oversight

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

Published by the Government Accountability Office on 2012-05-10.

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

             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
                                           May 2012

                                           SEAFOOD SAFETY
                                           Responsibility for Inspecting Catfish Should Not Be
                                           Assigned to USDA
Highlights of GAO-12-411, a report to
congressional requesters




Why GAO Did This Study                     What GAO Found
Since 2007, federal oversight of food      In determining that Salmonella is the primary food safety hazard in catfish, the
safety has been on GAO’s list of high-     U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS)
risk areas, largely because of             officials stated that the agency focused on Salmonella at the direction of the
fragmentation that has caused              Office of Management and Budget (OMB), which considered Salmonella the
inconsistent oversight, ineffective        most practical hazard to evaluate. However, GAO found that FSIS used outdated
coordination, and inefficient use of       and limited information in its risk assessment as its scientific basis for a catfish
resources. The Food, Conservation,         inspection program that seeks to mitigate that hazard. For example, FSIS
and Energy Act of 2008 (Farm Bill)         identified a single outbreak of Salmonella-caused illnesses, but this outbreak was
further fragmented the food safety
                                           not clearly linked to catfish. FSIS noted that this outbreak was before the Food
system by directing FSIS to issue
                                           and Drug Administration’s (FDA) 1997 Seafood Hazard Analysis and Critical
catfish inspection regulations. FSIS
prepared a risk assessment to
                                           Control Point regulations, which required firms to identify hazards in their
determine risks associated with catfish    processing systems and implement controls to prevent or mitigate these hazards;
and identified Salmonella as the           no similar outbreaks have occurred since. Other federal agencies questioned if
primary food safety hazard in catfish.     FSIS had adequately demonstrated a Salmonella problem in catfish. For
The Farm Bill split responsibility for     example, FDA does not generally have such concerns. Officials with the National
seafood safety between FSIS, for           Oceanic and Atmospheric Administration’s National Marine Fisheries Service
catfish inspection, and FDA, for           (NMFS) also stated that FSIS did not adequately demonstrate that Salmonella
seafood generally; in addition, NMFS       was a problem with catfish.
provides fee-for-service inspections of
                                           With the implementation of FSIS’s proposed catfish inspection program,
seafood-processing facilities. GAO was
asked to examine FSIS’s proposed           responsibility for overseeing seafood safety would be further divided and would
catfish inspection program.                duplicate existing federal programs at a cost. Under FSIS’s proposed program,
                                           processers would implement written sanitation and hazard control plans; FSIS
GAO examined (1) how FSIS                  would conduct continuous inspections of domestic catfish processing; and for
determined that Salmonella presented       imported catfish—which equal about 3 percent of all seafood imports—foreign
the primary food safety hazard in          countries would need to demonstrate equivalence to U.S. standards. According
catfish and (2) the anticipated impact     to FSIS, implementing this program will cost the government and industry about
of FSIS’s proposed catfish inspection      $14 million annually. If FSIS’s proposed program were implemented, GAO
program on other federal food safety
                                           expects it would cause duplication and inefficient use of resources in several key
inspection programs. GAO reviewed
                                           areas. First, the program requires implementation of hazard analysis plans that
FSIS’s proposed catfish program and
related documents and interviewed          are essentially the same as FDA’s hazard analysis requirements. Second, if the
officials from FSIS, FDA, and other        program is implemented, as many as three agencies—FDA, FSIS, and NMFS—
agencies.                                  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
What GAO Recommends                        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
Congress should consider repealing
                                           FDA Food Safety Modernization Act (FSMA) gives FDA authority to establish a
provisions of the Farm Bill assigning
USDA responsibility for catfish            system to accredit third party auditors, including foreign governments, to certify
inspection. USDA stated it is              imported seafood meets FDA regulatory requirements. FDA officials stated that
committed to completing the                this new authority complements FDA’s existing authority to obtain assurances
rulemaking process on catfish              about the safety of seafood exports from countries with food safety systems FDA
inspection consistent with the 2008        determined are comparable to the United States. Under these systems more
Farm Bill provisions.                      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
View GAO-12-411. For more information,     from FSIS’s implementation of its proposed program.
contact Lisa Shames at (202) 512-3841 or
shamesl@gao.gov.

                                                                                    United States Government Accountability Office
Contents


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




               Page i                                              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




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Page ii                                                        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
                                   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



                                   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 1                                                     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 2                                              GAO-12-411 Seafood Safety
in February 2012 that overlap and duplication of federal programs results
in inefficient use of taxpayer funds. 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.




