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United States Government Accountability Office: 
GAO: 

Report to Congressional Requesters: 

September 2012: 

Food Safety: 

FDA Can Better Oversee Food Imports by Assessing and Leveraging Other 
Countries' Oversight Resources: 

GAO-12-933: 

GAO Highlights: 

Highlights of GAO-12-933, a report to congressional requesters. 

Why GAO Did This Study: 

U.S. reliance on imported food increased from 2000 through 2011. For 
some products, imports make up a considerable share of the total 
amount consumed in the United States. FDA-—responsible for ensuring 
the safety of most imported foods-—received new authority under FSMA 
to enhance its oversight of food imports, including express authority 
to establish a system for accrediting third parties, which may include 
foreign governments and private auditing firms, to certify foreign 
food facilities’ compliance with U.S. food safety requirements. FDA 
has also begun to assess selected foreign food safety systems to 
determine if these systems provide the same level of public health 
protection, among other things. 

GAO was asked to (1) identify major actions FDA is to take to 
implement a system for accrediting third parties and challenges, if 
any, it and others report with these actions and (2) examine FDA's 
approach for using comparability assessments to leverage other 
countries' oversight capacity and enforcement authority. GAO reviewed 
FDA documents and interviewed officials from FDA and other agencies, 
and stakeholders, such as consumer groups and industry representatives. 

What GAO Found: 

We identified five major actions the Food and Drug Administration 
(FDA) is to complete under the FDA Food Safety Modernization Act 
(FSMA) to establish a reliable system that uses third-party audits 
conducted by foreign governments or other third parties to help ensure 
food safety. FDA officials and others report that each of these 
actions presents challenges that must be addressed. First, FDA is to 
develop new preventive controls and related guidance for all of the 
foods under its jurisdiction-—such as produce, milk, cheese, spices, 
soft drinks, and processed foods—-and will need to develop appropriate 
training, particularly for foreign producers and processors, which 
poses a challenge because FDA is responsible for a variety of food 
industries. Second, FDA is to establish a voluntary user fee program 
for importers that encourages the use of third-party certifications, 
and it faces a challenge in developing a program that encourages 
importers to participate. Third, FDA has to develop a system for 
recognizing accreditation bodies that can accredit third parties to 
certify foreign food facilities and is likely to face a challenge in 
addressing foreign governments’ concerns about being evaluated by an 
entity other than FDA. Fourth, FDA is to develop model standards for 
accreditation bodies to use in evaluating and accrediting third 
parties and faces challenges in, among other things, determining third-
party auditors’ competency and deciding on how to avoid potential 
conflicts of interest. Fifth, FDA is to oversee the third-party 
accreditation system, including periodically evaluating accreditation 
bodies and third parties, and faces a challenge in deciding the level 
of oversight it will provide to the multiple parties involved in third-
party certification. 

FDA’s approach for using comparability assessments can enable the 
agency to leverage other countries’ oversight capacity and enforcement 
authority. This could result in some of the same advantages as the 
equivalence approach used by the U.S. Department of Agriculture’s Food 
Safety Inspection Service (FSIS) and the European Union (EU) before 
specific food products can be imported. These advantages include 
having a foreign competent authority address any identified problems 
and take regulatory actions across the supply chain, as necessary. 
However, according to FDA officials, the agency expects few countries 
to seek comparability with the United States because, in part, most 
countries will not meet the FDA requirement that a foreign government’
s domestic and export food safety systems be comparable to the U.S. 
system for food products under FDA’s jurisdiction. According to FDA 
documents, some countries have robust export certification programs 
for a specific food product, but their overall food safety systems, 
including domestic production systems, may not be comparable with 
those of the United States. Consequently, FDA would be unable to 
leverage the resources of countries with comparable systems for just 
one food product, such as seafood, which FDA has experience in 
assessing through its foreign country assessments. Representatives 
from major seafood exporting countries GAO interviewed stated that 
they would like to have agreements with FDA covering seafood that are 
similar to those they have with the EU, which uses a targeted approach 
through equivalence to determine whether certain exported food 
products are safe for domestic consumption. 

What GAO Recommends: 

GAO recommends that FDA revise its comparability approach to one that 
also includes assessing foreign food safety systems for particular 
food products, such as seafood. FDA neither agreed nor disagreed with 
the recommendation. 

View [hyperlink, http://www.gao.gov/products/GAO-12-933]. For more 
information, contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

FDA Faces Challenges in Implementing a Third-Party Accreditation 
System to Help Ensure Imported Food Safety: 

FDA's Comparability Assessment Approach Could Enable FDA to Leverage 
Other Countries' Oversight Resources for Imported Foods: 

Conclusions: 

Recommendation for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Scope and Methodology: 

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

Appendix III: GAO Contact and Staff Acknowledgments: 

Figures: 

Figure 1: Top Six Seafood Importing Countries to the United States, 
2010: 

Figure 2: Uses and Potential Structure of an FDA Third-Party 
Accreditation System: 

Figure 3: Countries Approved to Export Specific Products by USDA's 
FSIS and the European Union: 

Abbreviations: 

AMS: Agriculture Marketing Service: 

ANSI: American National Standards Institute: 

CFIA: Canadian Food Inspection Agency: 

EU: European Union: 

FDA: Food and Drug Administration: 

FSMA: FDA Food Safety Modernization Act: 

FSIS: Food Safety and Inspection Service: 

GFSI: Global Food Safety Initiative: 

HACCP: Hazard Analysis and Critical Control Point: 

IAF: International Accreditation Forum: 

ISO: International Organization of Standardization: 

MOU: memorandum of understanding: 

SENASICA: Servicio Nacional de Sanidad, Inocuidad y Calidad 
Agroalimentaria: 

SIP: Seafood Inspection Program: 

USDA: U.S. Department of Agriculture: 

VQIP: Voluntary Qualified Importer Program: 

[End of section] 

United States Government Accountability Office: 
Washington, DC 20548: 

September 28, 2012: 

The Honorable John D. Rockefeller IV: 
Chairman: 
Committee on Commerce, Science, and Transportation: 
United States Senate: 

The Honorable Olympia J. Snowe: 
Ranking Member: 
Subcommittee on Oceans, Atmosphere, Fisheries, and Coast Guard: 
Committee on Commerce, Science, and Transportation: 
United States Senate: 

The Honorable Maria Cantwell: 
United States Senate: 

The Honorable Daniel K. Inouye: 
United States Senate: 

The U.S. reliance on imported food increased from 2000 through 2011. 
During this period, imported food as a percentage of all food consumed 
in the United States rose from about 9 percent to over 16 percent. 
Some food categories are more likely to come from foreign rather than 
domestic sources. For example, in 2009, we reported that 60 percent of 
fruits and vegetables and 80 percent of seafood in the U.S. food 
supply were imported. Some specific products are imported at an even 
higher rate. For instance, in 2010, over 90 percent of the U.S. shrimp 
supply consisted of imports. Imported foods can present food safety 
risks from the presence of pathogens, chemical contamination, and 
sanitary violations. The U.S. Department of Health and Human Services' 
Food and Drug Administration (FDA) has primary responsibility for 
ensuring the safety of about 80 percent of the U.S. food supply. The 
U.S. Department of Agriculture's (USDA) Food Safety and Inspection 
Service (FSIS) is responsible for meat, poultry, and processed egg 
products, while FDA is responsible for virtually all other foods, both 
domestic and imported, including produce and seafood. However, we have 
identified deficiencies in FDA's oversight of imported foods: in 
September 2009, we reported that FDA, among other federal agencies 
responsible for food safety oversight, needs to address gaps in 
enforcement and collaboration to enhance the oversight of food 
imports.[Footnote 1] In April 2011, we reported that imported seafood 
has been subject to limited U.S. oversight by FDA and that the agency 
needed to better leverage its resources.[Footnote 2] FDA generally 
agreed with our recommendations in the 2009 report and neither agreed 
nor disagreed with the recommendations in our 2011 report. FDA has 
stated that it needs new approaches to improve its oversight of 
imported food that take into account the entire food supply chain and 
that it needs to push prevention of food safety risks offshore and 
leverage the efforts of others to avoid duplication and better target 
its food safety efforts. 

The FDA Food Safety Modernization Act (FSMA) enacted in 2011 expands 
and modifies existing FDA authorities, among other things, giving FDA 
several new authorities that enhance the agency's oversight of 
imported food. Among other things, FSMA directed FDA to establish a 
system for recognizing accreditation bodies that would, in turn, 
accredit third-party auditors (third parties), which may include 
foreign governments and private auditing firms.[Footnote 3] These 
third parties would certify that food or eligible foreign entities, 
such as seafood processors, met applicable federal requirements. Third-
party certifications would serve the following purposes: (1) 
certifications for a voluntary program that offers expedited entry for 
food products certified by accredited third parties and (2) 
certifications as a condition for entry into the United States of 
certain articles of food if FDA determines such certifications or 
assurances are necessary for the food based on, among other things, 
the known safety risks for foods. 

Under its pre-FSMA authority, in early 2010, FDA began an effort to 
assess foreign food safety systems to determine if certain other 
countries have a regulatory system--food safety statutes, regulations, 
and an implementation strategy--that is comparable with the U.S. food 
safety system and that provides the same level of public health 
protection. FDA has stated that identifying countries with comparable 
food safety systems will, among other things, facilitate the agency's 
ability to develop closer regulatory partnerships, to exchange food 
safety-related information, and to leverage the work done by foreign 
competent food safety authorities. According to FDA officials, the 
agency envisions building a coalition of overseas regulators with 
which it can share information and leverage knowledge and resources to 
make more informed decisions on food imports. Under this effort, FDA, 
in 2010, developed a comparability tool to assess the overall food 
safety systems of foreign countries for foods under the agency's 
jurisdiction. FDA completed its on-site review for a comparability 
assessment pilot with New Zealand in late 2010 and is currently 
engaged in another such pilot with Canada. In May 2012, we reported 
that, by using third-party certifications and comparability 
assessments, FDA has the opportunity to enhance its oversight of 
imported catfish--and essentially all imported foods under FDA's 
oversight.[Footnote 4] 

In this context, you asked us to examine FDA's plans for improving its 
oversight of the safety of imported food under FDA's jurisdiction. Our 
objectives were to (1) identify the major actions FDA is to take to 
implement a system for accrediting third parties, as directed by FSMA, 
and the challenges, if any, FDA and others report will be associated 
with these actions and (2) examine FDA's approach for using its 
comparability assessments to leverage other countries' oversight 
capacity and enforcement authority. 

To identify major actions FDA is to take to develop a system for 
accrediting third parties and any challenges FDA and others reported 
in taking these actions, we reviewed FDA's responsibilities for 
developing a system to accept third-party certification under FSMA, 
its plans for implementation, and the results of FDA's third-party 
certification pilot for imported shrimp, which it initiated in 2008. 
We interviewed FDA officials on the agency's plans to implement a 
system for accrediting third parties and on the challenges identified 
during the third-party certification pilot for imported shrimp. We 
interviewed third parties who participated in FDA's third-party 
certification pilot for imported shrimp, as well as industry and 
consumer groups, to obtain their perspectives on FDA's new authorities 
and requirements for accepting third-party certifications. We spoke 
with the American National Standards Institute, a U.S. based, not-for-
profit accreditation organization that serves as the official U.S. 
representative to the International Organization for Standardization. 
[Footnote 5] We reviewed internationally recognized third-party 
accreditation systems and industry-based food safety certification 
systems that include those used by third parties in FDA's third-party 
certification pilot for imported shrimp, and we spoke with 
representatives of these industry systems. We reviewed USDA's policies 
and spoke with officials from the department's Agriculture Marketing 
Service about its management of the National Organics Program, which 
uses accredited third parties to complete certifications of organic 
operations that produce crops, livestock, and multi-ingredient foods 
domestically and overseas. We also reviewed policies and spoke with 
U.S. Customs and Border Protection officials about the agency's 
Customs-Trade Partnership Against Terrorism program and the results of 
its pilot using third parties. To examine FDA's approach for using its 
comparability assessment process, we reviewed the tool it is using in 
its comparability assessment pilots with Canada and New Zealand and 
reviewed FDA documents about the agency's approach for using 
comparability assessments. We spoke with (1) FDA officials about the 
agency's comparability assessment pilot and its plans for using 
comparability assessments and (2) New Zealand government officials 
about their experience with the pilot. We reviewed the approach used 
by FSIS and the European Union (EU) to determine if their practices 
for ensuring the safety of imported foods have the potential for 
enhancing FDA's practices, and we spoke with FSIS and EU officials. 
For both of our objectives, we reviewed policies and spoke with 
representatives of countries that are major seafood exporters to the 
United States--Canada, Ecuador, Indonesia, Thailand, and Vietnam--and 
a major trading partner, Mexico, about their perspectives on FDA's use 
of third-party certifications and approaches they use in supporting 
oversight of seafood exports to other countries. We chose to interview 
representatives of major seafood exporting countries, in part, because 
more seafood is imported than is produced domestically and because FDA 
has set internationally recognized Hazard Analysis and Critical 
Control Point (HACCP) standards as its main oversight tool for seafood 
safety. Under HACCP, processors are primarily responsible for the 
safety of food, including seafood, they process and are required to 
implement preventive controls to address any identified hazards. 
Appendix I provides additional information on our scope and 
methodology. 

