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United States Government Accountability Office: 
GAO: 

Report to Congressional Requesters: 

May 2012: 

Seafood Safety: 

Responsibility for Inspecting Catfish Should Not Be Assigned to USDA: 

GAO-12-411: 

GAO Highlights: 

Highlights of GAO-12-411, a report to congressional requesters. 

Why GAO Did This Study: 

Since 2007, federal oversight of food safety has been on GAO’s list of 
high-risk areas, largely because of fragmentation that has caused 
inconsistent oversight, ineffective coordination, and inefficient use 
of resources. The Food, Conservation, and Energy Act of 2008 (Farm 
Bill) further fragmented the food safety system by directing FSIS to 
issue catfish inspection regulations. FSIS prepared a risk assessment 
to determine risks associated with catfish and identified Salmonella 
as the primary food safety hazard in catfish. The Farm Bill split 
responsibility for seafood safety between FSIS, for catfish 
inspection, and FDA, for seafood generally; in addition, NMFS provides 
fee-for-service inspections of seafood-processing facilities. GAO was 
asked to examine FSIS’s proposed catfish inspection program. 

GAO examined (1) how FSIS determined that Salmonella presented the 
primary food safety hazard in catfish and (2) the anticipated impact 
of FSIS’s proposed catfish inspection program on other federal food 
safety inspection programs. GAO reviewed FSIS’s proposed catfish 
program and related documents and interviewed officials from FSIS, 
FDA, and other agencies. 

What GAO Found: 

In determining that Salmonella is the primary food safety hazard in 
catfish, the U.S. Department of Agriculture’s Food Safety and 
Inspection Service (FSIS) officials stated that the agency focused on 
Salmonella at the direction of the Office of Management and Budget 
(OMB), which considered Salmonella the most practical hazard to 
evaluate. However, GAO found that FSIS used outdated and limited 
information in its risk assessment as its scientific basis for a 
catfish inspection program that seeks to mitigate that hazard. For 
example, FSIS identified a single outbreak of Salmonella-caused 
illnesses, but this outbreak was not clearly linked to catfish. FSIS 
noted that this outbreak was before the Food and Drug Administration’s 
(FDA) 1997 Seafood Hazard Analysis and Critical Control Point 
regulations, which required firms to identify hazards in their 
processing systems and implement controls to prevent or mitigate these 
hazards; no similar outbreaks have occurred since. Other federal 
agencies questioned if FSIS had adequately demonstrated a Salmonella 
problem in catfish. For example, FDA does not generally have such 
concerns. Officials with the National Oceanic and Atmospheric 
Administration’s National Marine Fisheries Service (NMFS) also stated 
that FSIS did not adequately demonstrate that Salmonella was a problem 
with catfish. 

With the implementation of FSIS’s proposed catfish inspection program, 
responsibility for overseeing seafood safety would be further divided 
and would duplicate existing federal programs at a cost. Under FSIS’s 
proposed program, processers would implement written sanitation and 
hazard control plans; FSIS would conduct continuous inspections of 
domestic catfish processing; and for imported catfish-—which equal 
about 3 percent of all seafood imports-—foreign countries would need 
to demonstrate equivalence to U.S. standards. According to FSIS, 
implementing this program will cost the government and industry about 
$14 million annually. If FSIS’s proposed program were implemented, GAO 
expects it would cause duplication and inefficient use of resources in 
several key areas. First, the program requires implementation of 
hazard analysis plans that are essentially the same as FDA’s hazard 
analysis requirements. Second, if the program is implemented, as many 
as three agencies—-FDA, FSIS, and NMFS-—could inspect facilities that 
process both catfish and other types of seafood. Both FDA and NMFS 
officials stated that continuous inspection will not improve catfish 
safety and is counter to the use of FDA’s hazard analysis 
requirements, in which systems are most efficiently monitored 
periodically rather than daily. Third, the FDA Food Safety 
Modernization Act (FSMA) gives FDA authority to establish a system to 
accredit third party auditors, including foreign governments, to 
certify imported seafood meets FDA regulatory requirements. FDA 
officials stated that this new authority complements FDA’s existing 
authority to obtain assurances about the safety of seafood exports 
from countries with food safety systems FDA determined are comparable 
to the United States. Under these systems more than catfish could be 
covered. With FDA’s new authority under FSMA, the federal government 
has an opportunity to enhance the safety of all imported seafood—-
including catfish-—and avoid the duplication of effort and cost that 
would result from FSIS’s implementation of its proposed program. 

What GAO Recommends: 

Congress should consider repealing provisions of the Farm Bill 
assigning USDA responsibility for catfish inspection. USDA stated it 
is committed to completing the rulemaking process on catfish 
inspection consistent with the 2008 Farm Bill provisions. 

View [hyperlink, http://www.gao.gov/products/GAO-12-411]. For more 
information, contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

FSIS Used Outdated Data to Justify its Determination: 

FSIS's Proposed Program Mirrors Existing Programs, Introducing Overlap 
and Inefficiencies: 

Conclusion: 

Matter for Congressional Consideration: 

Agency Comments and Our Evaluation: 

Appendix I: Scope and Methodology: 

Appendix II: Comments from the U.S. Department of Agriculture: 

Appendix III: GAO Contact and Staff Acknowledgments: 

Table: 

Table 1: FDA and NMFS HACCP Plan Requirements, and FSIS Proposed 
Requirements: 

Figures: 

Figure 1: Typical Domestic and Imported Catfish: 

Figure 2: Domestic and Imported Siluriformes Catfish in the U.S. 
Market: 

Figure 3: Sources of Imported Siluriformes Catfish, 2010: 

Abbreviations: 

Farm Bill: Food, Conservation, and Energy Act of 2008: 

FDA: Food and Drug Administration: 

FSIS: Food Safety and Inspection Service: 

FSMA: FDA Food Safety Modernization Act: 

HACCP: Hazard Analysis and Critical Control Point: 

NMFS: National Marine Fisheries Service: 

OMB: Office of Management and Budget: 

USDA: U.S. Department of Agriculture: 

[End of section] 

United States Government Accountability Office: 
Washington, DC 20548: 

May 10, 2012: 

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

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

The Honorable Maria Cantwell: 
United States Senate: 

The Honorable Daniel K. Inouye: 
United States Senate: 

Since 2007, federal oversight of food safety has remained on our list 
of high-risk areas in need of broad-based transformation to achieve 
greater economy, efficiency, effectiveness, accountability, and 
sustainability,[Footnote 1] largely because of fragmentation that has 
caused inconsistent oversight, ineffective coordination, and 
inefficient use of resources. The Department of Health and Human 
Services' Food and Drug Administration (FDA) and the U.S. Department 
of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) have 
primary oversight responsibilities for the safety of the domestic and 
imported food supply. FSIS has historically been responsible for meat, 
poultry, and processed egg products, and FDA is responsible for all 
other food, including seafood. In addition, the National Oceanic and 
Atmospheric Administration's National Marine Fisheries Service (NMFS), 
through its fee-for-service inspection program, assesses seafood 
processors' compliance with federal regulations. 

