oversight

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

Published by the Government Accountability Office on 2012-09-28.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                 United States Government Accountability Office

GAO              Report to Congressional Requesters




September 2012
                 FOOD SAFETY

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




GAO-12-933
                                             September 2012

                                             FOOD SAFETY
                                             FDA Can Better Oversee Food Imports by Assessing
                                             and Leveraging Other Countries’ Oversight
                                             Resources
Highlights of GAO-12-933, a report to
congressional requesters




Why GAO Did This Study                       What GAO Found
U.S. reliance on imported food               We identified five major actions the Food and Drug Administration (FDA) is to
increased from 2000 through 2011. For        complete under the FDA Food Safety Modernization Act (FSMA) to establish a
some products, imports make up a             reliable system that uses third-party audits conducted by foreign governments or
considerable share of the total amount       other third parties to help ensure food safety. FDA officials and others report that
consumed in the United States. FDA—          each of these actions presents challenges that must be addressed. First, FDA is
responsible for ensuring the safety of       to develop new preventive controls and related guidance for all of the foods
most imported foods—received new             under its jurisdiction—such as produce, milk, cheese, spices, soft drinks, and
authority under FSMA to enhance its          processed foods—and will need to develop appropriate training, particularly for
oversight of food imports, including
                                             foreign producers and processors, which poses a challenge because FDA is
express authority to establish a system
                                             responsible for a variety of food industries. Second, FDA is to establish a
for accrediting third parties, which may
include foreign governments and
                                             voluntary user fee program for importers that encourages the use of third-party
private auditing firms, to certify foreign   certifications, and it faces a challenge in developing a program that encourages
food facilities’ compliance with U.S.        importers to participate. Third, FDA has to develop a system for recognizing
food safety requirements. FDA has            accreditation bodies that can accredit third parties to certify foreign food facilities
also begun to assess selected foreign        and is likely to face a challenge in addressing foreign governments’ concerns
food safety systems to determine if          about being evaluated by an entity other than FDA. Fourth, FDA is to develop
these systems provide the same level         model standards for accreditation bodies to use in evaluating and accrediting
of public health protection, among           third parties and faces challenges in, among other things, determining third-party
other things.                                auditors’ competency and deciding on how to avoid potential conflicts of interest.
                                             Fifth, FDA is to oversee the third-party accreditation system, including
GAO was asked to (1) identify major
                                             periodically evaluating accreditation bodies and third parties, and faces a
actions FDA is to take to implement a
system for accrediting third parties and     challenge in deciding the level of oversight it will provide to the multiple parties
challenges, if any, it and others report     involved in third-party certification.
with these actions and (2) examine           FDA’s approach for using comparability assessments can enable the agency to
FDA's approach for using comparability       leverage other countries’ oversight capacity and enforcement authority. This
assessments to leverage other                could result in some of the same advantages as the equivalence approach used
countries' oversight capacity and            by the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS)
enforcement authority. GAO reviewed
                                             and the European Union (EU) before specific food products can be imported.
FDA documents and interviewed
                                             These advantages include having a foreign competent authority address any
officials from FDA and other agencies,
and stakeholders, such as consumer           identified problems and take regulatory actions across the supply chain, as
groups and industry representatives.         necessary. However, according to FDA officials, the agency expects few
                                             countries to seek comparability with the United States because, in part, most
What GAO Recommends                          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
GAO recommends that FDA revise its
                                             food products under FDA’s jurisdiction. According to FDA documents, some
comparability approach to one that
                                             countries have robust export certification programs for a specific food product,
also includes assessing foreign food
safety systems for particular food           but their overall food safety systems, including domestic production systems,
products, such as seafood. FDA               may not be comparable with those of the United States. Consequently, FDA
neither agreed nor disagreed with the        would be unable to leverage the resources of countries with comparable systems
recommendation.                              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.

                                                                                       United States Government Accountability Office
Contents


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




               Page i                                                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


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Page ii                                                           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 1                                               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 FDA generally
agreed with our recommendations in the 2009 report and neither agreed
nor disagreed with the recommendations in our 2011 report. FDA has
stated that it needs new approaches to improve its oversight of imported
food that take into account the entire food supply chain and that it needs
to push prevention of food safety risks offshore and leverage the efforts of
others to avoid duplication and better target its food safety efforts.

