Food Safety
FDA Could Strengthen Oversight of Imported Food by Improving Enforcement and Seeking Additional Authorities
Gao ID: GAO-10-699T May 6, 2010
Food imported from around the world constitutes a substantial and increasing percentage of the U.S. food supply. Ensuring the safety of imported food challenges the Food and Drug Administration (FDA) to better target its resources on the foods posing the greatest risks to public health and to coordinate efforts with the Department of Homeland Security's Customs and Border Protection (CBP) so that unsafe food does not enter U.S. commerce. This testimony focuses on (1) FDA's overseas inspections, (2) identified gaps in agencies' enforcement efforts to ensure the safety of imported food, and (3) statutory authorities that GAO has identified that could help FDA's oversight of food safety. This testimony is principally based on GAO's September 2009 report, Food Safety: Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of Imported Food (GAO-09-873) and has been updated with information from FDA.
While the number of FDA overseas inspections has fluctuated, FDA has opened up several overseas offices to address the safety of imported food at the point of origin, and is testing a computer-based system to target high-risk imports for additional inspection when they arrive at ports of entry. Specifically, in 2008, FDA inspected 153 foreign food facilities out of an estimated 189,000 such facilities registered with FDA; in 2007, FDA inspected 95 facilities. FDA estimated that it would conduct 200 inspections in 2009 and 600 in 2010. In addition, FDA opened offices in China, Costa Rica, and India and expects to open offices in Mexico and Chile and to post staff at European Union agencies. Furthermore, FDA's testing of a new computer screening system--the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT)--indicates that the system could enhance FDA's risk-based screening efforts at ports of entry, but the system is not yet fully operational. 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 and to target for inspection products that have a high risk score. GAO previously identified several gaps in enforcement that could allow food products that violate safety laws to enter U.S. commerce. For example, FDA has limited authority to assess penalties on importers who introduce such food products, and the lack of a unique identifier for firms exporting food products may allow contaminated food to evade FDA's review. In addition, FDA's and CBP's computer systems do not share information. FDA does not always share certain distribution-related information, such as a recalling firm's product distribution lists with states, which impedes states' efforts to quickly remove contaminated products from grocery stores and warehouses. GAO identified certain statutory authorities that could help FDA in its oversight of food safety. Specifically, GAO previously reported that FDA currently lacks mandatory recall authority for companies that do not voluntarily recall food products identified as unsafe. Limitations in FDA's food recall authorities heighten the risk that unsafe food will remain in the food supply. In addition, under current FDA regulations, companies may conclude a food ingredient is generally recognized as safe without FDA's approval or knowledge. GAO recommended that if FDA determines that it does not have the authority to implement one or more recommendations, the agency should seek the authority from Congress. Finally, GAO reported that FDA has identified a need for explicit authority from Congress to issue regulations requiring preventive controls by firms producing foods that have been associated with repeated instances of serious health problems or death. FDA already has preventive regulations for seafood and juice, which require firms to analyze safety hazards and implement plans to address those hazards.
GAO-10-699T, Food Safety: FDA Could Strengthen Oversight of Imported Food by Improving Enforcement and Seeking Additional Authorities
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Testimony:
Before the Subcommittee on Oversight and Investigations, Committee on
Energy and Commerce, House of Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery:
Expected at 2:00 p.m. EDT:
Thursday, May 6, 2010:
Food Safety:
FDA Could Strengthen Oversight of Imported Food by Improving
Enforcement and Seeking Additional Authorities:
Statement of Lisa Shames, Director:
Natural Resources and Environment:
GAO-10-699T:
GAO Highlights:
Highlights of GAO-10-699T, testimony before the Subcommittee on
Oversight and Investigations, Committee on Energy and Commerce, House
of Representatives.
Why GAO Did This Study:
Food imported from around the world constitutes a substantial and
increasing percentage of the U.S. food supply. Ensuring the safety of
imported food challenges the Food and Drug Administration (FDA) to
better target its resources on the foods posing the greatest risks to
public health and to coordinate efforts with the Department of
Homeland Security‘s Customs and Border Protection (CBP) so that unsafe
food does not enter U.S. commerce.
This testimony focuses on (1) FDA‘s overseas inspections, (2)
identified gaps in agencies‘ enforcement efforts to ensure the safety
of imported food, and (3) statutory authorities that GAO has
identified that could help FDA‘s oversight of food safety. This
testimony is principally based on GAO‘s September 2009 report, Food
Safety: Agencies Need to Address Gaps in Enforcement and Collaboration
to Enhance Safety of Imported Food (GAO-09-873) and has been updated
with information from FDA.
What GAO Found:
While the number of FDA overseas inspections has fluctuated, FDA has
opened up several overseas offices to address the safety of imported
food at the point of origin, and is testing a computer-based system to
target high-risk imports for additional inspection when they arrive at
ports of entry. Specifically, in 2008, FDA inspected 153 foreign food
facilities out of an estimated 189,000 such facilities registered with
FDA; in 2007, FDA inspected 95 facilities. FDA estimated that it would
conduct 200 inspections in 2009 and 600 in 2010. In addition, FDA
opened offices in China, Costa Rica, and India and expects to open
offices in Mexico and Chile and to post staff at European Union
agencies. Furthermore, FDA‘s testing of a new computer screening
system”-the Predictive Risk-Based Evaluation for Dynamic Import
Compliance Targeting (PREDICT)”-indicates that the system could
enhance FDA‘s risk-based screening efforts at ports of entry, but the
system is not yet fully operational. 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 and to target for inspection products that have a high risk
score.