FDA has traditionally had oversight over the safety of all seafood, 
including catfish. The Food, Conservation, and Energy Act of 2008 
(Farm Bill), which was enacted in June 2008 and provides for the 
continuation of many agriculture programs through September 2012, 
assigned regulatory responsibility for the inspection of catfish to 
USDA once the agency issues final regulations for a mandatory catfish 
inspection program. Until those final regulations are issued, USDA has 
no responsibility for catfish safety. Specifically, among other 
things, the Farm Bill requires USDA, through FSIS, to provide 
continuous inspection of domestic catfish, including the processing of 
these fish. The Farm Bill also requires that FSIS issue final 
regulations for this inspection program after providing a period for 
public comments and public meetings before it implements the catfish 
inspection program. Congressional committees are in the process of 
considering proposals for a new Farm Bill. 

In February 2011, FSIS published and sought comments on a proposed 
rule outlining possible regulations for a new catfish inspection 
program. Among other things, FSIS's proposed program would require 
processers to implement written sanitation and hazard control plans; 
FSIS inspectors to conduct continuous inspection of domestic catfish 
processing; and for imported catfish, foreign countries would need to 
demonstrate equivalence to U.S. standards. Specifically, FSIS would 
have an inspector at the processing facility to monitor all aspects of 
domestic catfish processing, and for imported catfish, review the food 
safety systems of countries seeking to export catfish to the United 
States to determine whether the foreign systems are equivalent to the 
U.S. food safety system for catfish. FSIS sought public comments on 
(1) whether it should primarily regulate a type of catfish most 
commonly raised in the United States or whether the agency should 
regulate all catfish, including fish commonly farmed in southeastern 
Asian countries, such as Vietnam, and (2) the timing of the program's 
implementation. FSIS prepared a draft health risk assessment (risk 
assessment) that cited Salmonella as the primary food safety hazard in 
catfish and prepared a preliminary regulatory impact analysis (impact 
analysis) to examine the costs and benefits of the proposed 
regulations. FSIS is reviewing the comments it received on the 
proposed regulations and the data from subsequent catfish sampling 
studies from 2008 through 2011 to develop a baseline of contamination 
in catfish; the agency has not settled on a date to issue the final 
regulations. 

Once FSIS issues the final regulations required by the Farm Bill, 
FSIS, FDA, and NMFS will all have roles in the federal oversight of 
seafood products. We have reported many times that fragmentation in 
the nation's food safety system results in inconsistent oversight, 
ineffective coordination, and inefficient use of resources. For 
example, we reported in February 2012 that overlap and duplication of 
federal programs results in inefficient use of taxpayer 
funds.[Footnote 2] We also reported that reducing or eliminating 
fragmentation, overlap, or duplication could help agencies provide 
more efficient and effective services. We also stated that several 
duplication issues may require legislative action. 

In this context, this report responds to your request that we examine 
FSIS's proposed catfish inspection program. Our objectives were to 
determine (1) how FSIS determined that Salmonella presented the 
primary food safety hazard in catfish and (2) the anticipated impact 
of FSIS's proposed catfish inspection program on other federal food 
safety inspection programs. 

To address these objectives, we reviewed FSIS's proposed catfish 
inspection program and related documents, including the risk 
assessment and impact analysis. In addition, we reviewed written 
public comments on the proposed regulations provided by industry and 
consumer groups. We interviewed officials from FSIS involved in the 
development of the proposed regulations and officials from FDA, NMFS, 
and other federal agencies, as well as representatives from industry 
and consumer advocacy groups. We conducted site visits of two domestic 
processing facilities that process catfish and other seafood. We 
reviewed components and costs of FSIS's proposed catfish inspection 
program, FDA's seafood inspection program, and NMFS's fee-for-service 
seafood inspection program. Appendix I provides additional information 
on our scope and methodology. 

We conducted this performance audit from June 2011 to May 2012 in 
accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe 
that the evidence obtained provides a reasonable basis for our 
findings and conclusions based on our audit objectives. 

Background: 

FSIS and FDA are the two primary food safety agencies. FSIS is 
responsible for the safety of meat, poultry, and processed egg 
products, and, pursuant to the Farm Bill, is given authority to 
inspect catfish as soon as it issues final regulations to carry out a 
catfish inspection program. FDA is responsible for virtually all other 
food, including seafood. Under the Federal Food, Drug, and Cosmetic 
Act, FDA is responsible for ensuring that the nation's food supply, 
including seafood, is safe, wholesome, sanitary, and properly labeled. 
Since 1997, FDA has used the internationally recognized Hazard 
Analysis and Critical Control Point (HACCP) system as its main 
oversight tool for seafood safety. FDA requires seafood processing 
firms--those that, among other things, manufacture, pack, or label 
seafood products--to use a HACCP system. Under this system, processors 
are primarily responsible for the safety of the seafood they process. 
That is, processors are responsible for identifying where in their 
processing system one or more hazards are reasonably likely to occur 
(hazard analysis) and implementing control techniques to prevent or 
mitigate these hazards. Processors are to lay out their hazard 
analysis and control techniques in HACCP plans. FDA verifies through 
inspections that the techniques are adequate to control the identified 
significant hazards and are being effectively implemented. FDA 
inspects domestic and foreign seafood processors in an effort to 
ensure their compliance with HACCP regulations. FDA supplements its 
HACCP oversight activities with an import oversight program that 
includes examination and testing of some imported seafood at ports of 
entry to ensure the products meet U.S. requirements, including the 
absence of residues of drugs that are unapproved for use in the United 
States and would render the seafood adulterated under the Federal 
Food, Drug, and Cosmetic Act; FDA also maintains data on the shipments 
of seafood that it has refused to allow into the United States. 

The FDA Food Safety Modernization Act (FSMA), enacted in January 2011, 
gives FDA new authorities to improve its ability to oversee the safety 
of imported foods. As described in FSMA, FDA must establish a system 
for recognizing accreditation bodies to accredit third-party auditors, 
including foreign governments, to conduct food safety audits to 
determine compliance with the Federal Food, Drug, and Cosmetic Act and 
to certify that eligible foreign entities, including seafood 
processors, meet applicable requirements. FDA may directly accredit 
third-party auditors under certain circumstances.[Footnote 3] FSMA 
also contains provisions on laboratory accreditation that enable FDA 
to leverage state, foreign government, and private laboratory 
resources for food testing. Furthermore, these laboratories must meet 
model standards developed by FDA that ensure quality and reliability 
of the test results used to verify the safety of any food product, 
including imports. In April 2011, we stated that FDA's current program 
to ensure the safety of imported seafood is limited because the agency 
relies on document review at individual foreign processing facilities 
and on importers for HACCP compliance, conducts only a few inspections 
of foreign facilities, samples a limited number of imports at the U.S. 
border, and does not make effective use of laboratory resources. 
[Footnote 4] For example, in fiscal year 2011, FDA examined about 3.4 
percent of all seafood entries and performed laboratory analysis on 
0.7 percent of these entries. We recommended, in part, that FDA study 
the feasibility of adopting practices that the European Union employs 
to ensure the safety of imported seafood products, such as requiring 
foreign countries that want to export seafood to the United States to 
develop a national residues monitoring plan to control the use of 
drugs used in aquaculture (fish farming). Because fish grown in 
confined aquacultured areas can have high rates of bacterial 
infections, farmers may treat them with drugs, such as antibiotics and 
antifungal agents, to increase fish survival rates. According to a 
2008 FDA report, the residues of some of these drugs can cause cancer, 
allergic reactions, and antibiotic resistance when consumed by humans. 
As imports of aquacultured seafood products increase, so do the 
concerns over the presence of drug residues. 

