Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources
Published: 2011-04-14T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: About half of the seafood imported into the U.S. comes from farmed fish (aquaculture). Fish grown in confined aquacultured areas can have bacterial infections, which may require farmers to use drugs like antibiotics. The residues of some drugs can cause cancer and antibiotic resistance. The Department of Health and Human Services' (HHS) Food and Drug Administration (FDA) is charged with ensuring the safety of seafood against residues from unapproved drugs, and the Department of Commerce's National Marine Fisheries Service (NMFS) provides inspection services on request. In 2009, these agencies signed a memorandum of understanding (MOU) to enhance seafood oversight and leverage inspection resources. GAO was asked to assess the extent to which (1) FDA's program is able to ensure the safety of seafood imports against residues from unapproved drugs and (2) FDA and NMFS have implemented the 2009 MOU. GAO reviewed data and documents from each agency and interviewed agency officials and other key stakeholders.
section_title: What GAO Found
paragraphs: FDA's oversight program to ensure the safety of imported seafood from residues of unapproved drugs is limited, especially as compared with the European Union (EU). FDA's program is generally limited to enforcing the Hazard Analysis and Critical Control Point--the internationally recognized food safety management system--by conducting inspections of foreign seafood processors and importers each year. These inspections involve FDA inspectors reviewing records to ensure the processors and importers considered significant hazards, including those resulting from drug residues if the seafood they receive are from fish farms. The inspectors generally do not visit the farms to evaluate drug use or the capabilities, competence, and quality control of laboratories that analyze the seafood. In addition, FDA has conducted foreign country assessments in five countries to gather information about those countries' aquaculture programs. However, these assessments have been limited by FDA's lack of procedures, criteria, and standards. In contrast, the EU reviews foreign government structures, food safety legislation, the foreign country's fish farm inspection program, and visits farms to ensure that imported seafood products come from countries with seafood safety systems equivalent to that of the EU. In addition, the scope of FDA's sampling program, which supplements its oversight program, is limited. Specifically, the sampling program does not generally test for drugs that some countries and the EU have approved for use in aquaculture. Consequently, seafood containing residues of drugs not approved for use in the United States may be entering U.S. commerce. Further, FDA's sampling program is ineffectively implemented. For example, for fiscal years 2006 through 2009, FDA missed its assignment plan goal for collecting import samples by about 30 percent. In addition, in fiscal year 2009, FDA tested about 0.1 percent of all imported seafood products for drug residues. Moreover, FDA's reliance on 7 of its 13 laboratories to conduct all its aquaculture drug residue testing raises questions about the agency's use of resources. FDA and NMFS have made limited progress in implementing their 2009 MOU. The agencies have developed procedures for certain MOU activities, such as notifying NMFS of pending FDA regulatory actions. However, because FDA believes NMFS inspectors need training to conduct inspections according to FDA standards, it has not utilized NMFS' inspection resources or results in a systematic manner. Better leveraging available resources is critical, especially in places like China, where FDA has inspected 1.5 percent of Chinese seafood processing facilities in the last 6 years.
section_title: What GAO Recommends
paragraphs: GAO recommends that FDA study the feasibility of adopting practices used by other entities to better ensure the safety of imported seafood, enhance its import sampling program, and develop a strategic approach for enhancing collaboration with NMFS and better leveraging resources. HHS neither agreed nor disagreed with GAO's recommendations but cited actions in process or planned that are generally responsive to them.

section_title: Letter
paragraphs: The United States has increased the amount of seafood it imports over the  past 10 years, currently importing seafood from approximately 130  countries. According to estimates from the Department of Commerce’s  National Oceanic and Atmospheric Administration, in 2010 more than 80  percent of seafood consumed in the United States—such as shrimp,  salmon, and tilapia—was imported, with about half coming from  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 their  survival rates. Once drugs are introduced, their residue can remain in the  fish through harvesting, processing, and consumption. According to the  Department of Health and Human Services’ Food and Drug  Administration’s (FDA) 2008 Report to Congress, the residues of some  drugs can cause cancer, allergic reactions, and antibiotic resistance when  consumed by humans. As imports of aquacultured seafood products  increase, so too do the concerns over the presence of drug residues.
Under the Federal Food, Drug, and Cosmetic Act, FDA is responsible for  ensuring that the nation’s food supply, including imported seafood, is safe,  wholesome, sanitary, and properly labeled. Since 1997, when imported  seafood first accounted for more than 60 percent of the seafood consumed  in the United States, FDA has used the internationally recognized Hazard  Analysis and Critical Control Point (HACCP) system as its main safety  oversight program for imported seafood. Under HACCP requirements,  seafood processing firms, including firms that manufacture, pack, or label,  are responsible for conducting a hazard analysis and for developing and  implementing HACCP plans whenever an analysis shows that one or more  hazards are reasonably likely to occur. Food safety hazards may result  from, among other things, drug residues, pesticides, parasites, and  decomposition. HACCP requires (1) food processors to identify and  develop strategies to prevent, eliminate, or reduce to an acceptable level  the hazard and (2) importers to ensure that the products they import have  been processed in accordance with HACCP requirements or that the  products have been obtained from a country with an active agreement  with FDA covering the product that documents equivalence or compliance  with the U.S. system. FDA enforces HACCP requirements related to drug  residues in imported seafood in two main ways. First, FDA inspects a  number of foreign seafood processing facilities each year to ensure they  comply with HACCP requirements. If a processor fails to have and  effectively implement a HACCP plan, its products are considered  adulterated and may be refused entry into U.S. commerce. Second, FDA  conducts inspections at a designated number of U.S. importers each year  to determine if they have maintained the appropriate documents to prove  that the processors from whom they import seafood meet HACCP  requirements. If importers cannot provide assurance that the seafood  products they import have been processed under conditions established  by HACCP requirements, the products are considered adulterated and can  be refused entry into the United States. FDA is not required to preapprove  HACCP plans; however, FDA, not the processors or importers, is  responsible for determining whether processors and importers adequately  comply with seafood HACCP requirements. During facility inspections for  HACCP compliance, inspectors review HACCP plans and according to  FDA officials, determine if the plans are implemented. Supplementing its  HACCP oversight activities, FDA has an import sampling program that  tests imported seafood products at ports of entry to, among other things,  ensure that they do not contain certain targeted drug residues, including  residues of drugs that are unapproved for use in the United States and  render the seafood adulterated under the Federal Food, Drug, and  Cosmetic Act.
In addition to FDA’s seafood safety activities, the National Oceanic and  Atmospheric Administration’s National Marine Fisheries Service (NMFS)  Seafood Inspection Program provides fee-for-service inspection services,  on request to the seafood industry—including domestic and foreign  processors, distributors, and other firms—to, among other things, certify  that these seafood firms comply with HACCP and other federal food safety  standards. Some retailers require this certification as a condition for  purchasing the seafood products.
In 1974, FDA and NMFS signed a memorandum of understanding (MOU),  in part, to improve the efficient use of FDA’s inspection resources by  minimizing the number of FDA inspections at establishments already  inspected by NMFS. We reported in 2005 that FDA had not fully met its  responsibilities under the MOU and that, in some cases, the agency was  continuing to duplicate NMFS inspections. We recommended in that  report that FDA fully meet its responsibilities under the MOU. In that  same year, we identified promising practices for collaboration among  federal agencies, stating that collaboration can occur when they (1)  establish procedures and policies for working together systematically  across agency lines and (2) identify ways to leverage their resources to  maximize their effectiveness, among other things. In 2007, we added the  federal oversight of food safety to our list of high-risk areas needing broad- based transformation, largely because of continued ineffective  coordination and inefficient use of resources. In February 2009, we  reported that FDA and NMFS had not yet begun to work together and  recommended that the agencies collaborate to more effectively and  efficiently share information and leverage their inspection resources to  enhance federal oversight of seafood. In October 2009, FDA and NMFS  finalized a new MOU that updated the 1974 MOU—the agencies agreed, in  part, to maximize the use of their resources, when appropriate and as  resources permit, by taking advantage of each others’ inspection  capabilities.