GAO previously identified several gaps in enforcement that could allow
food products that violate safety laws to enter U.S. commerce. For
example, FDA has limited authority to assess penalties on importers
who introduce such food products, and the lack of a unique identifier
for firms exporting food products may allow contaminated food to evade
FDA‘s review. In addition, FDA‘s and CBP‘s computer systems do not
share information. FDA does not always share certain distribution-
related information, such as a recalling firm‘s product distribution
lists with states, which impedes states‘ efforts to quickly remove
contaminated products from grocery stores and warehouses.
GAO identified certain statutory authorities that could help FDA in
its oversight of the food supply. Specifically, GAO previously
reported that FDA currently lacks mandatory recall authority for
companies that do not voluntarily recall food products identified as
unsafe. Limitations in FDA‘s food recall authorities heighten the risk
that unsafe food will remain in the food supply. In addition, under
current FDA regulations, companies may conclude a food ingredient is
generally recognized as safe without FDA‘s approval or knowledge. GAO
recommended that, if FDA determines that it does not have the
authority to implement one or more recommendations, the agency should
seek the authority from Congress. Finally, GAO reported that FDA has
identified a need for explicit authority from the Congress to issue
regulations requiring preventive controls by firms producing foods
that have been associated with repeated instances of serious health
problems or death. FDA already has preventive regulations for seafood
and juice, which require firms to analyze safety hazards and implement
plans to address those hazards.
What GAO Recommends:
GAO recommended that FDA explore a unique identifier for firms, among
other things. GAO also recommended FDA seek statutory authorities,
such as for recalls and preventive controls. FDA agreed with these
recommendations and has sought authorities.
View [hyperlink, http://www.gao.gov/products/GAO-10-699T] or key
components. For more information, contact Lisa Shames at (202) 512-
3841 or shamesl@gao.gov.
[End of section]
Mr. Chairman and Members of the Subcommittee:
I am pleased to be here today to discuss findings from our work on the
Food and Drug Administration's (FDA's) efforts to ensure the safety of
imported food and on our other recently issued food safety work.
According to U.S. Department of Agriculture (USDA) data, food imported
from more than 150 countries and territories constitutes a substantial
and increasing percentage of the U.S. food supply. Imported food
constitutes 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 from fiscal years 2003 to 2008,
and the value of these products increased 65 percent. Ensuring the
safety 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.
We have reported on 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 1] More recently, we reported in September 2009
that agencies need to address gaps in enforcement and collaboration to
enhance the safety of imported food.[Footnote 2] Federal agencies
involved in the oversight of food imports include the following:
* FDA--which is responsible for dairy products, seafood, fruits, and
vegetables--oversees imported food safety through targeted
inspections, sampling, and surveillance, among other things. 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.
* 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. CBP
requires importers to (1) give a manufacturer identification number
for each imported shipment and (2) post a monetary bond for formal
entries to provide assurance that these shipments meet U.S.
requirements, among other things.
* The U.S. Department of Agriculture's Food Safety and Inspection
Service (FSIS) has responsibility for the safety of imported meat and
poultry and relies on an equivalency system whereby exporting
countries must demonstrate that their systems meet standards that are
equivalent to those of the U.S. system.
Furthermore, food safety responsibility is 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.
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 3]
Several food safety bills have recently been introduced in the
Congress, and a comprehensive bill, H.R. 2749, passed the House of
Representatives in July 2009.[Footnote 4] The House bill seeks tighter
control over food imports and would require importers to register
annually with FDA and to submit an appropriate unique facility
identifier as a condition of such registration, among other
provisions. The bill would also authorize FDA to issue a mandatory
recall of foods that may cause serious adverse health consequences or
death to humans or animals and would expand the agency's authority to
assess criminal and civil penalties. Our September 2009 report made
some of the same recommendations.
My testimony today will focus on three key issues: (1) FDA overseas
inspections to address the safety of imported food, (2) identified
gaps in agencies' enforcement that undermine efforts to ensure the
safety of imported food, and (3) statutory authorities that we have
identified that could help FDA's oversight of food safety.
As detailed in our reports, we found the following:
* First, while the number of FDA's foreign inspections has fluctuated,
the agency has opened several overseas offices to address the safety
of imported food at the point of origin. In addition, FDA testing of
PREDICT indicates that the system could enhance FDA's risk-based
screening efforts, but the system is not yet fully operational. FDA
officials stated that a scheduled nationwide rollout this summer of
PREDICT has been delayed primarily because of technical problems, such
as server crashes and overloads, which are affecting FDA's field data
systems nationwide.
* Second, gaps in FDA's and other agencies' enforcement could allow
violative food products to enter U.S. commerce. For example, FDA has
limited authority to assess penalties on importers who introduce
violative food products, and the lack of a unique identifier for firms
exporting food products may allow contaminated food to evade FDA
review.
* Finally, we have made several recommendations that would help FDA
improve food safety oversight. For example, we recommended that FDA
seek additional authorities, such as more explicit authority to create
preventive controls for high-risk foods, or that Congress consider
giving FDA additional authority, such as mandatory recall authority.
FDA agreed with these recommendations and has sought authority to
order food safety recalls and issue additional preventive controls for
high-risk foods.
This testimony is largely based on our September 2009 report on
imported food safety, as well as other recent reports, and updated
with information from FDA. See Appendix I for highlights of our prior
work. We conducted our work in accordance with generally accepted
government auditing standards.
While the Number of FDA Overseas Inspections Has Fluctuated, the
Agency Has Opened Overseas Offices, and Has Piloted PREDICT:
In 2008, FDA inspected 153 foreign food facilities out of an estimated
189,000 such facilities registered with FDA and estimated that it
would conduct 200 inspections in 2009 and 600 in 2010.[Footnote 5] In
2007, FDA inspected 95 facilities. Table 1 shows the number of FDA
inspections of foreign food facilities, by country, from fiscal years
2001 through 2008. As the table shows, FDA conducted 1,186 inspections
in 56 countries from fiscal years 2001 through 2008; the majority of
FDA inspections were in Mexico, followed by Ecuador, Thailand, and
Chile. FDA conducted a total of 46 inspections in China during this
period.
