;
International equivalence[B]: FTE: 8;
Total import inspection activities: Dollars: $10,000;
Total import inspection activities: FTE: 107.
2009 (est.):
Import inspection[A]: Dollars: $9,034;
Import inspection[A]: FTE: 99;
International equivalence[B]: Dollars: $1,266;
International equivalence[B]: FTE: 8;
Total import inspection activities: Dollars: $10,300;
Total import inspection activities: FTE: 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.
[End of table]
[End of section]
Appendix VIII: Comments from the Department of Homeland Security:
U.S. Department of Homeland Security:
Washington, DC 20528:
September 2, 2009:
Lisa Shames:
Director, Natural Resources and Environment:
U.S. Government Accountability Office:
441 G St., NW:
Washington, DC 20548:
Dear Ms. Shames:
The Department of Homeland Security (DHS) appreciates the opportunity
to review and comment on the Government Accountability Office's (GAO's)
draft report GAO-09-873: Food Safety: Agencies Need to Address Gaps in
Enforcement and Collaboration to Enhance Safety of Imported Food. DHS
concurs with the four GAO recommendations addressed to the U.S. Customs
and Border Protection (CBP). The content of the report, as well as, the
aforementioned recommendations have been addressed below; technical
comments have been provided under separate cover.
In the report, the GAO singles out the in-bond entry process as a gap
in the enforcement of foodstuffs. CBP considers this an unfounded
conclusion as the GAO provides no evidence that the risk of diversion
of foodstuffs is greater in the in-bond environment than any other
environment. The GAO also concludes that CBP does not effectively
manage in-bond shipments. CBP disagrees with this conclusion as it is
based solely on the premise that in-bond transit times have not yet
been changed. Moreover, the GAO does not offer any specific examples to
support its conclusion that unlawfully diverted foodstuffs are due to
existing regulatory transit times for in-bond shipments. CBP has made
significant improvements to how in-bond shipments are tracked and
reported and has provided appropriate guidance and training to field
personnel. CBP continues to improve its management of the in-bond
process with even greater enhancements to the Automated Commercial
Environment.
The report characterizes CBP's computer systems as failing to
communicate with the Food and Drug Administration's (FDA) systems
regarding time-of-arrival information. While CBP's systems are unable
to communicate time-of-arrival information at this time, it should have
a limited impact on FDA's enforcement as FDA is made aware that
products of interest are about to arrive or have arrived in the U.S.
via the other communication mechanisms. In addition, the GAO report
does not acknowledge that FDA has multiple opportunities to assess the
risk of incoming shipments prior to release of the cargo through the
Receipt of Prior Notice and the transmission of data through the CBP
electronic entry process.
Lastly, the report states that CBP has not yet developed a schedule to
provide time-of-arrival information udder the current interagency
agreement with FDA. The report should be clarified to state that CBP
completed the development of the modification to the software that will
provide FDA with the transmission of the conveyance arrival message and
information for air and truck shipments. CBP has been working with FDA
to complete the testing and requests that GAO change the wording in the
report to reflect ongoing activities with the FDA to implement the
interagency agreement between CBP and FDA.
The GAO report makes nine recommendations for executive action, four of
which are addressed to CBP. The following are DHS's recommendation
specific comments:
Recommendation 1:
The CBP Commissioner ensures that CBP's new screening system
communicates time-of-arrival information to FDA's and Food Safety and
Inspection Service's (FSIS) screening systems.
CBP Response:
Concur. Once CBP begins gathering time-of-arrival data in its new
screening system, CBP will have the capability to provide that data to
FDA providing that FDA requests, and has legal authority to collect,
the information.
If it is decided that an interface will be developed between FSIS and
CBP, CBP may accommodate a request from FSIS to receive the data,
provided that CBP and FSIS have the legal authority for this data
exchange. It should be noted that the requesting agency may be
responsible for CBP programming and other automation expenses to
support its request.
Recommendation 2:
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.
CBP Response:
Concur. CBP has completed the development of two work requests that
will send the arrival information to FDA for both Air and Truck
entries. The work requests are awaiting testing by FDA before
deployment.
If it determined that an interface will be developed between FSIS and
CBP, CBP may accommodate a request from FSIS to receive the data,
provided that CBP and FSIS have the legal authority for this data
exchange. It should be noted that the requesting agency may be
responsible for CBP programming and other automation expenses to
support its request.