In this context, you asked us to examine how federal agencies ensure the  safety of seafood, in particular imported seafood, from drug residues.  Specifically, this report addresses the extent to which (1) FDA’s program  is able to ensure the safety of seafood imports against residues from  unapproved drugs and (2) FDA and NMFS have implemented the 2009  MOU to enhance federal oversight of seafood and leverage federal  resources.
To assess the extent to which FDA’s program is able to ensure the safety  of seafood imports against residues from unapproved drugs, we analyzed  information on FDA’s oversight mechanism for seafood imports—importer  and foreign country processing facilities inspections—and its seafood  import sampling program. In particular, we analyzed information on the  major components and requirements of FDA’s importer and foreign facility  HACCP inspections. We analyzed fiscal years 2006 through 2009 data on  FDA’s import sampling test results and determined that the data were  sufficiently reliable for our purposes. In addition, we reviewed the  European Union’s (EU) seafood importing program to determine if its  practices for ensuring the safety of seafood imports have the potential for  enhancing our own practices. We also reviewed the imported seafood  sampling programs of the EU, the largest importer of seafood worldwide;  Japan, the second largest importer; and Canada, a major provider of  seafood to the United States, to determine if their sampling practices had  the potential for enhancing our own practices as well. Furthermore, we  reviewed oversight practices the Department of Agriculture’s Food Safety  and Inspection Service (FSIS) uses to ensure the safety of imported meat  and poultry products for the same purpose. We interviewed  knowledgeable FDA, FSIS, EU, Canadian, and Japanese officials to obtain  more information on how their respective programs function. We analyzed  relevant documents to assess the extent to which FDA and NMFS have  implemented the 2009 MOU to enhance federal oversight of seafood. We  also interviewed knowledgeable FDA and NMFS officials to determine  their progress in implementing the 2009 MOU. (See app. I for additional  information on our scope and methodology.)
We conducted this performance audit from April 2010 to April 2011 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: Fishery products, including wild catch, aquaculture, and processed fish  products, are one of the most traded commodities in the world today.  More than half of this commodity originates in developing countries, and  almost 75 percent of it ends up either in the EU, Japan, or the United  States. Not only is the United States importing more of the seafood it  consumes today than it did 10 years ago, but more of those imports are  from fish farms. Currently the United States imports 84 percent of the  seafood consumed, and about 50 percent of it is from aquaculture. Figure  1 shows the proportion of imports to the United States from the top six  countries exporting seafood to the United States.
Concerns regarding the use in aquaculture operations of veterinary d that are unapproved in the United States and the misuse of approved drugs have increased substantially as the aquaculture industry has grown,  according to FDA documents. While antimicrobials, including antibiotics,  are used to treat diseases in animals, including seafood, the use of  unapproved antibiotics in aquaculture has raised significant public health  concerns. For example, nitrofurans are specifically not allowed for use in  seafood, among other foods, by the United States because they have been  shown to have a carcinogenic effect after prolonged exposure. However,  some drugs that remain unapproved by FDA, such as emamectin benzoate  and oxolinic acid, may be used in aquaculture by other countries. Another  concern associated with the use of drugs in animals used for food,  including seafood, is the extent of their contribution to antimicrobial  resistance.
subsections: section_title: Processing Facilities and Importer Inspections
paragraphs: HACCP regulations require seafood processors to conduct a hazard  analysis and to develop and implement HACCP plans for hazards  whenever an analysis shows that one or more hazards are reasonably  likely to occur, including hazards resulting from drug residues. Processors  must verify that their HACCP plans are adequate to control the identified  significant hazards and are being effectively implemented. This  verification must include, at a minimum, a periodic reassessment of the  plan as well as ongoing verification activities, such as regular testing of the  product. Processors are responsible for addressing hazards that may have  been introduced into the products before they reach the processors, which  could include hazards resulting from drugs unapproved by FDA for use in  aquaculture. According to FDA documents, the agency targets countries  for inspection based on the volume of imports from that country, the  nature of the product (high- or low-risk potential), and violation history,  among other things. According to FDA officials, the agency also targets  facilities for inspection based on, among other things, their history of  violations and seafood products refused entry into the United States. FDA  has guidance that provides instructions on the inspection of foreign  seafood processing facilities and products. From fiscal years 2005 through  2010, FDA inspected, on average, 84 foreign processing facilities annually  out of an estimated 17,000 worldwide. (See app. II for additional  information on the foreign facilities FDA inspected.)
In addition, FDA inspects importers of seafood products to ensure their  compliance with HACCP requirements. HACCP regulations require  importers to demonstrate, through documentation, that the seafood the y  import into the United States complies with HACCP requirements. Under  HACCP, every importer of seafood products must either (1) obtain its  seafood products from foreign firms in countries that have an agreement  with FDA that documents the equivalency or compliance of the foreign  inspection system with the U.S. system for imported products or (2)  maintain written verification procedures that include product  specifications designed to ensure that the product is not adulterated and  take at least one of six affirmative steps to document that the foreign fi supplying the seafood products comply with HACCP requirements. We  discuss the most commonly used affirmative steps later in this report.  According to FDA officials, the agency currently has no such agreements  with any foreign countries. FDA has guidance that provides direction on  the inspection of seafood importers. From fiscal years 2005 through 2010,  FDA inspected, on average, 217 importers annually out of about 3,900  importers registered with the FDA.
section_title: FDA’s Sampling Program
paragraphs: The Department of Commerce’s NMFS also has a role in promoting  seafood safety and quality. Under the Federal Agricultural Marketing Act  of 1946, as amended, NMFS’ Seafood Inspection Program provides  inspection services on a fee-for-service basis to assist in marketing  seafood products. NMFS services include inspections for safety,  wholesomeness, and proper handling, as well as seafood grading,  laboratory analysis, training, and product inspection and certification. In  2010, NMFS had contracts with 123 domestic processing facilities under its  HACCP Quality Management Program, which requires NMFS to provide, at  a minimum, quarterly HACCP-based inspections. NMFS also had contracts  with 37 foreign seafood processing facilities to provide HACCP  inspections. According to NMFS officials, it inspects about one-third of all  seafood consumed in the United States.
The 1974 MOU outlined actions for each agency regarding, among other  things, FDA’s agreement to notify NMFS before taking regulatory action  and to conduct periodic joint meetings to develop collaboration efforts.  Despite the MOU, however, FDA did not take advantage of NMFS  inspection services or results to reduce its own inspection workload. In  particular, from fiscal years 2005 through 2009, we found that FDA  inspected 315 facilities that NMFS also inspected. In addition, in 2005, FDA  considered taking legal action against NMFS officials because FDA  believed NMFS was interfering with its responsibilities, according to  senior NMFS officials. In the end, FDA did not pursue this course of  action. According to NMFS officials, as a result of this incident, FDA and  NMFS began negotiating an update of the 1974 MOU that was finalized in  October 2009. According to NMFS officials, since the signing of the 2009  MOU, there have been instances where NOAA and FDA have worked  closely together to address safety issues that arose from the Gulf of  Mexico oil spill as well as coordinate on FDA regulatory actions.
section_title: FDA Food Safety Modernization Act
paragraphs: Provisions included in the FDA Food Safety Modernization Act, enacted in  January 2011, may impact FDA’s role in ensuring the safety of seafood. For  example, the act requires FDA to increase every year the number of  inspections of foreign food facilities. This may include additional  inspections of foreign seafood processing facilities. In addition, the act  includes provisions to encourage interagency cooperation in regards to  seafood inspections. This includes FDA coordinating with the Secretary of  Commerce on the inspections of foreign seafood facilities and using  Department of Commerce employees to conduct inspections for FDA. The  act’s provisions also give FDA the authority, as part of a third party  accreditation program, to review a foreign country’s food safety programs,  systems, and standards to determine that the foreign government is  capable of ensuring foods certified for export to the United States meet  the requirements of the Federal Food, Drug, and Cosmetic Act. In addition,  the act requires the Secretary of Health and Human Services to issue  guidance to assist importers in developing a foreign supplier verification  program to help importers perform risk-based activities to verify that  imported goods comply with U.S. requirements. Facilities that are required  to comply with seafood HACCP regulations are exempt from the supplier  verification program. FDA also noted that the act gives the agency  important new tools, such as suspension of a facility’s registration, to  ensure that imported seafood is as safe as domestic seafood (See app. IV,  where the Department of Health and Human Services provides details on  these tools in its comments on our report.)