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 3                                                  GAO-12-411 Seafood Safety
             FSIS and FDA are the two primary food safety agencies. FSIS is
Background   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




             Page 4                                                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 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



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 5                                                         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 6                                                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 7                                                    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 8                                                         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 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)



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).




Page 9                                                         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
FSIS Used Outdated    catfish, FSIS officials told us that the agency focused on Salmonella at
Data to Justify its   the direction of OMB, which considered Salmonella the most practical
                      hazard to evaluate. However, we found that FSIS used outdated and
Determination         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:




                      Page 10                                              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 11                                                         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 In addition, in commenting on FDA’s import samples,
     FSIS stated in its risk assessment that the limitations of the catfish


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).




Page 12                                                       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


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.




Page 13                                                        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
FSIS’s Proposed       responsibility for overseeing seafood safety and introduce overlap at
Program Mirrors       considerable cost. In our March 2011 report, we cited FSIS’s catfish
                      inspection program as an example of further fragmentation of the food
Existing Programs,    safety system. 14 In reviewing the proposed catfish program, we identified
Introducing Overlap   four areas that raise concerns about the potential for overlap or inefficient
and Inefficiencies    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.




                      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, GAO-11-318SP (Washington, D.C.: Mar. 1, 2011).




                      Page 14                                                     GAO-12-411 Seafood Safety
Table 1: FDA and NMFS HACCP Plan Requirements, and FSIS Proposed Requirements

                                              Division of Seafood                        Seafood Inspection        Office of Catfish Inspection
                                                  Safety, FDA                             Program, NMFS            Program (proposed), FSIS
Statutory authority                      Federal Food, Drug, and                  Agriculture Marketing Act of    Federal Meat Inspection Act, as
                                         Cosmetic Act; Public Health              1946                            applicable to catfish
                                         Service Act
Written HACCP plan required                               x                                           x                          x
HACCP plan requirements
List/identify chemical, physical,                         x                                           x                          x
and biological safety hazards
List/identify critical control points                     x                                           x                          x
(CCP)
List/identify critical limits for each                    x                                           x                          x
CCP
List procedures to monitor each                           x                                           x                          x
CCP including monitoring
frequency
                                                           a                                           a                          b
Include any corrective action plans                       x                                           x                         x
Provide a recordkeeping system                            x                                           x                          X
that documents the monitoring of
CCPs
List verification procedures and                          x                                           x                          x
frequency
Validate CCPs are effective in                            X                                           x                          x
controlling hazards
Require written Sanitation               No written procedures required                               x                          x
Standard Operating Procedures            but processors must implement
                                         and monitor sanitation controls
                                         and maintain records
Preoperational sanitation                Conducted as needed                                          x                          x
evaluation conducted as part of
inspection
Frequency of domestic site               Every 3 to 5 years for products          Minimum, quarterly audits       On-site inspection during
inspections                              FDA considers low risk, such                                             processing
                                         as catfish
                                                 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 15                                                               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 According to
NMFS documents we reviewed, many retail and distribution firms buying
processed catfish products currently require NMFS product verifications


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.




Page 16                                                       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 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.


Page 17                                              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


16
 GAO, 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).
17
 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.




Page 18                                                       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 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



19
 GAO-11-286.




Page 19                                              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
Conclusion   has proposed a program that seeks to mitigate the primary food safety
             hazard most associated with domestic and imported catfish, which FSIS


             Page 20                                              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
Matter for           avoid duplication of effort and cost, Congress should consider repealing
Congressional        provisions of the Farm Bill that assigned USDA responsibility for
                     examining and inspecting catfish and for creating a catfish inspection
Consideration        program.


                     We provided USDA and the Departments of Commerce and Health and
Agency Comments      Human Services with a draft of this report for their review and comment.
and Our Evaluation   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.


                     Page 21                                             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




Page 22                                               GAO-12-411 Seafood Safety
Appendix I: Scope and Methodology
             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


             Page 23                                            GAO-12-411 Seafood Safety
Appendix I: Scope and Methodology




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.




Page 24                                               GAO-12-411 Seafood Safety
Appendix II: Comments from the U.S.
              Appendix II: Comments from the U.S.
              Department of Agriculture



Department of Agriculture




              Page 25                               GAO-12-411 Seafood Safety
Appendix III: GAO Contact and Staff
                  Appendix III: GAO Contact and Staff
                  Acknowledgments



Acknowledgments

                  Lisa Shames, (202) 512-3481 or shamesl@gao.gov
GAO Contact
                  In addition to the individual named above, Anne K. Johnson (Assistant
Staff             Director), David Moreno (Analyst-in-Charge), Michele Sahlhoff, Carol
Acknowledgments   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.




(361364)
                  Page 26                                             GAO-12-411 Seafood Safety
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