SEAFOOD SAFETY

Responsibility for 

Inspecting Catfish 

Should Not Be 

Assigned to USDA

Report to Congressional Requesters

May 2012

GAO-12-411

United States Government Accountability Office

GAO
United States Government Accountability Office

Highlights of GAO-12-411, a report to 

congressional requesters

May 2012

SEAFOOD SAFETY

Responsibility for Inspecting Catfish Should Not Be 

Assigned to USDA 

Why GAO Did This Study

Since 2007, federal oversight of food 

safety has been on GAO’s list of highrisk 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 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. 

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 However, GAO found that FSIS used outdated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. 

 

View GAO-12-411. For more information, 

contact Lisa Shames at (202) 512-3841 or 

shamesl@gao.gov. 
Page i GAO-12-411 Seafood Safety

Letter 1 

Background 4

FSIS Used Outdated Data to Justify its Determination 10

FSIS’s Proposed Program Mirrors Existing Programs, Introducing 

Overlap and Inefficiencies 14

Conclusion 20

Matter for Congressional Consideration 21

Agency Comments and Our Evaluation 21

Appendix I Scope and Methodology 23

Appendix II Comments from the U.S. Department of Agriculture 25

Appendix III GAO Contact and Staff Acknowledgments 26

Table

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

Proposed Requirements 15

Figures

Figure 1: Typical Domestic and Imported Catfish 6

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

Market 7

Figure 3: Sources of Imported Siluriformes Catfish, 2010 8

Contents
Page ii GAO-12-411 Seafood Safety

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

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

United States. The published product may be reproduced and distributed in its entirety 

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

copyrighted images or other material, permission from the copyright holder may be 

necessary if you wish to reproduce this material separately.
Page 1 GAO-12-411 Seafood Safety

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,1

FDA has traditionally had oversight over the safety of all seafood, 

including catfish. The Food, Conservation, and Energy Act of 2008 (Farm 

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.

 

1

See GAO, High-Risk Series: An Update, GAO-11-278 (Washington, D.C.: February 

2011), and High-Risk Series: An Update, GAO-07-310 (Washington, D.C.: January 2007). 

 
 

Page 2 GAO-12-411 Seafood Safety

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 
 

Page 3 GAO-12-411 Seafood Safety

in February 2012 that overlap and duplication of federal programs results 

in inefficient use of taxpayer funds.2

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.

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.

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.

 

2

GAO, 2012 Annual Report: Opportunities to Reduce Duplication, Overlap and 

Fragmentation, Achieve Savings, and Enhance Revenue, GAO-12-342SP (Washington, 

D.C.: Feb. 28, 2012).
 

Page 4 GAO-12-411 Seafood Safety

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 

Background 
 

Page 5 GAO-12-411 Seafood Safety

auditors under certain circumstances.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.4

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 

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.

 

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, GAO-11-286 (Washington, D.C.: Apr. 14, 2011).
 

Page 6 GAO-12-411 Seafood Safety

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 fig. 1).

Figure 1: Typical Domestic and Imported Catfish
 

Page 7 GAO-12-411 Seafood Safety

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
 

Page 8 GAO-12-411 Seafood Safety

Figure 3: Sources of Imported Siluriformes Catfish, 2010

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

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 
 

Page 9 GAO-12-411 Seafood Safety

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.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.6

 

5

Although FSIS characterized its risk assessment as “illustrative,” the agency nonetheless 

focused on Salmonella as the most significant hazard associated with catfish.

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) 

6

“Regulatory Planning and Review,” Exec. Order No. 12866. 58 Fed. Reg. 51, 735 (Sept. 

30, 1993). 
 

Page 10 GAO-12-411 Seafood Safety

has a review function to, among other things; ensure that regulations are 

consistent with principles set forth in the executive order.

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:

FSIS Used Outdated 

Data to Justify its 

Determination 
 

Page 11 GAO-12-411 Seafood Safety

• 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.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 1995.8

• 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.

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 

 

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).
 

Page 12 GAO-12-411 Seafood Safety

Salmonella. In addition, even when a low prevalence of Salmonella is 

present, thorough cooking will eliminate the hazard.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.11

 

10United 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).