section_title: FDA’s Program to Ensure the Safety of Imported Seafood from Residues of Unapproved Drugs Is Limited, Especially as Compared with the EU
paragraphs: FDA’s program to ensure the safety of imported seafood from residues of  unapproved drugs is limited, because the agency’s primary oversight  program generally involves reviews of documents at individual foreign  processing facilities and importers for HACCP compliance. In contrast, the  EU reviews foreign government structures, food safety legislation, and the  foreign country’s fish farm inspection program to ensure imported seafood  products come from countries with seafood safety systems equivalent to  that of the EU. Moreover, FDA’s sampling program is limited in scope, is  not effectively implemented, and does not fully use the capabilities of  FDA’s laboratories.
subsections: section_title: FDA HACCP Inspections Are Limited When Compared to More Comprehensive Reviews of Food Safety Systems Conducted by the EU and the Department of Agriculture’s FSIS
paragraphs: FDA’s program to ensure the safety of imported seafood against  unapproved drugs is generally limited to the HACCP regulations it  enforces. While the EU also requires compliance with HACCP, it also takes  a wide-ranging review of the food safety system of the foreign country that  wants to export its seafood products to the EU. In order to export seafood  to the United States, foreign processors must meet the same HACCP  regulations as domestic processors and FDA inspects some foreign  seafood processors each year to ensure compliance. These inspections  involve reviewing the processors’ HACCP plans and other records to  ensure the processors have considered drug residues as a hazard that is  reasonably likely to occur if the seafood products it receives are from fish  farms. In general, as part of foreign HACCP inspections, FDA inspectors  do not visit fish farms to evaluate drug use or controls. FDA inspectors  also do not evaluate the capability, competence, and quality controls of  laboratories used to sample seafood from fish farms to determine if they  contain unapproved drugs because these facilities are not considered  processors under the regulations and are therefore not covered by  HACCP. We reviewed the 15 FDA inspection reports for seafood  processing facilities from fiscal years 2007 through 2009 from countries  exporting seafood to the United States—Bangladesh, Chile, China, and  Thailand. According to the reports, we found that during their visits to  these processing facilities, the inspectors generally conducted these  inspections as described above. In contrast, the EU includes inspection  visits to farms and other pertinent areas, such as laboratories, to  undertake a more comprehensive review of a foreign country’s food safety  system. The EU conducts a review of the country’s relevant legislation; the  government’s structure for implementing it; and the country’s  implementation of its national residues monitoring plan, which the EU  directs its trading partners to submit. Foreign countries that trade with the  EU are directed to implement the monitoring plan and sample for drugs of  specific concern to the EU. Once implemented, these foreign countries are  to provide an annual report on the sampling results. In addition, the EU  also reviews a sample of farms and processing facilities, and the  capabilities and quality of the country’s laboratories. The EU also requires  that foreign countries exporting seafood to the EU maintain seafood safety  systems that meet EU requirements or equivalent conditions, or meet  specific requirements provided in an agreement between the EU and the  foreign country.
In addition to FDA’s HACCP inspections, the agency conducts foreign  country assessments to gather information about other countries’  aquaculture programs including the country’s competent authority and  regulatory infrastructure. During these assessments, FDA officials visited  some farms where aquaculture products originated to evaluate veterinary  drug use and reviewed some laboratories that analyzed the seafood  products for drug residues for processors, among other places. FDA  officials stated that these visits are planned and tailored for each country  and conducted in a systematic and consistent manner. The information the  agency collects during these assessments results in a written report and  can be used to direct future foreign facility HACCP inspections and FDA’s  sampling program for imported seafood. However, according to FDA  officials, the agency does not have any written operating procedures or  any criteria or standards that it uses for these assessments to evaluate a  country’s regulatory infrastructure; farms; or the capabilities, competence,  and quality controls of foreign laboratories. Without policies and  procedures or guidance to direct the implementation of these assessments  and criteria or standards to evaluate foreign systems, it may be difficult for  FDA to conduct foreign country assessments that are either systematic or  consistent and that result in valid findings. By systematically and  consistently conducting its foreign country assessments, FDA can better  assure that it is using its resources effectively and efficiently. FDA has  conducted such foreign country assessments in five countries: Chile,  China, India, Indonesia, and Vietnam. FDA conducted its first foreign  country assessment in April 2006 and according to FDA officials, each  assessment cost about $45,000. About a week after our closing meeting,  FDA provided us with newly prepared standard operating procedures for  conducting its foreign country assessments. FDA prepared these  procedures almost 5 years after conducting its first assessment in Vietnam.  These new procedures include the purpose of the assessments, country  selection process, provisions on conducting these assessments, and  structure of the assessment reports, among other things. We did not  evaluate the newly prepared procedures. Still, FDA has not documented  (1) the assessments on its Web site, including any program guidance  manuals, and (2) the link between these assessments and its HACCP  inspections of foreign facilities or its imported seafood sampling program.
The following are examples of some of the limitations of FDA’s oversight  approach of reviewing records and other documentation of foreign  processors as required by HACCP and limited effectiveness of its foreign  country assessments.
As described in FDA’s inspection reports for three Chilean salmon  processing facilities in 2008, FDA’s review of their records during the  inspectors’ visits to these facilities revealed that, contrary to HACCP  regulations, they had received fish farm products that had been treated  with oxolinic acid, flumequine, or emamectin benzoate—drugs  unapproved for use in aquaculture in the United States. According to FDA  documents, the agency placed all three facilities on an import alert for  failing to comply with HACCP. FDA removed one of these facilities from  the import alert 14 days later and the other two facilities several weeks  later after they made changes to their respective HACCP plans. FDA,  however, could not provide documents detailing the changes these  facilities made in order for FDA to remove them from the import alert.  Two of the facilities then shipped salmon to the United States, where it  was accepted for import. While this approach is in concert with FDA’s  routine inspection process, FDA had no assurance that the changes the  facilities made to their HACCP plans were implemented, since it did not  reinspect the facilities to conduct follow-up reviews of their records. In  March and April of 2009, FDA officials conducting a foreign country  assessment visited Chile to gather information about Chile’s measures to  control drug residues in aquaculture seafood products it exported to the  United States. These officials found that the same unapproved drugs were  still in use in the country. According to these officials, Chilean officials  told them that the Chilean government could not prohibit the export of  products containing residues of drugs approved for use in Chile without a  special agreement with the importing country. According to FDA officials,  the agency has not taken steps to develop such an agreement. Chile  represents about 4 percent of seafood imported into the United States and  in 2009, it was the largest source of farmed salmon imports into the United  States.
In addition to the 15 inspection reports, FDA documented the results of its  officials’ visit, part of a foreign country assessment, in September 2008 to  Vietnam to gather information about the country’s drug residues control  program. The documentation indicated that all processing facilities’  HACCP plans stated if a drug unapproved by the EU is found in a seafood  product, that product should be diverted to another market. The FDA  officials concluded that this HACCP plan requirement could result in such  products being imported into the United States. In addition, the  documentation indicates these FDA officials found that Vietnam permitted  38 drugs, most of which are unapproved by the United States, to be used in  aquaculture. For example, FDA’s documentation on this visit stated that  fish farms were likely using fluoroquinolones. FDA officials asked that the  Vietnamese government notify processors that seafood products  purchased from farms using this drug could not be exported to the United  States. FDA also asked the government to test 100 percent of seafood  products destined for the United States for unapproved drugs such as  nitrofurans and chloramphenicol. The Vietnamese government responded  that it performed 100 percent testing only for products intended for  countries with which it had a bilateral agreement, of which the United  States was not one. The government stated, however, that it was taking  other actions that would preclude the need for this level of testing, such as  disseminating information on unapproved drugs, providing training to  local authorities, and disciplining violators. According to FDA officials, the  agency has not taken steps to develop such an agreement. Vietnam  represents about 5 percent of the seafood imported into the United States.  In 2009, Vietnam was the largest source of farmed catfish-pangasius  imports and the third largest source of farmed shrimp imports into the  United States.