We conducted this performance audit from June 2011 to September 2012 
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. 

Background: 

According to FDA documents, during the past 7 years, food imports have 
grown by an average of 10 percent each year, and over 16 percent of 
all food products now consumed in the United States are imported. Food 
imports are expected to continue to increase. According to FDA, from 
2007 to 2015, it is estimated that imports under FDA's jurisdiction--
including food--will triple, corresponding to a 15 percent growth 
rate. For some products, imports make up a considerable percentage of 
the total amount consumed in the United States. For example, in 2011, 
the United States imported 84 percent of the seafood consumed, and 
about half of such seafood was from aquacultured products. Figure 1 
shows the proportion of seafood from the top six importing countries 
to the United States for 2010. 

Figure 1: Top Six Seafood Importing Countries to the United States, 
2010: 

[Refer to PDF for image: illustrated world map and pie-chart] 

China: 23%; 
Thailand: 17%; 
Canada: 12%; 
Indonesia: 6%; 
Vietnam: 5%; 
Ecuador: 4%; 
All others: 33%. 

Source: GAO analysis of Department of Commerce and International Trade 
Commission data. 

[End of figure] 

Under the Federal Food, Drug, and Cosmetic Act, FDA is responsible for 
ensuring that about 80 percent of the nation's food supply--both 
domestic and imported--is safe, wholesome, sanitary, and properly 
labeled. Under the act, 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. 

As part of its oversight activities, FDA inspects a targeted number of 
foreign food facilities that process foods under its jurisdiction to 
(1) identify potential food safety problems before products arrive in 
the United States, (2) help the agency make risk-based admissibility 
decisions when food products are offered for importation into the 
United States, and (3) help ensure that food products under FDA's 
jurisdiction meet U.S. requirements. In fiscal year 2011, FDA 
inspected 1,002 (about 0.4 percent) out of more than 270,000 
registered foreign food facilities. 

FDA supplements its inspection activities with examination and testing 
of select imported foods at ports of entry identified during a two-
phase screening process of shipments' compliance with regulatory 
standards and requirements. First, before their arrival at a U.S. 
port, shipments are screened based on basic information required to be 
submitted to FDA as part of the Prior Notice requirements. Information 
that must be submitted includes the submitter's name and contact 
information; the article of food; the manufacturer or grower, if 
known; and the country from which the product was shipped. Second, 
shipments are subject to a separate assessment, called an 
admissibility review, which consists of screening the shipment for 
compliance with regulatory standards and requirements, as well as 
misbranding, adulteration, and safety. During the admissibility 
process, an FDA reviewer selects shipments for physical examination or 
testing, based on a review of shipment information, including, among 
other things, product type; manufacturer; and compliance history of 
manufacturers and importers. For example, for seafood, FDA conducts 
testing to identify the absence of residues of drugs that are 
unapproved for use in the United States and that would render the 
seafood adulterated under the Federal, Food, Drug, and Cosmetic Act. 
For fiscal year 2011, FDA reported that it examined about 2.2 percent 
of all food entry lines and specifically performed testing of samples 
from less than 0.5 percent of all food entry lines.[Footnote 6] 
Because items in an import entry having different tariff descriptions 
or FDA product codes must be listed separately, an entry line 
identifies each portion of an import shipment that is listed as a 
separate item on an entry document. 

Some foods under FDA's jurisdiction, including seafood, are covered 
separately by specific regulations. Since regulations for enhancing 
seafood safety became effective in 1997, FDA has used the 
internationally recognized HACCP standards as its main oversight tool 
for seafood safety. FDA requires all seafood processing firms--those 
that, among other things, manufacture, pack, store, or label seafood 
products--to meet HACCP standards. Under HACCP standards, processors 
are primarily responsible for the safety of the seafood they process 
and are required to implement preventive controls to address any 
identified hazards. Food safety hazards in seafood may result from, 
among other things, microbial contamination, drug residues, 
pesticides, parasites, and decomposition. Processors are to lay out 
their hazard analysis and control procedures in HACCP plans whenever 
an analysis shows that one or more hazards are reasonably likely to 
occur. During inspections of seafood processing facilities, FDA 
verifies that seafood processors are in compliance with HACCP 
regulations and that controls are effectively implemented to minimize 
the food safety risk from identified hazards. In addition, FDA 
inspects importers of seafood products to ensure their compliance with 
HACCP requirements. Under FDA regulations, importers are to 
demonstrate, through documentation, that the seafood they import into 
the United States complies with HACCP requirements. FDA regulations 
require that every importer of seafood products either (1) obtain its 
seafood products from foreign firms in countries that have an 
agreement with FDA that documents the equivalency or compliance of the 
foreign inspection system with the U.S. system for imported products 
or (2) have and implement written verification procedures, which 
include product specifications designed to ensure that the product is 
not adulterated, and take at least one of six affirmative steps to 
document that the foreign firms supplying the seafood products comply 
with HACCP requirements. If importers cannot provide assurance that 
the seafood products they imported have been processed under 
conditions established by HACCP requirements, the products are 
considered adulterated and can be refused entry into the United States. 

USDA's FSIS is responsible for ensuring the safety of domestic and 
imported meat, poultry, and processed egg products. FSIS uses a three-
part approach to overseeing the safety of imported food: (1) an 
equivalence system, whereby countries that wish to export meat and 
poultry products to the United States must demonstrate that their food 
safety systems for these food products are equivalent to those of the 
U.S. system; (2) periodic audits to verify that their system remains 
equivalent; and (3) reinspection of all imported shipments arriving at 
FSIS-approved import facilities located near about 30 U.S. ports of 
entry. Once FSIS determines equivalence, a single foreign government 
agency assumes responsibility for addressing any problems FSIS may 
identify with imported products, according to FSIS officials. 

The EU likewise uses an equivalence approach to oversee all products 
of animal origin exported from foreign countries to the EU. As part of 
its equivalence determination process, countries must demonstrate that 
their food safety systems for a specified product, like seafood, meet 
EU or equivalent requirements or meet requirements specified in an 
agreement between the EU and the exporting country. The EU generally 
conducts an initial on-site inspection of the foreign country's food 
safety system for the food product the foreign country wants to export 
to the EU, as well as periodic follow-up reviews. 

We and others have previously recommended that FDA take actions to 
both undertake equivalence determinations and use third parties. For 
example, in January 2001, to better ensure the safety of imported 
seafood, we recommended that FDA develop specific goals and time 
frames for establishing agreements with other countries to document 
that their seafood safety systems are equivalent to that of the United 
States.[Footnote 7] We stated that, without such equivalence 
agreements, FDA must rely principally on its reviews of importers' 
records to ascertain that imported seafood products are processed 
under an acceptable food safety system. FDA noted that foreign 
equivalencies was one of its priorities for fiscal year 2001 but added 
that a considerable exchange of data among the countries involved had 
to take place before equivalence determinations could be made. In 
January 2004,[Footnote 8] we recommended, among other things, that FDA 
make it a priority to establish equivalence or other similar types of 
agreements with seafood-exporting countries, starting first with 
countries that have high-quality food safety systems. We further 
recommended that the agency explore the potential for implementing a 
certification program for third-party inspectors, which would involve 
reviewing FDA's legal authorities and considering the costs and 
benefits, including developing and implementing the standards, 
controls, and oversight necessary to provide FDA with reasonable 
assurance that third-party inspectors are qualified and independent. 
FDA did not agree with our recommendation on equivalence but generally 
agreed with our recommendation to explore the potential for 
implementing a certification program for third-party inspectors. 
Furthermore, in June 2010, a committee of experts convened by the 
Institute of Medicine and the National Research Council issued a 
report examining gaps in public health protection afforded by the farm-
to-table food safety system under FDA's jurisdiction and identifying 
opportunities to fill those gaps. The report concluded that FDA needs 
to address barriers to improving the efficiency of inspections by, 
among other things, exploring third-party auditing of food facilities 
as an alternative model for measuring compliance. 

FSMA: 

Enacted in January 2011, FSMA gives FDA new authorities to require 
comprehensive, prevention-based controls, among other things, for food 
under the agency's jurisdiction and enhances FDA's authority to 
oversee the safety of these imported foods. For example, the act 
requires FDA to develop a preventive controls rule for food facilities 
that manufacture, process, pack, or hold food within the agency's 
jurisdiction, with certain exceptions, such as seafood and juice 
facilities. Under the act, these food facilities are required to 
implement a written preventive control plan, provide in the plan for 
the monitoring of the performance of the controls, and specify the 
corrective actions the facility will take when necessary. In addition, 
under FSMA, FDA must develop produce safety standards for the safe 
production and harvesting of fruits and vegetables that will address 
soil amendments, hygiene, packaging, temperature controls, and water, 
among other issues. 

With regard to overseeing imported food under its jurisdiction, the 
act requires FDA to incrementally increase the number of FDA 
inspections of foreign food facilities over a period of 6 years. In 
addition, the act enables FDA to enter into agreements with foreign 
governments to facilitate the inspection of foreign facilities. 
Separate from FDA inspections of food facilities, the act's provisions 
give FDA the authority to require certifications or assurances issued 
by accredited third parties, which may include foreign governments or 
agencies of foreign governments that foods exported to the United 
States are in compliance with the Federal Food, Drug, and Cosmetics 
Act, including new preventive control requirements outlined in FSMA. 
The act also directs FDA to establish new regulations requiring 
importers to verify that imported foods are produced in compliance 
with processes and procedures that provide the same level of 
protection as U.S. food safety requirements (e.g., risk-based 
preventive controls), except certain imports, such as seafood, which 
has existing importer verification requirements. Furthermore, the act 
includes a provision directing FDA to develop a comprehensive plan to 
expand the food safety capacity of foreign governments. This plan must 
include recommendations for agreements with exporting countries to 
ensure the safety of food; approaches for mutual recognition of 
inspection reports; acceptance of laboratory methods and testing 
techniques; and training for foreign governments and food producers 
regarding U.S. requirements for safe foods, among other things. 

According to FDA officials, the agency developed a structured 
implementation process to ensure clearly defined roles and 
responsibilities for meeting FSMA requirements. The structure consists 
of an implementation executive committee, as well as six 
implementation teams--including teams focused on preventive controls 
and imports that report directly to the senior leadership of FDA Foods 
Program and that are charged with developing related regulations and 
guidance. 

FDA Third-Party Accreditation System: 

FSMA requires FDA to establish a system for accrediting third parties 
that may certify foreign facilities or imported foods under the 
agency's jurisdiction. Under this system, accreditation bodies are 
responsible for accrediting third parties; third parties may conduct 
audits to certify that a foreign food product or facility complies 
with U.S. requirements, including new preventive control requirements. 
This system is to include model standards for accreditation bodies to 
use in evaluating and accrediting third parties. FDA may only directly 
accredit such third parties if it has not recognized an accreditation 
body within 2 years of establishing the accreditation system. Foreign 
governments, as well as foreign cooperatives that market the products 
of growers or processors, private firms, and individuals may qualify 
as third parties. Under FSMA, FDA has the authority to withdraw 
accreditation from an accredited third party or revoke recognition of 
an accreditation body. FDA must also establish procedures to 
reaccredit third parties and reinstate the recognition of 
accreditation bodies. 

According to FDA officials, third-party certifications may be used in 
two primary ways outlined in the act. First, FSMA requires FDA to 
establish a Voluntary Qualified Importer Program (VQIP) that allows 
FDA to offer expedited review and entry to participating importers who 
are importing foods from foreign facilities certified by accredited 
third parties. Second, FDA has the authority to require third-party 
certifications or other assurances as a condition of granting entry to 
imported foods based on a food safety risk. In addition, FSMA directs 
FDA to consider audits by accredited third parties in targeting FDA 
inspections of foreign facilities, as well as in targeting some 
imported foods for examination and testing at the ports of entry to 
ensure the products meet U.S. requirements. Moreover, FSMA directs FDA 
to operate the accreditation system as a revenue-neutral operation by 
developing a user fee to cover the cost of establishing and 
administering the system. Figure 2 shows how FDA may structure a 
system for recognizing third-party certification under FSMA, according 
to our review of FSMA and FDA documents. 

Figure 2: Uses and Potential Structure of an FDA Third-Party 
Accreditation System: 

[Refer to PDF for image: illustration] 

FDA: 
Recognizes accreditation bodies; 
May directly accredit third parties if it has not identified and 
recognized an accreditation body to meet requirements after a 2-year 
period.  

Recognized accreditation bodies: 
Accredit third parties to FDA accreditation standards.  

