Seafood Safety: Responsibility for Inspecting Catfish Should Not Be Assigned to USDA
Published: 2012-05-10T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.
section_title: What GAO Recommends
paragraphs: 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.

section_title: Letter
paragraphs: 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,  largely because of fragmentation that has caused inconsistent oversight,  ineffective coordination, and inefficient use of resources. The Department  of Health and Human Services’ Food and Drug Administration (FDA) and  the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection  Service (FSIS) have primary oversight responsibilities for the safety of the  domestic and imported food supply. FSIS has historically been  responsible for meat, poultry, and processed egg products, and FDA is  responsible for all other food, including seafood. In addition, the National  Oceanic and Atmospheric Administration’s National Marine Fisheries  Service (NMFS), through its fee-for-service inspection program, assesses  seafood processors’ compliance with federal regulations.
FDA has traditionally had oversight over the safety of all seafood,  including catfish. The Food, Conservation, and Energy Act of 2008 (Farm  Bill), which was enacted in June 2008 and provides for the continuation of  many agriculture programs through September 2012, assigned regulatory  responsibility for the inspection of catfish to USDA once the agency  issues final regulations for a mandatory catfish inspection program. Until  those final regulations are issued, USDA has no responsibility for catfish  safety. Specifically, among other things, the Farm Bill requires USDA,  through FSIS, to provide continuous inspection of domestic catfish,  including the processing of these fish. The Farm Bill also requires that  FSIS issue final regulations for this inspection program after providing a  period for public comments and public meetings before it implements the  catfish inspection program. Congressional committees are in the process  of considering proposals for a new Farm Bill.
In February 2011, FSIS published and sought comments on a proposed  rule outlining possible regulations for a new catfish inspection program.  Among other things, FSIS’s proposed program would require processers  to implement written sanitation and hazard control plans; FSIS inspectors  to conduct continuous inspection of domestic catfish processing; and for  imported catfish, foreign countries would need to demonstrate  equivalence to U.S. standards. Specifically, FSIS would have an  inspector at the processing facility to monitor all aspects of domestic  catfish processing, and for imported catfish, review the food safety  systems of countries seeking to export catfish to the United States to  determine whether the foreign systems are equivalent to the U.S. food  safety system for catfish. FSIS sought public comments on (1) whether it  should primarily regulate a type of catfish most commonly raised in the  United States or whether the agency should regulate all catfish, including  fish commonly farmed in southeastern Asian countries, such as Vietnam,  and (2) the timing of the program’s implementation. FSIS prepared a draft  health risk assessment (risk assessment) that cited Salmonella as the  primary food safety hazard in catfish and prepared a preliminary  regulatory impact analysis (impact analysis) to examine the costs and  benefits of the proposed regulations. FSIS is reviewing the comments it  received on the proposed regulations and the data from subsequent  catfish sampling studies from 2008 through 2011 to develop a baseline of  contamination in catfish; the agency has not settled on a date to issue the  final regulations.
Once FSIS issues the final regulations required by the Farm Bill, FSIS,  FDA, and NMFS will all have roles in the federal oversight of seafood  products. We have reported many times that fragmentation in the nation’s  food safety system results in inconsistent oversight, ineffective  coordination, and inefficient use of resources. For example, we reported  in February 2012 that overlap and duplication of federal programs results  in inefficient use of taxpayer funds. 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.
subsections: section_title: Background
paragraphs: FSIS and FDA are the two primary food safety agencies. FSIS is  responsible for the safety of meat, poultry, and processed egg products,  and, pursuant to the Farm Bill, is given authority to inspect catfish as soon  as it issues final regulations to carry out a catfish inspection program.  FDA is responsible for virtually all other food, including seafood. Under  the Federal Food, Drug, and Cosmetic Act, FDA is responsible for  ensuring that the nation’s food supply, including seafood, is safe,  wholesome, sanitary, and properly labeled. Since 1997, FDA has used  the internationally recognized Hazard Analysis and Critical Control Point  (HACCP) system as its main oversight tool for seafood safety. FDA  requires seafood processing firms—those that, among other things,  manufacture, pack, or label seafood products—to use a HACCP system.  Under this system, processors are primarily responsible for the safety of  the seafood they process. That is, processors are responsible for  identifying where in their processing system one or more hazards are  reasonably likely to occur (hazard analysis) and implementing control  techniques to prevent or mitigate these hazards. Processors are to lay out  their hazard analysis and control techniques in HACCP plans. FDA  verifies through inspections that the techniques are adequate to control  the identified significant hazards and are being effectively implemented.  FDA inspects domestic and foreign seafood processors in an effort to  ensure their compliance with HACCP regulations. FDA supplements its  HACCP oversight activities with an import oversight program that includes  examination and testing of some imported seafood at ports of entry to  ensure the products meet U.S. requirements, including the absence of  residues of drugs that are unapproved for use in the United States and  would render the seafood adulterated under the Federal Food, Drug, and  Cosmetic Act; FDA also maintains data on the shipments of seafood that  it has refused to allow into the United States.