In addition to foreign processors, FDA also inspects the records of  importers that bring seafood products into the United States to make sure  they follow HACCP regulations, which includes requirements that  importers maintain documents showing that the imported products are  from foreign suppliers that have themselves complied with HACCP  regulations or that the product is obtained from a country with an active  agreement with FDA covering the product that documents equivalence or  compliance with the U.S. system. We found limitations with this aspect of  FDA’s program as well. According to FDA officials, importers most  frequently comply with this regulation in one of the three following ways:  Importers obtain a copy of a foreign processor’s HACCP plan and an  attestation that the foreign firm processes its seafood products in  compliance with HACCP regulations. Importers review the HACCP plan  they get from their foreign suppliers and determine if all of the hazards the  importers identified in their specifications are controlled in the HACCP  plan. However, according to a senior FDA official, foreign processors can  obtain a HACCP plan that is not associated with its own operation, thus  defeating the purpose of importers’ acquiring a copy of the plan unless the  importers also visit the foreign processor to validate the information in the  plan and that it is being implemented. FDA does not require importers to  visit the foreign processors to ensure they effectively implement their  HACCP plans.
Importers obtain inspection certificates from what FDA calls a “competent  authority,” such as the Canadian Food Inspection Agency, that attests to  the safety of the seafood product. However, FDA has not made any formal  judgments about any entity’s capability to declare that any foreign seafood  products meet U.S. safety standards or concluded any agreements on a  foreign certification program.
Importers obtain seafood products from Canada or Japan from firms that  those governments stated both are in “good standing” and are listed on an  FDA Web site as processing seafood in accordance with HACCP  regulations. However, FDA has neither evaluated the Canadian or  Japanese seafood safety systems to determine the extent to which these  countries’ systems meet U.S. standards nor verified the lists or the  information on them. For example, FDA has inspected for HACCP  compliance, 4 Canadian and 22 Japanese seafood processing facilities out  of an estimated total of 944 and 2,697 facilities in each country,  respectively, from fiscal years 2005 through 2010.
The EU not only requires individual processors to meet HACCP  requirements, but also requires the foreign countries that want to export  farmed seafood to the EU to demonstrate that their seafood safety systems  meet EU or equivalent requirements, or meet requirements specified in an  agreement between the EU and the exporting country. The EU Web site  provides information for foreign countries on the EU standards for food  products, including seafood, destined for the EU. These standards are  used to evaluate foreign food safety systems. The EU publishes its foreign  country inspection reports on its Web site, along with the foreign country’s  comments and their plan to address the inspection report’s  recommendations. To ensure continuous compliance with EU  requirements, EU inspectors periodically conduct follow-up reviews of  foreign countries’ seafood safety systems. If inspectors identify  deficiencies, they recommend solutions and ask the government in  question to develop an action plan to address the recommendations. Using  this approach, the EU has been able to persuade foreign governments to  take appropriate action to address recommendations. For example:    The EU inspected Indonesia in November 2009 to evaluate, in part, the  country’s measures to control drug residues in animal products including  seafood. The inspectors concluded that the effectiveness of the system to  control drug residues was compromised by failings in the planning and  implementation of Indonesia’s national residue control plan and problems  in laboratory performance, including questionable validation of methods  to detect drug residues in aquaculture products. According to the EU  inspectors, the system to control drug residues did not provide guarantees  equal to those required by EU regulations. The EU inspectors made  specific recommendations to resolve the problems, including aligning the  Indonesian limits for drug residues with those of the EU and ensuring that  government controls on the distribution and use of veterinary medicinal  products were carried out throughout the distribution chain. The  Indonesian government developed an action plan to address all the  recommendations. Nevertheless, as a result of the inspection report  findings, the EU imposed a 20 percent sampling requirement at the EU  ports of entry for all farmed fish imports because it believed that there was  a risk that imported farmed products from Indonesia contained residues of  chloramphenicol, nitrofurans, and tetracyclines.
In November 2008, the EU inspected Bangladesh, in part, to evaluate the  country’s programs to control drug residues in seafood and review the  implementation of corrective actions promised by the Bangladesh  government to address previous EU recommendations. EU inspectors  found that Bangladesh was making changes to its sampling and laboratory  analysis, among other things. Nevertheless, the inspectors concluded that  despite the steps taken by the Bangladesh government to eliminate all  sources of nitrofurans and chloramphenicol from farmed fish, the high  detection rate of these drugs identified by Bangladesh’s own national  monitoring program suggested that fish farms were still using these drugs.  According to the EU inspectors, the Bangladesh system to control residues  did not provide assurances equal to those required by EU regulations,  among other things. In part because of the findings of this inspection, the  Bangladesh government imposed a voluntary ban on the export of  freshwater shrimp to the EU from May 2009 until January 2010. The  Bangladesh government recognized that it had a problem with nitrofurans  in freshwater shrimp and took this action to avert any potential ban by the  EU. The EU placed Bangladesh on special import conditions in 2008,  which required 100 percent testing of all shrimp bound for the EU for  chloramphenicol, tetracycline, nitrofurans, malachite green, and crystal  violet in Bangladesh prior to export. In addition, 20 percent of all shrimp  imports must also be tested at EU ports of entry at the importers’ expense.
In contrast, FDA inspected five Bangladesh seafood processing facilities in  February 2009, and a review of the inspection reports indicated that FDA  inspectors did not identify the continued use of nitrofurans and  chloramphenicol by the fish farms. Because FDA’s focus was on HACCP  compliance—which required the review of documents to ensure  consideration was given to whether potential hazards were reasonably  likely to occur as a result of drug residues, among other things—rather  than the review of elements of the Bangladesh seafood safety system, FDA  was unable to identify this issue. Although the Bangladesh government  considered the EU findings from 2008 significant enough to impose a ban  of shipments of freshwater shrimp to the EU about 3 months after the FDA  inspections, Bangladesh officials present at FDA’s inspections did not  provide information on the EU findings of the continued use of  unapproved drugs by fish farms to FDA. Moreover, Bangladesh did not  impose a similar ban on shipments to the United States, and according to  FDA officials, the agency, at the time, had no knowledge of the Bangladesh  ban on shipments to the EU. Had the FDA inspectors had this  information, they could have more effectively scrutinized the methods  processors used to ensure the safety of the seafood products they received  from fish farms. FDA inspectors could have also discussed Bangladesh  government efforts to eradicate the use of unapproved drugs by the fish  farms. With information on the use of nitrofurans by Bangladesh shrimp  farms, FDA inspectors could have helped direct FDA’s import sampling  program to target these products. Because it lacked this information, FDA  did not adjust its sampling program to take into account the likelihood  that shrimp exports from Bangladesh would be contaminated. In fact, from  June through December 2009—the period of the ban—FDA analyzed four  shrimp samples from Bangladesh for nitrofurans. Finally, equipped with  this information, the United States could have potentially received similar  consideration as was given to the EU in regards to the ban by the  Bangladesh government.
Like the EU, the Department of Agriculture’s FSIS regulations place  greater responsibility on the foreign country that wants to export meat,  poultry, or processed egg products to the United States. More specifically,  imported 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.  The FSIS Web site provides information on its equivalence process and on  the standard for eligibility of foreign countries to export FSIS regulated  products to the United States. FSIS audit reports also provide information  on the criteria used for its audits. In addition, FSIS publishes its foreign  country audit reports on its Web site. FSIS staff not only review  documents provided by foreign governments to ensure their food safety  regulations and oversight are adequate and that processors implement  HACCP, among other things, but also conduct onsite evaluations of the  governments’ inspections of slaughter processing facilities and their audits  of laboratories and controls over, among other things, drug residues,  sanitation, and animal disease of public health concern. In addition to the  reviews and onsite evaluations, FSIS also conducts drug residue sampling,  microbiological sampling, and labeling verification, among other things, at  U.S. ports of entry to promote compliance. FSIS’ program and the  requirements it places on foreign governments wishing to export food  products to the United States may have an effect on how countries react to  problems that FSIS identifies with their products.