Accredited third parties: 
May include: foreign governments, foreign cooperatives, private firms, 
or individuals; 
Certify foreign food facilities and imported foods to U.S. standards; 
Report audit findings to FDA; 
Immediately notify FDA of any condition that could cause or contribute 
to a serious risk to the public health.  

Uses for third-party certification: 

Voluntary Qualified Importer Program (VQIP): 
FDA allows foods from certified foreign facilities and from 
participating importers to qualify for expedited entry; 
* Importers: 
Pay a user fee to participate in VQIP. Import food from a facility 
certified by an accredited third party.     

Required certifications for foods that present a safety risk: 
FDA may require third-party certifications or other assurances, if it 
determines such certifications or assurances are necessary based on. 

Foreign food facilities: 
Choose to be audited by an accredited third party. 

Sources: GAO analysis of FSMA and FDA documents. 

[End of figure] 

FDA's Third-Party Certification Pilot for Aquacultured Shrimp: 

Before FSMA was enacted, FDA conducted a pilot of voluntary third-
party certification of aquacultured shrimp (shrimp pilot) produced in 
foreign facilities and farms. In July 2008, FDA invited interested 
third parties to participate in the pilot and, by September 2009, FDA 
completed its assessment of third-party attributes and observations of 
third-parties' audit performance. FDA issued a report on its 
assessment of the shrimp pilot in July 2011. This report raised a 
number of issues for FDA to consider as critical to the success of a 
full-scale third-party certification program, including the need for 
an appropriate infrastructure to be in place at FDA. According to this 
report, the goal of the shrimp pilot was for FDA to learn about third-
party certifications and evaluate the feasibility of using these 
certifications to help make decisions, such as selecting foreign 
facilities for inspection or selecting imported foods for sampling. As 
part of the pilot, FDA (1) observed auditors from six third parties 
conducting actual audits of 28 foreign shrimp processors and 8 shrimp 
farms and (2) conducted audits of 11 laboratories in six countries. 
FDA chose to focus the pilot on aquacultured shrimp because HACCP 
safety standards for such shrimp have been in place since 1997; the 
industry was experienced in using third-party certifications; FDA had 
a record of finding microbial contamination and unapproved drug use in 
aquacultured shrimp; and the United States imports a high volume of 
shrimp. On the same day that FDA invited interested third parties to 
participate in the shrimp pilot, it also published draft guidance for 
industry on voluntary third-party certification for foods and animal 
feeds. 

FDA Faces Challenges in Implementing a Third-Party Accreditation 
System to Help Ensure Imported Food Safety: 

We identified five major actions FDA is to complete under FSMA to 
establish a system that uses third parties to help ensure food safety, 
and FDA officials and others report that each of these actions 
presents challenges that must be addressed. First, FDA is to develop 
new preventive control requirements and supporting guidance for food 
products under its jurisdiction; the agency will also need to develop 
the appropriate training, particularly for foreign food producers and 
processors, which poses a challenge because FDA is responsible for 
ensuring the safety of a wide variety of food products, such as 
produce, milk, cheese, spices, bakery products, soft drinks, and 
processed foods. Second, FDA is to establish a voluntary user-fee 
program for importers that requires facility certification as a 
condition of VQIP eligibility. FDA may also require certification or 
other assurances as a condition for entry into the U.S. if it 
determines such certificates or assurances are necessary based on the 
known safety risks. However, the agency faces a challenge in laying 
out incentives for expediting imported food products under VQIP that 
will incur a fee and in establishing criteria to determine the risk of 
certain imported foods by, among other things, food product and 
country. Third, FDA has to develop a system for recognizing 
accreditation bodies and faces the challenge of addressing foreign 
governments' concerns about being reviewed by such bodies. Fourth, FDA 
is to develop model standards for accreditation bodies to use in 
evaluating and accrediting third parties and faces challenges in, 
among other things, determining third-party auditors' competence and 
deciding how to avoid potential conflicts of interest. Fifth, FDA is 
to oversee the third-party accreditation system, including 
periodically evaluating accreditation bodies and third parties, and 
faces a challenge in deciding the level of oversight it will provide 
to the multiple parties involved in the process for third-party 
certification. 

Developing Preventive Controls and Guidance for All Foods under Its 
Jurisdiction Requires FDA to Consider a Wide Variety of Food 
Industries: 

Under FSMA, FDA is required to develop minimum standards for 
implementing preventive controls and related guidance that consider 
the wide variety of foods under its jurisdiction. These controls are 
intended to minimize or prevent food safety hazards. Specifically, 
under FSMA, FDA was required to issue proposed produce safety 
standards by January 2012 and a final produce safety rule by 1 year 
after the close of the comment period for the proposed rule. In 
addition, FDA was required to issue a rule on minimum standards for 
the implementation of mandatory preventive controls for facilities 
that manufacture, process, pack, or hold food by July 2012. According 
to FDA officials, FDA has developed a proposed produce safety rule and 
has proposed preventive control rules for human food facilities and 
for pet food and animal feed facilities. As of August 2012, the Office 
of Management and Budget was reviewing these proposed rules. FDA 
officials stated that when the agency issues a final rule for 
preventive controls, it also plans to issue related guidance on how 
facilities are to implement the controls. Currently, facilities 
processing seafood and juice must comply with HACCP standards, which 
include preventive controls, and these facilities are exempt from the 
new preventive control requirements. 

To support the development of training and guidance on preventive 
controls for industry and regulators, in November 2010, FDA helped 
fund the Produce Safety Alliance and, in December 2011, FDA funded the 
development of the Food Safety Preventive Controls Alliance. The 
Produce Safety Alliance is a collaborative project that includes FDA, 
Cornell University, and USDA and is to provide the produce industry 
and associated groups with training and educational opportunities 
related to current best practices and guidance, among other things. 
Similarly, the Food Safety Preventive Controls Alliance is a 
collaborative project between FDA and the Illinois Institute of 
Technology's Institute for Food Safety and Health to develop training 
courses and materials on preventing contamination for both human and 
animal food during production to help industry--particularly small-and 
medium-sized companies--comply with the new preventive control rule. 
These alliances are modeled after other FDA alliances, including the 
Seafood HACCP Alliance--a coalition of federal and state regulators 
and representatives from academia and industry that developed training 
for industry and regulators to support implementation of seafood HACCP 
standards. As of June 2012, the Produce Safety Alliance had held 89 
focus groups with growers, and working committees of the alliance 
developed written recommendations on a training curriculum and 
training delivery. As of June 2012, the Food Safety Preventive 
Controls Alliance launched its website to maintain information on its 
activities; the alliance is in the process of forming work groups, 
according to its website. 

[Side bar: National Organics Program: 
According to USDA Agriculture Marketing Service (AMS) officials who 
manage the National Organics Program, it is important to maintain 
clear written guidance and have a strategy for updating guidance to 
help ensure that third parties consistently apply standards. The 
National Organics Program uses third parties to certify that companies 
are eligible to use USDA labeling and meet USDA organic standards. 
A2010 USDA Inspector General report found that third parties used 
differing criteria to evaluate organic operations in large part 
because AMS did not provide adequate guidance to third parties. Third 
parties indicated that guidance was not always clear or timely and 
noted that there was no centralized location for them to access 
existing guidance. Since then, according to AMS officials, AMS has 
provided program updates using a variety of means, such as increasing 
use of policy memos, which may be made available more quickly; an e-
mail alert system for interested stakeholders including third parties, 
certified food companies, and consumers; and an enhanced website that 
serves as a central resource location for all relevant program 
information. End of side bar] 

Developing guidance with the necessary level of detail on each food 
industry under its jurisdiction could present a challenge for FDA. For 
example, a senior FDA official stated that it will be difficult to 
develop preventive controls for all produce that are sufficiently 
flexible to consider the diversity of the crops regulated, 
geographical areas involved, and growing and packing practices, among 
other things. With the need for this degree of flexibility, FDA 
officials told us that they do not expect the preventive controls 
guidance to be as detailed as the guidance for implementing seafood 
HACCP. To support implementation of HACCP standards for seafood, FDA 
published the Fish and Fishery Products Hazards and Controls Guidance. 
The guidance contains information to help industry (1) identify 
hazards associated with each fish species and product type and (2) 
formulate appropriate control strategies. It was also developed to 
serve as a tool for federal and state regulatory officials evaluating 
HACCP plans, according to the guidance document. 

FDA may also face challenges in developing the necessary training and 
guidance, particularly for foreign food producers and processors, and 
it may take considerable time to achieve desired compliance levels at 
all facilities. For example, according to its evaluation reports of 
seafood HACCP implementation from 1998 to 2005, FDA expected HACCP 
implementation in developing countries to lag behind the domestic 
seafood industry, in part, because it was difficult for processors to 
obtain the necessary training and guidance. To help address this 
issue, FDA inspection teams for seafood focused on training both 
foreign seafood processors and foreign governments when they visited 
countries that were major seafood exporters to the United States, 
including China and Vietnam. Nevertheless, in fiscal year 2005, more 
than 8 years after HACCP requirements were put in place for seafood, 
FDA's evaluation of HACCP implementation indicated that of those 
seafood processors with required HACCP plans, 11 percent of domestic 
and 33 percent of foreign seafood processors did not adequately 
identify hazards in their plans. 

FDA Faces Challenges in Laying Out the Incentives for Voluntary Third-
Party Certifications and in Deciding on the Need for Mandatory 
Certifications for Certain Imported Foods: 

As directed by FSMA, FDA was to establish VQIP within 18 months of 
FSMA's enactment, or by July 2012. As part of program development, FDA 
is required to establish user fees for importers participating in 
VQIP. As outlined in FSMA, the fees will have to cover administrative 
costs, such as reviewing submitted applications for participation in 
the program. FDA officials told us they are in the process of 
developing VQIP, including establishing user fees. Some industry 
representatives we spoke with generally support the VQIP program, but 
according to a representative of an association of food importers, FDA 
faces a challenge in developing a voluntary program that provides 
sufficient incentives for expediting the import of food products to 
warrant the fee that importers will incur to participate in the 
program. For example, the representative told us that FDA will need to 
clearly articulate any benefits, including an explanation of what 
"expedited entry" will mean for importers so that importers can 
determine if the cost of participation is worthwhile. According to 
some industry representatives we spoke with, entry delays are largely 
related to detention times during FDA examinations and sampling of 
food imports at the port of entry and can take as long as a month or 
more. However, as noted earlier, only a small portion of all food 
entry lines--2.2 percent--were examined by FDA at ports of entry in 
fiscal year 2011. Industry representatives also stated that a VQIP 
user fee should be reasonable so that it is not perceived as a barrier 
to trade, especially for small businesses. 

FSMA also gives FDA the authority to mandate third-party 
certifications or other assurances for imported products if the agency 
determines it is necessary based on the food safety risks. Under FSMA, 
FDA is to base the risk determination on: (1) known safety risks 
associated with the food; (2) known safety risks associated with the 
country, territory, or region of origin of the food; (3) a finding, 
supported by scientific risk-based evidence, that food safety systems 
in the country, territory, or region of origin where the food is 
produced are inadequate and that certification would assist FDA in 
determining whether to refuse or admit the imported food product; and 
(4) the information submitted to FDA regarding improvements to food 
safety systems are found by FDA to be inadequate. 

FDA faces a challenge in deciding if it should use its authority to 
mandate third-party certifications. FDA's decisions could have an 
impact on whether a company, in turn, decides to export its food 
products to the United States, according to foreign government 
officials we spoke with from Thailand and Vietnam. For example, these 
officials told us that if FDA identifies seafood as a product that is 
considered a safety risk and requires third-party certification, 
companies may choose to reduce seafood exports to the United States 
and sell their product to different markets if any required 
certifications are too costly. 

FDA Is to Develop a System to Recognize Accreditation Bodies and Faces 
Challenges in Addressing Foreign Government Concerns: 

As directed by FSMA, by January 2013, FDA is required to establish a 
system for recognizing the accreditation bodies that can be 
responsible for accrediting third parties to certify foreign food 
facilities and imported food. According to FDA officials, FDA has 
gathered information on the number of accreditation bodies that might 
be interested in seeking recognition from FDA and participating in 
FDA's third-party accreditation system. Under the act, if FDA has not 
identified and recognized an accreditation body to meet the applicable 
requirements within 2 years of the establishment of the accreditation 
system, FDA can directly accredit third parties. Accreditation bodies 
are established in many countries with the primary purpose of ensuring 
that third parties are subject to oversight by an authoritative body 
and normally operate as not-for-profit organizations. For example, the 
American National Standards Institute (ANSI) is a not-for-profit 
accreditation organization in the United States. According to an ANSI 
official, the organization is the official U.S. representative at the 
International Organization of Standardization (ISO), which develops 
international standards. Founded in 1947, ISO has published more than 
19,000 international standards covering almost all aspects of 
technology and business, including food safety and agriculture. 