In addition, in commenting on FDA’s import samples, 

FSIS stated in its risk assessment that the limitations of the catfish 

11U.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).
 

Page 13 GAO-12-411 Seafood Safety

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.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

 

12Erica 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.
 

Page 14 GAO-12-411 Seafood Safety

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.13

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.14

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.

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.

 

13The other hazards FSIS considered included heavy metals, pesticides, unapproved 

antimicrobials, Listeria monocytogenes, and Enterotoxigenic E. coli. 

14GAO, Opportunities to Reduce Potential Duplication in Government Programs, Save 

Tax Dollars, and Enhance Revenue, GAO-11-318SP (Washington, D.C.: Mar. 1, 2011).

FSIS’s Proposed 

Program Mirrors 

Existing Programs, 

Introducing Overlap 

and Inefficiencies
 

Page 15 GAO-12-411 Seafood Safety

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

Division of Seafood 

Safety, FDA

Seafood Inspection 

Program, NMFS

Office of Catfish Inspection 

Program (proposed), FSIS

Statutory authority Federal Food, Drug, and 

Cosmetic Act; Public Health 

Service Act

Agriculture Marketing Act of 

1946

Federal Meat Inspection Act, as 

applicable to catfish

Written HACCP plan required x x x 

HACCP plan requirements 

List/identify chemical, physical, 

and biological safety hazards 

x x x 

List/identify critical control points 

(CCP)

x x x 

List/identify critical limits for each 

CCP

x x x 

List procedures to monitor each 

CCP including monitoring 

frequency

x x x 

Include any corrective action plans x

a xa xb

Provide a recordkeeping system 

that documents the monitoring of 

CCPs

x x X 

List verification procedures and 

frequency

x x x 

Validate CCPs are effective in 

controlling hazards

X x x 

Require written Sanitation 

Standard Operating Procedures 

No written procedures required 

but processors must implement 

and monitor sanitation controls 

and maintain records

x x 

Preoperational sanitation 

evaluation conducted as part of 

inspection 

Conducted as needed x x 

Frequency of domestic site 

inspections 

Every 3 to 5 years for products 

FDA considers low risk, such 

as catfish

Minimum, quarterly audits 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.

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 
 

Page 16 GAO-12-411 Seafood Safety

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.15

 

15NMFS’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.

According to 

NMFS documents we reviewed, many retail and distribution firms buying 

processed catfish products currently require NMFS product verifications 
 

Page 17 GAO-12-411 Seafood Safety

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 seafoodproducing 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.
 

Page 18 GAO-12-411 Seafood Safety

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.16 In 2011, we reported that NMFS and FDA were still not 

coordinating their inspection activities.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.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 

 

16GAO, Seafood Fraud: FDA Program Changes and Better Collaboration among Key 

Federal Agencies Could Improve Detection and Prevention, GAO-09-258 (Washington, 

D.C., Feb. 19, 2009). 

17GAO-11-286.

18USDA contracted with a private company to inspect this facility because the processing

facility provided seafood products to federal child nutrition programs.
 

Page 19 GAO-12-411 Seafood Safety

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.19

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 

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.

 

19GAO-11-286. 
 

Page 20 GAO-12-411 Seafood Safety

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.

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 

Conclusion 
 

Page 21 GAO-12-411 Seafood Safety

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.

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.

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.

Matter for 

Congressional 

Consideration 

Agency Comments 

and Our Evaluation
 

Page 22 GAO-12-411 Seafood Safety

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 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.

Lisa Shames

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

Page 23 GAO-12-411 Seafood Safety

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 

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

Page 24 GAO-12-411 Seafood Safety

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.
Appendix II: Comments from the U.S. 

Department of Agriculture

Page 25 GAO-12-411 Seafood Safety

Appendix II: Comments from the U.S. 

Department of Agriculture
Appendix III: GAO Contact and Staff 

Acknowledgments

Page 26 GAO-12-411 Seafood Safety

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

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.

Appendix III: GAO Contact and Staff 

Acknowledgments 

GAO Contact

Staff 

Acknowledgments 

(361364)
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