Table 1: 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];
2001: [Empty];
2002: [Empty];
2003: [Empty];
2004: [Empty];
2005: [Empty];
2006: [Empty];
2007: [Empty];
2008: [Empty];
Total: [Empty].
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: 1,186.
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]
For fiscal year 2009, FDA allocated 272 full-time employees to examine
imported food shipments at U.S. ports of entry and estimated a budget
of approximately $93.1 million for field import activities.[Footnote
6] The total estimated 2009 FDA budget for all FDA products and
programs, including food, drugs, medical devices, and other products,
was $2.7 billion. In 2008, we testified that if FDA were to inspect
each of the 189,000 registered foreign facilities--at the FDA
Commissioner's estimated cost of $16,700 per inspection--it would cost
FDA approximately $3.16 billion to inspect all of these facilities
once.[Footnote 7]
Since November 2008, FDA has opened overseas offices to help prevent
food that violates U.S. standards from reaching the United States.
These offices are expected to provide FDA with direct access to
information about foreign facilities' food manufacturing practices so
that its staff at U.S. ports of entry can make more informed decisions
about which food imports to examine. For example, FDA's overseas staff
are working with staff at counterpart regulatory agencies overseas, as
well as with other stakeholders who may be knowledgeable about certain
industries. Overseas staff are also educating local exporters to make
sure they understand U.S. food safety laws and regulations and FDA
expectations. FDA opened offices in China (Beijing, Guangzhou, and
Shanghai); in Europe (Brussels, London, and soon in Parma, Italy); in
Latin America (San Jose, Costa Rica; Santiago, Chile; and Mexico City,
Mexico); and in India (New Delhi and Mumbai). The FDA Middle East
Office is operating out of FDA headquarters because the Department of
State denied its request to locate in Amman, Jordan, due to security
concerns.
In addition to overseas offices assisting FDA's oversight of imported
food, the agency is developing PREDICT. PREDICT is intended to assist
FDA's oversight of imported food. PREDICT uses FDA-developed criteria
to estimate the risk of imported food shipments. These criteria are to
incorporate, among other things, the violative histories of the
product, importer, manufacturer, consignee, and country of origin; the
results of laboratory analyses and foreign facility inspections; and
general intelligence on recent world events--such as natural
disasters, foreign recalls, and disease outbreaks--that may affect the
safety of a particular imported food product. In addition, agency
officials stated that PREDICT will assign higher risk scores to firms
for which the system does not have historical data.
PREDICT generates a numerical risk score for all FDA-regulated
products. According to FDA, PREDICT is to present the shipment's risk
score to FDA reviewers if the score is above an FDA-specified
threshold. Shipments that are below the threshold are to receive a
system "may proceed" (cleared) message unless other conditions are
present, such as an FDA import alert.[Footnote 8] FDA intends that
reviewers using PREDICT will also be able to view the specific risk
factors that contributed to the shipment's risk score, such as whether
the product or importer has a history of FDA violations. FDA expects
entry reviewers to use PREDICT to supplement, rather than replace,
their professional judgment when deciding what food products to
inspect.
A 2007 pilot test of PREDICT in Los Angeles for seafood products
indicated that the system could enhance FDA's risk-based import
screening efforts. When compared with baseline data from FDA's
existing import screening system, the Operational and Administrative
System for Import Support (OASIS), PREDICT improved FDA's ability to
target imports that the agency considers to be high risk for further
examinations and allowed a greater percentage of products the agency
considers to be low risk to enter U.S. commerce without requiring a
reviewer's intervention. Specifically, PREDICT nearly doubled the
percentage of field examinations--and increased by approximately one-
third the percentage of laboratory examinations--that resulted in
violations, relative to baseline OASIS data. In addition, according to
FDA, the violations in shipments that reviewers targeted using
PREDICT, on average, posed a greater risk to human health than the
violations that OASIS detected.
FDA told us on April 12, 2010, that PREDICT is fully operational in
the Los Angeles and New York districts, but due to technical problems,
FDA has not determined when the system will be deployed in the Seattle
district. In addition, FDA officials stated that a scheduled
nationwide rollout this summer of PREDICT has been delayed primarily
because of technical problems, such as server crashes and overloads,
which are affecting FDA's field data systems nationwide.
Although the PREDICT pilot produced positive results and demonstrated
the system's potential to improve import screening efforts, we
reported that further agency actions were needed to help ensure that
the system is effective. For example, FDA had not yet developed a
performance measurement plan to evaluate, among other things,
PREDICT's ability to identify high-risk shipments for manual review
while simultaneously returning "may proceed" messages for low-risk
shipments and enabling them to enter U.S. commerce. We recommended FDA
develop such a plan. According to agency officials, since our report
was issued in September 2009, FDA had completed a draft performance
measurement plan. However, we have not reviewed this draft plan.
FDA and Other Agencies Face Gaps in Enforcement That Undermine Efforts
to Ensure the Safety of Imported Food:
We identified specific gaps in enforcement that could allow violative
food products to enter U.S. commerce: (1) FDA's limited authority to
assess civil penalties on certain violators; (2) lack of unique
identifiers for firms exporting FDA-regulated products; (3) lack of
information-sharing between agencies' computer systems and (4) FDA's
not sharing share product distribution information during a recall.