Under FSMA, accreditation bodies would also accredit any foreign 
countries that apply to be third parties and meet the model 
accreditation standards. However, country representatives we spoke 
with said that FDA is likely to face challenges in using accreditation 
bodies to accredit foreign countries. For example, foreign governments 
may be reluctant to apply for accreditation as a third party from a 
non-U.S. government agency, such as ANSI. Some foreign government 
officials we spoke with raised concerns about being evaluated by a 
private accreditation body, citing sovereignty issues as a concern. In 
addition, a foreign government official stated that, for seafood, his 
government preferred that FDA recognize the appropriate government 
agency as the accreditation body. 

A majority of accreditation bodies are government-owned or quasi-
governmental agencies, and some will not allow third parties to 
operate within their countries unless accredited by that country's 
accreditation body, according to ANSI officials. However, there is a 
potential conflict of interest in having a government accreditation 
body accrediting another government agency in its own country as a 
third party. According to ANSI officials, this type of an 
accreditation relationship makes it difficult to consider the process 
unbiased. For example, all third parties operating in China, including 
a Chinese government agency, must be accredited by the China National 
Accreditation Service for Conformity Assessment, also a Chinese 
government agency. Moreover, ANSI officials told us that they are not 
aware of any accreditation body evaluating a foreign government 
system. FDA officials did not explain how they would address these 
challenges. 

FDA Is to Develop Standards for Countries and Accrediting Private 
Organizations as Third Parties and Faces Challenges in Addressing 
Consumer Groups' Concerns: 

As required by FSMA, by July 2012, FDA was to develop model 
accreditation standards and conflict-of-interest regulations. The 
model accreditation standards must be used by accreditation bodies to 
evaluate third parties and include, for example, specific requirements 
for foreign governments that apply to serve as third parties in their 
own countries. In addition, conflict-of-interest regulations should 
protect against conflicts of interest between third parties and 
entities they audit by, among other things, including requirements on 
how audits are to be performed. Specifically, as directed by FSMA, FDA 
is to take the following actions: 

* Develop standards foreign governments must meet before being 
accredited that involve review of their food safety programs, among 
other things. To develop these standards, FDA is drawing on different 
sources of information. According to FDA officials, these sources 
include (1) FDA's Manufactured Food Regulatory Program Standards, 
[Footnote 9] which were developed by FDA to establish a uniform 
foundation for design and management across state inspection programs 
they contract with to conduct food safety inspections; and (2) its 
International Comparability Assessment Tool, which is being piloted 
for use in evaluating the comparability of foreign government systems. 

* Develop standards that other third parties, including private firms, 
must meet, which involves reviews and audits of third parties' 
training and qualifications, as well as reviews of internal systems 
and other investigations, as needed. 

* Review standards already in place, such as industry-based and 
international accreditation standards, as part of the development of 
accreditation standards for evaluating both foreign governments and 
others. This review is intended to help avoid unnecessary duplication 
of effort and cost in developing accreditation standards. FDA 
officials told us that the agency has reviewed information from a 
number of sources in developing these standards, including voluntary 
international standards and information on other federal agency 
programs that share common issues relating to third-party auditing and 
use of accreditation standards. 

* Issue audit reporting requirements as part of developing 
accreditation standards for third parties. In addition to meeting 
these audit reporting requirements, under FSMA, accredited third 
parties are required to notify FDA of any condition that could cause 
or contribute to a serious risk to the public health that they 
identify. 

* Issue conflict-of-interest regulations that are to provide for 
unannounced audits, an approach to decreasing potential conflict of 
interest, including timing and public disclosure for audit fees paid 
by eligible entities to accredited third-party auditors, and for 
limits on financial affiliations between third parties and audited 
companies. 

[Side bar: International Organization of Standardization (ISO): 
According to some industry representatives we spoke with, the most 
efficient approach for developing standards to accredit foreign 
governments and private organizations as third parties would be for 
FDA to add its standards to existing ISO standards, such as the ISO 
product certification standard (ISO 65-General Requirements for Bodies 
Operating Product Certification Systems). This ISO standard is 
commonly required of third parties focused on food safety, among other 
areas, according to industry representatives. The ISO product 
certification standard specifies requirements that a third party 
conducting certification activities for any product or process should 
meet if it is to be recognized as competent and reliable. Among other 
requirements, the ISO standard requires third parties to conduct 
periodic internal audits and management reviews, maintain a record 
system that demonstrates effectiveness of its certification program, 
and establishes minimum standards for auditors. End of side bar] 

According to FDA officials, FDA is in the process of gathering 
information to develop these model accreditation standards and 
conflict-of-interest regulations; the agency was unable to provide a 
time frame when proposed standards and regulation would be available 
for the Office of Management and Budget and then public review. 

FDA officials and industry representatives we spoke with identified 
the following three challenges associated with developing 
accreditation standards and conflict-of-interest regulations: 

* Develop standards for third parties. A senior FDA official has 
publicly stated that the agency faces many challenges in developing 
standards for third parties that ensure competency of individual third-
party auditors. These challenges include identifying the right level 
of training and experience for individual third-party auditors and 
determining the extent of specialized knowledge that they need to 
demonstrate. For example, in its assessment of its shrimp pilot, FDA 
reported that, in 79 percent of the 28 seafood processing audits FDA 
observed, individual third-party auditors performing these audits did 
not demonstrate an understanding of how to identify, evaluate, and 
control food safety hazards with the product and process being audited 
to FDA standards. In addition, FDA reported a wide variation in third-
party performance across participating companies and governments and 
less variation, although in some cases still significant, in the 
performance of individual auditors employed by a single third party. 
Moreover, FDA recognizes potential challenges in ensuring the capacity 
of qualified third parties to conduct third-party certifications. FDA 
stated that the agency will face challenges in determining how many 
qualified third parties will be needed, what expertise they need, what 
geographic areas they should cover, and how to attract and build a 
cadre of qualified auditors. 

Industry representatives also recognize the need to address ongoing 
challenges with ensuring the competency of third parties to 
consistently apply standards. For example, Food Safety Services 
Providers, a trade association of accredited certification auditing 
companies, has a technical working group that is developing a best 
practices guide to address third-party auditor competency issues. 
There is already a program to have outside accreditation agencies 
observe audits to better ensure consistency. Similarly, the Global 
Food Safety Initiative (GFSI)--a collaboration that includes retailers 
and manufacturing and food service companies and that evaluates 
private food safety standards against GFSI-established criteria--also 
has a working group focused on addressing issues related to individual 
third-party auditor competency. Furthermore, one industry 
representative we spoke with expressed concerns about the number of 
qualified third parties available to conduct FDA certifications and 
described a lack of formal education and a career path as barriers to 
having qualified third-party auditors. According to this industry 
representative, there is currently a relatively small community of 
qualified third parties, in total about 200 entities worldwide. 

* Issue reporting and immediate notification requirements. A senior 
FDA official stated that FDA will face challenges in determining the 
content for audit reports required for accredited third parties to 
submit to FDA. For example, FDA officials told us the level of detail 
that FDA may require is likely to depend on how it plans to use the 
information. In addition, according to FDA officials, the FSMA 
requirement for accredited third parties to notify FDA immediately of 
any observed condition that could cause or contribute to a serious 
risk to the public health provides a new role and new obligation for 
third parties. In audits conducted for private food safety standards, 
third parties typically have not had to report their audit findings, 
including findings of a serious public health risk, to any government 
agency. According to some third parties we spoke with, FDA will need 
to develop guidance on what qualifies as a serious public health risk 
and how third parties should report such risks. In addition, some 
industry representatives also told us that required reporting of 
"immediate public health risks" could cause third parties to be viewed 
as an extension of FDA inspectors or a regulatory agent, thereby 
creating disincentives for food production and processing 
establishments to participate in an FDA third-party certification 
system or use industry-based systems in general. For example, some 
third parties told us that foreign food producers and processors are 
concerned that any voluntary audit conducted to meet market demands 
could lead to regulatory actions, such as an import alert, for their 
facilities. 

* Develop conflict-of-interest regulations. In implementing conflict-
of-interest regulations, FDA will face a challenge in developing 
regulations that sufficiently address consumer groups' concerns about 
potential conflicts of interest in using private third parties and are 
still practical to implement, according to industry representatives we 
interviewed. For example, according to a trade association 
representing auditing companies, since most private certification 
systems require a detailed contract prior to the audit, typically 
these systems use announced audits because sites to be audited are 
aware that an audit is forthcoming. However, unannounced audits are an 
option in some programs. Under FSMA, FDA is required to issue 
regulations requiring third parties to conduct unannounced audits. 
Some third parties noted that unannounced audits present logistical 
challenges for planning a thorough audit and raised concerns about 
wasting time and resources if unannounced audits occur when facilities 
are not operating or when appropriate staff is unavailable to respond 
to questions. Other industry representatives we spoke with stated 
that, with a short notice period, unannounced audits may be reasonably 
conducted. In addition, regarding public disclosure of third-party 
audit fees, U.S. Customs and Border Protection reported that it had a 
disclosure requirement in its pilot using private third parties for 
its Customs Trade Partnership Against Terrorism program but could not 
enforce it. One industry representative we spoke with suggested a 
simple base fee for an FDA recognized audit could be disclosed, but 
this fee would not reflect the actual costs of the audit, which, 
according to third parties we spoke with, vary considerably and depend 
on many factors, including the location of the production or 
processing facility, the size of the facility, and the complexity of 
the operation. Representatives from some of these third parties told 
us that the costs for audits by private firms may range from less than 
$1,000 to more than $10,000. 

[Side bar: Mexico Addresses Conflicts of Interest: 
Consumer groups we spoke with expressed concern about the conflicts of 
interest that may arise when the producer or food facility responsible 
for payment to the third party is the person or entity receiving the 
audit. A federal agency, the USDA Food Safety Inspection Service 
(FSIS), raised similar concerns regarding potential conflicts of 
interest in third-party certification systems. For example, FSIS made 
an equivalence determination for Mexico for the export of meat and 
processed poultry products. In conducting its periodic equivalence 
verification audit of Mexico's inspection system for these products, 
the agency found that audited establishments directly paid third 
parties used by the Mexican government to support its oversight of 
food safety. FSIS saw this payment system as a potential conflict of 
interest. To address this problem, the Mexican government contracted 
with an outside agency to manage a centralized payment system. End of 
side bar] 

FDA Is to Monitor the Third-Party Accreditation System and Faces 
Challenges in Deciding on the Degree of Oversight: 

As part of overseeing the third-party accreditation system--which 
includes accreditation bodies responsible for accrediting third 
parties and third parties that conduct food safety audits of foreign 
food facilities--FSMA directs FDA to reevaluate accreditation bodies 
and to also evaluate the performance of each accredited third party at 
least every 4 years. FSMA does not specify how FDA would meet the 
requirement to reevaluate accreditation bodies; however, the act does 
provide direction on how FDA should evaluate third parties. For 
instance, FSMA states that FDA should at a minimum evaluate the 
performance of third parties by reviewing their audit reports and 
reviewing the compliance history of foreign food facilities the third 
parties have audited every 4 years. FSMA also authorizes FDA to 
conduct, at any time, site visits to any certified foreign facilities, 
with or without the third party present. 

To provide the necessary level of oversight, FDA faces the challenge 
of determining how it will most effectively and efficiently work with 
accreditation bodies responsible for accrediting third parties. ANSI 
officials we spoke with identified more than 60 accreditation bodies 
with a food safety scope that follow relevant ISO standards and guides 
for accreditation processes and product certification systems. 
[Footnote 10] Some industry representatives have suggested that FDA 
require accreditation bodies be members of the International 
Accreditation Forum (IAF)--an international association of 
accreditation bodies established to help ensure accreditation bodies 
are following accreditation rules--and subject to its peer evaluation 
process. Under IAF's peer evaluation process, members are regularly 
evaluated for conformance to ISO standards.[Footnote 11] However, 
according to ANSI officials, peer reviews do not evaluate how 
accreditation bodies implement additional requirements, such as any 
that FDA might have, although these officials told us that IAF plans 
to be able to do such evaluations in the future. In addition, if FDA 
recognizes many accreditation bodies, it may need to more formally 
oversee their work to ensure that these accreditation bodies are 
consistently evaluating third parties that they are responsible for 
accrediting. For example, Global G.A.P., a private food safety 
certification standards organization that issues among the largest 
number of food safety certifications, requires the more than 30 
accreditation bodies recognized by Global G.A.P. to participate in 
IAF's peer evaluation program and attend an annual 2-day harmonization 
meeting to help ensure that they consistently apply accreditation 
standards. During the annual harmonization meeting, managers obtain 
input from the accreditation bodies, share information on activities, 
and provide input to Global G.A.P. on the accreditation process. In 
addition, Safe Quality Foods, a U.S.-based food safety standards 
organization, works closely with only two accreditation bodies that 
are also required to be members of IAF and meets at least 2 times a 
year. 