NMFS's Seafood Inspection Program provides fee-for-service 
inspections, primarily under the authority of the Federal Agricultural 
Marketing Act of 1946. According to NMFS officials, NMFS's experience 
with seafood controls dates to the1970s, when the agency began 
systematically evaluating controls as part of its inspection program. 
NMFS more formally adopted the systematic evaluation with the 
development of its Quality Management Program in 1993, which 
integrates quality into its HACCP-based inspection system. Currently, 
NMFS provides inspection services on request to the seafood industry--
including domestic and foreign processors, distributors, and other 
firms--to certify that these seafood firms comply with HACCP 
requirements and other federal food safety standards, among other 
things. Some retailers require this certification as a condition for 
purchasing the seafood products. 

Before 2002, various fish in the order Siluriformes were commonly 
labeled and sold as "catfish." However, in 2002, Congress amended the 
Federal Food, Drug, and Cosmetic Act to allow only fish from the 
family Ictaluridae (in the order Siluriformes) to use the name catfish 
in labeling. All other fish, such as those from the Pangasiidae family 
(in the order Siluriformes) that had previously been labeled as 
catfish, had to have other names on labels, such as basa, swai, or 
tra. In making catfish subject to mandatory FSIS inspection, the Farm 
Bill gave the Secretary of Agriculture discretion to define "catfish" 
for the purposes of inspection--that is, to distinguish between 
different types of catfish or to consider all fish in the order 
Siluriformes as catfish. For purposes of this report, we refer to all 
catfish potentially subject to regulations as catfish, including fish 
in the family Ictaluridae, which are primarily of domestic origin, and 
Pangasiidae, which come primarily from Vietnam (see figure 1). 

Figure 1: Typical Domestic and Imported Catfish: 

[Refer to PDF for image: illustration] 

Order Siluriformes: 

Family Ictaluridae: 
* Produced primarily in the United States, with some imported from 
China; 
* Raised in ponds filled with groundwater or surface water; 
* Legally labeled and sold as "catfish" in the waters United States 
under the Federal Food, Drug, and Cosmetic Act. 

Family Pangasiidae: 
* Produced in Asian countries, primarily Vietnam
* Raised in ponds, net enclosures or floating cages in rivers, or in 
inlets fed by river; 
* Now commonly labeled as basa, swai, or tra. 

Source: GAO analysis. 

[End of figure] 

In recent years, the volume of imported catfish of all families 
entering the U.S. market has continued to increase, while the volume 
of domestic catfish entering the market has declined. In 2002, the 
percentage of imported catfish in the U.S. market was estimated at 2 
percent, and by 2006, imported catfish of all families accounted for 
an estimated 12 percent of the U.S. market. This trend has continued: 
by 2010, imported catfish accounted for 23 percent of the U.S. catfish 
market, and domestic catfish accounted for 77 percent. The most recent 
data show a 29-percent decline in domestic catfish production from 
2010 to 2011. Figure 2 shows the trend in the volume of domestic and 
imported catfish from 2006 to 2010. Overall, imported Siluriformes 
catfish constituted a small fraction of seafood imported to the U.S. 
in 2010, at about 3 percent. Figure 3 shows the major countries 
exporting catfish to the United States. 

Figure 2: Domestic and Imported Siluriformes Catfish in the U.S. 
Market: 

[Refer to PDF for image: vertical bar graph] 

Year: 2006; 
Domestic: 88% of weight; 566 million pounds; 
Imported: 12% of weight; 75 million pounds. 

Year: 2007; 
Domestic: 85% of weight; 496 million pounds; 
Imported: 15% of weight; 85 million pounds. 

Year: 2008; 
Domestic: 83% of weight; 5510 million pounds; 
Imported: 17% of weight; 102 million pounds. 

Year: 2009; 
Domestic: 78% of weight; 466 million pounds; 
Imported: 22% of weight; 129 million pounds. 

Year: 2010; 
Domestic: 77% of weight; 472 million pounds; 
Imported: 23% of weight; 138 million pounds. 

Source: GAO analysis of USDA National Agricultural Statistics Service 
and U.S. Census Bureau data. 

[End of figure] 

Figure 3: Sources of Imported Siluriformes Catfish, 2010: 

[Refer to PDF for image: illustrated U.S. map] 

Vietnam: 79%; 
China: 13%; 
Thailand: 6%; 
Other: 3%. 

Other includes: Brunei, Cambodia, Canada, Denmark, Ecuador, Iceland, 
Indonesia, Malaysia, Mexico, Singapore, South Korea, Spain, Suriname, 
and Taipei. 

Source: GAO analysis of Department of Commerce data and Map Resources 
(map). 

Note: Percentages do not add to 100 percent due to rounding. 

[End of figure] 

The volume of catfish subject to FSIS's proposed catfish inspection 
program will depend on the definition of catfish that the Secretary of 
Agriculture decides to apply. In 2010, 79 percent of the catfish in 
the U.S. market consisted primarily of domestically processed catfish 
as well as some imported catfish from the family Ictaluridae, while 
the remaining 21 percent consisted of imported catfish from the family 
Pangasiidae. If the Secretary of Agriculture chose to limit the 
definition to catfish to the family Ictaluridae, FSIS's inspection 
program would thus cover almost 80 percent of the catfish in the U.S. 
market in 2010. 

The Farm Bill requires that FSIS issue the final regulations for its 
new catfish inspection program before it can begin inspecting catfish. 
Citing requirements of the Federal Crop Insurance Reform Act of 1994, 
FSIS prepared a risk assessment and an impact analysis and made them 
available for public review. FSIS used the risk assessment to 
determine the primary hazard of concern associated with consuming farm-
raised catfish in the United States, and it conducted an impact 
analysis to examine the costs and benefits of the proposed 
regulations.[Footnote 5] FSIS prepared these documents to evaluate the 
potential public health benefits of its proposed program if the 
primary hazard were addressed. The Federal Crop Insurance Reform and 
Department of Agriculture Reorganization Act of 1994 requires an 
analysis of the health risks and costs and benefits for major proposed 
regulations that regulate human health, human safety, or the 
environment (i.e., defined as regulations the Secretary of Agriculture 
estimates are likely to have an annual impact on the U.S. economy of 
$100 million in 1994 dollars). In addition, Executive Order 12866 
established the guidance that agencies are to follow when developing 
regulations.[Footnote 6] Under this guidance, agencies are to identify 
the problem new regulations are intended to address and evaluate the 
significance of the problem. The executive order further directs that 
the agencies consider the alternative of not regulating, but it 
recognizes that agencies should issue regulations as required by law, 
as are the regulations for the catfish inspection program. The 
executive order directs agencies to provide a description of the need 
for any significant regulatory action, how that action meets the 
needs, and the costs and benefits of the action. A significant 
regulatory action includes any regulatory action that has an annual 
effect on the economy of $100 million or more or adversely affects, 
among other things, the economy or a sector of the economy. Under the 
executive order, the Office of Management and Budget (OMB) has a 
review function to, among other things; ensure that regulations are 
consistent with principles set forth in the executive order. 

