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Report to the Ranking Member, Subcommittee on Oceans, Atmosphere, 
Fisheries, and Coast Guard, Committee on Commerce, Science, and 
Transportation, U.S. Senate: 

United States Government Accountability Office: 
GAO: 

February 2009: 

Seafood Fraud: 

FDA Program Changes and Better Collaboration among Key Federal Agencies 
Could Improve Detection and Prevention: 

Seafood Fraud: 

GAO-09-258: 

GAO Highlights: 

Highlights of GAO-09-258, a report to the Ranking Member, Subcommittee 
on Oceans, Atmosphere, Fisheries, and Coast Guard, Committee on 
Commerce, Science, and Transportation, U.S. Senate. 

Why GAO Did This Study: 

In 2007, Americans consumed almost 5 billion pounds of seafood. Most 
seafood buyers, at many levels—importers, distributors, supermarkets, 
restaurants, and individual consumers—assume that the seafood they buy 
is what the seller claims it is. However, this is not always the case. 
Sometimes seafood products are mislabeled for financial gain—an 
activity called seafood fraud. Three federal agencies play key roles in 
detecting and preventing seafood fraud: the Department of Homeland 
Security’s Customs and Border Protection (CBP), the Department of 
Commerce’s National Marine Fisheries Service (NMFS), and the Department 
of Health and Human Services’ Food and Drug Administration (FDA). GAO 
was asked to determine (1) the actions key federal agencies take to 
help detect and prevent seafood fraud and (2) the extent to which these 
key federal agencies collaborate with each other to help detect and 
prevent seafood fraud. GAO reviewed data and documents from each agency 
on actions to detect and prevent seafood fraud, and interviewed agency 
officials and other key stakeholders. 

What GAO Found: 

CBP and NMFS conduct several activities to help detect and prevent 
seafood fraud, but FDA told GAO that it focuses on food safety and 
undertakes few fraud-related activities. Nonetheless, fraud can result 
in food safety problems. For example, fish that was mislabeled as a 
different species for financial gain has caused illnesses due to the 
presence of a potentially deadly toxin. 

* CBP reviews seafood import documentation to detect schemes to avoid 
paying the appropriate customs duties as seafood products enter the 
country, among other things. 

* NMFS addresses seafood fraud through its voluntary, fee-for-service 
inspection program, which includes inspecting seafood that retailers, 
among others, are purchasing to verify its net weight and ensure the 
species is correctly identified. According to NMFS officials, NMFS 
inspects approximately one-third of the seafood consumed in the United 
States. 

* FDA examines only about 2 percent of imported seafood annually, and 
its primary seafood oversight program does not address economic fraud 
risks, which limits its ability to detect fraud. An FDA seafood fraud-
related activity is the maintenance of a publicly available list of 
seafood names that is intended to help the industry correctly label 
products. However, until 2009, FDA had not fully updated the list it 
created in 1993 to reflect over 400 name changes. Finally, FDA’s 
guidance to help seafood processors comply with its seafood oversight 
program does not reflect the seafood labeling requirement of the Food 
Allergen Labeling and Consumer Protection Act of 2004 to include the 
species of fish or shellfish on product labels. Because of the limited 
scope of FDA’s seafood oversight program, its mismanagement of the 
Seafood List, and its failure to update its guidance to reflect the 
allergen labeling requirement, consumers have less assurance that the 
seafood they purchase is correctly labeled. 

The federal agencies that share responsibility for detecting and 
preventing seafood fraud—CBP, NMFS, and FDA—do not effectively 
collaborate with each other. Specifically, they have not identified a 
common goal, established joint strategies, or agreed on roles and 
responsibilities. As a result, the agencies have not taken advantage of 
opportunities to share information that could benefit each agency’s 
efforts to detect and prevent seafood fraud, nor have they identified 
similar and sometimes overlapping activities that could be better 
coordinated to use limited resources more efficiently. For example, 
each agency has its own laboratory capability for determining seafood 
species and uses different methodologies for creating standards for 
species identification. The result is that neither the laboratories nor 
the data developed in them are shared. 

What GAO Recommends: 

GAO is making recommendations to CBP, NMFS, and FDA that are intended 
to help reduce the prevalence of seafood fraud, increase interagency 
collaboration, improve information sharing, and reduce overlaps. In 
commenting on a draft of this report, CBP, NMFS, and FDA generally 
agreed with the recommendations. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-09-258]. For more 
information, contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

CBP and NMFS Take a Variety of Actions to Detect and Prevent Seafood 
Fraud, While FDA Takes Few Actions Related to Seafood Fraud: 

Limited Collaboration Exists among the Key Agencies Responsible for 
Detecting and Preventing Seafood Fraud: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Scope and Methodology: 

Appendix II: Comments from the Department of Commerce: 

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

Appendix IV: Comments from the Department of Homeland Security: 

Appendix V: GAO Contact and Staff Acknowledgments: 

Table: 

Table 1: Types of Seafood Fraud That Federal Agencies Might Detect: 

Abbreviations: 

CBP: Customs and Border Protection: 

FDA: Food and Drug Administration: 

HACCP: Hazard Analysis and Critical Control Point: 

HHS: Department of Health and Human Services: 

ICE: Immigration and Customs Enforcement: 

MOU: memorandum of understanding: 

NFI: National Fisheries Institute: 

NMFS: National Marine Fisheries Service: 

NOAA: National Oceanic and Atmospheric Administration: 

NTAG: National Targeting and Analysis Group: 

USDA: U.S. Department of Agriculture: 

[End of section] 

United States Government Accountability Office:
Washington, DC 20548: 

February 19, 2009: 

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

Dear Senator Snowe: 

In 2007, Americans consumed almost 5 billion pounds of seafood. Most 
seafood buyers, at many levels--importers, distributors, supermarkets, 
restaurants, and individual consumers--assume that the seafood they buy 
is what the seller claims it is. However, this is not always the case. 
Sometimes people mislabel seafood products for financial gain--an 
activity called seafood fraud. The most common types of seafood fraud 
are shipping products through an intermediary country to avoid customs 
duties (transshipping), adding excessive amounts of water or ice to the 
seafood to increase its weight (over-treating), substituting a 
different species of seafood for the species listed on the label 
(species substitution), including less seafood in a package than 
indicated by the label (short-weighting), and other types of 
mislabeling or misrepresenting of seafood products. 

Although comprehensive information on the extent of seafood fraud does 
not exist, seafood industry officials believe that seafood fraud is a 
problem. The available information suggests that the scope and economic 
impact of seafood fraud vary widely and can occur at any point in the 
seafood supply chain, from large-scale, multinational schemes involving 
importers--with impacts in the millions of dollars--to fraudulent 
activities at individual restaurants or grocery stores. Seafood fraud 
can have both food safety and economic consequences. For example, 
seafood fraud affected food safety in 2007 when imported puffer fish, 
which contains a potentially deadly toxin, was mislabeled as monkfish, 
and people became ill. Another example of fraud is including the ice- 
glaze covering used to freeze and preserve fish fillets in the net 
weight of the product, which has primarily an economic impact because 
consumers get less fish than they paid for. Seafood fraud can undermine 
consumer confidence in the U.S. seafood supply, over 80 percent of 
which is imported. 

Three federal agencies play key roles in detecting and preventing 
seafood fraud: the Department of Homeland Security's Customs and Border 
Protection (CBP), the Department of Commerce's National Marine 
Fisheries Service (NMFS), and the Department of Health and Human 
Services' Food and Drug Administration (FDA). CBP collects customs 
duties on imports, including seafood, and seeks to prevent the evasion 
of customs duties. Goods imported into the United States may be subject 
to duties on the basis of their product type, value, and country of 
origin, among other things. In addition, to limit the sale of foreign- 
made products in this country at less-than-normal value, called 
"dumping," some imported goods are also subject to antidumping duties. 
NMFS provides fee-for-service inspection services on request to the 
seafood industry, including processors, distributors, and other firms. 
These inspections can address economic integrity issues, such as the 
accuracy of a seafood product's label, as well as seafood safety 
issues. Finally, FDA is responsible for ensuring that the nation's food 
supply, including seafood, is safe, wholesome, and properly labeled. To 
that end, FDA is authorized to issue regulations to enforce the Federal 
Food, Drug, and Cosmetic Act. The act prohibits the misbranding or 
adulteration of food products, which would include the mislabeling and 
substituting of seafood products that constitute seafood fraud. FDA is 
responsible for seafood that is imported into the United States as well 
as seafood that is harvested and processed domestically. FDA inspects 
U.S. importers and domestic and foreign processors to ensure their 
compliance with applicable requirements, including labeling 
requirements and FDA's Seafood Hazard Analysis and Critical Control 
Point (HACCP) regulations. The HACCP regulations require seafood 
processors to identify and develop processes to mitigate biological, 
chemical, and physical hazards that are likely to occur. FDA also 
provides guidance to the seafood industry on the naming of seafood 
products and on food safety hazards. Table 1 shows the types of seafood 
fraud that these three agencies might detect when performing their 
authorized roles. 

Table 1: Types of Seafood Fraud That Federal Agencies Might Detect: 

Fraud type: Transshipment to avoid duties; 
CBP: [Check]; 
NMFS: [Empty]; 
FDA: [Empty]. 

Fraud type: Over-treating; 
CBP: [Empty]; 
NMFS: [Check]; 
FDA: [Check]. 

Fraud type: Species substitution; 
CBP: [Check]; 
NMFS: [Check]; 
FDA: [Check]. 

Fraud type: Short-weighting; 
CBP: [Empty]; 
NMFS: [Check]; 
FDA: [Check]. 

Fraud type: Other mislabeling or misrepresenting; 
CBP: [Check]; 
NMFS: [Check]; 
FDA: [Check]. 

Source: GAO analysis of documents obtained from and discussions with 
CBP, NMFS, and FDA. 

[End of table] 

When an issue crosses federal agency lines, as seafood fraud does, the 
agencies involved must collaborate to deliver results more efficiently 
and effectively. For the purpose of this report, we define 
"collaboration" as a joint effort by two or more agencies that is 
intended to produce a greater public benefit than when the agencies act 
alone. Our previous work indicated that federal agencies can 
efficiently and effectively collaborate when they, among other things, 
(1) identify a common goal, (2) establish joint strategies to achieve 
that goal, (3) agree on their roles and responsibilities, (4) identify 
ways to maximize and leverage their resources, and (5) establish 
procedures and policies for working together systematically across 
agency lines.[Footnote 1] When agencies do not collaborate efficiently 
and effectively, their individual efforts are carried out in an 
uncoordinated way, thereby limiting the overall effectiveness and 
efficiency of federal expenditures. For example, in 2007, we added the 
federal oversight of food safety to our high-risk list because this 
fragmented system--in which 15 federal agencies collectively administer 
at least 30 laws related to food safety--has caused inconsistent 
oversight, ineffective coordination, and inefficient use of resources. 
[Footnote 2] 

In this context, you asked us to determine (1) the actions key federal 
agencies take to help detect and prevent seafood fraud and (2) the 
extent to which these key federal agencies collaborate with each other 
to help detect and prevent seafood fraud. 

Our research identified CBP, NMFS, and FDA as the key agencies involved 
in detecting and preventing seafood fraud. To determine the actions 
these agencies have taken to detect and prevent seafood fraud, we 
reviewed data and documents from each agency on the amount and nature 
of seafood fraud that they have identified, actions they have taken to 
prevent seafood fraud, and actions they have taken against fraud 
perpetrators. At all three agencies, we reviewed program guidance, 
inspection operation manuals, and other documentation and interviewed 
knowledgeable officials. We also obtained examples of seafood fraud 
criminal investigation cases and met with representatives from the 
major seafood industry trade associations. To determine the extent to 
which key federal agencies collaborate with each other to help detect 
and prevent seafood fraud, we reviewed existing federal interagency 
agreements and spoke with agency officials from CBP, NMFS, and FDA. 
(Appendix I provides additional information on our scope and 
methodology.) 

We conducted this performance audit from January 2008 to February 2009, 
in accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives. 

Results in Brief: 

CBP and NMFS conduct several activities to help detect and prevent 
seafood fraud; however, FDA has taken few actions because it sees food 
safety as its top priority. These agency activities are described in 
the following text: 

* CBP focuses on detecting schemes to avoid paying customs duties as 
seafood products enter the country, such as transshipment to avoid 
antidumping duties. CBP's import specialists review seafood import 
documentation on product type, value, and country of origin to ensure 
that importers have paid the appropriate duties. The agency also uses 
information provided by one of its National Targeting and Analysis 
Groups to help identify potentially fraudulent seafood shipments. This 
group analyzes data on foreign producers and importers that may be 
involved in transshipment schemes to avoid paying antidumping duties 
and works with port officials to examine these shipments as they 
arrive. For example, Chinese shrimp have been subject to an antidumping 
duty since 2005 because producers have set prices on the shrimp that 
were lower than the normal value. On the basis of this information and 
allegations from the domestic shrimp industry, a National Targeting and 
Analysis Group began to scrutinize imports of shrimp from Chinese 
producers and identified approximately $6 million worth of Chinese 
shrimp that had been transshipped through Indonesia in 2005 to avoid 
antidumping duties. 