FDA Has Limited Authority to Ensure Importers' Compliance:
Importers can retain possession of their food shipments until FDA
approves their release into U.S. commerce. However, FDA and CBP
officials do not believe that CBP's current bonding procedures for FDA-
regulated food effectively deter importers from introducing violative
food products into U.S. commerce. Specifically, importers post a
monetary bond for formal entries (i.e., all shipments exceeding $2,000
or certain shipments valued below that amount) to provide assurance
that these shipments meet U.S. requirements. According to these
officials, many importers still consider the occasional payment of
forfeited bonds as part of the cost of doing business. Indeed, as we
reported in 1998, forfeiture of the shipment's maximum bond value is
often not sufficient to deter the sale of imported goods that FDA has
not yet released. In its response to our September 2009 report, FDA
agreed with this finding. According to FDA's regulatory procedures
manual, the bond penalty is intended to make the unauthorized
distribution of articles unprofitable, but liquidated damages incurred
by importers are often so small that they, in effect, encourage future
illegal distribution of imported shipments. Even though the bond may
be up to three times the value of the shipment, for a large importer,
this sum may be negligible, especially when the importer successfully
petitions CBP to reduce the amount.
We recommended that the FDA Commissioner seek authority from the
Congress to assess civil penalties on firms and persons who violate
FDA's food safety laws and that the Commissioner determine what
violations should be subject to this new FDA civil penalties
authority, as well as the appropriate nature and magnitude of the
penalties. FDA agreed with this recommendation and was working with
Congress to include civil penalty authority in food safety
legislation. FDA officials also told us that if the agency had the
authority to impose civil penalties on importers, which is also
provided for in H.R. 2749, FDA might be better able to deter
violations.
FDA and CBP Do Not Provide Unique Identification Numbers to Firms:
High-risk foods may enter U.S. commerce because the identification
numbers that FDA uses to target manufacturers that have violated FDA
standards in the past are not unique and therefore these
manufacturers, and their shipments, may evade FDA review. Importers
generate a manufacturer identification number at the time of import,
when, among other things, they electronically file entry information
with CBP. (CBP is responsible for validating the manufacturer
identification numbers and ensuring they are unique.) CBP
electronically sends this information to FDA's computer system. From
this new manufacturer identification number, FDA's computer system
automatically creates an FDA firm identification number--called the
FDA establishment identifier. Officials told us that a single firm may
often have multiple CBP manufacturer identification numbers--and
therefore multiple FDA establishment identifiers. FDA officials told
us that because CBP has multiple identification numbers for many
firms, FDA has an average of three "unique" identifiers per firm, and
one firm had 75 identifiers.
The creation of multiple identifiers can happen in a number of ways.
For example, if information about an establishment--such as its name--
is entered by importers incorrectly at the time of filing with CBP, a
new manufacturer identification number, and therefore a new FDA
establishment identifier, could be created for an establishment that
already has an FDA number. In this scenario, a importer may--
intentionally or unintentionally--enter a firm's name or address
slightly differently from the way it is displayed in FDA's computer
system. This entry would lead to the creation of an additional FDA
number for that firm. If an import alert was set using the original
FDA establishment identifier, a shipment that should be subject to the
import alert may be overlooked because the new number does not match
the one identified in the alert.
In addition, foreign facilities that manufacture, process, pack, or
hold food for consumption in the United States, with some exceptions,
are required to register with FDA. Upon registration, FDA assigns a
registration number. FDA calculated that in 2008, 189,000 foreign
firms were registered under this requirement. However, some of the
firms included in that total may be duplicates because the facility
may have been reregistered without the cancellation of the original
registration; consequently FDA may not know the precise number of
foreign firms registered. As we previously reported, FDA officials
told us they are working to address the unique identifier problem by
establishing an interactive process in which FDA's systems recognize
when a product's identifier does not match its manufacturer's
registration number.
As we reported, FDA could consider requiring food manufacturers to use
a unique identification number that FDA or a designated private sector
firm provides at the time of import. However, the use of this unique
number would necessitate collaboration with CBP, since importers would
use such a number each time they file with CBP to ship goods to the
United States. That is, CBP's computer system would need to be
programmed to accept an FDA unique identification number. According to
CBP officials, it is unknown if or when CBP's system will have this
capability. To improve FDA's and CBP's ability to identify foreign
firms with violative histories, we recommended that the FDA
Commissioner explore ways to improve the agency's ability to identify
foreign firms with a unique identifier and that the CBP Commissioner
ensure that its computer system is able to accept a unique
identification number for foreign firms that export FDA-regulated
foods. Both FDA and CBP agreed with our recommendation, and CBP
officials told us that the agency has developed a plan for
implementing a unique identifier. However, we have not reviewed this
plan. We observe that H.R. 2749 contains a provision that may allow
the Secretary of Health and Human Services, in consultation with the
Commissioner of CBP, to specify the unique numerical identifier system
to be used, taking into account compatibility with CBP's automated
systems. Such actions would help prevent high-risk foods from entering
U.S. commerce.
Information Is Not Shared between Computer Systems:
When we issued our report in September 2009, we reported that CBP's
computer system did not notify FDA's or FSIS's systems when imported
food shipments arrive at U.S. ports, which increases the risk that
potentially unsafe food may enter U.S. commerce, particularly at truck
ports. If FDA chooses to examine a shipment as part of its
admissibility review, the agency notifies both CBP and the importer
through its computer system, OASIS. However, once the shipment arrives
at the port and clears CBP's inspection process, the importer is not
required to wait at the port for FDA to conduct its examination.
Instead, the importer may choose to transport the shipment to the
consignee's warehouse or other facility within the United States. The
importer might choose to do so because, for example, CBP and FDA do
not have the same hours of operation at some ports, and FDA's port
office may be closed when the shipment arrives. In such cases, as a
condition of the bond with CBP, the importer agrees to hold the
shipment intact and not distribute any portion of it into U.S.
commerce until FDA has examined it.
