FOOD SAFETY

FDA Can Better 

Oversee Food Imports 

by Assessing and 

Leveraging Other 

Countries’ Oversight 

Resources

Report to Congressional Requesters

September 2012

GAO-12-933

United States Government Accountability Office

GAO
United States Government Accountability Office

Highlights of GAO-12-933, a report to 

congressional requesters

September 2012

FOOD SAFETY

FDA Can Better Oversee Food Imports by Assessing 

and Leveraging Other Countries’ Oversight 

Resources

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 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.

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 

View GAO-12-933. For more information, whether certain exported food products are safe for domestic consumption.

contact Lisa Shames at (202) 512-3841 or 

shamesl@gao.gov.
Page i GAO-12-933 Food Safety

Letter 1 

Background 5

FDA Faces Challenges in Implementing a Third-Party Accreditation 

System to Help Ensure Imported Food Safety 14

FDA’s Comparability Assessment Approach Could Enable FDA to 

Leverage Other Countries’ Oversight Resources for Imported 

Foods 26

Conclusions 37

Recommendation for Executive Action 39

Agency Comments and Our Evaluation 39

Appendix I Scope and Methodology 41

Appendix II Comments from the Department of Health and Human Services 45

Appendix III GAO Contact and Staff Acknowledgments 48

Figures

Figure 1: Top Six Seafood Importing Countries to the United 

States, 2010 6

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

Accreditation System 13

Figure 3: Countries Approved to Export Specific Products by 

USDA’s FSIS and the European Union 36

Contents
Page ii GAO-12-933 Food Safety

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

This is a work of the U.S. government and is not subject to copyright protection in the 

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without further permission from GAO. However, because this work may contain 

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Page 1 GAO-12-933 Food Safety

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 

 
 

Page 2 GAO-12-933 Food Safety

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.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.2

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.

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.

3

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 

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.

 

1

GAO, Food Safety: Agencies Need to Address Gaps in Enforcement and Collaboration to 

Enhance Safety of Imported Food, 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, 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.
 

Page 3 GAO-12-933 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.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 

 

4

GAO, Seafood Safety: Responsibility for Inspecting Catfish Should Not Be Assigned to 

USDA, GAO-12-411 (Washington, D.C.: May 10, 2012). 
 

Page 4 GAO-12-933 Food Safety

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.5

 

5

The International Organization for Standardization publishes international standards 

covering almost all aspects of technology and business, including food safety and 

agriculture.

We reviewed 

internationally recognized third-party accreditation systems and industrybased 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) 
 

Page 5 GAO-12-933 Food Safety

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. 

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.

Background 
 

Page 6 GAO-12-933 Food Safety

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

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 
 

Page 7 GAO-12-933 Food Safety

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 
 

Page 8 GAO-12-933 Food Safety

0.5 percent of all food entry lines.6

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 

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.

 

6

Examined food entry lines include lines that had an activity such as a field exam, label 

exam, or sample analysis performed.
 

Page 9 GAO-12-933 Food Safety

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 threepart 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.7

 

7

GAO, Food Safety: Federal Oversight of Seafood Does Not Sufficiently Protect 

Consumers, 

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 

GAO-01-204 (Washington, D.C.: Jan. 31, 2001).
 

Page 10 GAO-12-933 Food Safety

countries involved had to take place before equivalence determinations 

could be made. In January 2004,8 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 thirdparty 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.

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.

 

8

GAO Food Safety: FDA’s Imported Seafood Safety Program Shows Some Progress, but 

Further Improvements Are Needed, GAO-04-246 (Washington, D.C.: Jan. 30, 2004).

FSMA
 

Page 11 GAO-12-933 Food Safety

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.

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 

FDA Third-Party 

Accreditation System 
 

Page 12 GAO-12-933 Food Safety

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.
 

Page 13 GAO-12-933 Food Safety

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

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 

FDA’s Third-Party 

Certification Pilot for 

Aquacultured Shrimp
 

Page 14 GAO-12-933 Food Safety

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.

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 

FDA Faces 

Challenges in 

Implementing a ThirdParty Accreditation 

System to Help 

Ensure Imported 

Food Safety
 

Page 15 GAO-12-933 Food Safety

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.

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 

Developing Preventive 

Controls and Guidance for 

All Foods under Its 

Jurisdiction Requires FDA 

to Consider a Wide Variety 

of Food Industries
 

Page 16 GAO-12-933 Food Safety

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.

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.
 

Page 17 GAO-12-933 Food Safety

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 

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 
 

Page 18 GAO-12-933 Food Safety

seafood exports to the United States and sell their product to different 

markets if any required certifications are too costly.

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 quasigovernmental 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 

FDA Is to Develop a 

System to Recognize 

Accreditation Bodies and 

Faces Challenges in 

Addressing Foreign 

Government Concerns
 

Page 19 GAO-12-933 Food Safety

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.

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,9

• Develop standards that other third parties, including private firms, 

must meet, which involves reviews and audits of third parties’ training 

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. 

 

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.