FSIS Used Outdated Data to Justify its Determination: 

In determining that Salmonella is the primary food safety hazard in 
catfish, FSIS officials told us that the agency focused on Salmonella 
at the direction of OMB, which considered Salmonella the most 
practical hazard to evaluate. However, we found that FSIS used 
outdated and limited information as its scientific basis for 
implementing a catfish inspection program that was required by law. 

According to FSIS, the agency initially focused its risk assessment of 
potential contaminants in catfish primarily on public health outcomes 
associated with chemical contaminants, with limited attention to 
Salmonella. (The appendix to FSIS's risk assessment includes 
information on these hazards.) However, upon reviewing the initial 
FSIS assessment, agency officials said that OMB directed FSIS to focus 
its catfish risk assessment on Salmonella, not as the "riskiest 
hazard" but as the "most practical" and to note that there was 
uncertainty regarding the sufficiency of information used to 
demonstrate the association between Salmonella and catfish. 
Furthermore, FSIS officials agreed that Salmonella was a practical 
choice, in part, because the agency could show that it is a major 
cause of illnesses in the United States, although not necessarily from 
catfish. For example, a 2011 report from the Department of Health and 
Human Services' Centers for Disease Control and Prevention stated that 
Salmonella infection causes more hospitalizations and deaths than any 
other bacteria and showed that the major sources of illnesses caused 
by Salmonella from 2004 to 2008 were poultry; eggs; pork; beef; and 
vine vegetables, fruits, and nuts. Moreover, the risk assessment cited 
FSIS's knowledge and experience working with Salmonella detection and 
prevention, but that its knowledge and experience related to poultry, 
not seafood. 

According to FSIS officials, because of OMB direction and availability 
of information, FSIS identified Salmonella as the primary hazard for 
catfish in its risk assessment. FSIS's risk assessment stated it 
assumed that the prevalence of the identified primary hazard 
associated with catfish was the same for domestic and foreign catfish. 
The risk assessment cited the following to support the claim that 
Salmonella in catfish was the primary hazard: 

* Salmonella may be a concern with catfish because catfish are raised 
in fish farms, and Salmonella is a potential microbial hazard for 
aquatic environments. 

* Salmonella is a high-priority hazard and of great concern in the 
United States because of the general burden of illnesses associated 
with it. In particular, FSIS's risk assessment stated that the Centers 
for Disease Control and Prevention had identified a 1991 Salmonella 
outbreak in which catfish may have been the source. 

* A 1979 article in the Journal of Food Science indicated that 
Salmonella was found in 21 percent of catfish collected from ponds and 
retail markets.[Footnote 7] 

* A 1998 research study found that 2 percent of catfish fillets 
collected from three processing facilities were contaminated with 
Salmonella. Researchers collected these catfish fillet samples between 
August 1994 and May 1995.[Footnote 8] 

* According to an analysis by USDA's Economic Research Service of FDA 
data on imports that were denied entry into the United States from 
1998 to 2004 (i.e., import refusal data), about 42 percent of the 
violations listed for imported catfish were for Salmonella.[Footnote 9] 

The following describes limitations we identified in FSIS's rationale 
for designating Salmonella as the basis for regulation: 

* A 2010 United Nations Food and Agriculture Organization report on 
Salmonella contamination in aquaculture stated that products from fish 
farms are rarely involved in outbreaks of illnesses caused by 
Salmonella. In addition, even when a low prevalence of Salmonella is 
present, thorough cooking will eliminate the hazard.[Footnote 10] 

* FSIS's risk assessment provided one example of a Salmonella outbreak 
associated with catfish consumption. This outbreak occurred in 1991, 
and the Centers for Disease Control and Prevention was not completely 
sure that catfish was the source of the Salmonella that resulted in 
the illnesses. For example, coleslaw was also consumed along with 
catfish and could have been the source of the Salmonella. 

* The 1998 study cited in FSIS's risk assessment concluded that the 
health hazards from Salmonella and other bacteria in catfish were 
practically zero because the incidence in catfish was low and because 
catfish are cooked prior to consumption. 

* Most of the information listed earlier and used by FSIS to support 
Salmonella as the primary hazard associated with catfish was compiled 
before 1997, when FDA required seafood processing facilities to 
implement HACCP systems. According to FDA documents, HACCP regulations 
initiated a landmark program to reduce seafood-related illnesses to 
the lowest possible levels. In its proposed catfish inspection 
regulations, FSIS acknowledged the impact of HACCP controls, stating 
that the one outbreak it identified occurred before FDA's 
implementation of HACCP regulations. It also noted that since HACCP 
implementation, no cases of illnesses caused by Salmonella and linked 
to catfish have been reported. 

* In a subsequent report, USDA's Economic Research Service stated the 
analysis of FDA import refusal data that it provided to FSIS 
indicating a catfish violation rate of about 42 percent has its 
limitations and does not reflect the true violation level because this 
information is not based on a random sampling of imports. Rather, it 
reflects FDA's focus on areas with past compliance problems, such as 
companies and products.[Footnote 11] In addition, in commenting on 
FDA's import samples, FSIS stated in its risk assessment that the 
limitations of the catfish data would likely overestimate the 
prevalence of Salmonella contamination in catfish. FSIS also stated in 
its risk assessment that FDA sampling and testing limitations made 
reasonable assumptions about the prevalence of Salmonella in imported 
catfish nearly impossible. 

* Preliminary results of microbiological testing FSIS conducted in 
2011 to establish a baseline for Salmonella in catfish indicated the 
presence of Salmonella in over 1 percent of the total catfish samples 
taken in the study. This is lower than the presence of Salmonella 
identified in studies and other data sources that FSIS cited in its 
risk assessment (e.g., FDA import refusal data). 