* NMFS's seafood fraud detection activity consists of a voluntary, fee- 
for-service inspection program that supports the seafood industry in 
two ways. First, seafood retailers, such as supermarkets, may ask NMFS 
to inspect the seafood products they purchase to ensure the products 
have not been misrepresented. In such cases, NMFS's inspectors verify a 
product's net weight and ensure the species is correctly identified. 
Second, seafood processors may ask NMFS, through its Quality Management 
Program, to inspect their seafood processing operations to not only 
ensure compliance with FDA's HACCP regulations but also to identify 
measures that can help prevent seafood fraud. Such measures may include 
requiring the processor to weigh all products and compare that 
information with the stated weight on the package before the product 
leaves the facility and periodically testing the scales. According to 
officials in NMFS's Seafood Inspection Program, NMFS inspects 
approximately one-third of the seafood consumed in the United States. 

* FDA sees ensuring the safety of the nation's food supply as a top 
priority and, therefore, devotes minimal resources to detect and 
prevent seafood fraud. Nevertheless in the course of conducting its 
food safety activities, FDA has at times incidentally uncovered seafood 
fraud. More specifically, as part of its food safety activities to 
ensure that imports are not contaminated, among other things, FDA 
examines imported seafood products, which occasionally has resulted in 
its identifying seafood fraud. However, FDA's opportunities to identify 
fraud are limited because it examines only about 2 percent of imported 
seafood. FDA is also limited in its ability to detect seafood fraud 
because its primary oversight program for seafood processors--HACCP-- 
does not require them to identify and mitigate economic fraud risks 
that can occur during processing. However, seafood oversight programs 
operated by NMFS and the Canadian government include such requirements. 
An FDA seafood fraud-related activity is the maintenance of a publicly 
available list of scientific and market names of seafood--the Seafood 
List--that is intended to help the seafood industry comply with FDA's 
regulations on product mislabeling. However, FDA did not fully update 
the publicly available list it created in 1993 until January 2009, and 
does not provide stakeholders with an opportunity to comment on 
proposed changes before they are finalized. In addition, FDA provides 
guidance to seafood processors to help ensure that their seafood 
products are safe. However, this guidance does not reflect the seafood 
labeling requirements in the Food Allergen Labeling and Consumer 
Protection Act of 2004, which requires that the species of fish or 
shellfish be included on product labels to notify consumers who may be 
allergic to a particular species of fish. According to a senior FDA 
official, the act's labeling requirements also could help detect and 
prevent species substitution, since processors would need to verify the 
species of fish or shellfish to ensure accurate labeling. Because the 
seafood HACCP regulations do not address economic fraud risks; the 
Seafood List, until very recently, had not been kept up to date; and 
FDA's guidance does not reflect the allergen labeling requirements, the 
seafood industry may be less vigilant in ensuring their seafood 
products are correctly labeled and the public may more often encounter 
seafood products that are not what they are advertised to be. 
Consequently, we are recommending that FDA improve its ability to 
detect and prevent seafood fraud by (1) proposing amendments to its 
HACCP regulations to include measures to identify and mitigate economic 
fraud risks; (2) providing the opportunity for stakeholder comments 
prior to formalizing any changes to the Seafood List and routinely 
updating the public list; and (3) updating its guidance to reflect the 
seafood labeling requirements of the Food Allergen Labeling and 
Consumer Protection Act of 2004. 

The federal agencies that share responsibility for detecting and 
preventing seafood fraud--CBP, NMFS, and FDA--do not efficiently and 
effectively collaborate with each other, which can diminish the 
efficiency and effectiveness of their efforts. Specifically, these 
agencies have not worked together to identify a common goal related to 
seafood fraud, established joint strategies to achieve such a goal, or 
agreed on their roles and responsibilities. Moreover, they have not 
identified ways to maximize and leverage their resources or established 
processes and policies for working together systematically across 
agency lines. As a result, these agencies are not sharing important 
information that could be helpful in detecting and preventing seafood 
fraud. For example, when FDA reviews the labels of imported products to 
identify potentially fraudulent labeling, it does not systematically 
share the results of these reviews with CBP. If CBP had access to the 
results of the labeling reviews, it could compare this information with 
the labels on products entering the country and better determine 
whether a product was mislabeled to avoid a customs duty or other 
import restrictions. In addition, these agencies have not leveraged 
their resources to address seafood fraud efficiently and effectively. 
For example, NMFS's voluntary fee-for-service inspection program and 
FDA's health and safety inspections are similar. However, an FDA 
official said that the agency is not sure whether it can rely on NMFS 
inspections, in part due to concerns about potential conflicts of 
interest, because NMFS is paid by industry to conduct its inspections. 
FDA raised this same concern to us in 2004 but added that it already 
had agreements with NMFS to deal with seafood safety and inspections, 
and that it would look at other ways to better leverage NMFS resources. 
Nonetheless, FDA does not currently try to determine whether NMFS has 
already inspected a seafood facility when it is deciding which 
facilities to inspect. Consequently, some facilities may be "over- 
inspected," while others are not inspected frequently enough. For 
example, in fiscal year 2007, FDA inspected 104 seafood facilities that 
were also inspected by NMFS; while FDA had not inspected 1,464 other 
facilities since before fiscal year 2003. In addition, CBP, NMFS, and 
FDA each has its own laboratory capability for, among other things, 
determining the species of seafood samples they receive. The agencies 
also use different testing methodologies and standards for species 
identification and do not acknowledge each other's laboratory results, 
nor do they generally share the species standards they have developed. 
As a result, resources are not used efficiently or effectively. We are 
recommending that CBP, NMFS, and FDA collaborate to (1) develop goals, 
strategies, and mechanisms to efficiently and effectively share 
information and resources related to seafood fraud detection and 
prevention across agency boundaries and (2) create a federal agencywide 
library of seafood species standards. In commenting on a draft of this 
report, the Department of Commerce, representing NOAA; the Department 
of Health and Human Services, representing FDA; and the Department of 
Homeland Security, representing CBP, generally agreed with our 
recommendations. Appendixes II, III, and IV contain reprints of the 
departments' letters, respectively. 

Background: 

Seafood fraud can include a variety of illegal activities done for 
economic gain and can occur at any point in the seafood supply chain. 
The domestic seafood supply chain begins with the harvester--that is, 
the people who catch or farm the seafood. From there, seafood products 
are shipped to processors, which then produce fresh, frozen, breaded, 
or cooked seafood. Processors or distributors then sell the seafood to 
supermarkets or restaurants. The process is similar for foreign seafood 
products, with one exception: these products enter the country through 
an importer and then move on to a distributor. According to the 
National Oceanic and Atmospheric Administration (NOAA), in fiscal year 
2007, over 80 percent of the seafood consumed in this country was 
imported, and shrimp was the most widely consumed seafood. Seafood 
imports into the United States most frequently come from Canada, China, 
and Thailand, according to the U.S. Department of Agriculture's (USDA) 
Foreign Agriculture Service. 

Federal investigations have identified incidents of seafood fraud. For 
example, the Department of Homeland Security's Immigration and Customs 
Enforcement (ICE)[Footnote 3] and NOAA's Office for Law Enforcement 
investigation that began in 2004 identified seafood fraud that involved 
smuggling and distributing mislabeled catfish into the United States 
from Vietnam. According to the indictment, an individual and his 
companies in Florida aided by exporters in Vietnam imported thousands 
of pounds of catfish into the United States labeled as grouper to avoid 
paying antidumping duties that the Department of Commerce had imposed 
on Vietnamese catfish. The defendant pled guilty and was sentenced to 
51 months in prison. The judge also ordered the companies to forfeit 
property and pay over $1 million in restitution. 

Seafood fraud can include a variety of illegal activities undertaken 
for economic gain. Such fraud typically involves mislabeling the 
seafood product and can include the following actions: 

* Transshipment to avoid duties: Foreign producers may ship seafood 
products on route to the United States through a third country to avoid 
import duties by labeling the product's country of origin as the third 
country and also to avoid regulatory controls such as FDA import 
alerts.[Footnote 4] 

* Over-treating: Processors may, for example, over-bread prepared 
seafood products, use water-retaining chemicals, or over-glaze with an 
ice covering to artificially increase the weight of seafood products 
without indicating the true net weight of the seafood on the label. 

* Species substitution: Participants in the seafood supply chain may 
label a species of seafood as another species. Typically, a lower- 
market-value species is labeled as a higher-market-value species to 
realize a larger profit. This results in consumers paying too much for 
the product. 

* Short-weighting: Participants in the seafood supply chain may label 
packages of seafood as containing more than they actually contain. 

* Other mislabeling and misrepresenting: Participants in the seafood 
supply chain may provide various types of incorrect information about 
the seafood product or can commingle two or more different products 
having different values but sell the entire lot at the value of the 
highest priced product. 

Seafood fraud is an inherently deceptive activity and poses challenges 
for federal agencies to detect and prevent it while still maintaining 
the flow of legitimate seafood goods into and within the United States. 
Some fraudulent activity can even occur openly. For example, seafood 
companies receive public, written solicitations to purchase fraudulent 
seafood products. One type of solicitation offers to sell packages of 
fish fillets that are purposely mislabeled as another fish type to 
avoid antidumping duties and also capitalize on the higher market value 
of the falsely labeled fish type. These fish fillets are sold at a 
discount to the initial buyer, but then can be fraudulently resold for 
a higher price. Another type of solicitation offers to sell short- 
weight packages of seafood at a discount that the buyer could then 
fraudulently resell at the full price on the basis of the labeled 
package weight. 

Federal, state, and local agencies play a role in detecting and 
preventing seafood fraud throughout the supply chain. In general, 
federal agencies inspect seafood processors, distributors, and 
importers and imported seafood products. States also inspect seafood 
processors either through contracts with FDA or under their own 
authority. States and local governments inspect and regulate retail 
establishments such as restaurants and supermarkets. 

CBP's trade-related responsibilities include assessing the final 
customs duties, including antidumping duties, due on imports and 
collecting those duties. All goods imported into the United States are 
subject to a rate of duty, which may be free for certain products. The 
U.S. government has established a duty rate according to the product 
classification code--for example, fish sticks and other fillets that 
are breaded or coated with batter have a specific classification code 
and duty rate.[Footnote 5] Antidumping and countervailing duties may 
also be required on imported products. The U.S. government may impose 
antidumping duties on products exported to the United States at 
unfairly low prices (i.e., dumping) and countervailing duties on 
products exported to the United States that were subsidized by foreign 
governments. The Department of Commerce sets these duty rates for 
specific products, countries or manufacturers, or any combination of 
these factors. 

NMFS provides voluntary fee-for-service inspection services through its 
Seafood Inspection Program on request to the seafood industry, 
primarily under the authority of the Federal Agricultural Marketing Act 
of 1946. NMFS provides its services to domestic and foreign seafood 
firms to help them ensure compliance with all applicable federal food 
regulations, including FDA's seafood HACCP regulations. NMFS's services 
include inspections of a firm's processes and products to identify food 
safety and economic fraud risks as well as laboratory analyses. 

Along with its responsibility for ensuring the safety of other food 
products under the Federal Food, Drug, and Cosmetic Act, FDA has the 
primary responsibility for ensuring that the nation's seafood is safe, 
wholesome, and properly labeled.[Footnote 6] To carry out these 
responsibilities, FDA has created oversight programs designed to, among 
other things, examine and sample imported seafood products, inspect 
domestic and foreign seafood processors and importers, and assist state 
and local governments in their efforts to regulate retail 
establishments such as restaurants and supermarkets. Under the HACCP 
regulations, seafood processors are required to prepare and maintain a 
plan identifying critical points in the processing where contamination 
is reasonably likely to occur and implement control techniques to 
prevent or mitigate the contamination. FDA then inspects U.S. importers 
and domestic and foreign seafood processors to ensure their compliance 
with these HACCP regulations. When FDA first proposed the seafood HACCP 
regulations in 1994, the agency recommended that HACCP plans include 
controls for nonsafety hazards such as economic adulteration. 
Specifically, FDA recommended that the seafood industry adopt 
preventive processing measures to help ensure that, among other things, 
seafood was correctly identified and its weight properly recorded. 
Furthermore, FDA also proposed guidelines on how a seafood processor 
could use a HACCP-based approach to ensure that fish and fishery 
products were in compliance with the economic adulteration and 
misbranding provisions of the Federal Food, Drug, and Cosmetic Act. 
However, in finalizing its HACCP regulations, FDA eliminated these 
economic fraud controls. In discussing its reasoning for eliminating 
the economic fraud controls in the Federal Register, FDA stated that 
the seafood HACCP system would need to mature before the agency could 
determine whether it should address matters other than food safety 
hazards, such as economic fraud. 