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

Under its pre-FSMA authority, in early 2010, FDA began an effort to
assess foreign food safety systems to determine if certain other countries
have a regulatory system—food safety statutes, regulations, and an
implementation strategy—that is comparable with the U.S. food safety


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 2                                                            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 3                                                          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 We reviewed
internationally recognized third-party accreditation systems and industry-
based food safety certification systems that include those used by third
parties in FDA’s third-party certification pilot for imported shrimp, and we
spoke with representatives of these industry systems. We reviewed
USDA’s policies and spoke with officials from the department’s
Agriculture Marketing Service about its management of the National
Organics Program, which uses accredited third parties to complete
certifications of organic operations that produce crops, livestock, and
multi-ingredient foods domestically and overseas. We also reviewed
policies and spoke with U.S. Customs and Border Protection officials
about the agency’s Customs-Trade Partnership Against Terrorism
program and the results of its pilot using third parties. To examine FDA’s
approach for using its comparability assessment process, we reviewed
the tool it is using in its comparability assessment pilots with Canada and
New Zealand and reviewed FDA documents about the agency’s approach
for using comparability assessments. We spoke with (1) FDA officials
about the agency’s comparability assessment pilot and its plans for using
comparability assessments and (2) New Zealand government officials
about their experience with the pilot. We reviewed the approach used by
FSIS and the European Union (EU) to determine if their practices for
ensuring the safety of imported foods have the potential for enhancing
FDA’s practices, and we spoke with FSIS and EU officials. For both of our
objectives, we reviewed policies and spoke with representatives of
countries that are major seafood exporters to the United States—Canada,
Ecuador, Indonesia, Thailand, and Vietnam—and a major trading partner,
Mexico, about their perspectives on FDA’s use of third-party certifications
and approaches they use in supporting oversight of seafood exports to
other countries. We chose to interview representatives of major seafood
exporting countries, in part, because more seafood is imported than is
produced domestically and because FDA has set internationally
recognized Hazard Analysis and Critical Control Point (HACCP)



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




Page 4                                                            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
Background   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.




             Page 5                                                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 6                                              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 7                                                  GAO-12-933 Food Safety
0.5 percent of all food entry lines. 6 Because items in an import entry
having different tariff descriptions or FDA product codes must be listed
separately, an entry line identifies each portion of an import shipment that
is listed as a separate item on an entry document.

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




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




Page 8                                                             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 three-
part approach to overseeing the safety of imported food: (1) an
equivalence system, whereby countries that wish to export meat and
poultry products to the United States must demonstrate that their food
safety systems for these food products are equivalent to those of the U.S.
system; (2) periodic audits to verify that their system remains equivalent;
and (3) reinspection of all imported shipments arriving at FSIS-approved
import facilities located near about 30 U.S. ports of entry. Once FSIS
determines equivalence, a single foreign government agency assumes
responsibility for addressing any problems FSIS may identify with
imported products, according to FSIS officials.

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

We and others have previously recommended that FDA take actions to
both undertake equivalence determinations and use third parties. For
example, in January 2001, to better ensure the safety of imported
seafood, we recommended that FDA develop specific goals and time
frames for establishing agreements with other countries to document that
their seafood safety systems are equivalent to that of the United States. 7
We stated that, without such equivalence agreements, FDA must rely
principally on its reviews of importers’ records to ascertain that imported
seafood products are processed under an acceptable food safety system.
FDA noted that foreign equivalencies was one of its priorities for fiscal
year 2001 but added that a considerable exchange of data among the



7
 GAO, Food Safety: Federal Oversight of Seafood Does Not Sufficiently Protect
Consumers, GAO-01-204 (Washington, D.C.: Jan. 31, 2001).




Page 9                                                          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 third-
       party inspectors are qualified and independent. FDA did not agree with
       our recommendation on equivalence but generally agreed with our
       recommendation to explore the potential for implementing a certification
       program for third-party inspectors. Furthermore, in June 2010, a
       committee of experts convened by the Institute of Medicine and the
       National Research Council issued a report examining gaps in public
       health protection afforded by the farm-to-table food safety system under
       FDA’s jurisdiction and identifying opportunities to fill those gaps. The
       report concluded that FDA needs to address barriers to improving the
       efficiency of inspections by, among other things, exploring third-party
       auditing of food facilities as an alternative model for measuring
       compliance.


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


       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).




       Page 10                                                    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.