CBP and FDA officials told us that, occasionally, an importer will
transport the shipment to the consignee's warehouse without first
notifying FDA. If this occurs, FDA will not quickly know that the
shipment has arrived and been transported to a U.S. warehouse because
CBP's computer system does not notify FDA's OASIS computer system when
the shipment arrives at the port. Instead, from the perspective of an
FDA reviewer using OASIS, it will appear as if the shipment's arrival
is still pending. FDA port officials told us that it could be 2 or 3
days before FDA reviewers become suspicious and contact CBP to inquire
about the shipment's arrival status. By this time, an unscrupulous
importer could have distributed the shipment's contents into U.S.
commerce without FDA's approval. As we reported, if CBP communicated
time-of-arrival information directly to OASIS, then FDA would be able
to quickly identify shipments that are transported into the United
States without agency notification and arrange to examine them before
they are distributed to U.S. markets. Since our report was issued in
September 2009, CBP told us that it had modified its software to
notify FDA of a shipment's time of arrival. However, we have not
reviewed the effectiveness of these modifications. We are still
waiting to see whether CBP has an agreement regarding time of arrival
modifications for FSIS.
FDA Does Not Always Share Product Distribution Information During a
Recall:
One key issue of concern, according to officials we spoke with from
several states, is that FDA does not always share with states certain
distribution-related information, such as a recalling firm's product
distribution lists, which impedes the states' efforts to quickly
remove contaminated products from grocery stores and warehouses.
According to one state official, because FDA does not provide this
information, the state has to spend time tracking it down on its own.
Public health may be at risk during the time it takes for the states
to independently track distribution information when a product is
found to be contaminated. FDA told us that it usually considers such
information to be confidential commercial information, the disclosure
of which is subject to statutory restrictions, such as the Trade
Secrets Act. However, FDA's regulations allow for sharing of
confidential commercial information with state and local government
officials if, for example,
* the state has provided a written statement that it has the authority
to protect the information from public disclosure and that it will not
further disclose the information without FDA's permission, and FDA has
determined that disclosure would be in the interest of public health,
if such sharing is necessary to effectuate a recall, or:
* the information is shared only with state and local officials who
are duly commissioned to conduct examinations or investigations under
the Federal Food, Drug, and Cosmetic Act. In certain circumstances,
FDA may also seek a firm's consent to disclose its market distribution
information.
Statutory Authorities We Identified Could Help FDA Oversee Food Safety:
In our past work, we have pointed out that mandatory recall--the
authority to require a food company to recall a contaminated product--
would help ensure that unsafe food does not remain in the food supply.
We also reported that FDA should strengthen its oversight of food
ingredients determined to be generally recognized as safe for their
intended use and to seek the authority if the agency deems necessary.
Likewise, we reported that FDA has identified a need for explicit
authority from the Congress to issue regulations to require preventive
measures by firms producing foods that have been associated with
repeated instances of serious health problems or death.
FDA Lacks Mandatory Recall Authority:
We have reported that food recalls are largely voluntary; federal
agencies responsible for food safety, including FDA, have no authority
to compel companies to recall contaminated foods, with the exception
of FDA's authority to require a recall for infant formula.[Footnote 9]
FDA does have authority, through the courts, to seize, condemn, and
destroy adulterated or misbranded food under its jurisdiction and to
disseminate information about foods that are believed to present a
danger to public health. However, government agencies that regulate
the safety of other products, such as toys and automobile tires, have
recall authority not available to FDA for food and have had to use
their authority to ensure that recalls were conducted when companies
did not cooperate. We have noted that limitations in the FDA's food
recall authorities heighten the risk that unsafe food will remain in
the food supply and have proposed that the Congress consider giving
FDA similar authorities. H.R. 2749 authorizes the Secretary of Health
and Human Services to request that a person recall an article of food
if the Secretary has reason to believe it is adulterated, misbranded,
or otherwise in violation of the Federal Food, Drug, and Cosmetic Act;
and to require a person to cease distribution if the Secretary has
reason to believe the article of food "may cause serious adverse
health consequences or death to humans or animals." It also requires
the Secretary to order a recall of such an article of food if the
Secretary determines (after an informal hearing opportunity) it is
necessary. Finally, it authorizes the Secretary to proceed directly to
a mandatory recall order if the Secretary has credible evidence that
an article of food subject to an order to cease distribution presents
an imminent threat of serious adverse health consequences or death to
humans or animals. As our previous work has shown, mandatory recall
authority would allow FDA to ensure that unsafe food does not remain
in the food supply.
FDA Has Limited Oversight of Food Ingredients Determined to be
Generally Recognized as Safe:
We have reported that FDA should strengthen its oversight of food
ingredients determined to be generally recognized as safe (GRAS) for
their intended use.[Footnote 10] Manufacturers add these substances--
hundreds of spices and artificial flavors, emulsifiers and binders,
vitamins and minerals, and preservatives--to enhance a food's taste,
texture, nutritional content, or shelf life. Currently, companies may
conclude a substance is GRAS without FDA's approval or knowledge. We
reported that FDA only reviews those GRAS determinations that
companies submit to the agency's voluntary notification program. The
agency generally does not have information about other GRAS
determinations companies have made because companies are not required
to inform FDA of them. Among other things, we recommended to FDA that
it develop a strategy to require any company that conducts a GRAS
determination to provide the agency with basic information about this
determination, and to incorporate such information into its public Web
site. We also reported that FDA is not systematically ensuring the
continued safety of current GRAS substances. According to FDA
regulations, the GRAS status of a substance must be reconsidered as
new scientific information emerges, but the agency has not
systematically reconsidered GRAS substances since the 1980s. Rather,
FDA officials said, they keep up with new developments in the
scientific literature and, on a case-by-case basis, information
brought to the agency's attention could prompt them to reconsider the
safety of a GRAS substance. We recommended that FDA develop a strategy
to conduct reconsiderations of the safety of GRAS substances in a more
systematic manner. We also recommended that, if FDA determines that it
does not have the authority to implement one or more of our
recommendations, the agency should seek the authority from Congress.