FSIS stated in its risk assessment that data were limited regarding 
the prevalence of catfish contaminated with Salmonella. Furthermore, 
it stated there was substantial uncertainty about the number of 
illnesses caused by Salmonella that could be attributed to catfish 
consumption. Moreover, a peer-reviewed journal article by agency staff 
stated that scientific literature on foodborne hazards associated with 
catfish was limited and dated. The article added that extensive 
studies were needed to establish the baseline prevalence of Salmonella 
in catfish.[Footnote 12] 

FDA and NMFS, which each have about 14 years experience in inspecting 
catfish processing facilities under HACCP regulations, as well as 
experience in sampling catfish products, also questioned whether FSIS 
had adequately demonstrated that Salmonella in catfish was a problem. 
According to FDA and NMFS officials, FSIS did not provide any new 
information or data in its risk assessment indicating that catfish was 
unsafe to consume or that the current oversight system was not 
addressing any potential problems. According to FDA officials, based 
on the agency's experience and information from its own testing 
programs, catfish is a low-risk product, and the agency generally does 
not have any concerns related to Salmonella in catfish. According to 
NMFS officials, FSIS did not adequately demonstrate that Salmonella 
was a significant problem with catfish because data are not available 
to confirm this hazard. NMFS added that it was more likely that 
unapproved veterinary drugs and chemical residues were the hazards 
most associated with catfish. According to its proposed regulations, 
FSIS considered several other hazards it thought might be associated 
with catfish.[Footnote 13] 

FSIS's Proposed Program Mirrors Existing Programs, Introducing Overlap 
and Inefficiencies: 

FSIS's proposed catfish inspection program would further divide 
responsibility for overseeing seafood safety and introduce overlap at 
considerable cost. In our March 2011 report, we cited FSIS's catfish 
inspection program as an example of further fragmentation of the food 
safety system.[Footnote 14] In reviewing the proposed catfish program, 
we identified four areas that raise concerns about the potential for 
overlap or inefficient use of resources if FSIS were to implement the 
catfish inspection program: (1) similar HACCP requirements, (2) 
inspection overlap and unnecessary frequency of inspection, (3) 
inconsistent oversight of imported seafood, and (4) the cost of 
implementing FSIS's catfish inspection program. 

Similar HACCP requirements. FDA and NMFS require, and FSIS would 
require, facilities to implement HACCP systems to reduce the risk of 
illness from contaminated foods. Table 1 shows the requirements of a 
HACCP system for catfish and how each agency implements or would 
implement these requirements. 

Table 1: FDA and NMFS HACCP Plan Requirements, and FSIS Proposed 
Requirements: 

Division of Seafood Safety, FDA: 
Statutory authority: Federal Food, Drug, and Cosmetic Act; 
Written HACCP plan required: [Check]; 
HACCP plan requirements: 
List/identify chemical, physical, and biological safety hazards: 
[Check]; 
List/identify critical control points (CCP): [Check]; 
List/identify critical limits for each CCP: [Check]; 
List procedures to monitor each CCP including monitoring frequency: 
[Check]; 
Include any corrective action plans: [Check][A]; 
Provide a recordkeeping system that documents the monitoring of CCPs: 
[Check]; 
List verification procedures and frequency: [Check]; 
Validate CCPs are effective in controlling hazards: [Check]; 
Require written Sanitation Standard Operating Procedures: No written 
procedures required but processors must implement and monitor 
sanitation controls and maintain records; 
Preoperational sanitation evaluation conducted as part of inspection: 
Conducted as needed; 
Frequency of domestic site inspections: Every 3 to 5 years for 
products FDA considers low risk, such as catfish. 

Seafood Inspection Program, NMFS: 
Statutory authority: Agriculture Marketing Act of 1946; 
Written HACCP plan required: [Check]; 
HACCP plan requirements: 
List/identify chemical, physical, and biological safety hazards: 
[Check]; 
List/identify critical control points (CCP): [Check]; 
List/identify critical limits for each CCP: [Check]; 
List procedures to monitor each CCP including monitoring frequency: 
[Check]; 
Include any corrective action plans: [Check][A]; 
Provide a recordkeeping system that documents the monitoring of CCPs: 
[Check]; 
List verification procedures and frequency: [Check]; 
Validate CCPs are effective in controlling hazards: [Check]; 
Require written Sanitation Standard Operating Procedures: [Check]; 
Preoperational sanitation evaluation conducted as part of inspection: 
[Check]; 
Frequency of domestic site inspections: Minimum, quarterly audits. 

Office of Catfish Inspection Program (proposed), FSIS: 
Statutory authority: Federal Meat Inspection Act, as applicable to 
catfish; 
Written HACCP plan required: [Check]; 
HACCP plan requirements: 
List/identify chemical, physical, and biological safety hazards: 
[Check]; 
List/identify critical control points (CCP): [Check]; 
List/identify critical limits for each CCP: [Check]; 
List procedures to monitor each CCP including monitoring frequency: 
[Check]; 
Include any corrective action plans: [Check][B]; 
Provide a recordkeeping system that documents the monitoring of CCPs: 
[Check]; 
List verification procedures and frequency: [Check]; 
Validate CCPs are effective in controlling hazards: [Check]; 
Require written Sanitation Standard Operating Procedures: [Check]; 
Preoperational sanitation evaluation conducted as part of inspection: 
[Check]; 
Frequency of domestic site inspections: On-site inspection during 
processing. 

Source: GAO analysis of FDA, NMFS, and FSIS program documents. 

[A] Plans must include corrective action plans developed in accordance 
with the requirements of 21 C.F.R.§ 123.7. 

[B] Plans must include corrective action plans developed in accordance 
with the requirements of 9 C.F.R. § 417.3. 

[End of table] 

As table 1 shows, the three agencies essentially do not differ from 
each other in their HACCP requirements. FSIS acknowledges that many 
domestic processing facilities are already meeting many of its 
proposed requirements. Nevertheless, if FSIS implements its proposed 
catfish program, catfish processors are likely to see their paperwork 
requirements increase. For example, FSIS would require written 
sanitation plans, while FDA inspectors do not require written 
sanitation plans and instead require only that sanitation be monitored 
and records kept, according to FDA officials. Therefore, catfish 
processing facilities without written sanitation plans would now be 
required to develop them. Catfish processing facilities that already 
contract for inspection services with NMFS must have written 
sanitation plans, but FSIS officials said the format of the FSIS 
sanitation plan would differ from the one already required by NMFS. 
FSIS officials noted that some of the additional paperwork burden 
required for FSIS regulations would be offset by the reduction of FDA 
paperwork requirements. However, facilities that process catfish and 
other seafood would be required to meet both FSIS and FDA paperwork 
requirements, which may differ. For instance, FSIS plans to develop 
its own forms for documenting a HACCP system, which will require 
processors of catfish and other seafood under FSIS and FDA oversight 
to enter the same information twice--once for FSIS and once for FDA. 

