Imported Seafood Safety: FDA and USDA Could Strengthen Efforts to Prevent Unsafe Drug Residues
Released: 2017-10-02T00:00:00


Highlights: section_title: Why GAO Did This Study
paragraphs: Most seafood consumed in the United States is imported, and about half of it is raised on fish farms. Because farmed seafood is raised in confined areas and susceptible to infections, farmers may use drugs like antibiotics. The use of unapproved drugs or the misuse of approved drugs may result in unsafe residues in seafood that can cause cancer or allergic reactions, according to FDA, which is charged with ensuring the safety of most seafood. Beginning in April 2016, FSIS became responsible for ensuring the safety of imported catfish.

This report examines (1) how FDA helps ensure the safety of imported seafood from unsafe drug residues and ways the agency could strengthen its efforts; (2) how FSIS helps ensure the safety of imported catfish from unsafe drug residues and ways the agency could strengthen its efforts; and (3) the extent to which FDA and FSIS coordinate their oversight efforts. GAO reviewed information from each agency and interviewed agency officials and other key stakeholders.

section_title: What GAO Found
paragraphs: To help ensure the safety of imported seafood from unsafe drug residues, the Food and Drug Administration (FDA) generally depends on the actions of foreign processors and U.S. importers. FDA requires processors and importers to follow its Hazard Analysis and Critical Control Point (HACCP) regulations to identify hazards and the critical control points where the hazards, such as pathogen contamination, are likely to occur and take corrective action. FDA also performs a limited number of (1) inspections of processors and importers each year to ensure HACCP compliance, and (2) tests of imported seafood for contaminants, including unsafe drug residues. FDA could strengthen its efforts to ensure the safety of imported seafood from unsafe drug residues by pursuing agreements with other countries requiring that they test seafood exported to the United States for unsafe drug residues. Under an agency plan, FDA is to coordinate with other countries to increase their capabilities related to the safety of food exported to the United States and better leverage their resources. FDA has used country agreements with respect to pathogen hazards in molluscan shellfish intended for export to the United States. According to FDA officials, it might be worthwhile for the agency to pursue agreements with some countries, but FDA would have to carefully consider a number of factors in determining which countries would be appropriate, which it has not yet done.

In assuming responsibility for inspecting imported catfish, the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) provided foreign countries and others a transition period—March 1, 2016, through September 1, 2017—before full implementation of its catfish inspection program. Following the transition, countries seeking to continue exporting catfish to the United States are to request equivalence determinations by providing documentation showing that their catfish safety inspection systems are equivalent to the U.S. system. FSIS could strengthen its efforts to ensure the safety of imported catfish. The Agricultural Act of 2014 directs FSIS, in part, to consider the conditions under which catfish are raised, domestically and abroad, but FSIS has not made farm visits a routine part of an equivalence determination. It is not clear how FSIS could consider the conditions under which imported catfish are raised consistent with the act without visiting farms. In addition, during this determination, the agency will already have its inspectors in the foreign country for an on-site audit. FSIS officials generally visit government offices, commercial food processing facilities, and food testing laboratories in a foreign country. Without visiting a sample of farms whose catfish are exported to the United States, FSIS may be missing an opportunity to consider the conditions under which catfish are being raised.

FDA and FSIS took steps to accomplish the transfer of catfish oversight from FDA to FSIS, as called for in the 2014 memorandum of understanding (MOU) that both agencies signed. However, they generally have not coordinated on drug residue testing methods, resulting, in some cases, in differences in drug residue levels used to determine if seafood is unsafe—specifically for unapproved drugs—as called for in the 1984 MOU. Without this coordination, the agencies do not have reasonable assurance that they are consistently protecting consumers from unsafe drug residues.

section_title: What GAO Recommends
paragraphs: GAO is making five recommendations, including that FDA pursue agreements with other countries to test seafood exported to the United States and that FSIS visit a sample of fish farms as part of foreign country on-site audits; and that FDA and FSIS coordinate in developing testing methods and corresponding residue levels for imported seafood. FDA agreed with or partially agreed with two; FSIS partially agreed with two and stated it already addresses a third. GAO disagrees and believes the recommendations should be implemented.