FDA generally agreed with the report's findings and recommendations.
In addition, we reported that FDA has taken steps to make information
about its GRAS notification program available to the public by posting
its inventory of all GRAS notices FDA has received on its Web site. By
placing information about the GRAS notice and its response on its Web
site, FDA enhances the ability of the Congress, stakeholders, and the
general public to be better informed about GRAS substances. H.R. 2749
contains provisions on GRAS substances, including a requirement that
the Secretary post on FDA's Web site information about GRAS notices
submitted to FDA within 60 days of receipt of the notice.
FDA Lacks Explicit Authority to Issue Regulations Requiring Food
Producing Firms to Institute Preventive Measures:
We have also reported that FDA should strengthen its oversight of
fresh produce.[Footnote 11] For example, we noted that FDA has
identified a need for explicit authority from the Congress to issue
regulations requiring preventive controls (risk-based safety
regulations) by firms producing foods that have been associated with
repeated instances of serious health problems or death. FDA already
has preventive regulations for seafood and juice, which require firms
to analyze safety hazards and implement plans to address those
hazards. According to FDA, such authority would strengthen the
agency's ability to implement risk-based processes to reduce illnesses
from high-risk foods. FDA officials told us that issuing preventive
regulations may be one of the most important things they can do to
enhance their oversight of fresh produce. We therefore recommended
that the Commissioner of FDA seek authority from the Congress to make
explicit FDA's authority to adopt preventive controls for high-risk
foods. FDA agreed with this recommendation and has sought authority to
issue additional preventive controls for high-risk foods. Furthermore,
H.R. 2749 requires FDA to create preventive controls for produce and
certain raw agricultural commodities. Such measures could help the
agency reduce illnesses from these high-risk foods.
In conclusion, food imports from around the world constitute a
substantial and increasing volume of imported foods. Our work has
shown that FDA could strengthen its oversight of imported food by
improving its enforcement, such as by assessing civil penalties and
providing unique identification numbers to firms. Additional statutory
authorities, such as mandatory recall authority, could also help FDA
oversee food safety. FDA generally agreed with our recommendations and
has some taken actions to address them.
Mr. Chairman, this concludes my statement. I would be pleased to
answer any questions that you or other members of this subcommittee
may have.
Contact and Staff Acknowledgments:
For further information about this testimony, please contact Lisa
Shames at (202) 512-3841 or shamesl@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this statement.
Key contributors to this statement were José Alfredo Gómez, Assistant
Director; Kevin Bray; Candace Carpenter; Jeff Jensen; Anne Johnson;
Carol Herrnstadt Shulman; Nico Sloss; and Rebecca Yurman.
[End of section]
Appendix I: GAO-09-873 (Food Imports):
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]
Appendix II: GAO-07-785T (High-Risk Designation):
Testimony:
Before the Subcommittee on Oversight and Investigations, Committee on
Energy and Commerce, House of Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery:
Expected at 9:30 a.m. EDT:
Tuesday, April 24, 2007:
Federal Oversight of Food Safety:
High-Risk Designation Can Bring Attention to Limitations in the
Government's Food Recall Programs:
Statement of Lisa Shames, Acting Director:
Natural Resources and Environment:
GAO-07-785T:
GAO Highlights:
Highlights of GAO-07-785T, a testimony before the Subcommittee on
Oversight and Investigations, Committee on Energy and Commerce, House
of Representatives
Why GAO Did This Study:
Each year, about 76 million people contract a foodborne illness in the
United States; about 325,000 require hospitalization; and about 5,000
die. The outbreaks of E. coli in spinach and Salmonella in peanut
butter, along with contamination in pet food, have highlighted the
risks posed by accidental food contamination. The attacks of September
11, 2001, heightened awareness that the food supply could also be
vulnerable to deliberate contamination. This testimony focuses on the
(1) role that GAO‘s high-risk series can play in raising the priority
and visibility of the need to transform federal oversight of food
safety, (2) fragmented nature of federal oversight of food safety, and
(3) limitations in federal food recall programs.
What GAO Found:
GAO‘s High-Risk Series is intended to raise the priority and visibility
of government programs that are in need of broad-based transformation
to achieve greater economy, efficiency, effectiveness, accountability,
and sustainability. These reports also help Congress and the executive
branch carry out their responsibilities while improving the
government‘s performance and enhancing its accountability for the
benefit of the American people. In January 2007, as part of our regular
update of this series for each new Congress, GAO designated the federal
oversight of food safety as a high-risk area for the first time.
We designated federal oversight of food safety as a high-risk area
because of the need to transform this system to reduce risks to public
health as well as the economy. While this nation enjoys a plentiful and
varied food supply that is generally considered to be safe, the federal
oversight of food safety is fragmented, with 15 agencies collectively
administering at least 30 laws related to food safety. The two primary
agencies are the U.S. Department of Agriculture (USDA), which is
responsible for the safety of meat, poultry, and processed egg
products, and the Food and Drug Administration (FDA), which is
responsible for virtually all other food. We have identified examples
where the federal government‘s resources and enforcement activities can
better align with the risks of food contamination. For example, the
majority of federal expenditures for food safety inspection were
directed toward USDA‘s programs for ensuring the safety of meat,
poultry, and egg products; however, USDA is responsible for regulating
only about 20 percent of the food supply. In contrast, FDA, which is
responsible for regulating about 80 percent of the food supply,
accounted for only about 24 percent of expenditures.