Inspection overlap and unnecessary inspection frequency. FSIS's 
proposed catfish program would introduce inefficiencies into the U.S. 
catfish inspection system by duplicating existing FDA and NMFS 
inspections. Currently, about 18 major domestic facilities process 
catfish, according to FSIS, and an unknown number of facilities 
process both catfish and other seafood. With the implementation of 
FSIS's catfish inspection program, facilities that process only 
catfish may be inspected by FSIS and NMFS, and facilities that process 
both catfish and other seafood may be inspected by all three agencies--
FSIS, FDA, and NMFS. FDA inspects facilities that process only catfish 
every 3 to 5 years because it considers catfish a low-risk product, 
but it may inspect other facilities that process catfish, along with 
other seafood, more frequently, depending on the risks associated with 
the other seafood. NMFS conducts a minimum of quarterly inspections of 
processing facilities that participate in its Quality Management 
Program, including a majority of the domestic catfish-processing 
facilities FSIS identified.[Footnote 15] According to NMFS documents 
we reviewed, many retail and distribution firms buying processed 
catfish products currently require NMFS product verifications and are 
likely to still require NMFS verification after promulgation of the 
FSIS proposed regulations. For example, representatives we spoke with 
from two domestic facilities that process catfish and other seafood 
told us that they expect to continue to pay for NMFS inspections to 
meet retailer demands, despite any additional oversight FSIS provides. 
In addition to any NMFS services that they retain, facilities that 
process both catfish and other seafood will also be required to meet 
both FDA and FSIS requirements and will be subject to inspections by 
both agencies. According to FSIS officials, overlap of programs is 
outside the agency's control because the proposed program was mandated 
by Congress. 

Implementation of the proposed catfish inspection program would also 
fragment the export certification processes that some foreign 
governments require for the export of U.S.-produced seafood. Under its 
proposed regulations, FSIS would issue official export certificates 
for shipments of inspected and passed catfish products produced in the 
United States for export to foreign countries, as authorized by the 
Federal Meat Inspection Act. However, NMFS currently provides these 
certification services for all seafood, including catfish. According 
to NMFS officials, this dual certification creates a potential problem 
because NMFS already has approval from multiple foreign governments to 
serve as the U.S. certification authority for seafood exports. 

FSIS's proposed use of continuous monitoring in the form of daily 
inspections for catfish is also unlikely to reduce the hazard of 
contamination in catfish as intended and is not risk based, according 
to FDA and NMFS officials. (Under the Farm Bill, FSIS is required to 
issue final regulations to conduct continuous monitoring of catfish 
processing facilities, as it does for meat, poultry, and processed egg 
products facilities). FDA officials told us FSIS's continuous 
monitoring approach is counter to HACCP-based requirements for seafood 
and not based on risk. According to FDA and NMFS officials, only 
periodic inspection is necessary to verify that a HACCP plan is being 
implemented and adequate preventive controls are in place. According 
to NMFS documents we reviewed, the current HACCP approach to seafood 
safety is fundamental not only in the United States but also in most 
seafood-producing countries around the world. Consequently, these 
countries rely on periodic, not daily, inspections. In addition, NMFS 
stated that continuous inspection will not enhance the level of safety 
with catfish because disease cannot be identified by visual 
inspection, as it can for meat and poultry. NMFS noted that because 
continuous or daily inspection does not necessarily improve seafood 
safety, its use is more costly with little effect. 

We have reported on duplication and overlap in federal inspection of 
seafood in the past, when only FDA and NMFS were concerned. In 2009, 
we reported that FDA does not try to determine whether NMFS has 
already inspected a seafood facility when it is deciding which 
facilities to inspect.[Footnote 16] In 2011, we reported that NMFS and 
FDA were still not coordinating their inspection activities.[Footnote 
17] Lack of coordination can burden seafood processors. For example, 
according to representatives of a facility that processes seafood, the 
facility was inspected approximately 21 times by NMFS, FDA, and USDA 
over a 4-year period, from 2005 to 2008, with no significant problems 
identified in any of the inspections.[Footnote 18] 

Inconsistent oversight of imported seafood. Consistent with the 
Federal Meat Inspection Act, as amended by the Farm Bill, FSIS plans 
to apply an equivalency approach for catfish that is similar to the 
one it uses for imported meat, poultry, and processed egg products. 
Under FSIS's equivalency approach, meat, poultry and processed egg 
products are not eligible for export to the United States unless FSIS 
has determined that the exporting country has a food safety system 
equivalent to that of the United States. Among other things, FSIS 
reviews documents provided by foreign governments, conducts on-site 
evaluations of government inspections of processing facilities, and 
audits laboratories to ensure their food safety regulations and 
oversight are adequate. In addition, FSIS reinspects products at U.S. 
ports of entry to promote compliance. 

Some individuals and organizations that supported the transfer of 
catfish safety from FDA to FSIS, which include representatives of the 
catfish industry and consumer groups, stated that there were several 
problems with FDA's oversight system, such as limited inspection and 
sampling of imported seafood, and that FSIS's proposed catfish program 
regulations, if implemented, would enhance catfish safety. For 
example, in their written comments to FSIS, some supporters stated 
that imported catfish may be unsafe because they were raised under 
less stringent standards, such as allowing the catfish to be exposed 
to whatever pollutants were present in the river water where they were 
raised. Supporters also indicated that imported catfish may contain 
residues from drugs that FDA has not approved for use in aquaculture. 
Finally, supporters noted that FSIS staff would review foreign catfish 
safety systems to ensure these systems met U.S. requirements before 
such products were admitted into U.S. commerce. In addition, FSIS 
inspectors would reinspect catfish imports at the ports of entry. 

In April 2011, we reported that FDA's oversight of imports is limited 
when compared with FSIS's more comprehensive reviews of food safety 
systems under its equivalence program.[Footnote 19] However, FSMA 
gives FDA authority to establish a system to accredit third-party 
auditors, including foreign governments, to take responsibility for 
certifying seafood processors or seafood meets FDA regulatory 
requirements. Under this system, a foreign government would have to 
demonstrate that its food safety programs, systems, and standards are 
capable of adequately ensuring that the foreign government and the 
foods it certifies, including seafood, meet FDA requirements. 
According to FDA officials, its new FSMA authorities complement the 
authority it already had to conduct comparability assessments, which 
are intended to help ensure the safety of imported foods. With 
comparability assessments, FDA can leverage the work of foreign 
governments whose food safety systems FDA has determined provide 
protections that are comparable to those of the U.S. food safety 
system. FDA is currently piloting a comparability assessment process 
with the European Union and New Zealand. New authorities provided in 
FSMA, including third party certification, will enable FDA to leverage 
resources of countries with sufficient qualifications--even though 
they may not have comparable systems--to help ensure that foods 
exported to the United States meet FDA requirements. Enacted in 2011, 
these new FSMA authorities were not available to FDA when the Farm 
Bill assigned responsibility for catfish inspection to FSIS in 2008. 