section_title: Letter
paragraphs: The United States has increased the amount of seafood it imports in  recent years and is currently the world’s second largest importer of  seafood, importing from approximately 140 countries. These imports  account for over 90 percent of the seafood consumed in the United  States, with about half coming from aquaculture (fish farming). In 2015,  the United States imported almost 6 billion pounds of seafood, including  some of the most popular species with U.S. consumers, such as catfish  (about 4 percent of all U.S. seafood imports). Because fish grown in  confined aquaculture 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 farmers introduce drugs,  either in feed or water, drug residues can remain in the fish through  harvesting, processing, and consumption. According to the Food and  Drug Administration’s (FDA) 2008 report to Congress and FDA officials,  the residues of some drugs can cause cancer or allergic reactions. In  addition, some drugs administered to food-producing animal may cause  bacteria of human health concern to become resistant to antibiotics used  in humans. As imports of farmed seafood increase, so too do the  concerns over the presence of drug residues. The potential use of  unapproved drugs, or misuse of approved drugs, adds to these concerns.

Effective federal oversight is therefore important to help ensure that  imported seafood is safe for U.S. consumers.

Historically, FDA has had the responsibility of ensuring the safety of all  seafood consumed in the United States. More broadly, under the Federal  Food, Drug, and Cosmetic Act (FFDCA), FDA is generally responsible for  ensuring that the nation’s food supply is safe, wholesome, sanitary, and  properly labeled. All FDA-regulated food products imported into the  United States must meet the same legal and regulatory requirements as  food products produced domestically. The FDA Food Safety  Modernization Act (FSMA) provided FDA with additional authorities, such  as the authority to suspend the registration of a food facility when there is  a reasonable probability of food from the facility causing serious adverse  health consequences or death to humans or animals. With some  exceptions, food facilities, including seafood facilities, must be registered  with FDA to engage in the manufacturing, processing, packing, or holding  of seafood for consumption in the United States.

The Food, Conservation, and Energy Act of 2008 (2008 Farm Bill)  assigned regulatory responsibility, upon the issuance of final regulations,  for the inspection of domestic and imported catfish to the U.S.  Department of Agriculture (USDA). Within USDA, the Food Safety and  Inspection Service (FSIS) carries out this responsibility. FSIS is also  responsible for ensuring that meat, poultry, and processed egg products  are safe, wholesome, and accurately labeled. In May 2012, we reported  on the potential effects that FSIS’s then-proposed catfish inspection  program might have on other federal seafood safety inspection  programs. We stated that FSIS’s catfish inspection program would, in  part, further fragment the responsibility for seafood safety and introduce  overlap. We also testified on this issue in December 2016. The  Agricultural Act of 2014 (2014 Farm Bill), among other things, made all  fish of the order Siluriformes, hereafter referred to as catfish, subject to  FSIS inspection upon the issuance of final regulations. In addition, with  the 2014 Farm Bill, Congress reaffirmed its commitment to assigning  FSIS the responsibility for inspecting catfish. Prior to FSIS assuming this  responsibility, FDA was responsible for ensuring the safety of catfish. In  December 2015, FSIS issued a final rule for implementing a catfish  inspection program, and in March 2016, FSIS assumed responsibility for  inspecting domestic catfish processing facilities. In April 2016, FSIS  assumed responsibility for inspecting imported catfish. FSIS considers its  catfish program to be in a transitional period until September 1, 2017, at  which time FSIS will begin analyzing whether countries exporting catfish  to the United States have food safety systems for catfish that provide a  similar level of public health protection as found in the United States.

You asked us to examine how FDA and FSIS ensure the safety of  imported seafood from unsafe drug residues. This report examines (1)  how FDA helps ensure the safety of imported seafood from unsafe drug  residues and ways the agency could strengthen its efforts, (2) how FSIS  helps ensure the safety of imported catfish from unsafe drug residues and  ways the agency could strengthen its efforts, and (3) the extent to which  FDA and FSIS coordinate their oversight efforts.