The seafood industry also plays a role in detecting and preventing 
seafood fraud. Seafood industry associations represent various aspects 
of the industry throughout the supply chain, from harvesters to 
retailers. They include product-specific associations, such as the 
Southern Shrimp Alliance in southern states or the Maine Lobster 
Promotion Council, or business-specific associations, such as the 
National Restaurant Association. These industry associations work to 
protect the brand name and quality of their respective products or 
businesses; monitor issues and legislation that may impact the 
industry, including fraud and other illegal activities; and work with 
government agencies and other organizations to promote the health and 
viability of their industry. Some of these associations have also 
provided federal agencies with information on potential seafood fraud, 
such as transshipping schemes to avoid antidumping duties and 
advertisements for short-weighted seafood products. In addition, the 
National Fisheries Institute (NFI) also created the Better Seafood 
Bureau to help its members combat such seafood fraud problems as 
transshipping to avoid antidumping duties, species substitution, and 
short-weighting.[Footnote 7] According to NFI, the goal of the Better 
Seafood Bureau is to promote economic integrity in the seafood industry 
and assure customers of the quality of the institute's members' 
products. NFI requires a hand-signed contract from each member's Chief 
Executive Officer that he or she will comply with all U.S. laws and 
regulations, and has created an accountability system that requires 
members who break the contract to pay for a third-party audit of its 
processes.[Footnote 8] The Southeastern Fisheries Association also 
developed the Seafood Product Quality Code in 1984 to educate any 
interested harvesters, processors, distributors, wholesalers, 
retailers, and consumers on standards and measures to promote product 
quality and build confidence in the seafood industry. 

Federal agencies face challenges in achieving their missions, 
especially if they have limited resources and some elements of their 
missions are shared with other agencies. Effective collaboration is 
often key to overcoming these challenges, and our previous work has 
identified practices that can help enhance and sustain collaboration. 
[Footnote 9] First, collaboration requires agency staff, working across 
agency lines, to define and articulate the common federal outcome or 
goal they are trying to achieve. Second, once a common goal is 
established, agencies need to develop joint strategies. Such strategies 
help align the partner agencies' individual activities and resources to 
contribute to accomplishing the common goal. Third, the agencies should 
work together to agree on their roles and responsibilities. By agreeing 
on their roles and responsibilities, agencies can clarify who will do 
what, organize their joint and individual efforts, and determine who 
will lead the collaborative effort. Fourth, because each agency may 
contribute different activities and levels of resources toward 
achieving the common goal, by assessing their relative strengths and 
weaknesses, collaborating agencies can identify opportunities to 
leverage each other's resources. This may lead to additional benefits 
that would not have been available if they were working separately. 
Fifth, to ensure consistent implementation of their activities and a 
sustained collaborative effort to achieve the common goal, the agencies 
should develop compatible policies and procedures for all of the 
agencies to follow. (Appendix I includes a list of the three other 
collaboration practices we previously identified but did not address in 
this report.) 

CBP and NMFS Take a Variety of Actions to Detect and Prevent Seafood 
Fraud, While FDA Takes Few Actions Related to Seafood Fraud: 

CBP focuses on detecting schemes to avoid paying customs duties by 
reviewing import information; targeting and, along with ICE, 
investigating potential seafood fraud perpetrators; and taking 
enforcement actions, if warranted. NMFS offers a voluntary, fee-for- 
service seafood inspection program that can detect seafood fraud, such 
as short-weighting, and may also help prevent seafood fraud by 
identifying economic fraud risks during processing. However, NMFS 
inspects approximately one-third of the seafood consumed in the United 
States. FDA directs its field staff to minimize work on economic fraud 
issues because it considers food safety a higher priority than economic 
fraud. Nonetheless, FDA's health and safety actions, such as 
examinations of seafood imports, sometimes uncover seafood fraud 
incidentally. FDA's primary regulatory program for domestic seafood 
processors--HACCP--does not address the economic fraud risks also 
associated with processing. In addition, while FDA maintains a list of 
scientific and market names of seafood that is intended to help the 
seafood industry comply with FDA's regulations on product mislabeling, 
until January 2009, FDA had not fully updated the publicly available 
list it created in 1993, despite having made numerous changes since 
then. Finally, the guidance FDA provides to seafood processors to help 
ensure that their seafood products are safe does not reflect the 
seafood labeling requirements in the Food Allergen Labeling and 
Consumer Protection Act of 2004, which could incidentally help detect 
and prevent species substitution, since processors would need to verify 
the species of fish or shellfish to ensure accurate labeling. 

CBP Takes a Variety of Actions to Detect Schemes to Falsify Import 
Information and Thereby Avoid Paying Import Duties: 

For imported seafood to enter U.S. commerce, the importer must file for 
entry with CBP and submit electronic or paper entry documents to CBP. 
The entry documents include basic information about the imported 
product, such as its type, quantity, and value. As the first step, port 
officials select some of these entry documents to review to determine 
whether to allow the imported product, including seafood, to enter U.S. 
commerce.[Footnote 10] However, due to the large number of goods 
imported into the United States, port officials can only examine a 
fraction of incoming shipments. For example, from fiscal years 2004 to 
2008, CBP officials examined between approximately 1.0 to 2.4 percent 
of all seafood imports. Importers must file additional documents (known 
as "entry summary" documents) and pay the appropriate duties, taxes, 
and fees on imported merchandise for consumption, including seafood 
products, within 10 days after CBP releases them from its custody. 
CBP's import specialists and other port officials select some entry 
summary documents to review to ensure accurate duty collection, which 
includes some seafood. For example, Chinese shrimp and crawfish and 
Vietnamese frozen fish fillets are subject to antidumping duties. On 
the basis of these reviews, CBP officials select importers for further 
review whose documentation indicates that they may be trying to avoid 
paying the appropriate duties. 

In addition, CBP operates a national statistical sampling program, 
known as the Compliance Measurement Program, which randomly selects 
shipments of imports by commodity for review or examination to 
determine the degree to which they comply with customs trade laws and 
regulations, among other things. The Compliance Measurement Program was 
designed to identify trade problems or patterns of deception for 
specific commodities so that CBP officials can then focus their efforts 
against these illegal or fraudulent activities. Port officials only 
review a limited number of seafood entries under the program. For 
example, in fiscal year 2007, import specialists from all ports in the 
United States examined 766 seafood product entries out of 390,799 such 
entries and found a high compliance rate, 97.3 percent, for the 
applicable trade revenue laws. Although the Compliance Measurement 
Program could uncover seafood fraud or duty evasion, CBP officials 
noted that in-depth investigative work may be needed to uncover schemes 
to willfully defraud the U.S. government, which is beyond the scope of 
the examinations conducted under the program. 

Another step CBP takes to detect and prevent seafood fraud is to target 
shipments that CBP officials suspect are part of a scheme to evade 
customs duties. CBP has five National Targeting and Analysis Groups 
(NTAG) that develop criteria to target potentially fraudulent imports. 
One of these NTAGs develops criteria to target potentially fraudulent 
shipments of seafood and reviews leads from other CBP officials and 
external organizations, such as trade associations, on transshipping 
schemes to avoid paying antidumping and countervailing duties. This 
NTAG researches and monitors trade trends to identify changes or 
patterns in trade that may signal potential fraudulent activity. For 
example, as part of their 2005 inquiry into an allegation of illegal 
transshipment of Chinese shrimp through Indonesia, the NTAG staff 
reviewed information on the shippers of Indonesian shrimp before and 
after the antidumping duty order for Chinese shrimp was put in place. 
They found a sharp decrease in shrimp imports from China after the 
antidumping duty order was issued in early 2005 and a concurrent 
increase in shrimp imports from Indonesia, among other countries. The 
NTAG staff enlisted the support of ICE to investigate Indonesian shrimp 
exporters who they suspected were illegally transshipping Chinese 
shrimp. They found that some Indonesian firms were importing Chinese 
shrimp and then shipping them to the United States labeled as 
Indonesian shrimp. CBP found that, in 2005, approximately $6 million 
worth of Chinese shrimp had been illegally transshipped through 
Indonesia to avoid antidumping duties. 

While the illegal transshipment of Chinese shrimp continued through a 
different transshipping point, this time it also had a health-and food- 
safety-related effect. In June 2007, FDA announced a countrywide import 
alert on five Chinese-farmed seafood products, including shrimp. This 
import alert required that all Chinese shrimp be detained and refused 
entry, unless the importer could prove the absence of unapproved drugs 
in the shrimp. On the basis of industry information and CBP and ICE 
investigations, CBP determined that Chinese shrimp was being 
transshipped to the United States through Malaysia. Due to this illegal 
transshipment, importers of Chinese shrimp were able to circumvent not 
only the 2005 antidumping duty but also FDA's recent import alert. In 
September 2007, CBP tested shipments of suspected Chinese shrimp 
illegally transshipped through Malaysia for the presence of unapproved 
drugs and found some contaminated shrimp. On the basis of CBP's 
information, in March 2008, FDA issued a new import alert requiring 
importers of shrimp from one Malaysian manufacturer to prove the 
absence of unapproved drugs prior to entering future shipments of 
shrimp into U.S. commerce. 

In 2007, the NTAG that works on seafood fraud issues also helped 
identify another scheme importers were using in their attempt to evade 
antidumping duties on Chinese shrimp. Under this scheme, importers 
provided CBP with fraudulent information on the product type to evade 
antidumping duties. A precursor to breaded shrimp called "dusted 
shrimp" was exempted by the Department of Commerce from the antidumping 
duty order on imported Chinese shrimp.[Footnote 11] On the basis of 
allegations from the U.S. shrimp industry, CBP initiated an intensive 
examination and sampling operation to determine whether importers were 
bringing in shipments of falsely declared dusted shrimp to avoid the 
antidumping duties on Chinese shrimp. Over the course of a 90-day 
period, CBP found that of the 81 alleged dusted shrimp entries examined 
and sampled, approximately 64 percent of the shipments did not meet the 
criteria to qualify as dusted shrimp. The potential loss of trade 
revenue from these fraudulent dusted shrimp shipments was approximately 
$5 million. Extrapolating back to when the antidumping duty order first 
became effective in 2005, CBP concluded that the importers caught 
importing these fraudulent dusted shrimp imported approximately $117 
million worth of potentially fraudulent dusted shrimp with a possible 
loss of trade revenue from the uncollected antidumping duties of $132 
million. 

CBP's Office of Regulatory Audit provides additional support with 
suspected transshipping incidents to determine whether importers are 
participating in schemes to evade duties. CBP audits importers to 
ensure that they have reported and paid all trade revenue, such as 
antidumping duties, as required under trade laws and agreements. They 
perform two types of audits--a quick-response audit, which focuses on a 
specific issue, and a focused assessment audit, which evaluates all of 
a company's CBP activities and controls. The quick-response audits are 
focused on detecting fraudulent practices, such as unlawful 
transshipment of seafood to evade antidumping duties. For example, a 
quick-response audit concluded in 2007 found that an importer did not 
pay approximately $2.2 million in antidumping duties on imported 
Chinese shrimp that was transshipped through Indonesia. The focused 
assessment audits are comprehensive audits where the auditors review 
and test the company's management oversight processes or "internal 
controls" to identify areas of uncollected trade revenue, such as 
unpaid antidumping duties. The focused assessment audits have included 
seafood importers, but they have only uncovered one violation since 
2005 that was related to seafood fraud. 

Finally, in the event CBP identifies violations of laws, it can assess 
penalties against an importer. The maximum penalty amount that CBP can 
assess varies, depending upon whether the perpetrator's actions were 
fraudulent, negligent, or grossly negligent. Penalties can range from 
two to four times the loss of lawful duties, taxes, and fees to the 
U.S. government or the domestic value of the merchandise. In addition, 
CBP may cooperate with other agencies to pursue criminal charges 
against perpetrators of seafood fraud. For example, in July 2003, CBP 
cooperated with ICE to investigate a case where, according to ICE 
officials, one exporter and several importers conspired to evade 
antidumping duties in excess of $3 million on freshwater crawfish. 
According to these officials, the coconspirators were indicted for 
smuggling and conspiracy in November 2003, and one defendant was 
convicted of conspiracy in 2004. 