Cost of implementing FSIS's catfish inspection program. Currently, FDA 
estimates that it spends less than $700,000 annually to inspect 
catfish processing facilities, and NMFS inspection services pose no 
additional cost to the federal government because its costs are 
covered by industry service fees. FSIS estimates that the 
implementation of its proposed catfish inspection program would cost 
the federal government and industry an additional $14 million 
annually. As estimated by FSIS, the federal government bears most of 
the estimated cost, about 98 percent, and industry bears the remaining 
cost. We did not determine the accuracy of FSIS's estimate, but in our 
limited review we observed some limitations with FSIS's cost data and 
assumptions that would affect the final accuracy of the agency's 
estimate. For example, in its impact analysis, FSIS indicated that it 
did not have complete information on the total number of domestic and 
foreign catfish processing facilities that would be affected by the 
proposed regulations. In addition, the number of countries that will 
apply for equivalence determination is not known. The number of 
foreign applicants will, in turn, affect the cost FSIS will incur in 
making equivalence determinations and in examining shipments at ports 
of entry. In addition, FSIS may have overstated the federal dollars 
that FDA and NMFS would save if FSIS implements a catfish inspection 
program. For example, NMFS officials said that FSIS may have 
overstated the $1.5 million amount that would be saved if FSIS assumed 
all inspection duties previously carried out by NMFS inspectors. FDA 
officials stated that they could not validate the numbers FSIS used to 
estimate the amount of money FDA would save if FSIS implemented its 
proposed catfish program. In addition, FSIS estimated that it spent a 
total of $15.4 million from fiscal years 2009 to 2011 to develop the 
catfish inspection program, including costs related to catfish 
sampling studies. In fiscal year 2012, FSIS plans to spend an 
additional $4.4 million to support further program development. 

The cost effectiveness of FSIS's catfish inspection program is 
unclear. FSIS acknowledges in its risk assessment that there is 
substantial uncertainty about how effective FSIS's catfish inspection 
program will be in reducing the prevalence of Salmonella-contaminated 
catfish. In addition, FSIS acknowledged in its risk assessment that it 
lacks regulatory oversight experience with catfish processing 
facilities, although it has historically overseen the meat, poultry 
and processed egg products industries. FDA and NMFS officials we spoke 
with do not expect FSIS's proposed catfish inspection program to make 
catfish safer than it already is under current federal oversight 
programs. Moreover, FSIS would oversee a small fraction of all seafood 
imports to the United States--about 3 percent--while FDA, using its 
enhanced authorities, could undertake oversight of all imported 
seafood. 

Conclusion: 

To implement the catfish inspection requirement in the Farm Bill, FSIS 
has proposed a program that seeks to mitigate the primary food safety 
hazard most associated with domestic and imported catfish, which FSIS 
identified as Salmonella. However, the agency's proposed catfish 
inspection program further fragments the federal oversight system for 
food safety without demonstrating that there is a problem with catfish 
or a need for a new federal program. We recognize that FSIS developed 
this program because it was mandated to do so by the Farm Bill--before 
FDA received enhanced regulatory authority under FSMA. Even so, FSIS 
proposed a program that essentially mirrors the catfish oversight 
efforts already underway by FDA and NMFS. Furthermore, since FDA 
introduced HACCP requirements for seafood processing facilities--
including catfish facilities--in 1997, no reported outbreaks of 
illnesses caused by Salmonella contamination of catfish have been 
reported--the hazard identified by FSIS--indicating the low risk 
presented by this pathogen in catfish. Consequently, if implemented, 
the catfish inspection program would likely not enhance the safety of 
catfish but would duplicate FDA and NMFS inspections at a cost to 
taxpayers. With FDA's new authority under FSMA, the federal government 
has an opportunity to enhance the effectiveness of the food safety 
system of all imported seafood, including catfish, and avoid the 
duplication of effort and costs that would result from FSIS's 
implementation of its proposed catfish inspection program. 

Matter for Congressional Consideration: 

To enhance the effectiveness of the food safety system for catfish and 
avoid duplication of effort and cost, Congress should consider 
repealing provisions of the Farm Bill that assigned USDA 
responsibility for examining and inspecting catfish and for creating a 
catfish inspection program. 

Agency Comments and Our Evaluation: 

We provided USDA and the Departments of Commerce and Health and Human 
Services with a draft of this report for their review and comment. We 
also provided a draft of this report to the Department of State, the 
Office of the U.S. Trade Representative, and the Office of Management 
and Budget. On April 25, 2012, we received written comments from USDA, 
which are reproduced in appendix II. USDA and the Department of Health 
and Human Services provided technical comments, which we incorporated 
as appropriate. The Department of Commerce did not provide written 
comments. 

USDA stated that it appreciated our work in planning, conducting, and 
issuing the report. USDA added that it is committed to completing the 
rulemaking process on catfish inspection in a manner that is 
consistent with the 2008 Farm Bill provisions. 

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

If you or your staff have any questions about this report, please 
contact me at (202) 512-3841 or shamesl@gao.gov. Contact points for 
our Offices of Congressional Relations and Public Affairs may be found 
on the last page of this report. Key contributors to this report are 
listed in appendix III. 

Signed by: 

Lisa Shames: 
Director, Natural Resources and Environment: 

[End of section] 

Appendix I: Scope and Methodology: 

We were asked to examine the U.S. Department of Agriculture's (USDA) 
Food Safety Inspection Service's (FSIS) proposed catfish inspection 
program. Our objectives were to determine (1) how FSIS determined that 
Salmonella presented the primary food safety hazard in catfish and (2) 
the anticipated impact of FSIS's proposed catfish inspection program 
on other federal food safety inspection programs. 

To address the first objective, we reviewed documents FSIS had 
prepared including the draft risk assessment that assessed the hazards 
associated with consuming catfish. We also reviewed information on the 
Food and Drug Administration's (FDA) import refusals for imported 
catfish prepared by USDA's Economic Research Service for 1998 through 
August 2010. We also reviewed the results of FSIS's preliminary 
microbiological testing of catfish samples conducted in 2011. We 
interviewed officials from FSIS, FDA, and the National Marine 
Fisheries Service (NMFS) to better understand the food safety hazard 
catfish presents and the information FSIS presented in its draft risk 
assessment. We also interviewed officials from the Office of the U.S. 
Trade Representative, the Department of State, and the Office of 
Management and Budget. To gain stakeholders' perspectives on the food 
safety hazards that catfish present, we reviewed comments provided to 
FSIS during the public comment period. We also spoke with 
representatives from the Catfish Farmers of America, National 
Fisheries Institute, the Association of Food and Drug Officials, and 
the Center for Science in the Public Interest. 

To assess the anticipated impact of FSIS's proposed catfish inspection 
program on other federal food safety inspection programs, we reviewed 
the proposed regulations for the catfish inspection program and other 
agency documents including the preliminary regulatory impact analysis 
that describe the proposed program and the costs and benefits expected 
by FSIS after implementation. We reviewed the FDA Food Safety 
Modernization Act to identify the additional authorities to enhance 
the oversight of imported seafood this legislation granted FDA. We 
interviewed officials from FSIS, FDA, and NMFS to better understand 
FSIS's proposed program, its costs and benefits, and the similarities 
and differences between it and FDA and NMFS inspection programs. In 
our review of FDA and NMFS inspection programs, we also gathered 
information on program costs. To gain stakeholders' perspectives on 
FSIS's proposed regulations for continuous catfish inspection, we 
reviewed comments from industry and consumer groups provided to FSIS 
during the public comment period. We spoke with representatives of the 
Catfish Farmers of America and the National Fisheries Institute. We 
also spoke with representatives of two domestic seafood processors 
that process both catfish and other seafood during site visits to 
their facilities in Massachusetts to gain their perspectives on the 
potential impact of the proposed regulations on their operations. We 
reviewed past GAO reports relevant to this topic. 