To examine how FDA and FSIS help ensure the safety of imported  seafood and catfish, respectively, from unsafe drug residues, we  examined related legislation and regulations; relevant agency policies, manuals, directives, and guidance; and our past work on federal oversight  of seafood safety. We also interviewed agency officials to gain a better  understanding of their seafood safety programs. At FDA, we reviewed  program data for fiscal years 2010 through 2015, including data on  imported seafood sampling and testing and import refusals. We also  reviewed a random sample of 74 foreign processor inspection reports out  of a total of 318 reports prepared by FDA for fiscal years 2013 through  2015 to determine whether FDA’s processor inspections included visiting  farms and laboratories. In addition, we reviewed a random, non- generalizable sample of 9 FDA reports of importer inspections out of a  total of 232 reports for fiscal year 2015. At FSIS, we reviewed similar data  for catfish from May 1, 2016, when the agency began sampling catfish  imports, through July 9, 2017. To assess the reliability of the agencies’  data, we, among other things, reviewed controls for the systems that  house these data and interviewed agency officials regarding these  controls and found these FDA and FSIS data to be sufficiently reliable for  the purposes of our reporting objectives. In addition, to gain a better  understanding of the agencies’ programs, we visited selected U.S. ports  of entry in Otay Mesa, California; Long Beach, California; and Newark,  New Jersey. The Otay Mesa port is a land port of entry into California  and in proximity to the Long Beach port. The New Jersey port is the  largest port of entry for seafood products in the United States, and the  Long Beach port is the second largest port of entry for seafood in the  United States. We also visited an FDA laboratory and district office in  Irvine, California, to discuss FDA testing of seafood imports for drug  residues with laboratory officials. In addition, we interviewed  representatives of the National Fisheries Institute, whose members  include more than 200 seafood processors, importers, and exporters. We  also interviewed a representative from the Consumer Federation of  America, whose members include nearly 300 consumer groups, to  obtain their perspectives on the agencies’ seafood safety programs. To  examine ways, if any, that the agencies could strengthen their efforts, we  compared FDA’s and FSIS’s efforts to help ensure the safety of imported  seafood and catfish, respectively, to each other and to efforts of the  European Union (EU) to determine if EU practices for ensuring the safety  of imported foods have the potential for enhancing U.S. practices. We  discussed the EU’s practices with officials from the EU’s Food and  Veterinary Office (Grange, Ireland) to gain a better understanding of its  programs and oversight controls for seafood imports.

To review the extent to which FDA and FSIS coordinate their oversight  efforts, we reviewed memorandums of understanding on coordination  signed by the agencies and coordination activities between the two  agencies and also compared their coordination activities to key practices  that can help enhance and sustain federal agencies’ collaboration that we  previously identified, particularly the practice of identifying and  addressing needs by leveraging resources when responsibilities cut  across more than one federal agency. We also interviewed FDA and  FSIS officials to discuss information for all objectives, including obtaining  their views on the opportunities to enhance their programs regarding  unsafe drug residues in imported seafood. Appendix I provides additional  information on our scope and methodology.

We conducted this performance audit from January 2016 to September  2017 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 (i.e., seafood), including wild catch, aquaculture, and  processed fish products, are one of the most highly traded commodities in  the world today, and more than half of this commodity originates in  developing countries. The EU is the largest market for imported seafood,  followed by the United States and Japan. Roughly 20 years ago, about 60  percent of the seafood consumed in the United States was imported. As  of April 2016, over 90 percent of the seafood consumed in the United  States was imported, about half of which was produced from aquaculture  operations, also known as fish farms. In 2015, China was the overall  leading exporter of seafood to the United States, India was the leading  exporter of shrimp, and Vietnam was the leading exporter of catfish.  Figure 1 shows the proportion of U.S. imports from the five countries  exporting the most seafood to the United States in 2015. The “others”  category represents 137 countries that also exported seafood to the  United States in 2015. Figure 2 shows the countries that in 2015 were  the major exporters of shrimp, salmon, tilapia, and catfish to the United  States.

As with seafood more generally, the volume of imported catfish has been  increasing in recent years. In 2005, the United States imported over 30  million pounds of catfish. In 2010, the United States imported about 137  million pounds; the major catfish exporters were Vietnam, with 79  percent, and China, with 13 percent. By 2015, total catfish imports were  almost 250 million pounds, with Vietnam alone accounting for over 95  percent of all such imports. Domestically, catfish production is  concentrated in Alabama, Arkansas, Louisiana, and Mississippi. In  general, according to USDA, domestic catfish production has trended  downward in recent years, but data in this regard are incomplete. For  example, data reported by USDA’s National Agricultural Statistics Service  showed a general decline in domestic catfish production from 2006  through 2012, including a 36 percent decline from 2010 to 2012, from  about 472 million pounds in 2010 to about 300 million pounds in 2012.  But this agency did not collect and report similar data for the period 2013  through 2016.