The potential effect that the FSIS’ oversight approach can have on the  food safety actions of other countries can be illustrated in the situation  that occurred with Brazilian beef. In May 2010, as part of FSIS’ port-of- entry inspection program, the agency analyzed samples of cooked beef  products from a Brazilian plant and identified levels of ivermectin, an  antiparasitic agent, above allowed limits. FSIS increased its testing of  cooked beef products from this plant and continued to find drug residue  problems. Consequently, FSIS refused entry of cooked beef products into  the United States from this plant and expanded its sampling effort to  include Brazilian cooked beef products already in commerce and cooked  beef products from other Brazilian plants. The testing data indicated that  cooked beef products from other Brazilian plants also had levels of  ivermectin above allowed limits. Given the consistency of the data, FSIS  concluded that the Brazilian government’s oversight program—including  its residue sampling and control programs—had broken down. The U.S.  government communicated its findings to the Brazilian government and  asked that it resolve this violation of U.S. regulations. Although FSIS had  the authority to deny entry into the United States of the products of all of  these Brazilian plants if this issue had not been resolved appropriately, the  Brazilian government voluntarily stopped exporting cooked beef products  from 24 plants and prepared and submitted a plan to FSIS for how it  intended to address this issue. According to FSIS, on December 28, 2010,  FSIS accepted Brazil’s corrective action plan, resulting in Brazil removing  its voluntary suspension to allow 12 of the 24 plants to export cooked beef  products to the United States. In addition, to verify that Brazil’s corrective  actions are adequate and effective in preventing a recurrence of this  situation, FSIS will request Brazil to provide documentation demonstrating  that its residue plan is working.
section_title: FDA’s Sampling Program Is Limited in Scope, Not Effectively Implemented, and Does Not Fully Use Its Laboratories’ Capabilities
paragraphs: FDA’s sampling program for detecting residues from unapproved drugs in  imported seafood products is limited in scope. Although FDA tests for  residues of 16 unapproved drugs, some other countries importing from the  same countries as the United States test for up to 57 drugs. In addition,  although the 16 drugs include drugs such as flumequine and oxolinic acid,  which are approved in certain other countries, FDA is not testing for  residues of other drugs, such as emamectin benzoate or tetracycline, that  are approved in other countries but unapproved in the United States. Thus,  FDA does not generally test for drugs that some countries and the EU have  approved for use in aquaculture. Because these drugs may be used in  countries with which the United States conducts considerable trade,  seafood products containing these unapproved drugs may be entering the  country. For example, China, a major seafood exporter to the United  States, approves the use of tetracycline in aquaculture although the United  States does not. Vietnam, also a major seafood exporter to the United  States, approves the use of neomycin in aquaculture but the United States  does not. Both tetracycline and neomycin have been determined to be  highly important antimicrobials in humans; according to the World Health  Organization, however, the overuse of these drugs in food animals could  contribute to increasing the risk of antibiotic resistant bacterial infections  in humans. In 2007, Japan detected excessive levels of tetracycline  residues in the shrimp products it imported from China and in 2010, the  EU detected excessive levels of neomycin in imported catfish from  Vietnam. Because FDA does not include tetracycline and neomycin in its  sampling program, it has no assurance that seafood containing these drug  residues has not entered the United States.
In addition, FDA does not effectively implement its limited sampling  program. According to FDA officials, the equipment and personnel the  agency dedicates to its sampling program are sufficient to complete its  assignment plan in its entirety. However, FDA did not meet the  performance goals it set for its targeted unapproved drugs for fiscal years  2006 through 2009: the agency planned to collect on average 975 import  samples annually for testing but collected an average of about 680 samples  (or about 70 percent). According to FDA officials, the agency may not  achieve its goals because a specific seafood product may not come into  the country as anticipated or there may be a need to shift laboratory  resources to handle other urgent tasks, such as testing imported honey for  chloramphenicol. Moreover, FDA’s planned number of import samples to  collect represents a small portion of the annual seafood imports into the  United States. Thus, in fiscal year 2009, the seafood samples FDA reported  it collected for drug residue testing amounted to 0.1 percent of all the  seafood products imported into the United States. In addition, although  FDA’s import sampling program states that it prioritizes the testing of all  shrimp and all catfish and catfish-related species for residues of  nitrofurans, during fiscal years 2006 through 2009 FDA analyzed 279  shrimp samples out of the 1,060 shrimp samples collected for residues of  nitrofurans and did not analyze any catfish samples for nitrofurans. In  fiscal year 2008, according to its annual work plan, FDA planned to collect  125 shrimp samples for nitrofurans analysis. Although FDA collected a  total of 349 shrimp samples, it tested only 34 for residues of nitrofurans,  and 6 (18 percent) of these samples were found to contain nitrofurans.  Because of FDA’s limited sampling, some of the more than 2.5 million  metric tons of shrimp and 156,000 metric tons of catfish imports that  entered the United States during fiscal years 2006 through 2009 could have  contained residues of nitrofurans.
In addition to the limitations of FDA’s sampling program for drug residues,  the agency does not effectively use its laboratory resources. For example,  while some other countries have increased their laboratory capabilities  through programs to accredit commercial laboratories, FDA relies on 7 of  its 13 laboratories to conduct all of its aquaculture drug residue testing.  According to FDA officials, the number of laboratories participating in the  sampling program is not important because sufficient laboratory capacity  and capabilities are developed to meet obligations. However, as discussed  above, FDA has not met its sampling performance goals during the past  years and the number of laboratories participating in the sampling  program may play a part in this. In terms of the laboratories that FDA uses  for its sampling program, not all seven have the capability to test for all of  the drugs included in FDA’s sampling program. For example, one  laboratory is capable of testing for residues of chloramphenicol, and four  laboratories are capable of testing for nitrofurans, three of which have the  capability to test for malachite green, gentian violet, fluoroquinolones, and  quinolones. Further, FDA lacks some of the analytical methods that its  laboratories need to test for specific drugs in aquaculture. For example,  FDA has no method to detect residues of emamectin benzoate, a drug  unapproved for use in U.S. aquaculture but used in Chile, as noted above,  and approved for use in other countries as well. Moreover, although FDA  can test for nitrofurans in four of its laboratories, it has only one method  for testing nitrofurans in catfish samples. FDA’s laboratory capabilities  are also limited by the personnel available to perform the tests. Although  FDA has assigned personnel to its sampling program, these resources can  be shared across FDA’s food programs. Consequently, FDA can divert  personnel to other programs that it may consider higher priority when the  need arises, which could result in a lag in the turnaround time for drug  residue testing. For example, according to FDA officials, FDA allows 14  calendar days to test a sample for drug residues. In addition, time frames  for the completion of analyses under the sampling program will vary by  residue and species. We found that the average time between sample  collection and testing was about 22 calendar days. In one instance, testing  for one sample was completed 154 calendar days after it was collected; in  another instance, FDA took 56 days to complete the analysis of two  separate samples—both of which turned out to contain residues of  unapproved drugs.