The FDA Food Safety Modernization Act (FSMA), enacted in January  2011, gives FDA new authorities to improve its ability to oversee the  safety of imported foods. As described in FSMA, FDA must establish a  system for recognizing accreditation bodies to accredit third-party  auditors, including foreign governments, to conduct food safety audits to  determine compliance with the Federal Food, Drug, and Cosmetic Act  and to certify that eligible foreign entities, including seafood processors,  meet applicable requirements. FDA may directly accredit third-party  auditors under certain circumstances. 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. For example, in fiscal year 2011, FDA examined  about 3.4 percent of all seafood entries and performed laboratory analysis  on 0.7 percent of these entries. We recommended, in part, that FDA  study the feasibility of adopting practices that the European Union  employs to ensure the safety of imported seafood products, such as  requiring foreign countries that want to export seafood to the United  States to develop a national residues monitoring plan to control the use of  drugs used in aquaculture (fish farming). Because fish grown in confined  aquacultured areas can have high rates of bacterial infections, farmers  may treat them with drugs, such as antibiotics and antifungal agents, to  increase fish survival rates. According to a 2008 FDA report, the residues  of some of these drugs can cause cancer, allergic reactions, and  antibiotic resistance when consumed by humans. As imports of  aquacultured seafood products increase, so do the concerns over the  presence of drug residues.
NMFS’s Seafood Inspection Program provides fee-for-service  inspections, primarily under the authority of the Federal Agricultural  Marketing Act of 1946. According to NMFS officials, NMFS’s experience  with seafood controls dates to the1970s, when the agency began  systematically evaluating controls as part of its inspection program.  NMFS more formally adopted the systematic evaluation with the  development of its Quality Management Program in 1993, which  integrates quality into its HACCP-based inspection system. Currently,  NMFS provides inspection services on request to the seafood industry— including domestic and foreign processors, distributors, and other firms— to certify that these seafood firms comply with HACCP requirements and  other federal food safety standards, among other things. Some retailers  require this certification as a condition for purchasing the seafood  products.
Before 2002, various fish in the order Siluriformes were commonly  labeled and sold as “catfish.” However, in 2002, Congress amended the  Federal Food, Drug, and Cosmetic Act to allow only fish from the family  Ictaluridae (in the order Siluriformes) to use the name catfish in labeling.  All other fish, such as those from the Pangasiidae family (in the order  Siluriformes) that had previously been labeled as catfish, had to have  other names on labels, such as basa, swai, or tra. In making catfish  subject to mandatory FSIS inspection, the Farm Bill gave the Secretary of  Agriculture discretion to define “catfish” for the purposes of inspection— that is, to distinguish between different types of catfish or to consider all  fish in the order Siluriformes as catfish. For purposes of this report, we  refer to all catfish potentially subject to regulations as catfish, including  fish in the family Ictaluridae, which are primarily of domestic origin, and  Pangasiidae, which come primarily from Vietnam (see fig. 1).
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.
The volume of catfish subject to FSIS’s proposed catfish inspection  program will depend on the definition of catfish that the Secretary of  Agriculture decides to apply. In 2010, 79 percent of the catfish in the U.S.  market consisted primarily of domestically processed catfish as well as  some imported catfish from the family Ictaluridae, while the remaining 21  percent consisted of imported catfish from the family Pangasiidae. If the  Secretary of Agriculture chose to limit the definition to catfish to the family  Ictaluridae, FSIS’s inspection program would thus cover almost 80  percent of the catfish in the U.S. market in 2010.