Recommendation 5:
To improve CBP's and FDA's ability to identify foreign firms with
violative histories, we recommend the CBP Commissioner should ensure
that Automated Commercial Environment (ACE) is able to accept a unique
identification number for foreign firms that export FDA-regulated
foods.
CBP Response:
Concur. CBP will implement the specific participating government agency
(PGA) requirement for ACE that states "ACE shall accept a unique
identification number for foreign firms that export FDA-regulated foods
or other entities so designated by a PGA." This requirement currently
exists and will be delivered when the Cargo Release process is brought
into ACE.
Recommendation 7:
To enhance agency coordination and 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.
CBP Response:
Concur. CBP agrees that a study can be undertaken and will work with
field offices and FDA through ongoing joint initiatives.
Again, DHS would like to thank you for the opportunity to review and
comment on your draft report. We look forward to working with you on
future homeland security issues.
Sincerely,
Signed by:
Jerald E. Levine:
Director:
Departmental GAO/OIG Liaison Office:
[End of section]
Appendix IX: Comments from the Department of Health and Human Services:
Department Of Health & Human Services:
Office Of The Secretary:
Assistant Secretary for Legislation:
Washington, DC 20201:
September 4, 2009:
Lisa Shames, Director:
Natural Resources and Environment:
U.S. Government Accountability Office:
441 G Street N.W.
Washington, DC 20548:
Dear Ms. Shames:
Enclosed are comments on the U.S. Government Accountability Office's
(GAO) report entitled: "Food Safety: Agencies Need to Address Gaps in
Enforcement and Collaboration to Enhance Safety of Imported Food" (GAO-
09-873).
The Department appreciates the opportunity to review this report before
its publication.
Sincerely,
Signed by:
Andrea Palm:
Acting Assistant Secretary for Legislation:
Enclosure:
[End of letter]
Department Of Health And Human Services:
Food and Drug Administration:
Silver Spring, MD 20993:
Date: September 2, 2009:
To: Acting Assistant Secretary for Legislation:
From: Principal Deputy Commissioner of Food and Drugs:
Subject: FDA's General Comments to GAO's Draft Report entitled, Food
Safety: Agencies Need to Address Gaps in Enforcement and Collaboration
to Enhance Safety of Imported Food (GAO-09-873):
FDA is providing the attached general comments to the U.S. Government
Accountability Office's draft report entitled: FOOD SAFETY: Agencies
Need to Address Gaps in Enforcement and Collaboration to Enhance Safety
of Imported Food (GAO-09-873).
FDA appreciates the opportunity to review and comment on this draft
report before it is published.
Signed by:
Joshua M. Sharfstein, M.D.
Principal Deputy Commissioner of Food and Drugs:
Attachment:
FDA's General Comments to the U.S Government Accountability (GAO) Draft
Report Entitled, Food Safety”Agencies Need to Address Gaps in
Enforcement and Collaboration to Enhance Safety of Imported Food (GAO-
09-873):
The Food and Drug Administration (FDA) appreciates the opportunity to
review and comment on the Government Accountability Office's (GAO)
draft report. GAO has raised some important issues in this report. FDA
thanks GAO for its recommendations and will incorporate them as
appropriate into both short-term and long-term initiatives that will
continue to help ensure the safety of imported foods.
FDA strives to improve the safety and oversight of imported food. To
this end, FDA is working with regulatory partners such as the National
Oceanic and Atmospheric Administration, the Customs and Border
Protection (CBP), and the States to coordinate efforts and to find new
ways to collaborate. FDA also recognizes the need to continually update
its systems and processes. For example, when fully deployed, FDA's
Predictive Risk-based Evaluation for Dynamic Import Compliance
Targeting (PREDICT) system will improve import screening and targeting
to prevent the entry of adulterated, misbranded or otherwise violative
foods and will expedite the entry of non-violative foods. The new
system will provide additional information to FDA staff to help them
make improved decisions about targeting lines. FDA will continue to
evaluate and strengthen PREDICT as the project moves forward.