FDA Third-Party        FSMA requires FDA to establish a system for accrediting third parties that
Accreditation System   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


                       Page 11                                                  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 12                                                GAO-12-933 Food Safety
Figure 2: Uses and Potential Structure of an FDA Third-Party Accreditation System




FDA’s Third-Party                        Before FSMA was enacted, FDA conducted a pilot of voluntary third-party
Certification Pilot for                  certification of aquacultured shrimp (shrimp pilot) produced in foreign
Aquacultured Shrimp                      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


                                         Page 13                                                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
FDA Faces               establish a system that uses third parties to help ensure food safety, and
Challenges in           FDA officials and others report that each of these actions presents
                        challenges that must be addressed. First, FDA is to develop new
Implementing a Third-   preventive control requirements and supporting guidance for food
Party Accreditation     products under its jurisdiction; the agency will also need to develop the
System to Help          appropriate training, particularly for foreign food producers and
                        processors, which poses a challenge because FDA is responsible for
Ensure Imported         ensuring the safety of a wide variety of food products, such as produce,
Food Safety             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


                        Page 14                                                 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.


Developing Preventive        Under FSMA, FDA is required to develop minimum standards for
Controls and Guidance for    implementing preventive controls and related guidance that consider the
All Foods under Its          wide variety of foods under its jurisdiction. These controls are intended to
                             minimize or prevent food safety hazards. Specifically, under FSMA, FDA
Jurisdiction Requires FDA    was required to issue proposed produce safety standards by January
to Consider a Wide Variety   2012 and a final produce safety rule by 1 year after the close of the
of Food Industries           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


                             Page 15                                                    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 16                                                  GAO-12-933 Food Safety
FDA Faces Challenges in     As directed by FSMA, FDA was to establish VQIP within 18 months of
Laying Out the Incentives   FSMA’s enactment, or by July 2012. As part of program development,
for Voluntary Third-Party   FDA is required to establish user fees for importers participating in VQIP.
                            As outlined in FSMA, the fees will have to cover administrative costs,
Certifications and in       such as reviewing submitted applications for participation in the program.
Deciding on the Need for    FDA officials told us they are in the process of developing VQIP, including
Mandatory Certifications    establishing user fees. Some industry representatives we spoke with
for Certain Imported        generally support the VQIP program, but according to a representative of
Foods                       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


                            Page 17                                                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.


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

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

                           A majority of accreditation bodies are government-owned or quasi-
                           governmental agencies, and some will not allow third parties to operate
                           within their countries unless accredited by that country’s accreditation
                           body, according to ANSI officials. However, there is a potential conflict of
                           interest in having a government accreditation body accrediting another
                           government agency in its own country as a third party. According to ANSI
                           officials, this type of an accreditation relationship makes it difficult to


                           Page 18                                                 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.


FDA Is to Develop          As required by FSMA, by July 2012, FDA was to develop model
Standards for Countries    accreditation standards and conflict-of-interest regulations. The model
and Accrediting Private    accreditation standards must be used by accreditation bodies to evaluate
                           third parties and include, for example, specific requirements for foreign
Organizations as Third     governments that apply to serve as third parties in their own countries. In
Parties and Faces          addition, conflict-of-interest regulations should protect against conflicts of
Challenges in Addressing   interest between third parties and entities they audit by, among other
Consumer Groups’           things, including requirements on how audits are to be performed.
Concerns                   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 which were developed by FDA to establish a uniform
                               foundation for design and management across state inspection
                               programs they contract with to conduct food safety inspections; and
                               (2) its International Comparability Assessment Tool, which is being
                               piloted for use in evaluating the comparability of foreign government
                               systems.

                           •   Develop standards that other third parties, including private firms,
                               must meet, which involves reviews and audits of third parties’ training



                           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.




                           Page 19                                                         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 third-
    party auditors. These challenges include identifying the right level of
    training and experience for individual third-party auditors and
    determining the extent of specialized knowledge that they need to
    demonstrate. For example, in its assessment of its shrimp pilot, FDA
    reported that, in 79 percent of the 28 seafood processing audits FDA


Page 20                                                 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 third-
party auditor competency issues. There is already a program to have
outside accreditation agencies observe audits to better ensure
consistency. Similarly, the Global Food Safety Initiative (GFSI)—a
collaboration that includes retailers and manufacturing and food service
companies and that evaluates private food safety standards against
GFSI-established criteria—also has a working group focused on
addressing issues related to individual third-party auditor competency.
Furthermore, one industry representative we spoke with expressed
concerns about the number of qualified third parties available to conduct
FDA certifications and described a lack of formal education and a career
path as barriers to having qualified third-party auditors. According to this
industry representative, there is currently a relatively small community of
qualified third parties, in total about 200 entities worldwide.