FDA officials told us that they recognize that they will need to play 
an oversight role over all levels of the third-party accreditation 
system, including accredited third parties and their individual 
auditors. Specifically, these officials told us they face challenges 
in determining the extent of the oversight FDA will conduct. Using its 
authority to conduct oversight visits of accredited third parties 
presents FDA with cost and logistical challenges, as FDA reported in 
assessing its shrimp pilot. In addition, in its assessment of this 
pilot, FDA stated that it will be critical to provide robust formal 
training for agency personnel involved in on-site performance 
assessments of third parties to ensure consistent application of FDA 
criteria. Among the challenges related to oversight of third parties 
and individual auditors, a senior FDA official stated that the agency 
will need to determine the role of accreditation bodies in monitoring 
and ensuring the objectivity of accredited third parties and their 
individual auditors. In addition, it will be a challenge to determine 
the responsibilities of accredited third parties for ensuring the 
competence of auditors they employ. According to FDA officials, there 
is limited information available on the performance of third parties 
to date. 

[Side bar: Third-Party Oversight Approaches: 
Federal agencies and private-sector organizations that use third-party 
certification employ varying approaches to oversee third parties.
For example, USDA's Agriculture Marketing Service (AMS) directly 
accredits third parties to certify companies that meet USDA 
requirements for organics and conducts periodic on-site assessments of 
accredited third parties about every 2 to 3 years. In addition, to 
help facilitate communications regarding certification activities with 
over 90 accredited third parties, AMS assigns an accreditation manager 
to work with smaller groups of approximately 20 third parties. In the 
private sector, according to representatives of Global G.A.P.-—an 
organization that sets voluntary certification standards for 
agricultural products—-Global G.A.P. conducts its own oversight of 
third parties that complements the initial and periodic on-site 
reviews conducted by accreditation bodies. To track performance, 
Global G.A.P. conducts office assessments of accredited third parties 
at least every 2 years and also conducts reinspections of certified 
operations using its own assessors. As part of the third-party office 
assessment, Global G.A.P. is checking compliance with Global G.A.P 
rules based on record review. During the reinspection, the
Global G.A.P assessor conducts a Global G.A.P inspection of a recently 
inspected farm operation and compares his or her own findings with the 
third-party findings. A Global G.A.P. representative told us that new 
third parties are always entering the market, so there is a need for 
continual oversight. Some retailers we spoke with also have internal 
staff to conduct audits, in addition to third-party audits, to ensure 
that foreign suppliers meet their standards. End of side bar] 

In addition to facing challenges in providing general oversight of 
accreditation bodies and accredited third parties, FDA faces the 
challenge of being responsible for conducting any follow up 
investigations or taking regulatory actions when compliance issues are 
identified by accredited third parties. According to FDA documents, 
accredited third parties will not be commissioned by FDA and will not 
otherwise serve as regulatory authorities acting on FDA's behalf--even 
if the accredited third party is itself a government agency. Follow-up 
investigative visits, similar to oversight visits, present cost and 
logistical challenges for FDA, as identified in its shrimp pilot. 

FDA officials also told us they will need to invest in an appropriate 
information technology system to be able to use information for 
targeting inspections and entry examinations. According to these 
officials, using this information technology to resolve data 
management issues can be costly, difficult to set up, and difficult to 
coordinate. In 2012, we identified challenges FDA is facing in 
implementing and managing efforts to modernize the agency's 
information technology systems, including initiatives to improve 
sharing data with other entities.[Footnote 12] An FDA official stated 
that the agency also faces a challenge in determining what, if any, 
audit information will be made publicly available. Some industry and 
consumer representatives we spoke with said that transparency of the 
auditing process will be critical to building confidence in the third-
party accreditation system. 

Representatives of most consumer groups we spoke with raised concerns 
about FDA's reliance on third parties. They pointed to FDA's poor 
track record in overseeing inspections contracted to states as third 
parties as a reason for their concern. For example, in 2011, the 
Department of Health and Human Services' Inspector General reported 
that FDA did not complete 38 percent of the required oversight audits 
in one-third of states with contracts (14 of 41 states), citing lack 
of resources and limited trained FDA staff, and did not always follow 
up on identified systemic problems.[Footnote 13] According to FDA 
officials, the agency concurred with the report's findings and stated 
that it would develop processes and procedures to address them. The 
representatives of the consumer groups also told us that FDA will need 
to oversee all levels of the third-party accreditation system--the 
accreditation bodies, third parties, and individual third-party 
auditors. They also questioned the food safety assurances provided by 
private third parties that had issued certifications to facilities 
responsible for a 2011 Listeria outbreak in cantaloupes and the 2008 
to 2009 Salmonella outbreak from processed peanuts. Consumer groups we 
spoke with told us that their order of preference for overseeing food 
safety is (1) FDA, (2) other federal agencies, (3) trusted foreign 
governments, and (4) private third parties. 

In contrast, many industry representatives we spoke with--food 
retailers, manufacturers, and trade associations; organizations that 
developed private certification standards; and private third parties--
viewed third-party certification as beneficial. Accredited third-party 
certifications are increasingly used by large-scale retailers and 
commercial companies as a way to require and verify the safety and 
quality of food they market. For example, more than 123,000 farm 
operations in over 100 countries are certified to Global G.A.P. 
standards, and nearly 14,000 food processing or packing operations in 
over 100 countries are certified to the British Research Consortium 
standard for food safety. In addition, retailers we spoke with 
indicated that they require third-party certification of their 
suppliers and expressed confidence in accredited third-party 
certification systems. For instance, the certification standards we 
reviewed require any deficiency identified during the audit--minor or 
major--to be corrected within a specified time frame as a condition of 
certification, and some industry representatives told us that audited 
food facilities have sufficient incentives to address identified 
problems. Furthermore, according to a 2011 document prepared for the 
United Kingdom's Food Standards Agency to guide use of private 
certifications in setting priorities for inspecting domestic food 
facilities, most private certification standards for foods that 
researchers reviewed had well-established approaches to developing 
standards and conducting assessments, and clear requirements for 
auditor competency; many of these private certification standards met 
basic food safety laws for the United Kingdom. 

FDA's Comparability Assessment Approach Could Enable FDA to Leverage 
Other Countries' Oversight Resources for Imported Foods: 

FDA's approach for using comparability assessments, which is 
complemented by the use of third parties, could enable the agency to 
leverage other countries' oversight capacity and enforcement 
authority. Using this approach could result in some of the same 
advantages of equivalence used by FSIS and the EU before certain 
foreign food products can be imported. According to FDA documents and 
officials, few countries are likely to meet requirements for 
comparability with the U.S. food safety system because the agency will 
require comparability of a foreign country's entire food safety 
system. This involves a review of a foreign country's domestic and 
export systems for all food products that are under FDA's 
jurisdiction. However, FDA has already developed a process to assess a 
foreign country's export systems for seafood, and foreign government 
officials we spoke with would like FDA to assess their seafood safety 
systems for products exported to the United States. FSIS and the EU 
take a more targeted approach to determine the safety of imported food 
by examining whether a country's systems for ensuring the safety of a 
specific food product are equivalent to theirs. 

FDA Plans to Use Comparability Assessments to Leverage Oversight 
Resources of Other Countries to More Efficiently Oversee Imported 
Foods: 

In a public hearing FDA held in March 2011 to discuss new initiatives 
for ensuring the safety of foods and animal feed imported into the 
United States, as well as in agency documents, FDA provided general 
information about how it plans to develop comparability assessments 
and how it may use these assessments to efficiently enhance the safety 
of all imported food products by leveraging the oversight resources of 
foreign countries. According to the information FDA officials 
provided, a comparability assessment is a review of a foreign 
country's regulatory system for food safety--statutes and regulations--
to determine if that country's systems are comparable to the U.S. 
system and provide a comparable level of food safety protection. 
According to FDA documents, leveraging other countries' oversight 
resources could be accomplished through formal agreements. Thus, a 
result of an assessment may be an agreement between the United States 
and the foreign country, whereby the foreign country may assume 
greater responsibility for ensuring food products it exports to this 
country meet a comparable level of safety protection to that in United 
States, and these exports could move more expeditiously through U.S. 
ports of entry. 

FDA has developed a comparability assessment tool, which serves as 
criteria for assessing a foreign government's domestic and export food 
safety systems for all its food products. Using the tool, FDA plans to 
review and compare the following elements of a foreign country's food 
safety system with the same elements in the U.S. food safety system: 
(1) laws, regulations, rules, ordinances, or other regulatory 
requirements that govern the operation of the foreign food safety 
control system; (2) a food safety training program for food safety 
personnel; (3) a food safety inspection program; (4) quality assurance 
program reviews; (5) surveillance, investigation, response, and 
subsequent review of alleged food-related incidents; (6) compliance 
and enforcement program; (7) industry and community relations; (8) 
program resources; (9) interacting and communicating with the 
international community on food safety standards; and (10) laboratory 
support. 

According to FDA officials, the agency has used its assessment tool to 
conduct a comparability pilot with New Zealand, and it began another 
pilot with Canada in February 2012. The pilot with New Zealand took 
about 2 years, but the agency has not yet finalized the pilot project. 
FDA officials also told us that the agency does not have written 
procedures that it can use when assessing a foreign government's 
response to the assessment tool. Furthermore, FDA has not explained 
how it plans to integrate comparability assessments with the new 
authorities provided in FSMA, such as third-party certification or 
international capacity building. According to FDA officials, the 
agency expects to develop a plan for the use of comparability 
assessments once it concludes its pilot project with Canada in 2013. 

Few Countries Are Likely to Meet Requirements for Comparability with 
the U.S. Food Safety System: 

According to FDA officials, the agency expects a limited number of 
countries to seek comparability with the United States because, in 
part, most countries will not meet the FDA requirement that the 
foreign government's domestic and export food safety systems be 
comparable with the U.S. system for all their food products. According 
to FDA documents, some countries have robust export certification 
programs for a specific food product, but their overall food safety 
systems, including domestic production systems, may not be comparable 
with those of the United States, and therefore, FDA would not find 
their food safety systems comparable. However, according to FDA 
officials, such countries would be more suited to apply for 
accreditation as a third party. In situations where a foreign country 
could not function as a third party, FDA documents show that private 
third parties could conduct the certifications. Under FDA's 
comparability assessment approach, the agency would leverage the 
oversight resources of foreign countries whose overall food safety 
systems were comparable with that of the United States. 

FDA Has Experience in Conducting Focused Reviews of Foreign Seafood 
Safety Systems: 

According to FDA documents, the agency has developed a process for 
assessing a foreign country's aquaculture programs, including the 
agency responsible for overseeing aquaculture and the country's 
regulatory infrastructure. Specifically, FDA conducted foreign country 
assessments in five countries from 2006 to 2010: Chile, China, India, 
Indonesia, and Vietnam. According to FDA documents, these assessments 
were an integral part of its seafood safety program, and the agency 
used the assessment process to examine the other countries' laws for 
controlling drug residues in aquaculture products exported to the 
United States. For example, during these assessments, FDA officials 
visited some fish farms where aquaculture products originated to 
evaluate veterinary drug use and reviewed some laboratories that 
analyzed the seafood products for drug residues for processors. 
According to FDA officials, the agency is currently not conducting 
evaluations that focus only on seafood because it is now devoting its 
resources to the broader comparability assessments. However, FDA's 
publicly available website includes information on foreign country 
assessments and describes them as one of several tools that the agency 
uses for its imported seafood safety program. 

In addition to these reviews, FDA has entered into memorandums of 
understanding (MOU) with foreign governments and other parties when 
the agency determined that it needed to define lines of authority or 
responsibility or to clarify cooperative procedures, according to FDA 
documents. FDA has three active MOUs with Canada, Mexico, and New 
Zealand relating to molluscan shellfish. Only certified shippers from 
countries that have MOUs with FDA and have agreed to abide by the 
shellfish safety policies incorporated into the National Shellfish 
Sanitation Program--a federal/state cooperative program recognized by 
FDA for the sanitary control of shellfish produced and sold for human 
consumption--are permitted to export fresh or frozen uncooked 
shellfish into the United States. According to FDA, the agency used an 
audit process to establish these MOUs. The MOUs, however, are 
nonbinding agreements and were not developed as a result of an 
equivalence determination or a comparability assessment of the foreign 
country's capabilities for ensuring the safety of seafood. 