The Farm Bill requires that FSIS issue the final regulations for its new  catfish inspection program before it can begin inspecting catfish. Citing  requirements of the Federal Crop Insurance Reform Act of 1994, FSIS  prepared a risk assessment and an impact analysis and made them  available for public review. FSIS used the risk assessment to determine  the primary hazard of concern associated with consuming farm-raised  catfish in the United States, and it conducted an impact analysis to  examine the costs and benefits of the proposed regulations. 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. Under this guidance, agencies are to identify the  problem new regulations are intended to address and evaluate the  significance of the problem. The executive order further directs that the  agencies consider the alternative of not regulating, but it recognizes that  agencies should issue regulations as required by law, as are the  regulations for the catfish inspection program. The executive order directs  agencies to provide a description of the need for any significant regulatory  action, how that action meets the needs, and the costs and benefits of the  action. A significant regulatory action includes any regulatory action that  has an annual effect on the economy of $100 million or more or adversely  affects, among other things, the economy or a sector of the economy.  Under the executive order, the Office of Management and Budget (OMB)  has a review function to, among other things; ensure that regulations are  consistent with principles set forth in the executive order.
section_title: FSIS Used Outdated Data to Justify its Determination
paragraphs: In determining that Salmonella is the primary food safety hazard in  catfish, FSIS officials told us that the agency focused on Salmonella at  the direction of OMB, which considered Salmonella the most practical  hazard to evaluate. However, we found that FSIS used outdated and  limited information as its scientific basis for implementing a catfish  inspection program that was required by law.
According to FSIS, the agency initially focused its risk assessment of  potential contaminants in catfish primarily on public health outcomes  associated with chemical contaminants, with limited attention to  Salmonella. (The appendix to FSIS’s risk assessment includes  information on these hazards.) However, upon reviewing the initial FSIS  assessment, agency officials said that OMB directed FSIS to focus its  catfish risk assessment on Salmonella, not as the “riskiest hazard” but as  the “most practical” and to note that there was uncertainty regarding the  sufficiency of information used to demonstrate the association between  Salmonella and catfish. Furthermore, FSIS officials agreed that  Salmonella was a practical choice, in part, because the agency could  show that it is a major cause of illnesses in the United States, although  not necessarily from catfish. For example, a 2011 report from the  Department of Health and Human Services’ Centers for Disease Control  and Prevention stated that Salmonella infection causes more  hospitalizations and deaths than any other bacteria and showed that the  major sources of illnesses caused by Salmonella from 2004 to 2008 were  poultry; eggs; pork; beef; and vine vegetables, fruits, and nuts. Moreover,  the risk assessment cited FSIS’s knowledge and experience working with  Salmonella detection and prevention, but that its knowledge and  experience related to poultry, not seafood.
According to FSIS officials, because of OMB direction and availability of  information, FSIS identified Salmonella as the primary hazard for catfish  in its risk assessment. FSIS’s risk assessment stated it assumed that the  prevalence of the identified primary hazard associated with catfish was  the same for domestic and foreign catfish. The risk assessment cited the  following to support the claim that Salmonella in catfish was the primary  hazard:
Salmonella may be a concern with catfish because catfish are raised  in fish farms, and Salmonella is a potential microbial hazard for  aquatic environments.
Salmonella is a high-priority hazard and of great concern in the United  States because of the general burden of illnesses associated with it.  In particular, FSIS’s risk assessment stated that the Centers for  Disease Control and Prevention had identified a 1991 Salmonella  outbreak in which catfish may have been the source.
A 1979 article in the Journal of Food Science indicated that  Salmonella was found in 21 percent of catfish collected from ponds  and retail markets.
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.
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.
The following describes limitations we identified in FSIS’s rationale for  designating Salmonella as the basis for regulation:
A 2010 United Nations Food and Agriculture Organization report on  Salmonella contamination in aquaculture stated that products from  fish farms are rarely involved in outbreaks of illnesses caused by  Salmonella. In addition, even when a low prevalence of Salmonella is  present, thorough cooking will eliminate the hazard.
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.FSIS stated in its risk assessment that the limitations of the catfish   In addition, in commenting on FDA’s import samples,  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.