NMFS's Voluntary, Fee-for-Service Seafood Inspection Program Helps 
Industry Detect and Prevent Seafood Fraud: 

NMFS offers two types of services to help industry address seafood 
fraud. NMFS provides these voluntary, fee-for-service inspection 
services through its Seafood Inspection Program. This program currently 
serves approximately 375 domestic seafood firms and 63 foreign seafood 
firms, and, according to senior officials in NMFS's Seafood Inspection 
Program, NMFS inspects approximately one-third of the seafood consumed 
in the United States. First, NMFS inspects shipments (known as "lots") 
of seafood products purchased by its clients that include retailers 
such as supermarkets. During lot inspections, inspectors take a random, 
representative sample from the seafood lot and may perform several 
tests on this sample, including weighing it to ensure that the actual 
weight matches the labeled package weight. NMFS inspectors have 
identified instances of seafood fraud, especially short-weighting, in 
seafood products processed domestically and in foreign facilities. NMFS 
also may be able to uncover species substitution during a lot 
inspection in two ways: (1) according to senior officials in NMFS's 
Seafood Inspection Program, NMFS inspectors are trained to visually 
differentiate between different types and species of fish and (2) 
inspectors can use the capabilities of NOAA's National Seafood 
Inspection Laboratory to test for and identify the species of seafood. 
However, NMFS does not maintain a comprehensive list of all lot 
inspections conducted and, thus, does not have the ability to determine 
the frequency with which it uncovers fraudulent seafood products. 

Second, NMFS also offers a Quality Management Program that can help 
seafood processors decrease the potential for fraudulent seafood by 
applying HACCP principles to both food safety and economic fraud risks. 
In 2007, NMFS inspected 202 domestic seafood companies under its 
Quality Management Program. As part of this program, NMFS inspects 
seafood processors to ensure their compliance with FDA's seafood HACCP 
regulations that require processors to identify potential food safety 
hazards during processing and establish controls to mitigate them. NMFS 
also goes a step further and requires that seafood processors that 
choose to participate in the Quality Management Program (1) create a 
"Defect Action Plan," which identifies potential economic fraud risks 
during the processing of seafood, such as short-weighting, and (2) 
develop measures to mitigate those fraud risks. For example, the plan 
could require that samples of the finished seafood product be removed 
from the processing line every hour and the weight checked to ensure 
that the actual weight and the weight as stated on the package are the 
same. If any short-weights were identified, then all products since the 
last check would be weighed again, and the content amounts would be 
corrected. Also, the scales used in the processing phase would be 
checked and recalibrated, if necessary. In addition, processors can 
inspect seafood products upon receipt and compare the processors' 
species identification with the species listed on the invoices. Through 
these measures, processors can provide some assurance against short- 
weighting and species substitution. 

FDA Considers Economic Issues a Low Priority Compared with Health and 
Safety Issues, but It Has Incidentally Identified Instances of Seafood 
Fraud: 

FDA is responsible for ensuring that foods are safe, wholesome, 
sanitary, and properly labeled. To that end, FDA is authorized to issue 
regulations to enforce the Federal Food, Drug, and Cosmetic Act. The 
act prohibits the misbranding or adulteration of food products, which 
would include seafood products that have been mislabeled, substituted, 
or over-glazed. FDA considers detecting violations like these a low 
priority and devotes minimal resources to such work, according to 
published program guidance and senior FDA officials. For example, FDA's 
program guidance to its field staff on imported and domestic seafood 
products states that no resources have been allocated for seafood fraud-
related work, and that resource expenditures in this area should be 
kept to a minimum. According to FDA senior officials, the agency does 
not have the staff or resources to address economic fraud in addition 
to their food safety responsibilities, which they believe are a top 
priority and more important. 

Nevertheless, in the course of their work examining the safety of 
seafood imports, FDA inspectors may uncover seafood fraud. FDA 
inspectors review import entry information, such as the type of seafood 
being imported and the importer's history of violations, if any; 
physically examine the imported goods; and collect samples for 
laboratory analysis to identify those that are potentially in violation 
of U.S. food regulations and laws. FDA may refuse to allow an imported 
seafood product to enter U.S. commerce if it appears to be adulterated 
or misbranded or for other violations of regulations and laws that FDA 
administers. However, from fiscal years 2003 to 2008, only 1 percent of 
the refusals of imported seafood products were related to seafood 
fraud. 

FDA also maintains an "import alert" list to detain entries of imported 
foods that appear to have significant recurring violations. FDA 
currently has three import alerts related to seafood fraud. One import 
alert lists 10 foreign firms that were found to have declared an 
assortment of seafood products under the name of a fictitious, 
incorrect, or substituted species. The other two import alerts provide 
information to FDA's field staff about the potential mislabeling of two 
specific types of fish--catfish and red snapper. The import alerts 
inform field office staff of the species of fish that can legally be 
labeled as catfish or red snapper and guidance on how to handle 
incoming shipments that may not be accurately labeled. However, FDA 
officials only physically examine a small percentage of imported 
seafood--about 2 percent of all seafood entries from fiscal years 2003 
to 2008. Of the 2 percent of imported seafood examined by FDA 
officials, approximately 0.05 percent of these examinations were 
related to seafood fraud. 

FDA's primary oversight program for domestic seafood firms is the HACCP 
program, but the focus of this program is health and safety not 
economic fraud. FDA's seafood HACCP regulations require seafood 
processors to identify and establish controls to mitigate potential 
food safety hazards. FDA inspects domestic firms involved in the 
production, storage, and distribution of fish and fishery products to 
ensure that their HACCP plans are properly designed and implemented. 
However, FDA inspectors spend very little time looking for seafood 
fraud. For example, the percentage of domestic seafood firm inspections 
where investigators conducted seafood fraud work was approximately 0.5 
percent from fiscal years 2003 to 2008. FDA also inspects some 
importers and foreign processors for HACCP compliance because, as the 
agency noted in publishing its final HACCP regulations, the importer 
and foreign processor share responsibility in complying with importing 
regulations. Importers are required either to (1) obtain seafood 
products from a country that has an active memorandum of understanding 
or similar agreement with FDA that documents the equivalency or 
compliance of the foreign inspection system with the U.S. system or (2) 
implement written verification procedures to show that the foreign 
processor has complied with the HACCP regulations. Furthermore, FDA 
inspects foreign fish and fishery processors that export seafood to the 
United States, but this number of inspections is very limited. For 
example, in fiscal year 2007, FDA inspected only 61 of 14,569 
registered foreign seafood firms. 

In its 1994 seafood HACCP proposed rule, FDA recommended that seafood 
firms use HACCP-like measures to control for economic fraud because, as 
FDA stated, seafood fraud could also impact food safety. In the 
proposed rule, FDA stated that the " ... misidentification of species 
may also have adverse public health consequences."[Footnote 12] The 
connection between economic fraud and food safety can be seen in an 
incident in 2007 where two individuals became ill after eating puffer 
fish. According to FDA, the puffer fish was imported into the country 
mislabeled as monkfish. Unlike monkfish, puffer fish contains a 
potentially deadly toxin called tetrodotoxin. CBP and ICE's shrimp 
transshipping investigation also highlights the connection between 
economic fraud and food safety. CBP and ICE's investigation found that 
foreign manufacturers and importers were not only attempting to 
circumvent antidumping duties by sending Chinese shrimp to the United 
States through Malaysia, but these companies were also evading an FDA 
import alert aimed at stopping adulterated Chinese shrimp from entering 
the United States. Incidents like these and others have led FDA 
officials, including a senior official in FDA's Office of Food Safety, 
to reconsider the agency's limited level of effort regarding economic 
fraud because they now believe that, if left unregulated, over time, 
seafood fraud may create food safety problems. Specifically, that same 
official said that it may be time for FDA to reconsider incorporating 
nonfood safety hazards, such as economic fraud, in the seafood HACCP 
regulations. According to senior FDA officials, the agency can still 
take actions, such as reviewing labels and issuing import alerts to 
prevent seafood fraud. However, these officials acknowledged that 
requiring measures in HACCP to address seafood fraud would build 
prevention into the processing of seafood. In addition, NMFS officials 
that administer the agency's Quality Management Program believe that 
amending FDA's HACCP regulations to include measures to address 
economic fraud risks would require minimal resources for the seafood 
industry and FDA to implement. Moreover, according to officials in the 
Canadian Food Inspection Agency, Canada has a program similar to NMFS's 
program that requires seafood processors to identify and mitigate both 
food safety hazards and economic fraud risks. However, because FDA 
inspectors primarily inspect for compliance with HACCP regulations, 
until the agency amends the HACCP regulations to include measures to 
identify and mitigate economic fraud risks, its inspectors will 
continue to spend limited time ensuring against mislabeled products, 
and seafood processors may be less attentive to protecting against 
fraud. 

Another opportunity for FDA officials to detect seafood fraud is during 
their review of food labels. According to officials in FDA's Division 
of Import Operations and Policy, food label reviews sometimes occur 
during HACCP inspections of domestic seafood processors and 
examinations of imported seafood products. According to FDA guidance, 
investigators are to review labels on at least three food products when 
conducting a domestic or foreign firm inspection. The review entails 
ensuring that the label complies with all relevant food label laws and 
FDA regulations. For example, the Federal Food, Drug, and Cosmetic Act, 
as amended, prohibits the "misbranding" of food, which includes, among 
other things, labeling that is false or misleading. In addition, food 
labels must generally include an ingredients list that identifies the 
product's ingredients by their common or usual names in order of 
predominance by weight. Food labels must also accurately state the 
contents in terms of weight, measure, or numerical count of the 
product. However, our September 2008 report found that FDA does not 
have reliable data on the number of labels reviewed, nor does it track 
the complete and timely correction of the violations it identifies 
during the reviews.[Footnote 13] As a result, FDA cannot provide 
reliable information on the number of label reviews that identified 
seafood fraud, nor on any corrections of the seafood fraud violations 
it identified. 

FDA may also detect seafood fraud through complaints from industry 
associations. For example, on several occasions during 2008, NFI 
provided FDA with copies of public, written solicitations from foreign 
and domestic companies offering to sell packages of seafood packed to 
80 or 90 percent of the labeled package weight for a discount. These 
short-weighted products could then potentially be fraudulently sold in 
U.S. commerce for the full price on the basis of the labeled package 
weight. According to an FDA Consumer Safety Officer, FDA wanted NFI to 
provide additional information on these companies, such as their 
locations, because some of these companies were not in FDA's inventory 
of seafood processors or importers, and FDA could not identify them 
with certainty. However, we found that some of the companies were 
listed in FDA's inventory because FDA had previously inspected them. 
According to a senior FDA official, FDA is still working with NFI on 
this matter; however, as of December 2008, the agency had taken no 
action against any of the companies that sent solicitations. 

In addition, FDA may detect seafood fraud from consumers and others who 
contact FDA field staff, by telephone, to complain about issues such as 
suspected short-weighted seafood products or species substitution. For 
example, in one case, a consumer complained to FDA about frozen shrimp 
mislabeled as a product of Mexico when a second label underneath the 
first indicated that it was a product of Thailand. Typically, the FDA 
District Consumer Complaint Coordinator would field the telephone call, 
collect information from the consumer, such as the description of the 
product and the problem with the product, and would attempt to 
determine the responsible seafood firm. The Complaint Coordinator or 
other FDA field staff would evaluate the complaint and determine 
whether immediate action is required or whether the information would 
be used for surveillance in the next inspection of the seafood firm. 
However, our 2008 food labeling report found that FDA program managers 
could not use FDA's data system that captures consumer complaints to 
track their timely and appropriate resolution because these data were 
not entered into the system in a manner that would facilitate analysis. 
Specifically, standard terminology was not used and information on 
complaint resolutions was captured in different data fields.[Footnote 
14] We found similar issues regarding the follow-up of consumers' 
complaints of seafood fraud. We reviewed FDA summary data for 105 
consumer complaints related to such things as misbranded, mislabeled, 
and short-weighted seafood products from fiscal years 2004 through 
2007. We judgmentally selected and reviewed FDA's internal documents 
for 5 of 105 consumer complaints and found that for all 5 of the 
complaints, FDA indicated that it would follow up on the complaints 
during the next inspection of the firm that had produced the seafood 
product in question. However, we found no information in FDA's 
inspection reports to indicate that FDA had followed up on three 
complaints. There was no inspection report available for the fourth 
complaint, and for the fifth complaint, there was a report for an 
inspection that was conducted a few days prior to the filing of the 
complaint. 

There are several actions that FDA can take if seafood fraud is 
discovered during an inspection of a seafood firm. FDA may issue a 
warning letter--which is a notice that enforcement actions may be 
forthcoming if corrections are not made--to firms for serious 
violations of regulatory significance. For less serious violations, FDA 
may send an untitled letter, which is an informal communication that 
corrective actions are needed. However, FDA issued no warning letters 
or untitled letters regarding seafood fraud from fiscal years 2005 
through 2008. Additionally, FDA may initiate enforcement actions 
against seafood firms, such as seizing and removing seafood from the 
marketplace; obtaining an injunction to stop a company from engaging in 
behavior that violates certain prohibitions of the Federal Food, Drug, 
and Cosmetic Act and regulations; or barring seafood firms from 
importing goods into the United States. FDA, however, has not taken any 
of these actions for seafood fraud violations since 2000, according to 
a senior FDA official. However, FDA's Office of Criminal Investigations 
has investigated allegations of seafood fraud and provided information 
to the Department of Justice for legal action against the perpetrators. 