Among the reasons we designated federal oversight of food safety as a
high-risk area is that limitations in the federal government‘s food
recalls heighten the risk that unsafe food will remain in the food
supply and ultimately be consumed. Food recalls are voluntary, and
federal agencies responsible for food safety have no authority to
compel companies to carry out recalls”with the exception of FDA‘s
authority to require a recall for infant formula. USDA and FDA provided
guidance for companies to carry out voluntary recalls. We have reported
that USDA and FDA could do a better job carrying out their food recall
programs so they can quickly remove potentially unsafe food from the
marketplace. At the time of our review, these agencies did not know how
promptly and completely companies were carrying out recalls, did not
promptly verify that recalls had reached all segments of the
distribution chain, and used procedures that may not have been
effective to alert consumers to a recall.
What GAO Recommends:
While many of GAO‘s recommendations to promote the safety of the
nation‘s food supply have been acted upon, others have not yet been
addressed. For example, GAO recommended that the executive branch
reconvene the President‘s Council on Food Safety to facilitate
interagency coordination. GAO also proposed that Congress enact
comprehensive, uniform, and risk-based food safety legislation; analyze
alternative organizational food safety structures; and consider
legislation giving agencies authority to order food recalls.
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-785T].
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Lisa Shames at (202) 512-
3841 or ShamesL@gao.gov.
[End of section]
Appendix III: GAO-10-246 (GRAS):
Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
February 2010:
Food Safety:
FDA Should Strengthen Its Oversight of Food Ingredients Determined to
Be Generally Recognized as Safe (GRAS):
GAO-10-246:
GAO Highlights:
Highlights of GAO-10-246, a report to congressional requesters.
Why GAO Did This Study:
The Food and Drug Administration (FDA), which is responsible for
ensuring the safety of most of the U.S. food supply, is not required
to review substances, such as spices and preservatives, added to food
that are generally recognized as safe (GRAS) for their intended use.
Currently, companies may determine a substance is GRAS without FDA‘s
approval or knowledge. However, a few substances previously considered
GRAS have later been banned; and concerns have been raised about the
safety of other GRAS substances, including those containing engineered
nanomaterials, materials manufactured at a tiny scale to take
advantage of novel properties. GAO was asked to review the extent to
which (1) FDA‘s oversight of new GRAS determinations helps ensure the
safety of these substances, (2) FDA ensures the continued safety of
current GRAS substances, and (3) FDA‘s approach to regulating
engineered nanomaterials in GRAS substances helps ensure the safety of
the food supply. GAO reviewed FDA data on GRAS substances and
interviewed a range of stakeholders, among other things.
What GAO Found:
FDA‘s oversight process does not help ensure the safety of all new
GRAS determinations. FDA only reviews those GRAS determinations that
companies submit to the agency‘s voluntary notification program”the
agency generally does not have information about other GRAS
determinations companies have made because companies are not required
to inform FDA of them. Furthermore, FDA has not taken certain steps
that could help ensure the safety of GRAS determinations, particularly
those about which the agency has not been notified. FDA has not issued
guidance to companies on how to document their GRAS determinations or
monitored companies to ensure that they have conducted GRAS
determinations appropriately. Lastly, FDA has yet to issue a final
regulation for its 1997 proposed rule that sets forth the framework
and criteria for the voluntary notification program, potentially
detracting from the program‘s credibility.
FDA is not systematically ensuring the continued safety of current
GRAS substances. While, according to FDA regulations, the GRAS status
of a substance must be reconsidered as new scientific information
emerges, the agency has not systematically reconsidered GRAS
substances since the 1980s. FDA officials said they keep up with new
developments in the scientific literature and, on a case-by-case
basis, information brought to the agency‘s attention could prompt them
to reconsider the safety of a GRAS substance. However, FDA has largely
not responded to concerns about GRAS substances, such as salt and the
trans fats in partially hydrogenated vegetable oils, that individuals
and consumer groups have raised through 11 citizen petitions submitted
to the agency between 2004 and 2008. In fact, FDA has decided on the
validity of these concerns in only 1 of 11 cases. In addition, FDA
does not know to what extent, or even whether, companies track
evolving scientific information about their GRAS substances.
FDA‘s approach to regulating nanotechnology allows engineered
nanomaterials to enter the food supply as GRAS substances without
FDA‘s knowledge. While some uses of engineered nanomaterials have the
potential to help ensure food safety, uncertainties remain about how
to determine their safety in food. After reviewing the uncertainties
associated with the safety of engineered nanomaterials, FDA has
decided that it does not need additional authority to regulate
products containing such materials. Rather, FDA encourages, but does
not require, companies considering using engineered nanomaterials in
food to consult with the agency regarding whether such substances
might be GRAS. Because GRAS notification is voluntary and companies
are not required to identify nanomaterials in their GRAS substances,
FDA has no way of knowing the full extent to which engineered
nanomaterials have entered the U.S. food supply as part of GRAS
substances. In contrast to FDA‘s approach, all food ingredients that
incorporate engineered nanomaterials must be submitted to regulators
in Canada and the European Union before they can be marketed.
What GAO Recommends:
GAO recommends that FDA take steps to better ensure the safety of GRAS
substances, including developing a strategy to require any company
that conducts a GRAS determination to provide FDA with basic
information about it. FDA generally agreed, while raising concerns
about certain aspects of several of the recommendations.
View [hyperlink, http://www.gao.gov/products/GAO-10-246] or key
components. For more information, contact Lisa Shames at (202) 512-
3841 or shamesl@gao.gov.