FDA and NMFS, which each have about 14 years experience in  inspecting catfish processing facilities under HACCP regulations, as well  as experience in sampling catfish products, also questioned whether  FSIS had adequately demonstrated that Salmonella in catfish was a  problem. According to FDA and NMFS officials, FSIS did not provide any  new information or data in its risk assessment indicating that catfish was  unsafe to consume or that the current oversight system was not  addressing any potential problems. According to FDA officials, based on  the agency’s experience and information from its own testing programs,  catfish is a low-risk product, and the agency generally does not have any  concerns related to Salmonella in catfish. According to NMFS officials,  FSIS did not adequately demonstrate that Salmonella was a significant  problem with catfish because data are not available to confirm this  hazard. NMFS added that it was more likely that unapproved veterinary  drugs and chemical residues were the hazards most associated with  catfish. According to its proposed regulations, FSIS considered several  other hazards it thought might be associated with catfish.
section_title: FSIS’s Proposed Program Mirrors Existing Programs, Introducing Overlap and Inefficiencies
paragraphs: 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. In reviewing the proposed catfish program, we identified  four areas that raise concerns about the potential for overlap or inefficient  use of resources if FSIS were to implement the catfish inspection  program: (1) similar HACCP requirements, (2) inspection overlap and  unnecessary frequency of inspection, (3) inconsistent oversight of  imported seafood, and (4) the cost of implementing FSIS’s catfish  inspection program.
Similar HACCP requirements. FDA and NMFS require, and FSIS would  require, facilities to implement HACCP systems to reduce the risk of  illness from contaminated foods. Table 1 shows the requirements of a  HACCP system for catfish and how each agency implements or would  implement these requirements.
As table 1 shows, the three agencies essentially do not differ from each  other in their HACCP requirements. FSIS acknowledges that many  domestic processing facilities are already meeting many of its proposed  requirements. Nevertheless, if FSIS implements its proposed catfish  program, catfish processors are likely to see their paperwork  requirements increase. For example, FSIS would require written  sanitation plans, while FDA inspectors do not require written sanitation  plans and instead require only that sanitation be monitored and records  kept, according to FDA officials. Therefore, catfish processing facilities  without written sanitation plans would now be required to develop them.  Catfish processing facilities that already contract for inspection services  with NMFS must have written sanitation plans, but FSIS officials said the  format of the FSIS sanitation plan would differ from the one already  required by NMFS. FSIS officials noted that some of the additional  paperwork burden required for FSIS regulations would be offset by the  reduction of FDA paperwork requirements. However, facilities that  process catfish and other seafood would be required to meet both FSIS  and FDA paperwork requirements, which may differ. For instance, FSIS  plans to develop its own forms for documenting a HACCP system, which  will require processors of catfish and other seafood under FSIS and FDA  oversight to enter the same information twice—once for FSIS and once  for FDA.
Inspection overlap and unnecessary inspection frequency. FSIS’s  proposed catfish program would introduce inefficiencies into the U.S.  catfish inspection system by duplicating existing FDA and NMFS  inspections. Currently, about 18 major domestic facilities process catfish,  according to FSIS, and an unknown number of facilities process both  catfish and other seafood. With the implementation of FSIS’s catfish  inspection program, facilities that process only catfish may be inspected  by FSIS and NMFS, and facilities that process both catfish and other  seafood may be inspected by all three agencies—FSIS, FDA, and NMFS.  FDA inspects facilities that process only catfish every 3 to 5 years  because it considers catfish a low-risk product, but it may inspect other  facilities that process catfish, along with other seafood, more frequently,  depending on the risks associated with the other seafood. NMFS  conducts a minimum of quarterly inspections of processing facilities that  participate in its Quality Management Program, including a majority of the  domestic catfish-processing facilities FSIS identified. According to  NMFS documents we reviewed, many retail and distribution firms buying  processed catfish products currently require NMFS product verifications  and are likely to still require NMFS verification after promulgation of the  FSIS proposed regulations. For example, representatives we spoke with  from two domestic facilities that process catfish and other seafood told us  that they expect to continue to pay for NMFS inspections to meet retailer  demands, despite any additional oversight FSIS provides. In addition to  any NMFS services that they retain, facilities that process both catfish  and other seafood will also be required to meet both FDA and FSIS  requirements and will be subject to inspections by both agencies.  According to FSIS officials, overlap of programs is outside the agency’s  control because the proposed program was mandated by Congress.