Foreign Country Representatives We Interviewed Want FDA to Determine 
Comparability Specifically for Their Seafood Exports: 

According to representatives of major seafood exporting countries we 
spoke with, they want FDA to evaluate their seafood export programs so 
that they can develop agreements similar to those they have with the 
EU. They added that having such agreements with the United States 
offers potential benefits. Specifically, they told us the following: 

* Thailand. In 2010, the United States imported over 916 million 
pounds of edible seafood from Thailand, including catfish, shrimp, and 
tuna. For fiscal years 2005 through 2010, FDA had inspected about 14 
percent of Thailand's seafood processing facilities. According to Thai 
officials we spoke with, when Thailand has a government-to-government 
agreement, as with the EU, the Thai government can better ensure that 
the seafood processing facilities meet the standards of the country to 
which the seafood products are exported and can address problems 
identified by the importing country in a timely manner. In addition, 
the officials said that the Thai government can address the issues 
that go beyond the facility level. For example, if an importing 
country identifies drug residues at unacceptable levels, the Thai 
government can track the product to the farm of origin, investigate 
the situation, and enforce any corrective actions in a timely manner. 
As part of its oversight responsibilities, the Thai government sets 
standards and conducts inspections and certifications of the nearly 
19,000 aquaculture operations, as well as registered processing 
facilities in the country. According to Thai officials, the government 
has about 300 inspectors and over 3,000 local officers in the 77 
provinces that support inspection oversight. The Thai government has 
worked with FDA on the agency's best aquaculture practices program. 
However, Thai officials told us that because their government has no 
agreement with FDA on food safety and because no health certification 
is required for exports to the United States, the government cannot 
ensure the overall safety of the seafood products, particularly in the 
final processing stage. In addition, according to Thai officials, FDA 
and Thai officials do not formally communicate regarding the results 
of the inspections FDA conducts at processing facilities in Thailand 
and regarding examinations and testing at U.S. ports of entry. 
Instead, FDA contacts the Thai processing facilities, and the Thai 
government may not learn of the problem until 2 months later from 
those facilities. 

* Ecuador. In 2010, the United States imported almost 243 million 
pounds of edible seafood from Ecuador, including shrimp, tilapia, and 
tuna. For fiscal years 2005 through 2010, FDA had inspected about 26 
percent of Ecuador's seafood processing facilities. Ecuadoran 
officials stated that they have government staff who inspect and 
certify facilities that export seafood products to the EU, with which 
Ecuador has a formal agreement. Ecuadoran officials stated that the 
government developed a national control plan to address specific EU 
requirements and standards for seafood exports. This plan includes the 
rules for registering production facilities, verifying compliance with 
health regulations, and certifying compliance by issuing health 
certificates. For these facilities, Ecuadoran inspectors review 
controls over drugs and take samples during on-site visits. If a farm 
does not meet government standards, it can be decertified. Fish 
products from unapproved or decertified farms may not be delivered to 
registered and inspected processing facilities. According to Ecuadoran 
officials, if government inspectors identify a human health hazard, 
they will take steps to destroy the product. However, these farms can 
still sell their products to facilities not under government 
oversight, and these products can be exported to countries where 
Ecuadoran government certification is not required, such as the United 
States. In contrast, not all facilities exporting seafood products to 
the United States are registered and inspected by the Ecuadoran 
government. Because FDA has not entered into an agreement with 
Ecuador, Ecuadoran officials cannot require exporting facilities to 
register and be subject to inspection. 

* Indonesia. In 2010, the United States imported over 275 million 
pounds of edible seafood from Indonesia, including crabmeat, shrimp, 
and tuna. From fiscal years 2005 through 2010, FDA had inspected about 
1 percent of Indonesia's seafood processing facilities. In addition, 
in 2007, FDA evaluated Indonesia's overall control of drug residues in 
aquaculture products exported to the United States, identified 
deficiencies in the country's program to control drug residues in 
these products, and made several recommendations to improve the 
program. According to Indonesian officials, their government wants to 
be assessed by FDA again. Indonesian officials said that they believe 
a reassessment could result in an agreement that could benefit the 
United States. For example, according to Indonesian officials, all 
processing facilities exporting to countries where there is a 
government-to-government agreement, as with the EU, must meet HACCP 
certification requirements and obtain a health certificate and meet 
any additional requirements of the country receiving the product. No 
such agreement exists between Indonesia and the United States. These 
additional requirements may result in fewer processing facilities 
exporting their products to the countries having these agreements with 
the Indonesian government. For example, of the 500 seafood processing 
facilities registered with the Indonesian government, 176 are approved 
to export to the EU. In contrast, 422 export to the United States. 
Under government-to-government agreements, importing countries can 
notify the competent authority of rejected products, which enables the 
Indonesian government to take timely regulatory action. According to 
Indonesian officials, their government has oversight of different 
parts of the aquaculture supply chain, including hatcheries, 
production, and processing. In addition, in 2008, the Indonesian 
government began certifying farms using good aquaculture practices. 
Indonesian officials told us that when they are notified of a rejected 
product, the affected processing plant is suspended from exporting 
additional seafood products until it takes the corrective action the 
government has determined is needed. If the processing plant does not 
take the corrective action, the government can revoke the plant's 
registration. According to Indonesian officials, FDA and the 
Indonesian government do not communicate on products that FDA has 
rejected for import. As a result, the Indonesian government does not 
learn that a product has been rejected for 2 or 3 months. 

FSIS and the EU Use a Targeted Approach to Determine Whether Exported 
Food Is Safe for Domestic Consumption: 

For about 14 years, we have reported that FDA could enhance its 
oversight of imported food, including seafood, if it used an 
equivalence approach to place greater responsibility on exporting 
countries to ensure their food exports met U.S. requirements as 
follows: 

* In 1998, we determined that FDA's approach to ensuring the safety of 
imported food was not effective and recommended that Congress require 
all food imported into the United States be produced under equivalent 
food safety systems.[Footnote 14] FDA stated that it had the authority 
to enter into equivalence agreements with other countries but did not 
require such agreements as a precondition of trade. In a 1997 federal 
notice, FDA stated that equivalence agreements would enable the agency 
to target its limited resources for imports on the products from 
countries without an agreement, and thus FDA would use its resources 
more efficiently and effectively.[Footnote 15] FDA added that it would 
enter into agreements that covered only certain food products, such as 
fish and fishery products, if a foreign country's regulatory system 
was designed to achieve, or was capable of achieving, equivalence for 
some food products but not for others. 

* In 2001, we reviewed federal oversight of seafood safety and found 
that FDA still did not have seafood equivalence or compliance 
agreements with any foreign country.[Footnote 16] FDA noted that 
foreign equivalencies was one of its priorities for fiscal year 2001 
but added that a considerable exchange of data among the countries 
involved had to take place before equivalence determinations could be 
made. 

* In 2004, we reviewed FDA's imported seafood safety program and 
determined that the agency had made no progress in developing 
equivalence agreements with seafood exporting countries.[Footnote 17] 
FDA officials stated that developing these agreements was no longer a 
priority because the agency believed that equivalence agreements, as 
such, did not necessarily contribute to the enhanced safety of 
imported seafood. We stated that FDA should view the creation of these 
agreements as a long-term investment in improving imported seafood 
safety and recommended that the agency strengthen its imported seafood 
program by making it a priority to establish equivalence or other 
similar types of agreements with seafood-exporting countries, starting 
first with countries that have high-quality food safety systems. FDA 
did not agree with our recommendation. In commenting on this 
recommendation, FDA said the agency was not currently positioned to 
assign high priority to negotiating equivalence or other types of 
agreements with numerous countries that export seafood to the United 
States in light of the pressing priorities associated with 
implementation of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002. FDA also said that establishing 
these agreements is extraordinarily resource intensive. 

* In 2011, we reported that FDA was still using the same approach it 
developed more than 10 years earlier to ensure the safety of imported 
seafood, even though U.S. reliance on imported seafood had increased, 
and aquaculture had emerged as a major source of those imports. 
[Footnote 18] We determined that this approach was limited and, in 
some respects, ineffectively implemented. We recommended that the 
agency use a more broad-based approach to overseeing imported seafood 
and consider the feasibility of applying some of the practices 
employed by the EU and FSIS through their respective equivalence 
processes. The Department of Health and Human Services, responding for 
FDA, did not agree or disagree with our recommendations but provided 
information on the actions in progress or planned related to the 
recommendations we made. FDA does not currently have any equivalence 
agreements in place. 

According to FDA officials, equivalence determinations generally 
entail an intensive, standard-by-standard review of a foreign 
country's food safety system, and it has been a challenge for the 
agency to conduct equivalence determinations or enter into such 
agreements. Still, FDA officials told us that the agency reviewed FSIS 
and EU equivalence models, among others, to examine their general 
approach and determine if the agency could use comparability 
assessments to acquire some of the same advantages realized by the 
FSIS and the EU through equivalence. As part of this review, FDA 
completed its on-site review for a comparability assessment pilot with 
New Zealand in late 2010 and is currently engaged in another such 
pilot with Canada. 

Under FSIS's equivalence approach, imported meat, poultry, and 
processed egg products are not eligible for export to the United 
States unless FSIS has determined that the exporting country has a 
food safety system equivalent to that of the United States for one or 
all of these products. According to FSIS documents, FSIS determines 
that a foreign food safety system is equivalent if the sanitary 
measures applied in the foreign country, though different from those 
applied in the United States, achieve the same level of sanitary 
protection. As part of an equivalence determination, FSIS evaluates a 
foreign country's foreign meat and poultry food regulatory system 
through document analysis, on-site audit, and point-of-entry product 
reinspection. FSIS requires foreign countries to have an 
organizational structure and staffing to ensure uniform enforcement of 
the required laws and regulations throughout the system where products 
are prepared for export to the United States. FSIS staff review 
foreign governments' oversight of the food safety system, statutory 
authority and food safety regulations, sanitation standards, HACCP 
requirements, chemical residue control program, and microbiological 
testing program. According to FSIS documents, the agency's initial 
equivalence determinations can take from 3 to 5 years to complete. 
FSIS does not rely on third-party certifications because, under its 
equivalence approach, the foreign government becomes responsible for 
addressing any problems FSIS identifies. 

In 2008 and 2011, we reported that, in the EU, foreign countries that 
want to export all products of animal origin, including seafood, to EU 
countries must demonstrate that their food safety systems meet EU or 
equivalent requirements, or meet requirements specified in an 
agreement between the EU and the exporting country.[Footnote 19] 
According to EU regulations, foreign countries seeking EU equivalence 
for their food exports must provide information on their food safety 
laws; the organization of the competent authority, competent authority 
powers and independence, the supervision to which the competent 
authority is subject, and its enforcement authority; training of 
staff; resources, including diagnostic facilities; documented control 
procedures and control systems based on priorities; the situation 
regarding animal health, infectious diseases, and plant health; the 
extent and operation of official controls on imports of animals, 
plants, and animal or plant products; and the assurances the country 
can give regarding compliance with or equivalence to EU requirements. 
In our 2011 report, we stated that the EU generally conducts an on-
site inspection of the foreign country's food safety system for a food 
product that the foreign country exports to the EU. These inspections 
include visits to farms and processing facilities and reviews of the 
capabilities and quality of the country's laboratories. To ensure 
continuous compliance with EU requirements, EU inspectors periodically 
conduct follow-up reviews of foreign countries' food safety systems 
for the specific food products, such as seafood. In addition, foreign 
countries that trade with the EU are directed to implement national 
residue monitoring plans and sample for drugs of specific concern to 
the EU for the food product exported to the EU. 

According to FSIS and EU officials, when they have determined that a 
country has an equivalent food safety system for a particular food 
product, the foreign government becomes the competent and responsible 
authority for meeting FSIS and EU requirements. This competent 
authority becomes the single foreign government contact to address any 
identified problems and takes regulatory actions across the supply 
chain, from the farm to the processing facility, as necessary. For 
this reason, neither FSIS nor the EU needs to use third-party 
certifications. As a result, FSIS and the EU can leverage the 
oversight capacity and resources of many foreign governments 
determined to have equivalent export systems for specific food 
products. For example, FSIS has determined equivalence with 34 
countries for the exportation of meat, poultry, or processed egg 
products; the EU has determined equivalence with 100 countries for the 
exportation of seafood products. See figure 3 for information on the 
countries that have been approved to export specific food products 
under the oversight of FSIS and the EU. 

Figure 3: Countries Approved to Export Specific Products by USDA's 
FSIS and the European Union: 

[Refer to PDF for image: illustrated world map] 

Countries approved by EU to export fishery products to the EU: 
Total=100; 
Algeria; 
Angola; 
Antigua and Barbuda; 
Armenia; 
Australia; 
Azerbaijan; 
Bahamas; 
Bangladesh; 
Belarus; 
Belize; 
Benin; 
Bosnia and Herzegovina; 
Cape Verde; 
Colombia; 
Democratic Republic of the Congo; 
Cote D'Ivoire; 
Cuba; 
Ecuador; 
Egypt; 
El Salvador; 
Eritrea; 
Falkland Islands (Malvinas); 
Fiji; 
French Polynesia; 
Gabon; 
Gambia; 
Ghana; 
Greenland; 
Grenada; 
Guatemala; 
Guinea; 
Guyana; 
Hong Kong; 
India; 
Indonesia; 
Republic of Iran (Islamic); 
Jamaica; 
Kazakhstan; 
Kenya; 
Republic of Korea; 
Madagascar; 
Malaysia; 
Maldives; 
Mauritania; 
Mauritius; 
Mayotte; 
Montenegro; 
Morocco; 
Mozambique; 
Myanmar; 
Namibia; 
Netherlands Antilles; 
New Caledonia; 
Nigeria; 
Oman; 
Panama; 
Papua New Guinea; 
Peru; 
Philippines; 
Russian Federation; 
Saudi Arabia; 
Senegal; 
Serbia; 
Seychelles; 
Singapore; 
Solomon Islands; 
South Africa; 
Sri Lanka; 
St. Helena; 
St. Pierre and Miquelon; 
Suriname; 
Taiwan; 
United Republic of Tanzania; 
Thailand; 
Togo; 
Tunisia; 
Turkey; 
Uganda; 
Ukraine; 
United Arab; 
Emirates; 
United States; 
Venezuela; 
Vietnam; 
Yemen; 
Zambia. 