FDA helps the seafood industry avoid species substitution by 
maintaining on its agency Web site a publicly available "Seafood List," 
which is a compilation that includes the scientific and market names 
for imported and domestic seafood. The Seafood List is intended to 
promote uniformity in the use of FDA-acceptable market names by the 
seafood industry and to provide consistent advice on these names. For 
example, "catfish" can only be used as a market name for fish that 
belong to the family Ictaluridae, even though there are other species 
of fish whose vernacular name may include the word catfish. However, 
before January 2009, the public version of the Seafood List had not 
been kept up to date. According to an FDA official responsible for the 
Seafood List, even though over 400 changes have been made to FDA's 
internal version of the list since 1993, only about 22 changes had been 
made to the public version of the list as of the end of 2008. However, 
in January 2009, FDA made the revised and fully updated list available 
to the public on its Web site. 

Other countries, such as Canada and Australia, maintain a similar type 
of Seafood List. However, their policies and procedures for maintaining 
these lists differ from those of FDA. For example, Canada publishes on 
the Internet guidelines and criteria that it uses to assign a new name 
for a species of seafood. In addition, the Canadian government will not 
allow a new name for a fish if it is similar or resembles the name of a 
fish with a higher market value. Also, changes made to Canada's seafood 
list are disseminated to an e-mail distribution list that interested 
parties can join. In contrast, until January 2009, FDA did not provide 
information to the public on the guidelines or criteria that it used to 
determine acceptable market names for seafood. In addition, 
stakeholders do not have the opportunity to comment on proposed changes 
to the Seafood List, unless the change was required by law or 
regulation. In contrast, Australia allows for a 3-month public 
consultation period prior to finalizing the change. A senior FDA 
official told us that stakeholders can write to FDA at any time with 
comments about the Seafood List, but that there is no formal comment 
period before changes are made to the list because it is considered 
guidance, not an agency regulation. 

A recent example of a change to the Seafood List illustrates some of 
these issues. In April 2005, FDA allowed a restaurant to advertise 
langostino--with the common names "squat lobster" and "Colorado 
langostino"--as "langostino lobster." However, as of December 2008, the 
publicly available Seafood List had not been updated to reflect this 
change. According to the list on December 10, 2008, the market name for 
langostino is "langostino," and the common names are "squat lobster" or 
"Colorado langostino." Furthermore, according to officials from the 
Maine Lobster Promotion Council, the council wrote to FDA to protest 
this change to the naming of langostinos because it allows a lower- 
market-value seafood, langostinos, to take advantage of the higher 
market value and reputation of the American lobster name.[Footnote 15] 
According to officials from the Maine Lobster Promotion Council, FDA 
did not respond to its inquiries regarding the reasons for the name 
change for langostinos. An FDA official responsible for the Seafood 
List told us that FDA responded to the council by e-mail in August 2008 
stating that, "we have not objected to use of the term langostino 
lobster for various species of squat lobsters." 

According to a senior FDA official, seafood labeling requirements from 
the Food Allergen Labeling and Consumer Protection Act of 2004 may help 
prevent species substitution, but FDA has not updated its guidance to 
the seafood industry to fully reflect the act's labeling requirements. 
The act requires the product label to contain the name of a food source 
from which a major food allergen is derived, and, when the major food 
allergen is fish or Crustacean shellfish, the specific species of fish 
or shellfish must be listed to notify consumers with food allergies of 
a particular type of fish species. According to the same FDA official, 
the act's labeling requirement may help detect and prevent species 
substitution, since processors would need to verify the type of fish or 
shellfish they are processing to ensure accurate labeling. However, 
these seafood labeling requirements are not reflected in FDA's guidance 
to the seafood industry on the development of their HACCP plans to 
prevent and control the health and food safety hazards associated with 
seafood--the Fish and Fisheries Products Hazards and Controls Guidance. 
[Footnote 16] According to a senior FDA official, seafood processors 
should be aware of the act's requirements, and FDA can still enforce 
those requirements, even if they are not reflected in the guidance. 
Even so, senior FDA officials told us that they plan to update the 
guidance to reflect the Food Allergen Labeling and Consumer Protection 
Act of 2004 labeling requirements, but they could not provide us with a 
publication time frame. 

Limited Collaboration Exists among the Key Agencies Responsible for 
Detecting and Preventing Seafood Fraud: 

Limited collaboration among CBP, NMFS, and FDA to detect and prevent 
seafood fraud can diminish their efficiency and effectiveness in 
dealing with this issue. CBP, ICE, FDA and its Office of Criminal 
Investigations, and NOAA's Office for Law Enforcement have worked 
together on criminal cases against individuals and companies suspected 
of committing seafood fraud. CBP, ICE, and FDA are working together to 
target commodities that pose health and safety risks, and NMFS and FDA 
have worked on joint laboratory efforts to share standards for seafood 
species identification. However, CBP, NMFS, and FDA have not 
established common goals related directly to detecting and preventing 
seafood fraud or joint strategies to help achieve the goals. In 
addition, these key agencies have not established policies and 
procedures to promote effective collaboration and better leverage 
resources to achieve their common goal. As a result, the agencies have 
not taken advantage of opportunities to share information that could 
benefit each agency's efforts to detect and prevent seafood fraud, nor 
have they identified similar and sometimes overlapping activities that 
could be better coordinated to use limited resources more efficiently 
and effectively. 

CBP, NMFS, and FDA Have Not Taken Any of the Key Steps to Develop an 
Enhanced Collaborative Working Relationship Related to Detecting and 
Preventing Seafood Fraud: 

CBP, ICE, FDA and its Office of Criminal Investigations, and NOAA's 
Office for Law Enforcement have worked together on developing and 
investigating criminal cases against individuals and companies 
suspected of committing seafood fraud. For example, in one situation, 
ICE and the Office for Law Enforcement developed a case against an 
individual and his companies in Florida, who, aided by exporters in 
Vietnam, imported thousands of pounds of catfish into the United States 
labeled as grouper and other fish to avoid paying antidumping duties. 
The case resulted in an indictment and a guilty plea by the defendant. 
In addition, CBP, ICE, and FDA are working together to target 
commodities that pose health and safety risks through Operation 
Guardian, which is an enforcement initiative to deal with imported 
substandard, tainted, and counterfeit products. Operation Guardian's 
efforts have led to seizures of such commodities as pharmaceuticals, 
steel components, honey, shrimp, and toys. 

However, despite CBP, NMFS, and FDA having responsibilities related to 
seafood fraud detection and prevention, these agencies have not 
implemented key practices our previous work has identified that can 
enhance and sustain collaboration among federal agencies.[Footnote 17] 
Specifically, CBP, NMFS, and FDA have not worked with each other to (1) 
identify their shared individual goals related to seafood fraud 
detection and prevention and (2) develop a common overarching goal or 
goals. Because these agencies have not identified a common goal, they 
also have not implemented the next practices we identified for 
effective collaboration and established joint strategies to achieve 
that goal or agreed on their respective roles and responsibilities in 
achieving the shared goal. The agencies also have not identified ways 
to maximize and leverage their resources by agreeing on the resources 
and activities each agency can commit to accomplishing the common goal, 
nor have they established procedures and policies for working together 
systematically across agency lines. Because the agencies have not 
implemented any of the key practices that enhance collaboration, they 
have missed opportunities to share data among themselves that could 
enhance seafood fraud detection and prevention and leverage resources. 
They also have not identified similar or overlapping activities that 
could be better coordinated or consolidated so that limited funds would 
be used more efficiently and effectively. 

CBP, NMFS, and FDA Are Missing Opportunities to Share Information to 
Better Detect and Prevent Seafood Fraud: 

CBP, NMFS, and FDA each collect information on seafood products to meet 
their respective responsibilities, but they do not always share 
information that could be used to detect and prevent seafood fraud. CBP 
collects information on seafood imports, such as product type, product 
quantity, and country of origin, through the review and examination of 
imported goods and import entry documents, audits, and laboratory 
analysis. NMFS collects information in lot inspection reports that 
identify short-weighted domestic and imported products. FDA collects 
information on imported seafood products, such as the accuracy of 
product labeling, through entry document reviews, food label reviews, 
product examinations, inspections, and laboratory analysis. Some of the 
information these agencies collect could be used to identify seafood 
fraud, such as the names of the importers and the seafood products that 
were illegally transshipped to avoid customs duties or were mislabeled. 
However, these agencies have not developed procedures to identify or 
share useful information. For example, CBP and FDA both find seafood 
imports with inaccurate product type, weight, and country-of-origin 
labels. By sharing this information, CBP and FDA would have more data 
about violative imported products and could target those products with 
the most violations or greater likelihood to be violative for more 
frequent inspections. Additionally, CBP and FDA could compare 
information each agency receives from importers on the product type and 
country of origin to determine if this information is consistent, which 
would help ensure that importers were not attempting to circumvent an 
antidumping duty or an FDA import alert. An official in FDA's Division 
of Import Operations and Policy told us that while there are no formal 
mechanisms for sharing this information between FDA and CBP, FDA makes 
referrals regarding violative imported products to CBP on an ad hoc 
basis. 

In addition to information on seafood products, CBP, NMFS, and FDA also 
have information on seafood importers that each collects through audits 
and inspections, respectively, but do not share this information with 
each other. During an importer audit, CBP ensures that importers have 
reported and paid all trade duties as required under trade laws and 
agreements on the basis of the product documentation and labeling. 
During an inspection of a seafood importer, FDA may review importer 
documentation and collect samples to identify products not in 
compliance with the Federal Food, Drug, and Cosmetic Act's labeling 
requirements. FDA and CBP may both identify discrepancies in product 
information supplied by seafood importers, such as declaring incorrect 
information on import documents or having inadequate proof of 
documentation, when checking for compliance with labeling requirements. 
Because CBP and FDA do not share the results of their respective audits 
and inspections, they do not have the most comprehensive information on 
noncompliant seafood importers that could help identify those with a 
greater likelihood of problems in the future. In addition, NMFS does 
not share information with FDA from its lot inspections about importers 
and processors that produced short-weighted seafood products on a 
regular basis, so FDA could further investigate this concern during 
future examinations or inspections. 

In investigating illegal transshipment or other schemes to avoid 
duties, CBP and ICE may require information on foreign seafood 
producers critical to their investigations. However, CBP and ICE may be 
denied access to the countries where the problematic seafood producers 
are located. For example, in 2007, CBP and ICE were denied entry into a 
country to investigate an alleged transshipping scheme to avoid paying 
antidumping duties and, thus, could not collect crucial information 
about the foreign seafood producers in question. CBP could potentially 
benefit from information obtained from FDA and NMFS, both of which 
conduct inspections of foreign seafood producers.[Footnote 18] 
According to senior CBP and ICE officials, they would find information 
from FDA's and NMFS's foreign inspections beneficial, depending on the 
facts of particular enforcement activities they are pursuing. 

Lack of Collaboration by CBP, NMFS, and FDA to Detect and Prevent 
Seafood Fraud Has Resulted in Overlapping Actions and Inefficient Use 
of Resources: 

Not only does the lack of collaboration create inefficient information 
sharing between the key federal agencies, it also creates overlapping 
agency efforts and inefficient use of government resources. NMFS and 
FDA have similar inspection programs--NMFS inspects facilities, on 
request, for health, safety, and economic integrity issues, while FDA 
focuses its inspections on health and safety concerns. However, an FDA 
official said that the agency is not sure whether it can rely on NMFS 
inspections, in part due to concerns about potential conflicts of 
interest because NMFS is paid by industry to conduct its inspections. 
FDA has identified these potential conflicts as an impediment to fully 
using NMFS inspection efforts in the past. In our 2004 report on FDA's 
imported seafood safety program, we stated that an official raised 
concerns about potential conflicts of interest with NMFS inspections, 
but that other officials thought that these concerns could be addressed 
in an agreement between the two agencies.[Footnote 19] We recommended 
that FDA and NMFS develop a memorandum of understanding (MOU) that, in 
part, would use and leverage NMFS inspection services to more 
efficiently and effectively monitor the safety of imported seafood. In 
response, FDA stated that there were already three MOUs between FDA and 
NMFS that dealt with seafood safety and inspection operations, but that 
it would explore additional opportunities to better leverage NMFS 
inspection resources and more efficiently and effectively protect the 
public health. Among the three MOUs, the 1974 MOU between FDA and NMFS 
stated, in part, that NMFS would provide FDA with information on 
establishments under contract with it, and that such inspections and 
consultations with FDA should diminish the need for FDA inspections. 
Despite FDA's statements and the provisions in its 1974 MOU, FDA still 
does not take into account whether NMFS has already inspected a 
facility when FDA determines which facilities it will inspect. For 
example, from 2005 through 2008, NMFS inspected one facility we visited 
at least four times a year, yet FDA also inspected it in 2005, 2006, 
and 2008. Furthermore, neither agency found any significant issues 
during their inspections of this facility. Overall, in fiscal year 
2007, FDA inspected 120 facilities that were also inspected by NMFS, 
while FDA had not inspected 1,464 other facilities since before fiscal 
year 2003. Also during fiscal year 2007, NMFS inspected 88 facilities 
that FDA either had not inspected within the same fiscal year or had 
not inspected at all. In its technical comments to our draft report, 
FDA stated that it is currently negotiating an MOU with NMFS that is 
intended to address its concerns about potential conflicts of interest. 