•   Issue reporting and immediate notification requirements. A senior
    FDA official stated that FDA will face challenges in determining the
    content for audit reports required for accredited third parties to submit
    to FDA. For example, FDA officials told us the level of detail that FDA
    may require is likely to depend on how it plans to use the information.
    In addition, according to FDA officials, the FSMA requirement for
    accredited third parties to notify FDA immediately of any observed
    condition that could cause or contribute to a serious risk to the public
    health provides a new role and new obligation for third parties. In
    audits conducted for private food safety standards, third parties



Page 21                                                  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 industry-
    based systems in general. For example, some third parties told us
    that foreign food producers and processors are concerned that any
    voluntary audit conducted to meet market demands could lead to
    regulatory actions, such as an import alert, for their facilities.

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


Page 22                                                   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.

FDA Is to Monitor the       As part of overseeing the third-party accreditation system—which
Third-Party Accreditation   includes accreditation bodies responsible for accrediting third parties and
System and Faces            third parties that conduct food safety audits of foreign food facilities—
                            FSMA directs FDA to reevaluate accreditation bodies and to also
Challenges in Deciding on   evaluate the performance of each accredited third party at least every 4
the Degree of Oversight     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
                            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


                            10
                             Includes ISO/IEC Guide 65—General Requirements for Bodies Operating Product
                            Certification Systems.
                            11
                              These standards are the ISO/IEC 17011, Conformity Assessment—General
                            Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies and
                            ISO/IEC Guide 65—General Requirements for Bodies Operating Product Certification
                            Systems.




                            Page 23                                                       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 24                                                  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 An FDA official
stated that the agency also faces a challenge in determining what, if any,
audit information will be made publicly available. Some industry and
consumer representatives we spoke with said that transparency of the
auditing process will be critical to building confidence in the third-party
accreditation system.

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


12
  GAO, Information Technology: FDA Needs to Fully Implement Key Management
Practices to Lessen Modernization Risks, GAO-12-346 (Washington, D.C.: Apr. 14, 2011).
13
 U.S. Department of Health and Human Services, Office of the Inspector General,
Vulnerabilities in FDA’s Oversight of State Food Facility Inspections (Washington, D.C.:
December 2011).




Page 25                                                           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 third-
                       party certification as beneficial. Accredited third-party certifications are
                       increasingly used by large-scale retailers and commercial companies as a
                       way to require and verify the safety and quality of food they market. For
                       example, more than 123,000 farm operations in over 100 countries are
                       certified to Global G.A.P. standards, and nearly 14,000 food processing
                       or packing operations in over 100 countries are certified to the British
                       Research Consortium standard for food safety. In addition, retailers we
                       spoke with indicated that they require third-party certification of their
                       suppliers and expressed confidence in accredited third-party certification
                       systems. For instance, the certification standards we reviewed require
                       any deficiency identified during the audit—minor or major—to be
                       corrected within a specified time frame as a condition of certification, and
                       some industry representatives told us that audited food facilities have
                       sufficient incentives to address identified problems. Furthermore,
                       according to a 2011 document prepared for the United Kingdom’s Food
                       Standards Agency to guide use of private certifications in setting priorities
                       for inspecting domestic food facilities, most private certification standards
                       for foods that researchers reviewed had well-established approaches to
                       developing standards and conducting assessments, and clear
                       requirements for auditor competency; many of these private certification
                       standards met basic food safety laws for the United Kingdom.


                       FDA’s approach for using comparability assessments, which is
FDA’s Comparability    complemented by the use of third parties, could enable the agency to
Assessment Approach    leverage other countries’ oversight capacity and enforcement authority.
                       Using this approach could result in some of the same advantages of
Could Enable FDA to    equivalence used by FSIS and the EU before certain foreign food
Leverage Other         products can be imported. According to FDA documents and officials, few
Countries’ Oversight   countries are likely to meet requirements for comparability with the U.S.
                       food safety system because the agency will require comparability of a
Resources for          foreign country’s entire food safety system. This involves a review of a
Imported Foods         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


                       Page 26                                                 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.


FDA Plans to Use          In a public hearing FDA held in March 2011 to discuss new initiatives for
Comparability             ensuring the safety of foods and animal feed imported into the United
Assessments to Leverage   States, as well as in agency documents, FDA provided general
                          information about how it plans to develop comparability assessments and
Oversight Resources of    how it may use these assessments to efficiently enhance the safety of all
Other Countries to More   imported food products by leveraging the oversight resources of foreign
Efficiently Oversee       countries. According to the information FDA officials provided, a
Imported Foods            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


                          Page 27                                                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.