Implementation of the proposed catfish inspection program would also  fragment the export certification processes that some foreign  governments require for the export of U.S.-produced seafood. Under its  proposed regulations, FSIS would issue official export certificates for  shipments of inspected and passed catfish products produced in the  United States for export to foreign countries, as authorized by the Federal  Meat Inspection Act. However, NMFS currently provides these  certification services for all seafood, including catfish. According to NMFS  officials, this dual certification creates a potential problem because NMFS  already has approval from multiple foreign governments to serve as the  U.S. certification authority for seafood exports.
FSIS’s proposed use of continuous monitoring in the form of daily  inspections for catfish is also unlikely to reduce the hazard of  contamination in catfish as intended and is not risk based, according to  FDA and NMFS officials. (Under the Farm Bill, FSIS is required to issue  final regulations to conduct continuous monitoring of catfish processing  facilities, as it does for meat, poultry, and processed egg products  facilities). FDA officials told us FSIS’s continuous monitoring approach is  counter to HACCP-based requirements for seafood and not based on  risk. According to FDA and NMFS officials, only periodic inspection is  necessary to verify that a HACCP plan is being implemented and  adequate preventive controls are in place. According to NMFS documents  we reviewed, the current HACCP approach to seafood safety is  fundamental not only in the United States but also in most seafood- producing countries around the world. Consequently, these countries rely  on periodic, not daily, inspections. In addition, NMFS stated that  continuous inspection will not enhance the level of safety with catfish  because disease cannot be identified by visual inspection, as it can for  meat and poultry. NMFS noted that because continuous or daily  inspection does not necessarily improve seafood safety, its use is more  costly with little effect.
We have reported on duplication and overlap in federal inspection of  seafood in the past, when only FDA and NMFS were concerned. In 2009,  we reported that FDA does not try to determine whether NMFS has  already inspected a seafood facility when it is deciding which facilities to  inspect. In 2011, we reported that NMFS and FDA were still not  coordinating their inspection activities. 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.
Inconsistent oversight of imported seafood. Consistent with the  Federal Meat Inspection Act, as amended by the Farm Bill, FSIS plans to  apply an equivalency approach for catfish that is similar to the one it uses  for imported meat, poultry, and processed egg products. Under FSIS’s  equivalency approach, meat, poultry and processed egg products are not  eligible for export to the United States unless FSIS has determined that  the exporting country has a food safety system equivalent to that of the  United States. Among other things, FSIS reviews documents provided by  foreign governments, conducts on-site evaluations of government  inspections of processing facilities, and audits laboratories to ensure their  food safety regulations and oversight are adequate. In addition, FSIS  reinspects products at U.S. ports of entry to promote compliance.
Some individuals and organizations that supported the transfer of catfish  safety from FDA to FSIS, which include representatives of the catfish  industry and consumer groups, stated that there were several problems  with FDA’s oversight system, such as limited inspection and sampling of  imported seafood, and that FSIS’s proposed catfish program regulations,  if implemented, would enhance catfish safety. For example, in their  written comments to FSIS, some supporters stated that imported catfish  may be unsafe because they were raised under less stringent standards,  such as allowing the catfish to be exposed to whatever pollutants were  present in the river water where they were raised. Supporters also  indicated that imported catfish may contain residues from drugs that FDA  has not approved for use in aquaculture. Finally, supporters noted that  FSIS staff would review foreign catfish safety systems to ensure these  systems met U.S. requirements before such products were admitted into  U.S. commerce. In addition, FSIS inspectors would reinspect catfish  imports at the ports of entry.
In April 2011, we reported that FDA’s oversight of imports is limited when  compared with FSIS’s more comprehensive reviews of food safety  systems under its equivalence program. However, FSMA gives FDA  authority to establish a system to accredit third-party auditors, including  foreign governments, to take responsibility for certifying seafood  processors or seafood meets FDA regulatory requirements. Under this  system, a foreign government would have to demonstrate that its food  safety programs, systems, and standards are capable of adequately  ensuring that the foreign government and the foods it certifies, including  seafood, meet FDA requirements. According to FDA officials, its new  FSMA authorities complement the authority it already had to conduct  comparability assessments, which are intended to help ensure the safety  of imported foods. With comparability assessments, FDA can leverage  the work of foreign governments whose food safety systems FDA has  determined provide protections that are comparable to those of the U.S.  food safety system. FDA is currently piloting a comparability assessment  process with the European Union and New Zealand. New authorities  provided in FSMA, including third party certification, will enable FDA to  leverage resources of countries with sufficient qualifications—even  though they may not have comparable systems—to help ensure that  foods exported to the United States meet FDA requirements. Enacted in  2011, these new FSMA authorities were not available to FDA when the  Farm Bill assigned responsibility for catfish inspection to FSIS in 2008.