Furthermore, CBP, NMFS, and FDA each have their own laboratory 
capabilities for, among other things, determining the species of 
seafood samples they receive. Moreover, because these agencies use 
different testing methodologies and standards for species 
identification, they do not acknowledge each others' laboratory 
results, nor do they share the species standards they have developed. 
CBP uses DNA sequencing to identify a seafood species, and FDA and NMFS 
use the isoelectrophoresis method.[Footnote 20] While CBP has developed 
some authenticated DNA samples of fish species, it uses GenBank DNA 
sequences as a guide to conduct most of its laboratory testing for 
species identification.[Footnote 21] FDA and NMFS do not believe that 
the GenBank data are sufficiently accurate to use as the basis for a 
regulatory action, such as providing validated evidentiary support to 
prove species substitution during a criminal prosecution. As a result, 
FDA is in the process of developing its own secure database of DNA 
sequences for seafood species identification. FDA laboratory officials 
told us the agency has developed DNA sequences for 72 seafood species 
and is in the process of adding about 100 more species. NMFS has its 
own library of standards for seafood species identification but has had 
meetings with FDA regarding sharing species standards and getting DNA 
analysis approved by an international accreditation agency as an 
official method for species identification. According to FDA laboratory 
officials, the agency would be willing to share its species standards 
with CBP as well, but neither agency has had any discussions on this 
matter. According to a senior CBP laboratory official, CBP has no need 
to access any standards other than those contained in GenBank. Both CBP 
and FDA could increase the number of DNA sequences they have available 
to identify species substitution by combining and sharing their 
standards. However, CBP, NMFS, and FDA have not collaborated with each 
other to develop a comprehensive DNA database. 

Conclusions: 

Although FDA has tools that it could use to help detect and prevent 
seafood fraud, the agency is not using them as efficiently and 
effectively as it could. For example, the agency's primary regulatory 
program for seafood firms--HACCP--does not require firms to identify 
and establish controls to mitigate economic fraud risks, only potential 
food safety hazards. Also, the agency does not provide the opportunity 
for stakeholder comments prior to making changes to the Seafood List, 
and it has not routinely updated the public version of the list 
whenever FDA makes changes to it. This has limited the effectiveness of 
the list in promoting uniformity in seafood species names and in 
preventing species substitution. Likewise, not updating the Fish and 
Fisheries Products Hazards and Controls Guidance to reflect the 
labeling requirements of the Food Allergen Labeling and Consumer 
Protection Act of 2004 has limited the usefulness of the guidance in 
preventing species substitution. 

Because responsibilities for detecting and preventing seafood fraud are 
shared among three key federal agencies--CBP, NMFS, and FDA--effective 
collaboration is important to operating efficiently and effectively and 
to producing a greater public benefit than if the agencies acted alone. 
Currently, however, the three agencies are mostly acting alone and have 
not implemented key practices to begin collaborating more efficiently 
and effectively, such as identifying a common goal and establishing 
joint strategies to achieve the goal. As a result, the three agencies 
are not sharing information that could be used to detect or prevent 
seafood fraud and are working on creating individual databases of 
seafood species standards and using different methods to do so. Until 
these agencies begin collaborating more efficiently and effectively to 
detect and prevent seafood fraud, duplication of efforts may continue 
to occur, and the agencies may continue to miss opportunities to use 
limited federal funds more efficiently and effectively. 

Recommendations for Executive Action: 

To help reduce the prevalence of seafood fraud and improve FDA's 
actions to detect and prevent seafood fraud, we are recommending that 
the Commissioner of the Food and Drug Administration take the following 
three actions: 

* propose amendments to FDA's seafood HACCP regulations to include 
requirements that covered facilities include control points that can be 
used to identify and mitigate economic fraud risks; 

* provide the opportunity for stakeholder comments prior to formalizing 
any changes to the Seafood List not required by law or regulation and 
routinely update the public version of the list whenever FDA makes any 
changes; and: 

* update the Fish and Fisheries Products Hazards and Controls Guidance 
to reflect the seafood labeling requirements of the Food Allergen 
Labeling and Consumer Protection Act of 2004. 

To maximize the efficiency and effectiveness of each agency's efforts 
to detect and prevent seafood fraud and to increase interagency 
collaboration, improve information sharing, and reduce overlaps, we 
recommend that the Commissioner of Customs and Border Protection, the 
Under Secretary of Commerce for Oceans and Atmosphere, and the 
Commissioner of the Food and Drug Administration take the following two 
actions: 

* develop goals, strategies, and mechanisms to share information and 
resources related to seafood fraud detection and prevention across 
agency boundaries and: 

* create a federal agencywide library of seafood species standards. 

Agency Comments and Our Evaluation: 

We provided the Departments of Commerce, Health and Human Services, and 
Homeland Security with a draft of this report for their review and 
comment. Commerce, representing NOAA, said that the draft report did a 
fair and thorough job in assessing and isolating seafood fraud issues 
and concerns shared by Commerce, HHS, and Homeland Security, and the 
agency agreed with the two recommendations regarding interagency 
collaboration that involved Commerce. Commerce also noted that while 
the draft report emphasized the activities of the Seafood Inspection 
Program, NOAA's Office for Law Enforcement also plays a pivotal role in 
seafood fraud activities when detected. Commerce's specific comments 
are presented in appendix II. 

HHS, representing FDA, said that the draft report raised some important 
issues regarding FDA's seafood program, and the agency generally agreed 
with our recommendations. HHS provided additional information about 
activities that FDA has under way related to specific recommendations. 
Regarding our first recommendation, HHS said that FDA agrees that it is 
appropriate to reassess whether to recommend that processors include 
nonsafety hazards in their HACCP plans but did not say that the agency 
would propose amending HACCP regulations to require such changes. We 
continue to believe that the regulations should be amended. Regarding 
our second recommendation, HHS said that FDA would reassess the 
mechanism to seek stakeholder comments on changes to the Seafood List 
but did not commit to providing stakeholders with the opportunity to 
comment before changes are made to the list, as we recommended. We 
continue to believe that it is important that stakeholders be able to 
comment before changes are made to the list. While HHS said that FDA 
had revised the Seafood List and would post it on its Web site soon, 
HHS did not say whether FDA planned to routinely update the public 
version of the list whenever it makes any changes, as we recommended. 
We continue to believe that this is important. Regarding our fourth 
recommendation, HHS said that FDA agrees that it should collaborate 
with the other federal agencies to maximize efficient use of resources, 
but HHS also said that FDA is currently involved in many collaborative 
activities related to seafood fraud. We recognize that FDA has 
collaborative activities under way; however, as this report indicates, 
we believe that many opportunities exist to improve collaboration, 
specifically in the detection and prevention of seafood fraud, by 
following the key collaboration practices our report identifies. These 
practices can increase the opportunities to identify and share the 
relevant information and resources necessary for effective and 
efficient prevention and detection of seafood fraud. HHS provided 
technical comments that we incorporated into the report as appropriate. 
HHS's specific comments are presented in appendix III. 

Homeland Security, representing CBP, generally agreed with the two 
recommendations that involved CBP. Regarding our recommendation to 
create a federal agencywide library of seafood species standards, CBP 
said that it believes that it would be more efficient for the agencies 
to work with the National Institutes of Health in the maintenance of 
GenBank and assist in addressing whatever shortcoming might be 
associated with that data bank. We are not recommending whether CBP, 
FDA, and NMFS should agree to use an existing data bank or to create a 
new one. Rather, we are recommending that, to improve efficiency and 
reduce costs, the three agencies collaborate to fully understand each 
others needs, capabilities, and plans so they can agree on a single 
species standards library. Homeland Security also provided technical 
comments that we incorporated into the report as appropriate. Homeland 
Security's specific comments are presented in appendix IV. 

As agreed with your office, 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 Commerce, 
Health and Human Services, and Homeland Security; and other interested 
parties. In addition, the report will be available at no charge on the 
GAO Web site at [hyperlink, http://www.gao.gov]. 

If you or your staff 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 V. 

Sincerely yours, 

Signed by: 

Lisa Shames: 
Director, Natural Resources and Environment: 

[End of section] 

Appendix I: Scope and Methodology: 

The three federal agencies that play key roles in detecting and 
preventing seafood fraud are (1) the Department of Homeland Security's 
Customs and Border Protection (CBP), (2) the Department of Commerce's 
National Marine Fisheries Service (NMFS), and (3) the Department of 
Health and Human Services' Food and Drug Administration (FDA). We 
reviewed data and documents from each agency on the amount and nature 
of seafood fraud that they have identified and any corrective actions 
they have taken against fraud perpetrators. We also reviewed program 
guidance, inspection operation manuals, and other documentation and 
interviewed knowledgeable officials to determine each agency's overall 
approach and specific actions to detect and prevent seafood fraud-- 
including the priority given to seafood fraud detection and prevention 
among their other responsibilities. We also observed FDA's and NMFS's 
inspections of seafood processing facilities. In addition, we obtained 
examples of criminal investigations of seafood fraud to understand the 
nature and impact of seafood fraud. 

For this report, we relied on the findings of our September 2008 report 
to assess the reliability of FDA's data.[Footnote 22] The data we used 
came from the same data sources used in our 2008 report, in which we 
found the FDA data to be sufficiently reliable for the purposes of this 
report. To assess the reliability of CBP and NMFS data, we performed 
testing for obvious errors in accuracy and completeness and reviewed 
relevant documentation. We also worked closely with agency officials to 
identify and resolve any data problems. We determined that the data 
from these three agencies were sufficiently reliable for the purposes 
of this report. 

Finally, we also met with representatives from six major seafood 
industry associations to determine their views on the nature of the 
seafood fraud problem, the actions they have taken to help prevent 
seafood fraud, and how they interact with the key federal agencies. We 
interviewed officials from the Catfish Farmers of America, Maine 
Lobster Promotion Council, National Fisheries Institute, National 
Restaurant Association, Southeastern Fisheries Association, and 
Southern Shrimp Alliance. 

We visited the Boston, New York/Newark, and Los Angeles/Long Beach 
ports of entry. During these visits, we observed CBP's process for 
reviewing import entry documents, discussed local targeting efforts and 
whether any collaborative efforts related to seafood fraud existed 
between CBP and FDA, and toured the port facilities. At the Los 
Angeles/Long Beach ports, we also met with FDA officials to discuss and 
observe their process for inspecting imported seafood. 

We also interviewed officials from four states--California, Florida, 
New York, and Texas--to determine their roles, responsibilities, and 
interactions with the federal agencies in detecting and preventing 
seafood fraud. We selected these states on the basis of their 
population size and, because of their coastal location, their having a 
potential port of entry for imported seafood. Additionally, we 
interviewed officials at Alabama's Food and Drug Laboratory because of 
its active efforts in developing laboratory methods for testing seafood 
products. 

To determine the extent that the key federal agencies collaborate with 
each other to help detect and prevent seafood fraud, we first 
identified practices that our previous work indicated can help enhance 
and sustain collaboration among federal agencies.[Footnote 23] For the 
purposes of this report, we focused on the first five of the eight 
practices we previously identified for enhancing and maintaining 
effective collaboration among federal agencies: (1) define and 
articulate a common goal; (2) establish mutually reinforcing or joint 
strategies to achieve that goal; (3) identify and address needs by 
leveraging resources; (4) agree on roles and responsibilities; and (5) 
establish compatible policies, procedures, and other means to operate 
across agency boundaries. We did not address the following practices: 
(1) develop mechanisms to monitor, evaluate, and report on results; (2) 
reinforce agency accountability for collaborative efforts through 
agency plans and reports; and (3) reinforce individual accountability 
for collaborative efforts through performance management systems. We 
did not address these practices because we found that CBP, NMFS, and 
FDA had not implemented the first five practices. As a result, because 
limited collaborative activities were under way, we did not expect the 
agencies to have developed mechanisms to monitor and report on the 
results of their collaboration, reinforce accountability by preparing 
reports, or establish performance management systems. We also analyzed 
agency documents and interviewed officials from CBP, NMFS, and FDA to 
determine the extent to which they had (1) implemented the first five 
previously mentioned collaboration practices, (2) identified and shared 
information that could be beneficial in addressing seafood fraud, and 
(3) engaged in overlapping seafood fraud-related activities. 