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


FDA Has Experience in      According to FDA documents, the agency has developed a process for
Conducting Focused         assessing a foreign country’s aquaculture programs, including the agency
Reviews of Foreign         responsible for overseeing aquaculture and the country’s regulatory
                           infrastructure. Specifically, FDA conducted foreign country assessments
Seafood Safety Systems     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


                           Page 28                                                 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.


Foreign Country           According to representatives of major seafood exporting countries we
Representatives We        spoke with, they want FDA to evaluate their seafood export programs so
Interviewed Want FDA to   that they can develop agreements similar to those they have with the EU.
                          They added that having such agreements with the United States offers
Determine Comparability   potential benefits. Specifically, they told us the following:
Specifically for Their
Seafood Exports           •   Thailand. In 2010, the United States imported over 916 million pounds
                              of edible seafood from Thailand, including catfish, shrimp, and tuna.
                              For fiscal years 2005 through 2010, FDA had inspected about 14
                              percent of Thailand’s seafood processing facilities. According to Thai
                              officials we spoke with, when Thailand has a government-to-
                              government agreement, as with the EU, the Thai government can
                              better ensure that the seafood processing facilities meet the
                              standards of the country to which the seafood products are exported
                              and can address problems identified by the importing country in a
                              timely manner. In addition, the officials said that the Thai government
                              can address the issues that go beyond the facility level. For example,
                              if an importing country identifies drug residues at unacceptable levels,
                              the Thai government can track the product to the farm of origin,
                              investigate the situation, and enforce any corrective actions in a timely



                          Page 29                                                 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 30                                                  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-to-
    government agreements, importing countries can notify the competent
    authority of rejected products, which enables the Indonesian
    government to take timely regulatory action. According to Indonesian
    officials, their government has oversight of different parts of the
    aquaculture supply chain, including hatcheries, production, and
    processing. In addition, in 2008, the Indonesian government began
    certifying farms using good aquaculture practices. Indonesian officials
    told us that when they are notified of a rejected product, the affected
    processing plant is suspended from exporting additional seafood
    products until it takes the corrective action the government has
    determined is needed. If the processing plant does not take the
    corrective action, the government can revoke the plant’s registration.
    According to Indonesian officials, FDA and the Indonesian
    government do not communicate on products that FDA has rejected
    for import. As a result, the Indonesian government does not learn that
    a product has been rejected for 2 or 3 months.




Page 31                                                   GAO-12-933 Food Safety
FSIS and the EU Use a       For about 14 years, we have reported that FDA could enhance its
Targeted Approach to        oversight of imported food, including seafood, if it used an equivalence
Determine Whether           approach to place greater responsibility on exporting countries to ensure
                            their food exports met U.S. requirements as follows:
Exported Food Is Safe for
Domestic Consumption        •     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 FDA added that it would
                                  enter into agreements that covered only certain food products, such
                                  as fish and fishery products, if a foreign country’s regulatory system
                                  was designed to achieve, or was capable of achieving, equivalence
                                  for some food products but not for others.

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

                            •     In 2004, we reviewed FDA’s imported seafood safety program and
                                  determined that the agency had made no progress in developing
                                  equivalence agreements with seafood exporting countries. 17 FDA
                                  officials stated that developing these agreements was no longer a
                                  priority because the agency believed that equivalence agreements, as
                                  such, did not necessarily contribute to the enhanced safety of


                            14
                              GAO, Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are
                            Inconsistent and Unreliable, GAO/RCED-98-103 (Washington, D.C.: Apr. 30, 1998).
                            15
                                62 Fed. Reg. 30,593 (June 4, 1997).
                            16
                                GAO-01-204.
                            17
                                GAO-04-246.




                            Page 32                                                       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 seafood-
      exporting countries, starting first with countries that have high-quality
      food safety systems. FDA did not agree with our recommendation. In
      commenting on this recommendation, FDA said the agency was not
      currently positioned to assign high priority to negotiating equivalence
      or other types of agreements with numerous countries that export
      seafood to the United States in light of the pressing priorities
      associated with implementation of the Public Health Security and
      Bioterrorism Preparedness and Response Act of 2002. FDA also said
      that establishing these agreements is extraordinarily resource
      intensive.