In addition, we analyzed Department of Commerce data on imported 
seafood, including catfish, for 2010. We present these data as 
background to illustrate the relative volume of catfish and other 
seafood. We also analyzed USDA National Agricultural Statistics 
Service data on catfish processing to illustrate trends in domestic 
catfish production and imports from 2006 to 2010, also as background. 
For both of these data sets we reviewed existing documentation about 
these data and any limitations. We found both data sets to be 
sufficiently reliable for the above-mentioned purposes. 

We conducted this performance audit from June 2011 to May 2012 in 
accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe 
that the evidence obtained provides a reasonable basis for our 
findings and conclusions based on our audit objectives. 

[End of section] 

Appendix II: Comments from the U.S. Department of Agriculture: 

Department of Agriculture: 
Office of The Secretary: 
Washington, D.C. 20250: 

April 24, 2012: 

Ms. Lisa Shames: 
Director: 
Natural Resources and Environment: 
United States Government Accountability Office: 
441 G Street, N.W. 
Washington, D.C. 20538: 

Dear Ms. Shames: 

The United States Department of Agriculture (USDA) appreciates the 
opportunity to review the "Seafood U.S. Government Accountability 
Office's (GAO) draft report entitled, Safety: Responsibility for 
Catfish Safety Should Be Transferred from USDA to FDA" (12-411). USDA 
appreciates GAO's work in planning, conducting and issuing this report. 

The Department, specifically the Food Safety and Inspection Service 
(FSIS), is currently proposing regulations requiring continuous 
inspection of catfish and catfish products. FSIS is proposing these 
regulations to implement provisions of the Food, Conservation, and 
Energy Act (Farm Bill) of 2008. Although the GAO draft report does not 
contain any recommendations specifically directed at USDA, the 
Department, specifically FSIS, remains committed to completing the 
rulemaking process on catfish inspection in a manner that is 
consistent with the Farm Bill provisions. 

Again, thank you for the opportunity to review and comment on this 
draft report. Technical comments were submitted under separate cover. 
We look forward to working with you on future Department of 
Agriculture engagements. 

Sincerely, 

Signed by: 

Brian Ronholm: 
Deputy Under Secretary: 
Food Safety: 

[End of section] 

Appendix III: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Lisa Shames, (202) 512-3481 or shamesl@gao.gov: 

Staff Acknowledgments: 

In addition to the individual named above, Anne K. Johnson (Assistant 
Director), David Moreno (Analyst-in-Charge), Michele Sahlhoff, Carol 
Herrnstadt Shulman, Swati Sheladia Thomas, and Kiki Theodoropoulos 
made key contributions to this report. Important contributions were 
also made by Kevin Bray, Michele Fejfar, Jose Alfredo Gomez, and Jena 
Sinkfield. 

[End of section] 

Footnotes: 

[1] See GAO, High-Risk Series: An Update, [hyperlink, 
http://www.gao.gov/products/GAO-11-278] (Washington, D.C.: February 
2011), and High-Risk Series: An Update, [hyperlink, 
http://www.gao.gov/products/GAO-07-310] (Washington, D.C.: January 
2007). 

[2] GAO, 2012 Annual Report: Opportunities to Reduce Duplication, 
Overlap and Fragmentation, Achieve Savings, and Enhance Revenue, 
[hyperlink, http://www.gao.gov/products/GAO-12-342SP] (Washington, 
D.C.: Feb. 28, 2012). 

[3] If FDA has not identified and recognized an accreditation body to 
meet the requirements within 2 years of the establishment of the 
accreditation system, FDA can directly accredit third-party auditors. 

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

[5] Although FSIS characterized its risk assessment as "illustrative," 
the agency nonetheless focused on Salmonella as the most significant 
hazard associated with catfish. 

[6] "Regulatory Planning and Review," Exec. Order No. 12866. 58 Fed. 
Reg. 51, 735 (Sept. 30, 1993). 

[7] Wyatt, L.E., Nickelson, R. II, & Vanderzant, C., "Occurrence and 
Control of Salmonella in Freshwater Catfish," Journal of Food Science, 
vol. 44 (1979), 1067-1073. 

[8] McCaskey, T., Hannah, T.C., Lovell, T., Silva, J.L., Fernandes, 
C.F., & Flick, G.J., "Safe and Delicious Study Shows Catfish is Low 
Risk for Foodborne Illness," Highlights of Agricultural Research, vol. 
45, no. 4 (1998). 

[9] U.S. Department of Agriculture, Economic Research Service, 
Economic Research Service Staff Analysis of FDA Import Refusals for 
Catfish, 1998-2004 (Washington, D.C., 2009). 

[10] United Nations, Food and Agriculture Organization, FAO Expert 
Workshop on the Application of Biosecurity Measures to Control 
Salmonella Contamination in Sustainable Aquaculture, Fisheries and 
Aquaculture Report No. 937 (Mangalore, India, January 2010). 

[11] U.S. Department of Agriculture, Economic Research Service, 
Economic Research Service Staff Analysis of FDA Import Shipments, 
Refusals, and Violations for Catfish and Non-Ictalurus Fish. January 
1, 1998-August 21, 2010 (Washington, D.C., 2011). 

[12] Erica McCoy, Jaime Morrison, Victor Cook, John Johnston, Denise 
Eblen, and Chuanfa Guo, "Foodborne Agents Associated with the 
Consumption of Aquaculture Catfish," Journal of Food Protection, vol. 
74, no. 3, (2011), pages 500-516. Risk Assessment Division, Office of 
Public Health Science, U.S. Department of Agriculture, Food Safety and 
Inspection Service. Washington, D.C. 

[13] The other hazards FSIS considered included heavy metals, 
pesticides, unapproved antimicrobials, Listeria monocytogenes, and 
Enterotoxigenic E. coli. 

[14] GAO, Opportunities to Reduce Potential Duplication in Government 
Programs, Save Tax Dollars, and Enhance Revenue, [hyperlink, 
http://www.gao.gov/products/GAO-11-318SP] (Washington, D.C.: Mar. 1, 
2011). 

[15] NMFS's Quality Management Program integrates HACCP preventive 
control strategies to ensure seafood is safe, complies with all food 
regulations, and meets internationally recognized quality standards. 

[16] GAO, Seafood Fraud: FDA Program Changes and Better Collaboration 
among Key Federal Agencies Could Improve Detection and Prevention, 
[hyperlink, http://www.gao.gov/products/GAO-09-258] (Washington, D.C., 
Feb. 19, 2009). 

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

[18] USDA contracted with a private company to inspect this facility 
because the processing facility provided seafood products to federal 
child nutrition programs. 

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

[End of section] 

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