[End of section]
Appendix IV: GAO-08-1047 (Fresh Produce):
Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
September 2008:
Food Safety:
Improvements Needed in FDA Oversight of Fresh Produce:
GAO-08-1047:
GAO Highlights:
Highlights of GAO-08-1047, a report to congressional requesters.
Why GAO Did This Study:
In recent years, both domestic and imported produce have been linked to
reported outbreaks of foodborne illness. Contamination in produce is of
particular concern because produce is often consumed raw. The Food and
Drug Administration (FDA) has primary responsibility for ensuring the
safety of both domestic and imported fresh produce. GAO was asked to
examine (1) the resources FDA has spent on fresh produce safety and how
it has allocated those resources, (2) the effectiveness of FDA‘s
actions to oversee fresh produce safety, and (3) the extent to which
FDA‘s planned actions to enhance fresh produce oversight address
identified challenges. For this review, GAO analyzed FDA spending data
and estimates and FDA activities data, reviewed FDA plans, and
interviewed FDA officials and others.
What GAO Found:
While FDA has considered fresh produce safety a priority for many
years, resource constraints and other work”including counterterrorism
efforts and unplanned events such as foodborne illness outbreaks”have
caused FDA to delay key produce safety activities. FDA has no formal
program devoted exclusively to fresh produce and has not consistently
and reliably tracked its fresh produce spending. Based on FDA
estimates, FDA spent at least $20 million and 130 staff years on fresh
produce in fiscal year 2007”or about 3 percent of its food safety
dollars and 4 percent of its food safety staff years. In addition, FDA
had few staff dedicated solely to fresh produce safety. Moreover, FDA
acknowledged that it has not yet been able to conduct certain fresh
produce work crucial to understanding the incidence of contamination of
produce by pathogens such as E. coli O157:H7 or Salmonella, because it
has lacked the resources to either fund its extramural research grant
program or perform some critical research internally. Finally, FDA
delayed issuing final fresh-cut produce guidance at least 6 years
because it had to shift staff to counterterrorism and outbreak
investigation work.
FDA has provided limited oversight of domestic and imported fresh
produce. For example, while FDA has issued guidance for industry on
recommended practices for reducing the risk of contamination during the
processing of fresh-cut produce, it has not issued regulations
requiring firms to take action to prevent contamination, even though
some industry groups would like it to do so. FDA‘s intervention efforts
have also been limited. Specifically, domestic fresh produce firms were
inspected infrequently. Furthermore, FDA examined less than 1 percent
of the 7.6 million fresh produce lines imported from fiscal years 2002
through 2007. Finally, FDA has improved some elements of its emergency
response by, for example, partnering with California on outbreak
investigations. However, it faces challenges in tracing an outbreak
involving fresh produce back to its source because produce is highly
perishable and may no longer be available for testing. Also, when
product is available, it may be unlabeled or mixed in packages
containing products from multiple sources.
FDA has proposed changes through its Food Protection Plan that could
significantly enhance its fresh produce oversight. However, the agency
is still in the planning stages for several enhancements and has not
provided specific information on strategies and resources, making it
difficult to assess the likelihood of success. To help prevent
contamination, FDA plans to update its existing guidance on good
agricultural practices and regulations on current good manufacturing
practice for food, and has identified a need for explicit authority to
issue preventive safety regulations for high-risk foods and enhanced
access to records. To enhance intervention efforts, FDA plans to use
more rigorous risk-based criteria to target domestic firm inspections
and is testing a new import screening software tool. To improve
response efforts, FDA is examining best practices for tracing
contaminated foods to their source.
What GAO Recommends:
GAO recommends, among other things, that the Commissioner of FDA update
its guidance on good agricultural practices and its regulations on
current good manufacturing practice for food, and seek explicit
authority from the Congress to adopt preventive controls for high-risk
foods and authority for enhanced access to records.
FDA agreed with most of GAO‘s recommendations but believed that it had
sought authority from the Congress. FDA should continue to take steps
to obtain these authorities so that it can conduct its oversight
responsibilities.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-1047]. For more
information, contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov.
[End of section]
Footnotes:
[1] 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).
[2] GAO, Food Safety: Agencies Need to Address Gaps in Enforcement and
Collaboration to Enhance Safety of Imported Food, [hyperlink,
http://www.gao.gov/products/GAO-09-873] (Washington, D.C.: Sept. 15,
2009).
[3] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-07-310] (Washington, D.C.: January
2007).
[4] H.R. 2749, 111th Cong. See also S. 510, 111th Cong.
[5] FDA was not able to provide 2009 inspection data in time for this
statement, according to FDA officials.
[6] 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, as well as associated infrastructure support.
[7] 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).
[8] 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 is provided
an opportunity to prove that the imported product is compliant, such
as by providing FDA with the results of third-party laboratory
analysis of the product.
[9] GAO, Food Safety: USDA and FDA Need to Better Ensure Prompt and
Complete Recalls of Potentially Unsafe Food, [hyperlink,
http://www.gao.gov/products/GAO-05-51] (Washington, D.C.: Oct. 6,
2004) and GAO, Federal Oversight of Food Safety: High Risk Designation
Can Bring Attention to Limitations in the Federal Government's Food
Recall Programs, [hyperlink, http://www.gao.gov/products/GAO-07-785T]
(Washington, D.C.: Apr. 24, 2007)
[10] GAO, Food Safety: FDA Should Strengthen Its Oversight of Food
Ingredients Determined to Be Generally Recognized as Safe (GRAS),
[hyperlink, http://www.gao.gov/products/GAO-10-246] (Washington, D.C.:
Feb. 3, 2010).
[11] GAO, Food Safety: Improvements Needed in FDA Oversight of Fresh
Produce, [hyperlink, http://www.gao.gov/products/GAO-08-1047]
(Washington, D.C.: Sept. 26, 2008).
[End of section]
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