FDA Is to Develop 

Standards for Countries 

and Accrediting Private 

Organizations as Third 

Parties and Faces 

Challenges in Addressing 

Consumer Groups’ 

Concerns 
 

Page 20 GAO-12-933 Food Safety

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.

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 thirdparty 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 
 

Page 21 GAO-12-933 Food Safety

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 thirdparty 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 
 

Page 22 GAO-12-933 Food Safety

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 industrybased 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-ofinterest 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 thirdparty 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 
 

Page 23 GAO-12-933 Food Safety

that the costs for audits by private firms may range from less than 

$1,000 to more than $10,000.

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.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.11

 

10Includes ISO/IEC Guide 65—General Requirements for Bodies Operating Product 

Certification Systems. 

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 

11These 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. 

FDA Is to Monitor the 

Third-Party Accreditation 

System and Faces 

Challenges in Deciding on 

the Degree of Oversight
 

Page 24 GAO-12-933 Food Safety

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.

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 
 

Page 25 GAO-12-933 Food Safety

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.12

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.

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.

13

 

12GAO, Information Technology: FDA Needs to Fully Implement Key Management 

Practices to Lessen Modernization Risks, 

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. 

GAO-12-346 (Washington, D.C.: Apr. 14, 2011).

13U.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).
 

Page 26 GAO-12-933 Food Safety

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 thirdparty 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 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 

FDA’s Comparability 

Assessment Approach 

Could Enable FDA to 

Leverage Other 

Countries’ Oversight 

Resources for 

Imported Foods
 

Page 27 GAO-12-933 Food Safety

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.

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 

FDA Plans to Use 

Comparability 

Assessments to Leverage 

Oversight Resources of 

Other Countries to More 

Efficiently Oversee 

Imported Foods
 

Page 28 GAO-12-933 Food Safety

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.

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.

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 

Few Countries Are Likely 

to Meet Requirements for 

Comparability with the 

U.S. Food Safety System

FDA Has Experience in 

Conducting Focused 

Reviews of Foreign 

Seafood Safety Systems
 

Page 29 GAO-12-933 Food Safety

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. 

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-togovernment 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 

Foreign Country 

Representatives We 

Interviewed Want FDA to 

Determine Comparability 

Specifically for Their 

Seafood Exports
 

Page 30 GAO-12-933 Food Safety

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 
 

Page 31 GAO-12-933 Food Safety

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-togovernment 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.
 

Page 32 GAO-12-933 Food Safety

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.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.15

• 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.

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.

16

• 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.

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.

17

 

14GAO, Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are 

Inconsistent and Unreliable, 

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 

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

1562 Fed. Reg. 30,593 (June 4, 1997). 

16GAO-01-204. 

17GAO-04-246. 

FSIS and the EU Use a 

Targeted Approach to 

Determine Whether 

Exported Food Is Safe for 

Domestic Consumption
 

Page 33 GAO-12-933 Food Safety

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 seafoodexporting 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.18

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. 

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.

 

18GAO-11-286. 
 

Page 34 GAO-12-933 Food Safety

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.19

 

19See GAO, Food Safety: Selected Countries’ Systems Can Offer Insights into Ensuring 

Import Safety and Responding to Foodborne Illness, 

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; 

GAO-08-794 (Washington, D.C.: 

June 10, 2008) and GAO-11-286. 
 

Page 35 GAO-12-933 Food Safety

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.
 

Page 36 GAO-12-933 Food Safety

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

Page 37 GAO-12-933 Food Safety

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.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.

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 

 

20GAO-11-286. 

Conclusions 
 

Page 38 GAO-12-933 Food Safety

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, 
 

Page 39 GAO-12-933 Food Safety

this approach will still require full comparability of foreign countries’ food 

safety systems, rather than comparability for particular food products.

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.

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 thirdparty certifications, would enable FDA to use the outcome of a 

comparability assessment to gain the same advantages realized by FSIS 

Recommendation for 

Executive Action

Agency Comments 

and Our Evaluation
 

Page 40 GAO-12-933 Food Safety

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 thirdparty 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 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.

Lisa Shames

Director, Natural Resources and Environment
Appendix I: Scope and Methodology

Page 41 GAO-12-933 Food Safety

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 thirdparty 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 

Appendix I: Scope and Methodology
Appendix I: Scope and Methodology

Page 42 GAO-12-933 Food Safety

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 
Appendix I: Scope and Methodology

Page 43 GAO-12-933 Food Safety

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 abovementioned 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 
Appendix I: Scope and Methodology

Page 44 GAO-12-933 Food Safety

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.
Appendix II: Comments from the Department 

of Health and Human Services

Page 45 GAO-12-933 Food Safety

Appendix II: Comments from the Department 

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

of Health and Human Services

Page 46 GAO-12-933 Food Safety
Appendix II: Comments from the Department 

of Health and Human Services

Page 47 GAO-12-933 Food Safety
Appendix III: GAO Contact and Staff 

Acknowledgments

Page 48 GAO-12-933 Food Safety

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

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.

Appendix III: GAO Contact and Staff 

Acknowledgments 

GAO Contact

Staff 

Acknowledgments 

(361297)
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