Countries approved by USDA's Food Safety Inspection Service to export 
meat, poultry, or processed egg products to the United States: 
Total=34; 
Austria; 
Belgium; 
Czech Republic; 
Denmark; 
Finland; 
France; 
Germany; 
Great Britain; 
Hungary; 
Iceland; 
Ireland; 
Italy; 
Netherlands; 
Northern Ireland; 
Poland; 
Romania; 
San Marino; 
Spain; 
Sweden. 

Countries approved by both EU and USDA's Food Safety Inspection 
Service: Total=15; 
Albania; 
Argentina; 
Brazil; 
Canada; 
Chile; 
China; 
Costa Rica; 
Croatia; 
Honduras; 
Israel; 
Japan; 
Mexico; 
New Zealand; 
Nicaragua; 
Uruguay. 

Sources: GAO; Map Resources (map). 

[End of figure] 

The equivalence approach has enabled both FSIS and the EU to review a 
foreign government's system for a particular food product and, in the 
opinion of officials from both entities, has allowed them to use their 
import oversight resources effectively and efficiently. In addition, 
both entities can monitor compliance by reviewing the residue 
monitoring test results that countries must submit annually. In April 
2011, we reported that, using this approach, both FSIS and EU were 
able to get foreign governments to take appropriate actions to address 
identified deficiencies.[Footnote 20] 

Other countries have also identified the effectiveness of leveraging 
the resources of the exporting county, including the United States. 
For example, according to the National Oceanic and Atmospheric 
Administration's Seafood Inspection Program (SIP) documents and the 
Director of SIP, Vietnam requires U.S. facilities that want to export 
seafood products to Vietnam to obtain an export health certificate. 
Under an MOU with FDA, the SIP will issue these certificates. The SIP 
will attest to the fact that the exported seafood products meet not 
only U.S. seafood safety requirements, but also Vietnam's 
requirements. In addition, the SIP may attest to the safety of the 
seafood exports through its inspections of the U.S. food facilities 
that want to export to Vietnam. Vietnamese government officials 
recently visited the United States to audit the SIP, among other 
programs. According to the SIP Director, the program will also provide 
this same service for seafood exports to China, and China may require 
the SIP to conduct inspections and laboratory testing. China also 
plans to review the SIP, including the relevant laws and regulations 
covered and their enforcement. In both of these cases, the SIP will 
serve as the point of contact for these certificates for Vietnam and 
China in the event that any issues arise with U.S. exported seafood 
products. 

Conclusions: 

FDA, which is responsible for ensuring the safety of most imported 
foods, is in the process of developing programs to enhance the safety 
of imported food products, including seafood. FDA has stated that it 
needs new approaches to improve its oversight of imported food that 
take into account the entire food supply chain and that it needs to 
push prevention of food safety risks offshore and leverage the efforts 
of others to avoid duplication and better target its food safety 
efforts. Since 1998, we have reported on the need for FDA to enhance 
its oversight of imported food products, including seafood, and have 
recommended that FDA use the tools available to it, such as 
equivalence, to leverage the resources of foreign countries to ensure 
exports meet U.S. requirements. Both FSIS and the EU have used 
equivalence as a tool to leverage exporting countries' resources by 
having the foreign governments ensure that certain foods imported into 
the United States and the EU meet their respective standards for 
safety. FDA has not used equivalence to leverage the oversight 
resources of foreign countries but has developed a new tool for 
conducting comparability assessments to assess a foreign country's 
entire food safety system, determine if it is comparable with the U.S. 
system, leverage the country's oversight resources, and place greater 
responsibility on the foreign government to ensure food products 
exported to this country meet a comparable level of safety protection 
to that in United States. Given the numerous challenges that FDA faces 
in developing and implementing a third-party accreditation system, the 
agency could reduce the need for accrediting and using third parties 
by using comparability assessments. However, FDA will find few 
countries that have systems comparable with the U.S. system because 
the agency would require comparability with a foreign government's 
entire domestic and export food safety systems for all food products. 
Consequently, FDA would be unable to leverage the resources of 
countries with comparable systems for just one food product. FDA can 
only take full advantage of comparability assessments if it modifies 
its approach for selecting comparable foreign countries and uses 
comparability assessments to identify countries that have similar food 
safety systems for targeted food products, such as seafood. This 
modification would be consistent with the approach FDA had originally 
envisioned in 1997 for the use of equivalence agreements--agreements 
that covered only certain food products that the foreign government's 
regulatory system was designed to achieve, or was capable of achieving 
equivalence. Representatives of major seafood exporting countries told 
us that they want FDA to evaluate their countries' food safety systems 
for seafood and obtain the benefits that accompany government-to-
government agreements. Evaluating foreign countries on their seafood 
safety systems can be an effective and efficient approach to promoting 
the safety of imported seafood products because U.S. safety 
requirements for seafood have long been established and implemented 
and because FDA already has experience in assessing a foreign 
country's seafood safety system through its foreign country 
assessments. FDA officials told us that the agency will develop a 
written plan for developing and implementing comparability assessments 
when it completes its pilot with Canada. However, it is unclear 
whether this plan will clarify how FDA will integrate its new 
authorities under FSMA with the approach it plans for its 
comparability assessments. Furthermore, this approach will still 
require full comparability of foreign countries' food safety systems, 
rather than comparability for particular food products. 

Recommendation for Executive Action: 

To better leverage the oversight resources of foreign countries and 
ensure the safety of food imports, we recommend that the Secretary of 
Health and Human Services direct the Commissioner of FDA to revise 
FDA's comparability approach to one that allows for the flexibility of 
assessing foreign food safety systems for particular food products, 
such as seafood, when a full comparability assessment of foreign 
countries' food safety systems may not be feasible. 

Agency Comments and Our Evaluation: 

We provided the departments of Health and Human Services, Agriculture, 
Commerce, and Homeland Security with a draft of this report for their 
review and comment. We also provided a draft of this report as a 
courtesy to the Department of State and the Office of the U.S. Trade 
Representative. The Department of Health and Human Services provided 
written comments in which it neither agreed nor disagreed with our 
recommendation, and its comments appear in appendix II. The remaining 
departments did not provide any comments on a draft of this report. 

In commenting on a draft of this report, the Department of Health and 
Human Services stated that FDA believes that comparability is a more 
efficient and appropriate tool for it to use in assessing whether a 
country's entire food safety system provides adequate assurances of 
comparable public health outcomes, and third-party certification is a 
more appropriate approach for FDA to use when assessing a particular 
segment of a country's food safety system, such as export controls for 
one or more commodities. However, FDA also stated that it intends to 
seek public comment on its current comparability approach, and in that 
context, stakeholders will have an opportunity to comment on GAO's 
recommended approach. 

We understand how comparability assessments and third-party 
certification can be complementary and noted this relationship in our 
report. We do not believe, however, that the use of third parties is 
preferable to comparability assessments to establish agreements with 
foreign governments. The role of third parties will be to certify that 
food or eligible foreign entities, such as seafood processors, meet 
the applicable federal requirements. However, comparability 
assessments, unlike third-party certifications, would enable FDA to 
use the outcome of a comparability assessment to gain the same 
advantages realized by FSIS and the EU as part of their use of 
equivalence. In our opinion, the relationships that the EU has with 
foreign governments are more comprehensive than those that could be 
accomplished through a third-party accreditation arrangement. More 
specifically, if FDA had a comparability assessment agreement with a 
foreign country, similar to an EU equivalence agreement, a foreign 
competent authority would address any identified problems and take 
regulatory actions across the supply chain, as necessary. 

Moreover, as we stated in our report, FDA faces multiple challenges in 
implementing a third-party accreditation program, and the use of 
comparability assessments could reduce the need for third parties. 
Specifically, foreign governments may be reluctant to apply for 
accreditation as a third party from a non-U.S. government agency, 
citing sovereignty issues as a concern. In addition, in some 
countries, third parties cannot operate in the territory unless 
accredited by that country's accreditation body. In these cases, there 
is a potential conflict of interest in having a government 
accreditation body accredit another government agency from the same 
country as a third party. This type of accreditation relationship may 
make it difficult to consider the process unbiased. 

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 the 
appropriate congressional committees; the Secretaries of Health and 
Human Services, Agriculture, Commerce, Homeland Security, and State; 
the U.S. Trade Representative; and other interested parties. In 
addition, the report will be available at no charge on the GAO website 
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. Key contributors to this report 
are listed in appendix III. 

Signed by: 

Lisa Shames: 
Director, Natural Resources and Environment: 

[End of section] 

Appendix I: Scope and Methodology: 

Our objectives were to (1) identify the major actions the Food and 
Drug Administration (FDA) is to take to implement a system for 
accrediting third parties, as directed by the FDA Food Safety 
Modernization Act (FSMA), and the challenges, if any, FDA and others 
report will be associated with these actions and (2) examine FDA's 
approach for using its comparability assessments to leverage other 
countries' oversight capacity and enforcement authority. 

To address the first objective, we reviewed FDA's responsibilities for 
developing a system to accept third-party certification in FSMA; the 
agency's plans for implementing this system; the results of FDA's 
third-party certification pilot for imported shrimp, which it 
conducted in 2009; and reports evaluating implementation of FDA's 
Hazard Analysis and Critical Control Point (HACCP) program 
requirements for seafood. We also reviewed public comments from 
industry and consumer groups to FDA on the agency's plans to implement 
third-party accreditation and certification provisions under FSMA. We 
interviewed FDA officials on the agency's plans to implement a third-
party accreditation system and on any challenges identified during the 
third-party certification pilot for imported shrimp. We interviewed 
third parties who participated in FDA's third-party certification 
pilot for imported shrimp. Specifically, we interviewed 
representatives of Bureau Veritas and SGS (formerly known as Société 
Générale de Surveillance)--both of which are private companies that 
offer inspection, verification, testing, and certification services--
and officials from the Department of Commerce's National Marine 
Fisheries Service and the Global Aquaculture Alliance Best Aquaculture 
Practice, a standard-setting organization for aquaculture seafood. We 
also spoke with representatives involved in the shrimp pilot from the 
Inspectorate America Corporation, which is now a part of Bureau 
Veritas. We interviewed officials from the American National Standards 
Institute, a U.S. based not-for-profit accreditation organization that 
serves as the official U.S. representative to the International 
Organization for Standardization. We reviewed internationally 
recognized standards for third-party accreditation systems and 
industry food safety certification systems and spoke with 
representatives of these systems. Most of the certification systems 
were used by third parties in FDA's shrimp pilot or recognized by the 
Global Food Safety Initiative (GFSI)-a nonprofit foundation that 
resulted from the collaboration of retailers, manufacturing and food 
service companies and that compares private food safety certification 
systems against GFSI-established requirements. Specifically, we spoke 
with representatives of the British Research Consortium, Canada GAP, 
Global Aquaculture Alliance Best Aquaculture Practices, Global G.A.P., 
Mexico Calidad Suprema, and Safe Quality Foods. To gain other 
stakeholder perspectives on FDA's new authorities and requirements for 
accepting third-party certifications, we spoke with representatives 
from: 

* industry (Costco, Darden, Walmart, Sogelco International); 

* trade associations (the Association of Food Industries, Inc., Food 
Safety Services Providers, National Fisheries Institute, Grocery 
Manufacturers Association); and: 

* consumer advocacy groups (the Center for Science in the Public 
Interest, Consumer Federation of America, and Food and Water Watch). 

We also visited two domestic seafood processors at their facilities in 
Massachusetts to get their perspectives on FDA's future use of third-
party certifications. We reviewed policies and spoke with the U.S. 
Department of Agriculture's (USDA) Agriculture Marketing Service about 
its management of the National Organics Program, which uses accredited 
third parties to complete certifications overseas. We reviewed 
policies and spoke with U.S. Customs and Border Protection officials 
about its Customs-Trade Partnership Against Terrorism program and the 
results of its pilot using third parties. 