In contrast with FDA’s import sampling program, the sampling programs  of Canada, the EU, and Japan test for significantly more drugs: Canada  tests its imported seafood products for more than 40 different drugs, select  EU member countries test for 50 drugs, and Japan tests for 57. In addition,  Canada and Japan test for levels of drugs they have approved for use in  aquaculture as well as for drugs that are unapproved in their own country  but approved in other countries. Moreover, Canada, the EU, and Japan  generally test more samples of seafood and have more extensive  laboratory capabilities than FDA. For example, Canada routinely tests at  least 5 percent of all seafood imports, and Japan tested about 11 percent of  seafood imports in fiscal year 2009. Select EU member countries test for  as much as 4 percent of their seafood imports. In addition, the EU requires  more testing for countries that produce larger quantities of seafood  because of the increased risk of more adulterated products. Further,  unlike FDA, which relies only on its own laboratory capabilities, Canada,  the EU, and Japan have systems in place to accredit commercial  laboratories which may be involved in the testing for drug residues in  seafood products. For example, Belgium has 8 national laboratories as  well as a network of 62 EU member state and commercial laboratories to  assist with drug residue testing.
section_title: FDA and NMFS Have Made Limited Progress to Implement the 2009 MOU, and FDA Has Not Leveraged NMFS Inspection Resources
paragraphs: FDA and NMFS have made limited progress in implementing the 2009  MOU, resulting in a lack of systematic collaboration between the agencies.  Since March 2010, the agencies have collaborated to some extent in  developing procedures for certain MOU responsibilities, specifically FDA  notification of regulatory action. In addition, while FDA and NMFS  effectively collaborated and successfully leveraged each others’ resources  during the 2010 emergency Gulf of Mexico oil spill, FDA has not yet fully  met its MOU responsibility to utilize NMFS’ foreign and domestic  inspection resources in a systematic manner. NMFS Seafood Inspection  Program describes its mission as ensuring the safety and quality of the  seafood it inspects. FDA officials stated that training NMFS inspectors  would bring them to a level commensurate with the level that FDA  requires of its own inspectors. By effectively utilizing NMFS inspections  resources to help minimize its own inspection responsibilities, FDA could  inspect other facilities that have not yet been inspected.
subsections: section_title: FDA and NMFS Have Made Limited Progress in Implementing Specific MOU Responsibilities
paragraphs: During a meeting to discuss the MOU in March 2010, the agencies agreed  to create standard operating procedures for certain MOU responsibilities.  FDA officials told us that in September 2010 they sent NMFS a letter  notifying them of an FDA regulatory action, which is one of the MOU  responsibilities. According to NMFS officials, this letter was the first prior  notification of regulatory action FDA had ever provided. NMFS officials  added that communication between the agencies has consisted of periodic  conference calls that included discussions of the oil spill. Frequent  communication among collaborating agencies is a means to facilitate  working across agency boundaries and prevent misunderstanding; without  such communication, enhanced collaboration may not be sustained.  According to NMFS officials, NMFS has developed guidance for its staff  regarding its 2009 MOU responsibilities. Similarly, according to FDA  officials, the agency has developed some guidance like the notification  letter template. However, the agencies have not developed guidance for  items of mutual responsibility. As we previously reported, agencies need  to address the compatibility of standards, policies, and procedures in  order to facilitate collaboration. The agencies have agreed to develop  standard operating procedures for information sharing and cross training  of personnel, but they have not yet done so.
section_title: Success in Leveraging Resources for the Gulf of Mexico Oil Spill Has Not Translated to FDA Leveraging NMFS Inspection Resources or Results in a Systematic Manner
paragraphs: Even with FDA’s and NMFS’ success in leveraging each other’s resources  in the 2010 Gulf of Mexico oil spill, FDA has yet to fully meet its  responsibility under the MOU to utilize NMFS inspection resources or  results in a systematic manner. While NMFS describes its mission as  ensuring the safety and quality of the seafood it inspects, FDA officials  stated that training NMFS inspectors would bring them to a level  commensurate with the level that FDA requires of its own inspectors.
The leveraging of resources played a crucial role in FDA and NMFS’ ability  to address the effects of the Gulf of Mexico oil spill. Using guidance  developed from previous oil spills, the agencies quickly and jointly  developed a protocol to reopen oil-impacted areas closed to seafood  harvesting. The emergency nature of the spill meant that implementing the  protocol required timely collaboration between FDA and NMFS. The  agencies successfully implemented their reopening protocol by, among  other things, sharing staff and laboratory resources and cooperating  efficiently. In accordance with the reopening protocol, the agencies jointly  organized the seafood sampling plan and agreed upon the use of NMFS’  sensory testing protocol following FDA review. The agencies successfully  coordinated the chemical testing of samples for oil residue among their  respective laboratories. As agreed upon in their reopening protocol, both  agencies reviewed all sample results and consulted with each other before  NMFS communicated the results to the states.
Going forward, FDA has not developed a process to leverage NMFS’  domestic and foreign inspections or results in order to maximize its  limited resources and inspect other facilities that have not yet been  inspected. Both the 1974 and 2009 MOUs address the leveraging of NMFS’  inspections by FDA in order to maximize the use of available resources. As  we stated in our October 2005 report, collaborating agencies bring  different levels of resources and capacities to the collaborative effort and  can leverage each others’ resources to obtain additional benefits that  would not be available if they were working separately. FDA’s inspection  work plan does not consider establishments under contract with NMFS in  determining the facilities FDA plans to inspect in any given year. In  addition, by not effectively utilizing NMFS inspection resources or results,  FDA has allowed some processing facilities to go without an inspection. A  2010 audit by the Department of Health and Human Services’ Office of  Inspector General found that 56 percent of domestic food facilities had  gone 5 years or more without an FDA inspection. The audit report pointed  out that FDA cannot ensure that these facilities are complying with  applicable laws and regulations if it does not routinely inspect them. The  need to leverage NMFS inspection resources or results was especially  critical in China, which accounts for 23 percent of seafood imports into  the United States. FDA has inspected 41 of 2,744 (or 1.5 percent) Chinese  seafood processing facilities in the last 6 years.
FDA officials provided new information during our closing meeting  concerning the agency’s plans to use NMFS inspections results. According  to these officials, the agency needs to first increase the level of training of  NMFS inspectors. Towards that goal, FDA has begun to train NMFS  inspectors using an advanced FDA course to increase the inspection  capabilities of NMFS inspectors to a level commensurate with the level  that FDA requires of its own inspectors. For example, FDA plans to train  at least 16 NMFS inspectors during fiscal year 2011. NMFS officials  confirmed that NMFS inspectors are attending FDA’s training in order to  meet FDA’s training requirement and advance the MOU’s provision of  leveraging resources. In addition, these NMFS inspectors who completed  the training and took the FDA exam, passed. However, according to NMFS  officials, NMFS training and its inspectors’ capabilities are already  equivalent to those of FDA inspectors. According to FDA officials, once  NMFS inspectors are trained, the agency plans to inspect some Chinese  seafood processing facilities jointly with NMFS to evaluate the NMFS  inspectors’ capabilities. FDA officials also noted that once NMFS  inspection capabilities reach FDA’s required level, the agency will  consider using NMFS inspection results as another source of information  that will feed into FDA’s risk analysis process for determining the facilities  to inspect in any given year. However, FDA has yet to fully develop this  risk approach and no time frames or documentation exists for its full  development. FDA noted that the use of NMFS inspection results would be  part of FDA’s implementation of any third-party certification program,  which is mandated by the FDA Food Safety Modernization Act. Therefore,  at this point, FDA has not documented how it plans to use NMFS  inspection results.