Cost of implementing FSIS’s catfish inspection program. Currently,  FDA estimates that it spends less than $700,000 annually to inspect  catfish processing facilities, and NMFS inspection services pose no  additional cost to the federal government because its costs are covered  by industry service fees. FSIS estimates that the implementation of its  proposed catfish inspection program would cost the federal government  and industry an additional $14 million annually. As estimated by FSIS, the  federal government bears most of the estimated cost, about 98 percent,  and industry bears the remaining cost. We did not determine the accuracy  of FSIS’s estimate, but in our limited review we observed some limitations  with FSIS’s cost data and assumptions that would affect the final  accuracy of the agency’s estimate. For example, in its impact analysis,  FSIS indicated that it did not have complete information on the total  number of domestic and foreign catfish processing facilities that would be  affected by the proposed regulations. In addition, the number of countries  that will apply for equivalence determination is not known. The number of  foreign applicants will, in turn, affect the cost FSIS will incur in making  equivalence determinations and in examining shipments at ports of entry.  In addition, FSIS may have overstated the federal dollars that FDA and  NMFS would save if FSIS implements a catfish inspection program. For  example, NMFS officials said that FSIS may have overstated the $1.5  million amount that would be saved if FSIS assumed all inspection duties  previously carried out by NMFS inspectors. FDA officials stated that they  could not validate the numbers FSIS used to estimate the amount of  money FDA would save if FSIS implemented its proposed catfish  program. In addition, FSIS estimated that it spent a total of $15.4 million  from fiscal years 2009 to 2011 to develop the catfish inspection program,  including costs related to catfish sampling studies. In fiscal year 2012,  FSIS plans to spend an additional $4.4 million to support further program  development.
The cost effectiveness of FSIS’s catfish inspection program is unclear.  FSIS acknowledges in its risk assessment that there is substantial  uncertainty about how effective FSIS’s catfish inspection program will be  in reducing the prevalence of Salmonella-contaminated catfish. In  addition, FSIS acknowledged in its risk assessment that it lacks  regulatory oversight experience with catfish processing facilities, although  it has historically overseen the meat, poultry and processed egg products  industries. FDA and NMFS officials we spoke with do not expect FSIS’s  proposed catfish inspection program to make catfish safer than it already  is under current federal oversight programs. Moreover, FSIS would  oversee a small fraction of all seafood imports to the United States— about 3 percent—while FDA, using its enhanced authorities, could  undertake oversight of all imported seafood.
section_title: Conclusion
paragraphs: To implement the catfish inspection requirement in the Farm Bill, FSIS  has proposed a program that seeks to mitigate the primary food safety  hazard most associated with domestic and imported catfish, which FSIS  identified as Salmonella. However, the agency’s proposed catfish  inspection program further fragments the federal oversight system for  food safety without demonstrating that there is a problem with catfish or a  need for a new federal program. We recognize that FSIS developed this  program because it was mandated to do so by the Farm Bill—before FDA  received enhanced regulatory authority under FSMA. Even so, FSIS  proposed a program that essentially mirrors the catfish oversight efforts  already underway by FDA and NMFS. Furthermore, since FDA  introduced HACCP requirements for seafood processing facilities— including catfish facilities—in 1997, no reported outbreaks of illnesses  caused by Salmonella contamination of catfish have been reported—the  hazard identified by FSIS—indicating the low risk presented by this  pathogen in catfish. Consequently, if implemented, the catfish inspection  program would likely not enhance the safety of catfish but would duplicate  FDA and NMFS inspections at a cost to taxpayers. With FDA’s new  authority under FSMA, the federal government has an opportunity to  enhance the effectiveness of the food safety system of all imported  seafood, including catfish, and avoid the duplication of effort and costs  that would result from FSIS’s implementation of its proposed catfish  inspection program.
section_title: Matter for Congressional Consideration
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided USDA and the Departments of Commerce and Health and  Human Services with a draft of this report for their review and comment.  We also provided a draft of this report to the Department of State, the  Office of the U.S. Trade Representative, and the Office of Management  and Budget. On April 25, 2012, we received written comments from  USDA, which are reproduced in appendix II. USDA and the Department  of Health and Human Services provided technical comments, which we  incorporated as appropriate. The Department of Commerce did not  provide written comments.