To address the second objective, we reviewed the assessment tool FDA 
is using in its comparability assessment pilots with New Zealand and 
Canada. We reviewed FDA documents on the agency's plans and approach 
for the use of comparability assessments. We spoke with FDA officials 
about these pilots and the agency's plans for using comparability 
assessments and also spoke with New Zealand government officials about 
their experience with the pilot. We reviewed the approach used by 
USDA's Food Safety and Inspection Service (FSIS) and the European 
Union (EU) and compared their approach with FDA's to determine if 
their practices for ensuring the safety of imported foods have the 
potential for enhancing FDA's practices and spoke with FSIS and EU 
officials. We also reviewed the FSIS and EU approaches to their 
foreign equivalence determinations to learn about the time required 
for these determinations and the scope of their reviews. We reviewed 
past GAO reports relevant to this topic. 

For both of our objectives, we reviewed policies and spoke with 
representatives of major seafood exporters to the United States--
Canada, Ecuador, Indonesia, Thailand, and Vietnam--and a major trading 
partner, Mexico, about their perspectives on FDA's third-party 
certification program and approaches they use in supporting oversight 
of seafood exports to the U.S. and other countries. We chose to 
interview representatives of major seafood exporting countries, in 
part, because more seafood is imported than produced domestically and 
because FDA has set HACCP standards for seafood. We visited the 
Canadian Food Inspection Agency (CFIA) in Ottawa, Canada, to learn 
about its seafood safety programs for both domestically produced 
seafood and imported seafood products. We visited Servicio Nacional de 
Sanidad, Inocuidad y Calidad Agroalimentaria (SENASICA), the primary 
food safety agency in Mexico for domestically produced food products, 
in Mexico City, to learn about its food safety oversight programs. We 
also toured SENASICA's food testing center in Tecamac, Mexico, to 
learn about their lab testing capabilities. During our visits with 
CFIA and SENASICA, we also learned about their programs using third 
parties to support oversight of food safety for domestically produced 
and processed products. 

We visited the Port of Boston in Boston, Massachusetts, where seafood 
is among the major food products entering the port, and met with 
Customs and Border Protection officials to learn about the agency's 
activities related to ensuring the safety of seafood imports. We also 
visited a cold storage facility--in close vicinity to the Boston port 
and where FSIS inspectors conduct reinspections--to learn about 
measures FSIS uses to ensure the safety of imported meat and poultry 
products. During the same trip, we visited FDA's New England District 
Office in Stoneham, Massachusetts, to learn about FDA import entry 
review processes used to ensure the safety of imported foods under 
FDA's jurisdiction, and its laboratory in Winchester, Massachusetts, 
to learn about FDA food testing of imported foods. 

We analyzed Department of Commerce data on imported seafood for 2010 
and presented these data as background to illustrate the relative 
volume of imported seafood from top importing countries to the United 
States. For this data set, we reviewed existing documentation about 
the data and any limitations. In addition, we analyzed data on 
examination and testing rates for food and seafood entry lines in 
fiscal year 2011 as background and reported percentage of testing 
based on total import entry lines. We reviewed existing documentation 
on this data set. We found both of these data sets to be sufficiently 
reliable for the above-mentioned purposes. We also included data that 
we previously used in our 2011 report and presented it as background 
information to illustrate FDA's foreign facility inspection coverage 
for Ecuador, Indonesia, and Thailand. As determined in our 2011 
report, these data were sufficiently reliable for the purpose stated 
above. 

We conducted this performance audit from June 2011 to September 2012 
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: 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 17, 2012: 

Lisa Shames, Director: 
Natural Resources and Environment: 
U.S. Government Accountability Office: 
441 G Street NW: 
Washington, DC 20548: 

Dear Ms. Shames: 

Attached arc comments on the U.S. Government Accountability Office's 
(GAO) report entitled: "Food Safety: FDA Can Better Oversee Food 
Imports by Assessing and Leveraging Other Countries' Oversight 
Resources" (GAO-12-933). 

The Department appreciates the opportunity to review this report prior 
to publication. 

Sincerely, 

Signed by: 

Jim R. Esquea: 
Assistant Secretary for Legislation: 

Attachment: 

General Comments Of The Department Of Health And Human Services (HHS) 
On The Government Accountability Office's (GA0) Draft Report Entitled, 
"Food Safety: FDA Can Better Oversee Food Imports By Assessing And 
Leveraging Other Countries' Oversight Resources" (GA0-12-933): 

The Department appreciates the opportunity to review and comment on 
the findings in the Government Accountability Office's (GAO) draft 
report. Through the implementation of the FDA Food Safety 
Modernization Act (FSMA), FDA already has begun establishing 
additional processes and systems that will enhance the safety of food, 
including imported food. 

GAO recommends that FDA revise its comparability approach to one that 
allows for the flexibility of assessing foreign food safety systems 
for particular food products, when a full comparability assessment of 
foreign countries' food safety systems may not be feasible. 

To clarify, an FDA comparability assessment will involve a review of 
the country's food safety system and the ability of the food safety 
authority to oversee that system so as to ensure a comparable level of 
public health assurance as the U.S. System. An assessment for third 
party accreditation will involve a review of the food safety 
authority's ability to ensure that facilities or foods it certifies 
meet U.S. requirements. While the two programs fall along a spectrum, 
there is a clear distinction in the outcomes. 

FDA believes that comparability is a more efficient and appropriate 
tool for FDA to use in assessing whether a country's entire food 
safety system provides adequate assurances of comparable public health 
outcomes, and third party certification is a more appropriate approach 
for FDA to use when assessing a particular segment of the food safety 
system—-e.g., export controls for one or more commodities. FDA intends 
to seek public comment on FDA's current approach to comparability, and 
in that context, stakeholders will have an opportunity to comment on 
GAO's recommended approach. 

FDA is developing the Accredited Third Party Program and the 
Comparability[Footnote 1] program as complementary tools that FDA may 
use to assess countries' food safety systems, or parts thereof, 
specific to countries' particular capabilities, interests, and the 
maturity of their regulatory system. 

Food safety authorities in other countries may wish FDA to assess 
their food safety systems as a whole through comparability or they may 
pursue assessments of the food safety controls and oversight in place 
for particular export products through accreditation as a third-party 
auditor. The selection of the most appropriate tool for a particular 
country will be made by FDA in consultation with the food safety 
authority of that country. We expect that countries with mature food 
safety systems that can ensure comparable levels of public health 
protection will likely seek an FDA system-wide determination of 
comparability—-even those that currently rely on third-party auditors. 
Nevertheless, such countries could opt instead to seek accreditation 
as third-party auditors and would be assessed for their capabilities 
with respect to those standards. 

In cases where a country's overall system is not comparable to that of 
the United States, but the competent authority has effective programs 
in place to meet FDA food safety requirements for certain commodities 
for export (including from a subset of producing firms in the 
country), the country may pursue an assessment under FDA's program 
currently under development for Third Party Accreditation. Indeed, the 
examples from GAO's report of Thailand, Ecuador, and Indonesia 
interaction with the E.U. is akin to FDA's Third Party Accreditation 
program, in that those countries ensure that they export seafood to 
the E.U. that meets the F.U.'s standards. A food safety authority that 
is accredited as a third party certification body for a particular 
product may, in the future, seek to complete a comparability 
determination for its full food safety system, once its food safety 
system matures into a system that can ensure a comparable level of 
public health protection as the U.S. system. As mentioned earlier, the 
Comparability and Third Party Programs provide a spectrum approach for 
countries to choose from, as appropriate. The result from both 
initiatives is that FDA will have additional high quality, credible 
information to help make risk based decisions on admissibility of food 
products. 

In summary, while both programs are still in the formative stages, FDA 
intends that comparability and the third party program to be 
complementary tools suited to help enhance the safety of foods 
imported from countries with a wide range of food safety resources and 
capabilities. The Agency will look forward to comments on this 
approach from stakeholders as it moves forward. 

Appendix II Footnote: 

[1] FDA has historically explored the use of equivalence programs and 
believes that, given the number and complexity of products for which 
FDA has oversight, using comparability-assessments and third party 
certification will provide a better means to ensure the safety of 
imported products. The term "equivalence" is used principally in the 
context of the international trading regime established under the 
World Trade Organization and its associated agreements, including the 
Sanitary and Phytosanitary Measures (SPS) Agreement, as well as in 
other free trade agreements, such as the North American Free Trade 
Agreement. The SI'S Agreement, for example, sets out basic rules 
governing the adoption and application of certain food safety and 
animal and plant health standards. To date, FDA has considered 
equivalence as most appropriately applied to the assessment of a 
foreign government's specific programs for certain high risk foods. 
This type of assessment provides a very detailed comparison of each 
measure that each country applies in controlling risks associated with 
the particular commodity under review. while this approach may be 
appropriate for assessing particular measures in specific commodity 
areas, the measure by measure approach is extremely burdensome
when applied to entire food safety systems and is not required for the 
assessment of a system-wide level of protection.—In contrast, FDA will 
apply comparability to the assessment of a country's overall food 
safety system (both domestic and export), to determine whether the 
system as a whole offers a similar, though not identical, system of 
protections as does the FDA food safety system. 

[End of section] 

Appendix III: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Lisa Shames, (202) 512-3841 or shamesl@gao.gov: 

Staff Acknowledgments: 

In addition to the individual named above, Anne K. Johnson, Assistant 
Director; David Moreno, Analyst-in-Charge; Carol Herrnstadt Shulman; 
Swati Sheladia Thomas; and Kiki Theodoropoulos made key contributions 
to this report. Important contributions were also made by Kevin Bray, 
Michele Fejfar, Armetha Liles, and Michelle Sahlhof. 

[End of section] 

Footnotes: 

[1] 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). 

[2] GAO, Seafood Safety: FDA Needs to Improve Oversight of Imported 
Seafood and Better Leverage Limited Resources, [hyperlink, 
http://www.gao.gov/products/GAO-11-286] (Washington, D.C.: Apr. 14, 
2011). 

[3] According to a February 2011 report by the Congressional Research 
Service, the use of third parties has been promoted as a method for 
helping FDA carry out its responsibilities and target enforcement and 
inspections while better using existing personnel. 

[4] GAO, Seafood Safety: Responsibility for Inspecting Catfish Should 
Not Be Assigned to USDA, [hyperlink, 
http://www.gao.gov/products/GAO-12-411] (Washington, D.C.: May 10, 
2012). 

[5] The International Organization for Standardization publishes 
international standards covering almost all aspects of technology and 
business, including food safety and agriculture. 

[6] Examined food entry lines include lines that had an activity such 
as a field exam, label exam, or sample analysis performed. 

[7] GAO, Food Safety: Federal Oversight of Seafood Does Not 
Sufficiently Protect Consumers, [hyperlink, 
http://www.gao.gov/products/GAO-01-204] (Washington, D.C.: Jan. 31, 
2001). 

[8] GAO Food Safety: FDA's Imported Seafood Safety Program Shows Some 
Progress, but Further Improvements Are Needed, [hyperlink, 
http://www.gao.gov/products/GAO-04-246] (Washington, D.C.: Jan. 30, 
2004). 

[9] FDA's Manufactured Food Regulatory Program Standards establish 
critical elements of a regulatory program designed to protect the 
public from foodborne illness and injury and are being used on a 
voluntary basis by state regulatory programs that are providing 
contracted regulatory oversight of food facilities. The following 10 
key elements are included in the program standards: (1) regulatory 
foundation, (2) training program, (3) inspection program, (4) 
inspection audit program, (5) food-related illness and outbreaks and 
response, (6) compliance and enforcement program, (7) industry and 
community relations, (8) program resources, (9) program assessment, 
and (10) laboratory support. 

[10] Includes ISO/IEC Guide 65--General Requirements for Bodies 
Operating Product Certification Systems. 

[11] These standards are the ISO/IEC 17011, Conformity Assessment--
General Requirements for Accreditation Bodies Accrediting Conformity 
Assessment Bodies and ISO/IEC Guide 65--General Requirements for 
Bodies Operating Product Certification Systems. 

[12] GAO, Information Technology: FDA Needs to Fully Implement Key 
Management Practices to Lessen Modernization Risks, [hyperlink, 
http://www.gao.gov/products/GAO-12-346] (Washington, D.C.: Apr. 14, 
2011). 

[13] U.S. Department of Health and Human Services, Office of the 
Inspector General, Vulnerabilities in FDA's Oversight of State Food 
Facility Inspections (Washington, D.C.: December 2011). 

[14] 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). 

[15] 62 Fed. Reg. 30,593 (June 4, 1997). 

[16] [hyperlink, http://www.gao.gov/products/GAO-01-204]. 

[17] [hyperlink, http://www.gao.gov/products/GAO-04-246]. 

[18] [hyperlink, http://www.gao.gov/products/GAO-11-286]. 

[19] See 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) and [hyperlink, 
http://www.gao.gov/products/GAO-11-286]. 

[20] [hyperlink, http://www.gao.gov/products/GAO-11-286]. 

[End of section] 

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