FDA has previously provided other reasons for not using NMFS inspection  resources or results. In 2005, we recommended that FDA recognize the  results of NMFS inspections when the agency determined the frequency of  its seafood inspections. In response, FDA stated that it would assess this  issue. However, FDA officials also stated that the agency did not rely on  NMFS’s inspection information because NMFS could have conflicts of  interest due to its fee-for-service inspection approach and because FDA  did not know what facilities NMFS was inspecting. A year earlier, we  recommended that FDA and NMFS develop a MOU so that FDA, in part,  would use and leverage NMFS inspection services to more efficiently and  effectively monitor the safety of imported seafood. In response, FDA  stated that it would explore additional opportunities to better leverage  NMFS inspection resources and more efficiently and effectively protect  the public health. We also noted that an FDA official raised concerns  about potential conflicts of interest with NMFS inspections, but that other  officials thought that these concerns could be addressed in an agreement.
section_title: Conclusions
paragraphs: With about a 20 percent increase in the consumption of imported seafood  in the last 10 years, FDA’s responsibility has also increased for ensuring  the safety of the nation’s food supply, including imported seafood.  However, FDA still uses the same approach it developed more than 10  years ago to ensure the safety of imported seafood, even though the  United States’ reliance on imported seafood has increased and aquaculture  has emerged as a major source of those imports. FDA’s approach is  generally focused on reviewing records of foreign processors and  importers and does not consider other pertinent areas of a foreign  country’s food safety system. Its foreign country assessments have been  limited by the lack of formal structure and necessary policies, guidance,  and criteria. In addition, FDA’s sampling program does not give  appropriate consideration to testing for the drugs approved for use in  aquaculture by major U.S. seafood trading partners but unapproved by the  United States and does not effectively use its laboratory resources. There  are practices employed by other entities with similar regulatory  responsibilities as FDA, including another U.S. government agency, which  show potentially more effective alternatives to the current FDA approach.  The recently enacted food safety legislation provides FDA with new  authorities that may enable it to more comprehensively review a foreign  country’s seafood safety system and implement the practices that other  entities employ to ensure the safety of imported food products. For  example, the EU requires foreign countries with which it trades to  maintain seafood safety systems that meet EU requirements or equivalent  conditions, or meet specific requirements provided in an agreement  between the EU and the foreign country before the EU will accept seafood  imports from that country. Also, the EU specifically directs that the  foreign country submit a national residues monitoring plan, which  provides information on the sampling for drugs of concern to the EU for  seafood products destined to the EU. That monitoring plan must have an  effect at least equivalent to those required within the EU. To facilitate  consideration and implementation of a different oversight approach to  ensure the safety of imported seafood, FDA must utilize its current  resources in the most efficient manner. However, FDA is not efficiently  using its resources when it does not effectively implement the 2009 MOU  with NMFS and fully utilize the resources of NMFS’ Seafood Inspection  Program, an agency dedicated specifically and solely to ensuring the  quality and safety of seafood. According to FDA officials, training NMFS  inspectors would bring their capabilities to a level commensurate with  FDA requirements. Furthermore, although FDA worked effectively with  NMFS in ensuring the safety of domestic seafood during the Gulf of  Mexico oil spill, it lacks systematic collaboration with that agency.  Provisions in the new food safety legislation also provide FDA with more  specific direction and opportunity for greater collaboration with NMFS  through, in part, more effective use of its inspection resources or results.
section_title: Recommendations for Executive Action
paragraphs: To better ensure the safety of seafood imports, we recommend that the  Secretary of Health and Human Services direct the Commissioner of FDA  to take the following three actions:    study the feasibility of adopting other practices used by other entities,  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 aquaculture drugs, to more efficiently ensure the safety of imported  seafood and report its findings to the Secretary;   develop a more comprehensive import sampling program for seafood by  more effectively using its laboratory resources and taking into account the  imported seafood sampling programs of other entities and countries; and   develop a strategic approach with specific time frames for enhancing  collaborative efforts with NMFS and better leveraging NMFS inspection  resources.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided the Departments of Agriculture, Commerce, and Health and  Human Services (HHS) a draft of this report for their review and comment.  We also provided a draft of this report as a courtesy to the Department of  Homeland Security, the Department of State, and the Office of the United  States Trade Representative. On March 23, 2011, we received written  comments from HHS, which are reproduced in appendix IV; HHS neither  agreed nor disagreed with the findings and recommendations in the report.  The Departments of Agriculture and Commerce did not provide written  comments.
HHS notes that our report represents a baseline against which FDA can  measure its ongoing progress. The department also states, however, that  reading our report may not result in a full understanding of FDA’s  multifaceted and risk-informed seafood safety program that relies on  information from various sources and provided additional information in  this regard. (See app. IV for our response to this and other general  comments.) In addition, while HHS did not explicitly agree or disagree  with our recommendations, the department provided information in its  written comments on actions in process or planned related to each of the  recommendations we made in our draft report. The additional information  related to each of our three recommendations follows:    Study the feasibility of adopting other practices used by other entities,  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 aquaculture drugs, to more efficiently ensure the safety of  imported seafood and report its findings to the Secretary: HHS stated  that as part of implementing the Food Safety Modernization Act, FDA will  determine whether the legislation supports the kind of precondition for  export to the United States that the FDA stated our recommendation  envisioned.
Develop a more comprehensive import sampling program for seafood by  more effectively using its laboratory resources and taking into account  the imported seafood sampling programs of other entities and countries:  HHS stated that FDA agrees that effective use of laboratory resources and  import sampling programs are important facets of a comprehensive and  risk-informed program to ensure seafood safety. HHS stated that FDA is  evaluating proposed research to further expand residue and species  coverage and identify areas for improved laboratory testing efficiencies.
Develop a strategic approach with specific time frames for enhancing  collaborative efforts with NMFS and better leveraging NMFS inspection  resources: HHS stated that FDA agrees that it is important for the agency  to maintain and foster this collaborative and effective working relationship  with NMFS. Further, FDA will work with NMFS to develop strategic  approaches for enhancing collaboration and better leveraging seafood  inspection resources. However, the agency did not comment on its intent  to establish specific time frames for this enhanced collaboration, which  we believe remains essential to help ensure accountability for and  expeditious implementation of this strategic approach.
HHS and the Department of Commerce also provided technical comments,  which we incorporated as appropriate.
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 Health and Human Services,  Agriculture, Commerce, Homeland Security, and State; the United States  Trade Representative; and other interested parties. In addition, the report  will be available at no charge on the GAO Web site 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 V.
section_title: Appendix I: Scope and Methodology
paragraphs: The Department of Health and Human Services’ Food and Drug  Administration (FDA) has responsibility for ensuring the safety of seafood  imports. The Department of Commerce’s National Marine Fisheries  Service (NMFS) provides voluntary fee-for-service inspections to ensure  compliance with FDA’s Hazard Analysis and Critical Control Point  (HACCP) regulations, among other things. To assess the extent to which  FDA ensures the safety of seafood imports against residues from  unapproved drugs, we analyzed information on FDA’s oversight  mechanism for seafood imports—importer and foreign country processing  facilities inspections—and its seafood import sampling program. In  particular, we analyzed information on the major components and  requirements of FDA’s importer and foreign facility HACCP inspections.  Specifically, we reviewed FDA’s inspection reports for seafood processing  facilities from major seafood exporting countries to the United States— Bangladesh, Chile, China, and Thailand—and focused our review on 15  FDA inspection reports for facilities that processed aquaculture seafood  products during fiscal years 2007 through 2009. We analyzed fiscal years  2006 through 2009 data on FDA’s import sampling program’s test results to  determine the magnitude and scope of the program. As part of our data  request, we asked FDA to provide the drug residue being tested for in each  analysis. However, information on drug residue, country of origin, and  type of seafood was in data fields combined with other information and  not easily analyzable. Consequently, we used a statistical program  searching for key words to analyze the data. After this preliminary  identification of the drug being analyzed, country, and seafood type, we  independently verified that the information was correct. In addition, we  conducted several data checks, including reviewing the data for missing or  incomplete information and testing for obvious errors in accuracy and  completeness, to ensure the reliability of the data. Furthermore, we  interviewed knowledgeable FDA officials to discuss the database’s internal  controls and other measures used to ensure the reliability of the data. We  determined that the data were sufficiently reliable for our purposes.
We reviewed documents regarding the seafood importing programs of the  European Union (EU), the largest importer of seafood worldwide; Japan,  the second largest importer of seafood worldwide; and Canada, a major  provider of seafood to the United States. We reviewed the EU’s importing  program to determine if its practices for ensuring the safety of seafood  imports have the potential for enhancing our own practices. As part of this  effort, we reviewed the EU’s inspection reports of select foreign countries  that are the major providers of seafood products. We reviewed the  imported seafood sampling programs of Canada, the EU, and Japan to  determine if their sampling practices had the potential for enhancing our  own practices as well. We reviewed information on import refusals and  alerts identified by Canada, the EU, and Japan’s to determine the types of  drug residues identified in these countries’ seafood imports. In addition,  we reviewed the approach the Department of Agriculture’s Food Safety  and Inspection Service (FSIS) uses to ensure the safety of imported meat  and poultry products to identify promising practices used by another  federal agency responsible for the safety of imported food products. We  visited the European Commission (Brussels, Belgium) and its inspection  office—the Food and Veterinary Office (Grange, Ireland)—to gain a better  understanding of its programs and oversight controls for seafood imports.  During the visit, we met with officials from the Belgian and Irish  governments to learn about their drug residue testing programs for  seafood imports. In addition, we visited a government laboratory in Ghent,  Belgium, and Rinville, Ireland, each to learn about the analytical methods  available to detect drug residues in seafood products. We also visited the  Port of Antwerp (Antwerp, Belgium), the largest port of entry for seafood  products in the EU, to learn about oversight controls for seafood imports.