USDA stated that it appreciated our work in planning, conducting, and  issuing the report. USDA added that it is committed to completing the  rulemaking process on catfish inspection in a manner that is consistent  with the 2008 Farm Bill provisions.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies to the appropriate  congressional committees; the Secretaries of Agriculture, Commerce,  Health and Human Services, and State; the U.S. Trade Representative;  the Director of the Office of Management and Budget; and other  interested parties. In addition, the report will be available at no charge on  the GAO website at 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.
section_title: Appendix I: Scope and Methodology
paragraphs: We were asked to examine the U.S. Department of Agriculture’s (USDA)  Food Safety Inspection Service’s (FSIS) proposed catfish inspection  program. Our objectives were to determine (1) how FSIS determined that  Salmonella presented the primary food safety hazard in catfish and (2)  the anticipated impact of FSIS’s proposed catfish inspection program on  other federal food safety inspection programs.
To address the first objective, we reviewed documents FSIS had  prepared including the draft risk assessment that assessed the hazards  associated with consuming catfish. We also reviewed information on the  Food and Drug Administration’s (FDA) import refusals for imported catfish  prepared by USDA’s Economic Research Service for 1998 through  August 2010. We also reviewed the results of FSIS’s preliminary  microbiological testing of catfish samples conducted in 2011. We  interviewed officials from FSIS, FDA, and the National Marine Fisheries  Service (NMFS) to better understand the food safety hazard catfish  presents and the information FSIS presented in its draft risk assessment.  We also interviewed officials from the Office of the U.S. Trade  Representative, the Department of State, and the Office of Management  and Budget. To gain stakeholders’ perspectives on the food safety  hazards that catfish present, we reviewed comments provided to FSIS  during the public comment period. We also spoke with representatives  from the Catfish Farmers of America, National Fisheries Institute, the  Association of Food and Drug Officials, and the Center for Science in the  Public Interest.
To assess the anticipated impact of FSIS’s proposed catfish inspection  program on other federal food safety inspection programs, we reviewed  the proposed regulations for the catfish inspection program and other  agency documents including the preliminary regulatory impact analysis  that describe the proposed program and the costs and benefits expected  by FSIS after implementation. We reviewed the FDA Food Safety  Modernization Act to identify the additional authorities to enhance the  oversight of imported seafood this legislation granted FDA. We  interviewed officials from FSIS, FDA, and NMFS to better understand  FSIS’s proposed program, its costs and benefits, and the similarities and  differences between it and FDA and NMFS inspection programs. In our  review of FDA and NMFS inspection programs, we also gathered  information on program costs. To gain stakeholders’ perspectives on  FSIS’s proposed regulations for continuous catfish inspection, we  reviewed comments from industry and consumer groups provided to FSIS  during the public comment period. We spoke with representatives of the  Catfish Farmers of America and the National Fisheries Institute. We also  spoke with representatives of two domestic seafood processors that  process both catfish and other seafood during site visits to their facilities  in Massachusetts to gain their perspectives on the potential impact of the  proposed regulations on their operations. We reviewed past GAO reports  relevant to this topic.
In addition, we analyzed Department of Commerce data on imported  seafood, including catfish, for 2010. We present these data as  background to illustrate the relative volume of catfish and other seafood.  We also analyzed USDA National Agricultural Statistics Service data on  catfish processing to illustrate trends in domestic catfish production and  imports from 2006 to 2010, also as background. For both of these data  sets we reviewed existing documentation about these data and any  limitations. We found both data sets to be sufficiently reliable for the  above-mentioned purposes.
We conducted this performance audit from June 2011 to May 2012 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
section_title: Appendix II: Comments from the U.S. Department of Agriculture
section_title: Appendix III: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: 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.