We conducted this performance audit from January 2008 to February 2009, 
in accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives. 

[End of section] 

Appendix II: Comments from the Department of Commerce: 

United States Department Of Commerce: 
The Deputy Under Secretary for Oceans and Atmosphere: 
Washington, D.C. 20230: 

January 27, 2009: 

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

Dear Ms. Shames: 

Thank you for the opportunity to review and comment on the Government 
Accountability Office's draft report entitled, Seafood Fraud: FDA 
Program Changes and Better Collaboration among Key Federal Agencies 
Could Improve Detection and Prevention (GAO-09-78). On behalf of the 
Department of Commerce, I enclose the National Oceanic and Atmospheric 
Administration's programmatic comments to the draft report. 

Sincerely, 

Signed by: 

Mary M. Glackin: 
Deputy Under Secretary for Oceans and Atmosphere: 

Enclosure: 

Department of Commerce: 
National Oceanic and Atmospheric Administration: 
Comments on the Draft GAO Report Entitled "FDA Program Changes and 
Better Collaboration among Key Federal Agencies Could Improve Detection 
and Prevention" (GAO-09-258/January 2009): 

General Comments: 

In general, the report on seafood fraud detection does a fair and 
thorough job in assessing and isolating the issues and concerns shared 
by the named agencies, including the National Oceanic and Atmospheric 
Administration (NOAA). The report will be used to assist NOAA to 
determine more effective methods in seafood fraud detection and assist 
in prioritizing the concerns for correction and implementation. The 
report and the recommended NOAA solutions will be shared with the 
proper industry groups to facilitate changes in seafood fraud and its 
detection. 

It should be noted that, while throughout the draft report much 
emphasis was placed on the NOAA activities relative to the Seafood 
Inspection Program, NOAA's Office of Law Enforcement also plays a 
pivotal role in seafood fraud activities when detected. 

NOAA Response to GAO Recommendations: 

"To maximize the efficiency and effectiveness of each agency's efforts 
to detect and prevent seafood fraud and to increase interagency 
collaboration, improve information sharing, and reduce overlaps, we 
recommend that the Commissioner of Customs and Border Protection, the 
Under Secretary of Commerce for Oceans and Atmosphere, and Commissioner 
of the Food and Drug Administration take the following two actions." 

Recommendation 1: "develop goals, strategies, and mechanisms to share 
information and resources related to seafood fraud detection and 
prevention across agency boundaries." 

NOAA Response: NOAA agrees with this recommendation. Such strategies 
and mechanisms have already been initiated in relation to other areas 
of seafood inspection and production. The NOAA Seafood Inspection 
Program, aligned with other NOAA agencies has recently adopted the 
strategy to research and implement proactive testing and evaluation 
methods to detect and isolate economic fraud practices to protect the 
consumer and assist industry in enhanced processing methods. NOAA will 
certainly work with the Department of Homeland Security's Customs and 
Border Protection and the Department of Health and Human Services' Food 
and Drug Administration to further this goal and to reduce seafood 
fraud in the United States. 

Recommendation 2: "create a federal agency-wide library of seafood 
species standards." 

NOAA Response: NOAA agrees with this recommendation. Such a library of 
documented seafood species standards shared among federal agencies 
would lead to increased program efficiencies and effectiveness by 
reducing duplication and creating a more comprehensive collection of 
species standards. The National Seafood Inspection Laboratory is 
currently holding discussions with the other agencies on this subject 
and NOAA's National Marine Fisheries Service will continue to implement 
this recommendation using existing resources. 

[End of section] 

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

Department Of Health & Human Services: 
Office Of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

January 30, 2009: 

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

Dear Ms. Shames: 

Enclosed are comments on the U.S. Government Accountability Office's 
(GAO) report entitled: "Seafood Fraud: FDA Program Changes and Better 
Collaboration Among Key Federal Agencies Could Improve Detection and 
Prevention (GAO-09-258). 

The Department appreciates the opportunity to review this report before 
its publication. Sincerely, 

Signed by: 

Barbara Pisaro Clark: 
Acting Assistant Secretary for Legislation: 

Attachment: 

FDA's General Comments to the U.S. Government Accountability Office's 
(GAO) Draft Report Entitled, Seafood Fraud - FDA Program Changes and 
Better Collaboration Among Key Federal Agencies Could Improve Detection 
and Prevention (GAO-09-258): 

The Food and Drug Administration (FDA) appreciates the opportunity to 
review and comment on the Government Accountability Office's (GAO) 
draft report. GAO has raised some important issues regarding FDA's 
seafood program. FDA strives continually to advance its public health 
mission, and this includes efforts to improve the safety, sanitation, 
suitability, and proper labeling of seafood. 

FDA's Specific Comments on GAO Recommendations: 

GAO Recommendation 1: 

To help reduce the prevalence of seafood fraud and improve FDA's 
actions to detect and prevent seafood fraud, we are recommending that 
the Commissioner of the Food and Drug Administration propose amendments 
to FDA's seafood HACCP regulations to include requirements that covered 
facilities include control points that can be used to identify and 
mitigate economic fraud risks. 

FDA Response: 

FDA agrees with GAO that it is appropriate at this time to reassess 
whether to recommend that processors include nonsafety hazards. When 
FDA proposed the Seafood HACCP Regulation, 21 CFR 122, in 1994, FDA 
included a recommendation, not a requirement, that HACCP plans include 
controls for hazards unrelated to safety, such as economic fraud. 
Approximately 75 comments addressed this provision, the vast majority 
of which urged that it be eliminated from the regulations. Those that 
argued for removal stated that 1) HACCP for safety purposes would be a 
big challenge for both the industry and regulators, and that inclusion 
of nonsafety hazards might be overwhelming; 2) nonsafety hazards are 
covered adequately by existing FDA regulations and by industry quality 
control programs; 3) inclusion of nonsafety hazards deviates from 
internationally recognized HACCP principles; and, 4) inclusion of 
nonsafety hazards would dilute and jeopardize a desirable industry 
focus on safety. Those that argued for inclusion of economic 
adulteration stated that 1) the same conditions of processing that 
affect the occurrence of safety hazards affect the occurrence of 
nonsafety hazards, making the two control systems compatible; 2) an 
improvement in consumer confidence in seafood cannot be achieved 
without improvements relative to economic deception; 3) the seafood 
industry considers economic fraud to be the most significant hazard 
affecting the marketing of its products; 4) species substitution can be 
safety related; 5) HACCP controls would likely enhance compliance with 
existing nonsafety standards; and, 6) inclusion of controls for 
economic fraud would not significantly increase the costs to industry. 

After review of the comments, FDA concluded that the HACCP system would 
have to mature and FDA would need to learn more before it could 
determine whether a mandatory HACCP program should include nonsafety 
matters. Additionally, the agency noted that the statutory provisions 
that form the basis for the Seafood HACCP regulations are safety 
provisions. 

FDA's application of HACCP is intended for the effective enforcement of 
sections 402(a)(1) and (a)(4) of the Federal Food, Drug, and Cosmetic 
Act, which apply to products that contain substances that may render 
the product injurious to health and to processing conditions that are 
insanitary and that could render a product injurious to health. Thus, 
the only issue for FDA to consider in the preparation of the final 
regulations was whether to retain the recommendation, not requirement, 
to include nonsafety hazards in processors' HACCP programs. FDA was 
persuaded by the point raised by some comments that advisory provisions 
of regulations are often confused with or misapplied as requirements. 
For these reasons, the recommendation to include economic fraud in 
HACCP plans was not included in the final regulation. 

After more than a decade of implementation, FDA recognizes the Seafood 
HACCP program as a mature program, and agrees with GAO that this is an 
appropriate time to reassess whether to recommend that processors 
include nonsafety hazards, such as economic fraud, in their HACCP 
plans. 

GAO Recommendation 2: 

To help reduce the prevalence of seafood fraud and improve FDA's 
actions to detect and prevent seafood fraud, we are recommending that 
the Commissioner of the Food and Drug Administration publicize the 
criteria FDA uses to revise the Seafood List, provide the opportunity 
for stakeholder comments prior to formalizing any changes to the list 
not required by law or regulation, and routinely update the public 
version of the list whenever FDA makes any changes. 

FDA response: 

FDA agrees with GAO that it should reassess the mechanism to seek 
stakeholder comments on potential changes in the list of acceptable 
market names and inform stakeholders of the changes. 

The last hard copy version of The Seafood List was published in 1993. 
Since then FDA has made the decision to produce the document only in an 
electronic version, available on the Agency website. The first and most 
recent electronic-only version of the document was published in 2002. 
Between the 1993 and 2002 version, there were market name changes 
associated with 22 species of fish, all mandated by law or regulation 
(e.g., catfish and brown king crab). Changes mandated by regulation 
undergo a public notice and comment period. Since 2002, FDA has 
accepted new market names for an additional 23 species of fish, none of 
them mandated by law or regulation. 

FDA has recently completed work on the next version of the document and 
expects that it will be posted on the Agency's website very shortly. 
This version will include the 23 most recent market name changes (e.g., 
langostino lobster). It will also include approximately 400 changes in 
scientific names and additional species names in order to stay current 
with taxonomic convention. These latter changes do not affect 
industry's understanding of suitable market names. In addition, the 
guidance will include a description of the factors that FDA uses in 
determining acceptable market names. 

GAO Recommendation 3: 

To help reduce the prevalence of seafood fraud and improve FDA's 
actions to detect and prevent seafood fraud, we are recommending that 
the Commissioner of the Food and Drug Administration update the Fish 
and Fisheries Products Hazards and Controls Guidance to reflect the 
seafood labeling requirements of the Food Allergen Labeling and 
Consumer Protection Act. 

FDA Response: 

The Fish and Fishery Products Hazards and Controls Guidance is a set of 
recommendations from FDA to the fish and fishery products processing 
industry regarding the hazards that are reasonably likely to occur in 
such products and providing suitable controls to minimize the risk of 
occurrence of those hazards. FDA intends to reflect the labeling 
requirements of the Food Allergen Labeling and Consumer Protection Act 
in the fourth edition of Fish and Fishery Products Hazards and Controls 
Guidance. The document is currently in Agency clearance. 

GAO Recommendation 4: 

To maximize the efficiency and effectiveness of each agency's efforts 
to detect and prevent seafood fraud and to increase interagency 
collaboration, improve information sharing, and reduce overlaps, we 
recommend that the Commissioner of Customs and Border Protection, the 
Under Secretary of Commerce for Oceans and Atmosphere, and Commissioner 
of the Food and Drug Administration develop goals, strategies, and 
mechanisms to share information and resources related to seafood fraud 
detection and prevention across agency boundaries. 

FDA Response: 

Three key federal agencies share responsibilities for detecting and 
preventing seafood fraud. According to GAO's report, each Agency mostly 
acts alone and has not implemented key practices to begin collaborating 
more effectively. FDA agrees that it should collaborate with the other 
federal agencies to maximize efficient use of resources and is 
currently collaborating with National Marine Fisheries Service (NMFS) 
to develop an inter-agency library of seafood species standards. As 
mentioned by GAO, FDA also has collaborated, leveraged resources, and 
shared data with the Department of Homeland Security's Customs and 
Border Protection (CBP) in efforts such as Operation Guardian and in 
sharing weekly refusal reports. 

In December of 2007, Department of Homeland Security, Immigration, and 
Customs Enforcement (ICE) implemented Operation Guardian to combat the 
growth in the importation and distribution of a variety of consumer 
products, which potentially threaten the health and safety of U.S. 
consumers. Since the inception of Operation Guardian, several joint 
enforcement efforts have been initiated against imported food, 
including seafood, involving ICE, CBP, and FDA. In May 2007, Guardian 
regional working groups composed of ICE, CBP, and FDA personnel were 
formed throughout the country. Sixty-one agents from FDA's Office of 
Criminal Investigations (OCI) are assigned to the ICE-chaired 35 
regional working groups. 

Guardian headquarters representatives and regional working group 
members generally meet monthly to evaluate ongoing investigations and 
incoming fraud allegations, and to initiate new enforcement actions. 
Several of these investigations are targeted at individuals and 
entities responsible for the fraudulent importation, through 
transshipment, of seafood subject to CBP anti-dumping duties and FDA 
import alerts which are intended to prevent seafood containing 
unapproved antibiotics from entering the United States. ICE and OCI 
will continue cooperative investigative efforts into such areas as 
transshipment or adulteration of seafood products. In addition, 
collaboration between CBP and the FDA has resulted in regulatory 
actions and import alerts. 