We visited the Port of New York/Newark in Newark, New Jersey, the  largest port of entry for seafood products on the East Coast, and met with  Customs and Border Protection to learn about its activities related to  ensuring the safety of seafood imports. We also visited a cold storage  facility—in close vicinity to the New York/Newark port and where FSIS  inspectors are stationed—to learn about the measures FSIS uses to ensure  the safety of imported meat and poultry products. During the same trip, we  visited FDA’s Northeast laboratory in Jamaica, New York, and a Customs  and Border Protection’s laboratory in Newark to learn about the analytical  methods available to detect drug residues in seafood products.
We visited FDA’s and NMFS’ laboratories that specialize in seafood  research—FDA’s Gulf Coast Seafood Laboratory (Dauphin Island,  Alabama) and NMFS’s National Seafood Inspection Laboratory  (Pascagoula, Mississippi)—to learn about the research the agencies are  conducting on drug residues in seafood products. We visited a state  actively involved in testing seafood imports—Florida’s Department of  Agriculture’s laboratory (Tallahassee, Florida) and the Florida Agricultural  and Mechanical University’s Research and Extension facility (Quincy,  Florida)—to learn about fish farming practices.
We interviewed knowledgeable officials from Canada; FDA’s Center for  Food Safety and Applied Nutrition, Office of Regulatory Affairs, and  Center for Veterinary Medicine; FSIS; and Japan to better understand how  their respective programs function. For informational purposes, we spoke  with representatives from the states of Alabama and Mississippi because  of their testing program for imported seafood and proximity to the Gulf of  Mexico. To gain various stakeholders’ perspectives on the safety of  seafood imports, we also spoke with representatives from  industry (Charm Sciences, Inc.; Costco; Darden; and SGS—a third party  entity that certifies seafood farms and processors), trade associations (the Catfish Farmers of America; National Aquaculture  Association, National Fisheries Institute; and Southeastern Fisheries  Association, Inc.), and   consumer advocacy groups (the Center for Science in the Public Interest  and Food and Water Watch).
To assess the extent to which FDA and NMFS have implemented the 2009  memorandum of understanding (MOU) to enhance federal oversight of  seafood, we analyzed relevant agency documents on its implementation.  Specifically, we obtained and reviewed the 1974 MOU, letters of  notification between the agencies, and MOU guidance provided by each  agency to their respective field offices. We focused on two of the eight  practices identified in our previous work to enhance cooperation between  federal agencies in order to determine the extent that a collaborative  working relationship exists between FDA and NMFS: (1) establish policies  and procedures to facilitate systematic collaboration across agency lines  and (2) identify potential ways to leverage resources to maximize and  sustain collaborative effort. We did not address the remaining practices:  (1) define and articulate a common outcome; (2) establish mutually  reinforcing or joint strategies; (3) agree on roles and responsibilities; (4)  develop mechanisms to monitor, evaluate, and report on results; (5)  reinforce agency accountability for collaborative efforts; and (6) reinforce  individual accountability for collaborative efforts. We did not address the  first three practices because the agencies have already implemented them;  additionally, due to the lack of compatible policies and leveraging of  resources, we did not expect the agencies to have developed mechanisms  for evaluation or agency and individual accountability. We obtained and  reviewed the 2009 MOU implementation plan as well as compared lists of  establishments that received FDA or NMFS inspections for fiscal years  2005 through 2009 to determine the extent of inspection duplication. In  order to present information on possible duplication for background  purposes, we matched facility names and addresses using a statistical  program; for any potential but nonexact matches, we independently  verified the matches to determine whether they were correct. We  determined that the inspection data were sufficiently reliable for our  purposes. We interviewed knowledgeable FDA and NMFS headquarters  officials to determine their progress in implementing the 2009 MOU. We  reviewed the National Oceanic and Atmospheric Administration’s report  on ensuring seafood safety after an oil spill and the jointly written 2010  protocol for reopening oil-impacted areas to assess the cooperation  between FDA and NMFS in response to the oil spill in the Gulf of Mexico.  We interviewed officials at NMFS’ laboratory in Pascagoula, Mississippi, as  well as FDA’s mobile laboratory in Tallahassee, Florida, and Gulf Coast  Seafood Laboratory in Dauphin Island, Alabama, to determine the extent  to which the agencies coordinated efforts and leveraged resources during  this emergency situation.
We conducted this performance audit from April 2010 to April 2011 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: FDA Foreign Facility Inspections and Number of Processing Facilities in the Country
section_title: Appendix III: FDA Import Alerts Related to Drug Residue or HACCP Violations
section_title: Appendix IV: Comments from the Department of Health and Human Services
subsections: section_title: GAO Comments
paragraphs: The following are GAO’s comments on the Department of Health and  Human Services’ (HHS) letter dated March 23, 2011.  1.  We acknowledge that FDA has a multifaceted seafood safety program,  and our report discusses various measures that the agency uses to  ensure the safety of imported seafood. For example, our report  discusses facility and importer HACCP inspections, FDA’s drug residue  sampling program, and foreign country assessments. As we note in the  report, these measures are limited when compared to more  comprehensive reviews conducted by the EU and the Department of  Agriculture’s FSIS. FDA notes that another measure is information  from its overseas offices. In our September 2010 report on FDA’s  overseas offices, however, we found that although the offices have  engaged in a variety of activities to help ensure the safety of all FDA  imported products, overseas FDA officials report facing a variety of  challenges that may limit their ability to enhance agency oversight. 2.  HHS notes that FDA is also implementing the Predictive Risk-based  Evaluation for Dynamic Import Compliance Targeting (PREDICT),  which the department states will improve its current electronic  screening system by targeting higher risk products for exam and  sampling. The department notes that PREDICT will make more  efficient use of FDA’s import resources and allow the agency to adjust  its import sampling level for seafood products over time. In our April  2010 report, we found that according to FDA officials, the agency had  delayed a nationwide rollout of PREDICT due primarily to information  technology infrastructure problems, such as server crashes and  overloads. 3.  HHS describes the role of FDA’s foreign country assessments in  ensuring the safety of imported seafood by evaluating a foreign  country’s aquaculture systems and controls and to assess products. We  state in our report, however, that until recently, FDA had not  developed written standard operating procedures for conducting its  foreign country assessments. In its comments, HHS states that, during  a foreign country assessment, FDA assesses a foreign country’s laws  and their implementation for the control of animal drug residues in the  aquaculture products it ships to the United States. However, in the  absence of written criteria, standards, and program policies, it may be  difficult for FDA to carry on such an effort in a systematic or  consistent manner. In its comments, HHS describes the breadth and  value of FDA’s foreign country assessments as part of its import  oversight program, but these assessments are not identified in FDA’s  publicly available information as is its HACCP inspection program.  FDA also has not documented that these assessments are linked to any  inspection or sampling program.
section_title: Appendix V: GAO Contact and Staff Acknowledgments
subsections: section_title: Staff Acknowledgments
paragraphs: In addition to the individual named above, Jose Alfredo Gomez (Assistant  Director), David Moreno (Analyst-in-Charge), David Adams, Nancy  Crothers, Diana Goody, Christine Ramos, and Kiki Theodoropoulos made  key contributions to this report. Important contributions were also made  by Kevin Bray, Michele Fejfar, and Catherine Hurley.