•     In 2011, we reported that FDA was still using the same approach it
      developed more than 10 years earlier to ensure the safety of imported
      seafood, even though U.S. reliance on imported seafood had
      increased, and aquaculture had emerged as a major source of those
      imports. 18 We determined that this approach was limited and, in some
      respects, ineffectively implemented. We recommended that the
      agency use a more broad-based approach to overseeing imported
      seafood and consider the feasibility of applying some of the practices
      employed by the EU and FSIS through their respective equivalence
      processes. The Department of Health and Human Services,
      responding for FDA, did not agree or disagree with our
      recommendations but provided information on the actions in progress
      or planned related to the recommendations we made. FDA does not
      currently have any equivalence agreements in place.
According to FDA officials, equivalence determinations generally entail an
intensive, standard-by-standard review of a foreign country’s food safety
system, and it has been a challenge for the agency to conduct
equivalence determinations or enter into such agreements. Still, FDA
officials told us that the agency reviewed FSIS and EU equivalence
models, among others, to examine their general approach and determine
if the agency could use comparability assessments to acquire some of the
same advantages realized by the FSIS and the EU through equivalence.



18
    GAO-11-286.




Page 33                                                    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 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;



19
  See GAO, Food Safety: Selected Countries’ Systems Can Offer Insights into Ensuring
Import Safety and Responding to Foodborne Illness, GAO-08-794 (Washington, D.C.:
June 10, 2008) and GAO-11-286.




Page 34                                                        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 35                                                 GAO-12-933 Food Safety
Figure 3: Countries Approved to Export Specific Products by USDA’s FSIS and the European Union




                                       Page 36                                                   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,
Conclusions   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



              20
               GAO-11-286.




              Page 37                                                 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 38                                                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
Recommendation for   ensure the safety of food imports, we recommend that the Secretary of
Executive Action     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,
Agency Comments      Commerce, and Homeland Security with a draft of this report for their
and Our Evaluation   review and comment. We also provided a draft of this report as a courtesy
                     to the Department of State and the Office of the U.S. Trade
                     Representative. The Department of Health and Human Services provided
                     written comments in which it neither agreed nor disagreed with our
                     recommendation, and its comments appear in appendix II. The remaining
                     departments did not provide any comments on a draft of this report.

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

                     We understand how comparability assessments and third-party
                     certification can be complementary and noted this relationship in our
                     report. We do not believe, however, that the use of third parties is
                     preferable to comparability assessments to establish agreements with
                     foreign governments. The role of third parties will be to certify that food or
                     eligible foreign entities, such as seafood processors, meet the applicable
                     federal requirements. However, comparability assessments, unlike third-
                     party certifications, would enable FDA to use the outcome of a
                     comparability assessment to gain the same advantages realized by FSIS


                     Page 39                                                   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 third-
party accreditation arrangement. More specifically, if FDA had a
comparability assessment agreement with a foreign country, similar to an
EU equivalence agreement, a foreign competent authority would address
any identified problems and take regulatory actions across the supply
chain, as necessary.

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


As agreed with your offices, unless you publicly announce the contents of
this report earlier, we plan no further distribution until 30 days from the
report date. At that time, we will send copies to the appropriate
congressional committees; the Secretaries of Health and Human
Services, Agriculture, Commerce, Homeland Security, and State; the U.S.
Trade Representative; and other interested parties. In addition, the report
will be available at no charge on the GAO website at 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




Page 40                                                  GAO-12-933 Food Safety
Appendix I: Scope and Methodology
             Appendix I: Scope and Methodology




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

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


             Page 41                                                 GAO-12-933 Food Safety
Appendix I: Scope and Methodology




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



Page 42                                                GAO-12-933 Food Safety
Appendix I: Scope and Methodology




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

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

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



Page 43                                                GAO-12-933 Food Safety
Appendix I: Scope and Methodology




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.




Page 44                                               GAO-12-933 Food Safety
Appendix II: Comments from the Department
             Appendix II: Comments from the Department
             of Health and Human Services



of Health and Human Services




             Page 45                                     GAO-12-933 Food Safety
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
                  Appendix III: GAO Contact and Staff
                  Acknowledgments



Acknowledgments

                  Lisa Shames, (202) 512-3841 or shamesl@gao.gov
GAO Contact
                  In addition to the individual named above, Anne K. Johnson, Assistant
Staff             Director; David Moreno, Analyst-in-Charge; Carol Herrnstadt Shulman;
Acknowledgments   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.




(361297)
                  Page 48                                           GAO-12-933 Food Safety
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