Pending legislation, if enacted, would also strengthen FDA's efforts in
this area. For example, the Food Safety Enhancement Act (RR. 2749) as
passed by the House would enhance FDA's ability to prioritize
prevention, strengthen FDA's surveillance and enforcement efforts, and
improve FDA's response and recovery functions. The legislation would
also enable FDA to implement further preventative measures, such as by
issuing new food safety regulations, and would provide mechanisms to
help ensure such measures are appropriately implemented.
Responses to GAO Recommendations for Executive Action:
To enhance FDA's authority to oversee the safety of imported food, GAO
recommends that the FDA Commissioner seek authority from the Congress
to assess civil penalties on firms and persons who violate FDA's food
safety laws.
FDA agrees with this recommendation. FDA is working with Congress to
include civil money penalty authority in food safety legislation.
Section 135 of H.R. 2749, the Food Safety Enhancement Act, which was
passed by the House of Representatives on July 30, 2009, would
establish civil monetary penalties that FDA would be able to impose for
violations relating to food.
The Administration has issued a Statement of Administration Position in
support of H.R. 2749.
GAO further recommends that the Commissioner determine what violations
should be subject to this new FDA civil penalties authority, as well as
the appropriate nature and magnitude of the penalties.
FDA agrees that the agency should determine whether or not to seek
civil money penalties for particular violations under any new authority
and that FDA would take into account, as appropriate under such
authority, the nature of the violation and other factors in determining
the magnitude of a penalty.
The CBP Commissioner should ensure that ACE is able to accept a unique
identification number for foreign firms that export FDA-regulated foods.
FDA has supported and will continue to support CBP's efforts in this
area.
The FDA Commissioner should explore ways to improve the agency's
ability to identify foreign firms with a unique identifier.
FDA agrees that the use of a unique identifier would improve the
agency's ability to accurately identify foreign firms. Use of unique
identifiers would also aid FDA in targeting high risk shipments, which
are currently hindered when a firm that FDA has previously identified
and targeted due to history of exporting high risk shipments, uses a
different identifier, or where a new identifier is assigned to the firm
by the database that receives the import entry information.
FDA supports new authority to require the use of a unique identifier by
food facilities. FDA is currently working with Congress to include such
new authority in food safety legislation. The House of Representatives
recently passed H.R. 2749, the Food Safety Enhancement Act, which
contains a provision (Section 206) that would give FDA the authority to
specify the unique numerical identifier system under which persons must
submit such unique identifiers as part of the requirement to register
their food facilities with FDA. The Administration has issued a
Statement of Administration Position in support of H.R. 2749.
To enhance agency coordination and to streamline FDA's refusal process
with CBP's redelivery process, GAO recommends that the FDA Commissioner
and the CBP Commissioner jointly study, with input from agency field
officials, ports where a joint initiative would be feasible.
FDA does not believe a study is warranted, but does believe that
continuing to engage with CBP to develop a joint refusal/redelivery
process is important. CBP and FDA have begun discussions of the joint
form, as a prerequisite to consider this joint notice as a national
procedure. Additional discussions are needed to complete this
evaluation, after which it may be that national procedures can be
drafted, cleared, and implemented.
If approved, the joint notice should:
* Improve importer compliance with FDA refusal procedures;
* Help ensure that violative products are exported or destroyed; and;
* Expedite the response time for the entry refusal process.
To better leverage state resources for protecting the safety of
imported food, GAO recommends that the FDA Commissioner reach out to
states to find opportunities for additional collaboration through
contracts, cooperative agreements, and informal partnerships.
FDA agrees with this recommendation and its Office of Regulatory
Affairs has included an option in the state contracts for import work
for the past 5 years. Future planned State Infrastructure and National
Integrated Food Safety System Cooperative Agreements would include the
sharing of information on imported products and coordination of both
import and domestic import surveillance. The long term solution would
also involve enhancing the IT infrastructure of FDA to develop portals
or other IT solutions to connect this data to programs such as eSAF
(electronic State Access to FACTS) or other state accessible programs.
However, even if FDA receives funding to increase the number of
inspections conducted by states under contract, it may be difficult to
get states to commit to new or significantly more inspections. Several
states, under current food safety contracts, are now requiring furlough
days each month because of state budgets and regardless of contract
funding. In addition, even if FDA food contract funding is
significantly increased for one year, FDA must be able to ensure
funding on a long term basis for states to invest in the staff needed
to conduct increased inspections.