Some other specific examples of FDA's collaborative efforts include the 
following: 

* FDA collected a sample of "langostino" meats through the Port of 
Blaine, Washington that FDA determined were freshwater crawfish instead 
of langostinos. Freshwater crawfish from China are subject to an anti-
dumping duty of 223 percent. An initial review of entries indicated 
that there were at least 23 entries of "langostino" meat valued at $2.3 
million. FDA's report of these findings to members of the ICE resulted 
in the collection of $2.9 million in tariff duties from a Canadian firm 
that exports seafood to the United States. The firm admitted that it 
had misclassified tariff duties on freshwater crawfish from China. 

* FDA participated in a joint investigation with United States Fish 
&Wildlife Service (USFWS) and ICE that involved the smuggling of 
illegal caviar and the sale of adulterated and misbranded product 
throughout the United States. Marky's Caviar, also doing business as 
Optimus, Inc., purchased sturgeon caviar smuggled into the United 
States by couriers inside suitcases without a CBP declaration or USFWS 
inspection. The investigation determined that the sturgeon caviar and 
other fish roe sold were adulterated and misbranded. The caviar was 
adulterated by mixing Beluga caviar with less valuable caviar. The 
caviar was misbranded because it was labeled as Russian caviar when it 
was in fact Chinese. On April 15, 2005, the firm was sentenced to pay a 
$1 million criminal fine into the Lacey Act Reward Fund, to adhere to a 
stringent wildlife compliance plan, and 5 years probation. The sentence 
was imposed for knowingly purchasing sturgeon caviar with false 
wildlife invoices, knowingly purchasing smuggled caviar, and failing to 
exercise due care in purchasing smuggled caviar. 

GAO Recommendation 5: 

To maximize the efficiency and effectiveness of each agency's efforts 
to detect and prevent seafood fraud and to increase interagency 
collaboration, improve information sharing, and reduce overlaps, we 
recommend that the Commissioner of Customs and Border Protection, the 
Under Secretary of Commerce for Oceans and Atmosphere, and Commissioner 
of the Food and Drug Administration create a federal agency-wide 
library of seafood species standards. 

FDA Response: 

FDA is collaborating with other Federal agencies in developing a 
library of seafood species standards. FDA held a two-day workshop in 
January 2008 entitled Regulatory Applications of DNA-Barcoding for the 
Species Identification of Fish which was attended by members of the 
NMFS National Seafood Inspection Laboratory, the NMFS Northwest 
Fisheries Science Center, the Smithsonian National Museum of Natural 
History, the Canadian Center for DNA Barcoding, and the International 
Consortium for the Barcode of Life. In collaboration with the 
Smithsonian NMNH and the Canadian Center for DNA Barcoding, FDA 
published a paper in 2008 entitled Potential Use of DNA Barcodes in 
Regulatory Science: Applications of the Regulatory Fish Encyclopedia in 
the Journal of Food Protection. This paper laid the groundwork for DNA 
barcoding at FDA and provided a bridge for the new methodology with 
FDA's established set of reference tissues used in the old protein 
isoelectric focusing method. FDA also published an FDA Laboratory 
Information Bulletin method in 2008 entitled, A Protocol for Validation 
of DNA-Barcoding for the Species Identification of Fish for FDA 
Regulatory Compliance, which is currently in the final stages of a 
three laboratory inter-lab trial. This trial is the first step 
necessary for performing a full collaborative study required for 
international accreditation. 

FDA has also established a contract with the Smithsonian National 
Museum of Natural History for authentication and vouchering of seafood 
standards collected by FDA. FDA believes that this contract could 
potentially be the foundation for the GAO-recommended library of 
seafood species standards, and will be discussing that possibility with 
NMFS and CBP. 

[End of section] 

Appendix IV: Comments from the Department of Homeland Security: 

U.S. Department of Homeland Security: 
Washington, DC 20528: 

January 30, 2009: 

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

Dear Ms. Shames: 

The Department of Homeland Security (DHS) appreciates the opportunity 
to review and provide comment on the Government Accountability Office's 
(GAO) draft report titled, SEAFOOD FRAUD: FDA Program Changes and 
Better Collaboration among Key Federal Agencies Could Improve Detection 
and Prevention (GAO-09-258). 

DHS generally concurs with the report's two recommendations. Following 
are our recommendation-specific comments; technical comments were 
provided under separate cover. 

Recommendation 1: Develop goals, strategies, and mechanisms to share 
information and resources related to seafood fraud detection and 
prevention across agency boundaries. 

Response: Concur. Customs and Border Protection (CBP) will consider 
issues related to seafood fraud in its regular assessment of trade risk 
and its annual planning process in a continuing an ongoing effort to 
address these matters. 

CBP was an active member of the President's interagency work group 
addressing import safety concerns. The interagency work group developed 
the Import Safety Action Plan, which acknowledges multiple areas of 
import safety concerns including information sharing among agencies. 
The action plan recognizes that agency collaboration, including the 
International Trade Data System (ITDS), is essential for addressing 
import safety concerns effectively. ITDS is a single window information 
integration program that will allow agencies to collaborate in the 
identification and prioritization of high-risk shipments, including 
those considered import safety risks and anti-dumping risks, such as 
those identified in this report. 

On the heels of the President's Action Plan for Import Safety, the 
implementation of interagency workgroups led DHS agencies to conduct 
special operations and other efforts targeted at addressing health and 
safety issues. Throughout the report, GAO makes note of these special 
operations, specifically Operation Guardian, where interagency 
collaboration is demonstrated. 

Recommendation 2: Create a federal agency-wide library of seafood 
species standards. 

Response: Concur. CBP would not oppose the development of a national 
agency database provided that CBP be issued the funding and the 
authority to maintain the database. 

CBP currently uses "Gen-Bank" which is a DNA Sequence Library of 
different species that is maintained by the National Institutes of 
Health/National Center for Biotechnical Information. This database 
accepts DNA Sequence Data from around the world and is truly 
international in nature and wide ranging. Prior to the entry of 
information into the database the information is reviewed by a panel of 
NIH DNA specialists. Being international in nature, it is more widely 
accepted around the world for a number of purposes. CBP frequently uses 
Gen-Bank and has not identified problems or issues with the data to 
date. 

The proposal to create an agency wide database would appear to be 
duplicative of the Gen-Bank but only on a smaller National level. CBP 
would not oppose the development of a national agency database provided 
that CBP be issued the funding and the authority to maintain the 
database. However, CBP believes that it would be more efficient for the 
agencies to work with NIH in the maintenance of Gen-Bank and assist in 
whatever shortcoming might be associated with that data bank. 

Again, we thank you for the opportunity to review and provide comments 
on this draft report and look forward to working with you on future 
homeland security issues. 

Sincerely, 

Signed by: 

Jerald E. Levine Director: 
Departmental GAO/OIG Liaison Office: 

[End of section] 

Appendix V: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

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

Staff Acknowledgments: 

In addition to the individual named above, Stephen D. Secrist, 
Assistant Director; Ami Ballenger; Carolyn M. Boyce; Carol Bray; Kevin 
S. Bray; Nancy Crothers; Winchee Lin; David Moreno; and Matt Sumpter 
made significant contributions to this report. 

[End of section] 

Footnotes: 

[1] GAO, Results Oriented Government: Practices That Can Help Enhance 
and Sustain Collaboration among Federal Agencies, [hyperlink, 
http://www.gao.gov/products/GAO-06-15] (Washington, D.C.: Oct. 21, 
2005). The other three practices discussed in our report on effective 
collaboration are (1) develop mechanisms to monitor, evaluate, and 
report on results; (2) reinforce agency accountability for 
collaborative efforts through agency plans and reports; and (3) 
reinforce individual accountability for collaborative efforts through 
performance management systems. 

[2] See our most recent series, GAO, High-Risk Series: An Update, 
[hyperlink, http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: 
January 2009). Also see, GAO, High-Risk Series: An Update, [hyperlink, 
http://www.gao.gov/products/GAO-07-310] (Washington, D.C.: January 
2007). 

[3] ICE is the largest investigative branch of the Department of 
Homeland Security. According to ICE, the agency assigns special agents 
to, among other things, investigate manufacturers and importers 
allegedly involved in the duty evasion schemes and uses agents 
stationed in foreign countries to conduct investigations. 

[4] Import alerts are designed to ensure that products from processors 
covered by the alert are detained and refused entry into the United 
States until the importer can prove that the imported product is safe 
and complies with all applicable regulations, generally by providing 
FDA with the results of third-party laboratory analysis of the product. 

[5] Generally, the Congress establishes normal customs duties and 
authorizes the executive branch to impose special customs duties, such 
as antidumping and countervailing duties. 

[6] The 2008 Farm Bill made catfish subject to mandatory inspection by 
USDA. The new law requires that USDA continuously inspect domestic 
catfish, and that imported catfish meet equivalent standards before 
being imported into the United States. The Secretary of Agriculture in 
consultation with the Commissioner of the Food and Drug Administration 
has until the end of 2009 to issue regulations to implement the new 
law. 

[7] NFI is a seafood industry advocacy organization. According to NFI, 
its mission is to educate the American public about seafood safety, 
sustainability, and nutrition. NFI's nearly 400 members range from the 
owners of small, family-owned fishing vessels to large, nationally 
traded corporations and include representatives of business, education, 
and government. 

[8] The third-party audit of the member's processes is the normal 
practice NFI uses to hold its member accountable, but it reserves the 
right to dismiss the member from the Better Seafood Bureau without a 
third-party inspection or to take a different action, depending upon 
the type of violation. 

[9] [hyperlink, http://www.gao.gov/products/GAO-06-15]. 

[10] All imported goods are reviewed for national security purposes in 
a screening process that occurs prior to the importer filing for entry 
of the imported goods. 

[11] The Department of Commerce's definition of true, dusted shrimp is 
that having a coating of rice or wheat flour constituting between 4 and 
10 percent of the product's total weight after being dusted, but prior 
to the shrimp being frozen. In conjunction with subject matter experts, 
CBP developed a set of characteristics that a product is required to 
meet to be considered true, dusted shrimp. 

[12] Proposal to Establish Procedures for the Safe Processing and 
Importing of Fish and Fishery Products, 59 Fed. Reg. 4142 (Jan. 28, 
1994). 

[13] GAO, Food Labeling: FDA Needs to Better Leverage Resources, 
Improve Oversight, and Effectively Use Available Data to Help Consumers 
Select Healthy Foods, [hyperlink, 
http://www.gao.gov/products/GAO-08-597] (Washington, D.C.: Sept. 9, 
2008). 

[14] [hyperlink, http://www.gao.gov/products/GAO-08-597]. 

[15] The Maine Lobster Promotion Council, established by Maine in 1991, 
markets and promotes the sale of Maine lobster in local, regional, 
national, and world markets year-round. The council comprises 
harvesters, dealers, and public members from each of Maine's three 
regions. 

[16] U.S. Food and Drug Administration, Center for Food Safety and 
Applied Nutrition, Fish and Fisheries Products Hazards and Controls 
Guidance: Third Edition (June 2001). See the following Web address: 
[hyperlink, http://www.cfsan.fda.gov/~comm/haccp4.html]. 

[17] [hyperlink, http://www.gao.gov/products/GAO-06-15]. 

[18] NMFS inspected 63 foreign facilities from 2007 through November 
2008, and FDA inspected 112 foreign facilities from October 2006 
through June 2008. 

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

[20] Isoelectrophoresis is a method of testing that uses an electric 
field to separate proteins for a species to create a distinct pattern 
that can be used to compare with and identify a seafood species, among 
other types of species. This method of testing has been authenticated 
as an official method for species identification by an international 
accreditation agency. 

[21] GenBank is an open-access DNA sequence database that is maintained 
at the National Institutes of Health's National Center for 
Biotechnology Information. GenBank receives DNA sequences from 
laboratories throughout the world. After being reviewed by National 
Center staff, these DNA sequences are placed in the public database. 

[22] GAO, Food Labeling: FDA Needs to Better Leverage Resources, 
Improve Oversight, and Effectively Use Available Data to Help Consumers 
Select Healthy Foods, [hyperlink, 
http://www.gao.gov/products/GAO-08-597] (Washington, D.C.: Sept. 9, 
2008). 

[23] GAO, Results Oriented Government: Practices That Can Help Enhance 
and Sustain Collaboration among Federal Agencies, [hyperlink, 
http://www.gao.gov/products/GAO-06-15] (Washington, D.C.: Oct. 21, 
2005). 

[End of section] 

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