To enhance public safety, GAO recommends 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.
FDA agrees with this recommendation and already shares product
distribution lists and other confidential commercial information with
states in certain circumstances when permitted by law. However, FDA
also supports changes to existing law to strengthen the ability of the
agency to share information with states. The Food Safety Enhancement
Act includes such legislative changes.
The Administration has issued a Statement of Administration Position in
support of H.R. 2749.
To help ensure that PREDICT is effectively targeting high-risk imported
food shipments for field and laboratory examinations, GAO recommends
that the FDA Commissioner develop a performance measurement plan prior
to deploying the system at additional U.S. ports.
FDA agrees that a performance measurement plan is key to successfully
evaluating PREDICT and modifying it as appropriate prior to widespread
deployment. FDA is currently developing such a plan.
[End of section]
Appendix X: GAO Contact and Staff Acknowledgments:
GAO Contact:
Lisa Shames (202) 512-3841 or shamesl@gao.gov:
Staff Acknowledgments:
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.
[End of section]
Footnotes:
[1] GAO, Food Safety: Selected Countries' Systems Can Offer Insights
into Ensuring Import Safety and Responding to Foodborne Illness,
[hyperlink, http://www.gao.gov/products/GAO-08-794] (Washington, D.C.:
June 10, 2008).
[2] GAO, Standards for Internal Control in the Federal Government,
[hyperlink, http://www.gao.gov/products/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, [hyperlink, http://www.gao.gov/products/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, [hyperlink,
http://www.gao.gov/products/GAO/RCED-98-103] (Washington, D.C.: Apr.
30, 1998).
[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, [hyperlink,
http://www.gao.gov/products/GAO-07-561] (Washington, D.C.: Apr. 17,
2007).
[5] [hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1].
[6] GAO, Information Technology: FDA Needs to Establish Key Plans and
Processes for Guiding Systems Modernizations Efforts, [hyperlink,
http://www.gao.gov/products/GAO-09-523] (Washington, D.C.: June 2,
2009).
[7] [hyperlink, http://www.gao.gov/products/GAO/RCED-98-103].
[8] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-07-310] (Washington, D.C.: January
2007).
[9] [hyperlink, http://www.gao.gov/products/GAO-06-15].
[10] Generally, 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 FSIS-regulated foods; this notification is
independent of the Bioterrorism Act requirements.
[11] Buzby, 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).
[12] Taylor, 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).
[13] Taylor et al. 2009.
[14] GAO, Federal Oversight of Food Safety: FDA has Provided Few
Details on the Resources and Strategies Needed to Implement its Food
Protection Plan, [hyperlink, http://www.gao.gov/products/GAO-08-909T]
(Washington, D.C.: June 12, 2008).
[15] Department 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).
[16] GAO, Information Technology: Customs Automated Commercial
Environment Program Progressing, but Need for Management Improvements
Continues, [hyperlink, http://www.gao.gov/products/GAO-05-267]
(Washington, D.C.: Mar. 14, 2005).
[17] [hyperlink, http://www.gao.gov/products/GAO-06-15] and [hyperlink,
http://www.gao.gov/products/GAO/AIMD-00-21.3.1].
[18] CBP refers to the amount of the forfeited bond as liquidated
damages; FDA sometimes refers to this amount as a bond penalty.
[19] [hyperlink, http://www.gao.gov/products/GAO/RCED-98-103].
[20] Import 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.
[21] For 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.
[22] [hyperlink, http://www.gao.gov/products/GAO-07-561].
[23] [hyperlink, http://www.gao.gov/products/GAO-06-15].
[24] FDA 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.
[25] Import 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.
[26] For 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.
[27] [hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1].
[28] [hyperlink, http://www.gao.gov/products/GAO-09-523].
[29] An 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.
[30] [hyperlink, http://www.gao.gov/products/GAO-08-794].
[31] For 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, [hyperlink, http://www.gao.gov/products/GAO-07-592]
(Washington, D.C.: July 6, 2007).
[32] For 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, [hyperlink,
http://www.gao.gov/products/GAO-09-258] (Washington, D.C.: Feb. 19,
2009).
[33] 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.
[End of section]
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