Before 2002, various fish in the order Siluriformes were commonly  labeled and sold as “catfish.” However, in 2002 Congress amended  FFDCA 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. However, as discussed, the 2014 Farm Bill  made all fish in the order Siluriformes subject to FSIS inspection upon the  issuance of final regulations. For purposes of this report, we refer to all  fish potentially subject to FSIS regulations as “catfish,” including fish in  the family Ictaluridae, which are primarily of domestic origin, and  Pangasiidae, which come primarily from Vietnam.
subsections: section_title: FDA’s Approval of Drugs
paragraphs: In the United States, new animal drugs (veterinary drugs) used in animals  that are used for food, including seafood, generally must be approved by  FDA. According to FDA officials, the process for obtaining a new animal  drug approval, including drugs used in aquaculture, originates with an  entity or individual (sponsor) submitting an application for review. FDA  may approve a drug for, among other things, certain disease conditions in  specific species (e.g., catfish). When FDA approves a drug, it may  establish a tolerance for the safe use of the drug. If residues of the  approved drug are detected in a food product above the tolerance, the  product is unsafe and therefore adulterated under FFDCA. Once  residues are confirmed above a tolerance, which can vary by species and  drug, FDA may take regulatory action. In addition, if any residue of a drug  unapproved by FDA is detected, the food product is likewise unsafe and  adulterated under FFDCA. In general, drugs used in aquaculture may  include anesthetics, antibiotics, disinfectants, hormones, parasiticides,  and germicidal agents. Table 1 lists the drugs that FDA has approved for  aquaculture use in the United States as of February 2017.

For testing drug residues, FDA has established three types of maximum  residue levels (MRL) for seafood intended for consumption in the United  States. FDA applies two of these levels—the “tolerance” and “regulatory”  levels—to domestic and imported seafood. The third, “import tolerance”  applies only to imported seafood. FDA regards the presence of drug  residues above any of these levels to be potentially harmful to human  health and may consider taking regulatory action, such as refusing a  product’s entry into the United States if it contains drug residues above  such levels. More specifically, the three levels are as follows:

Tolerance: For drugs FDA has approved for use in aquaculture, the  approval is often for specific species, disease conditions, and a  maximum drug residue tolerance. A food product with a residue above  the tolerance established for the drug in that food is adulterated under  FFDCA. Tolerances for approved drugs are established in regulation  and codified in the U.S. Code of Federal Regulations. FDA applies  established tolerances for FDA approved drugs to imported and  domestic seafood.

Regulatory level: For certain unapproved drugs, FDA has also  established maximum drug residue levels that for purposes of this  report, we refer to as regulatory levels. In general, these levels  correspond to the limits of detection achievable by the testing  methods and equipment used by FDA laboratories. FDA does not  generally publicly disclose regulatory levels for residues of  unapproved drugs. According to agency officials, FDA is concerned  that disclosing its regulatory levels for unapproved drugs may  encourage some foreign fish farmers to use these drugs if they  believe that they can do so in a manner that would result in residue  levels below FDA’s regulatory levels.

Import tolerance: For certain drugs that may be used by foreign fish  farmers, FDA has established import tolerances. These drugs are not  approved for use by domestic fish farmers. FDA has established  import tolerances for three drugs that can be used in other countries  on seafood, but none of them are for catfish.

section_title: The EU’s Equivalence Process
paragraphs: The EU, which is the largest importer of seafood worldwide, takes a wide- ranging review of the food safety systems of foreign countries that want to  export their seafood products to it. Specifically, the EU requires that other  countries seeking to export seafood to it demonstrate that their seafood  safety systems meet its or equivalent requirements or comply with  specific requirements established in an agreement between the EU and  the exporting country. According to EU regulations, for other countries to  demonstrate that their seafood safety systems meet EU or equivalent  requirements, they must provide information on their food safety systems,  including relevant laws, regulatory enforcement powers, and the  laboratories that test seafood products. According to EU officials, once  they determine that a country has an equivalent food safety system for a  particular food product, the government of that country is then responsible  for meeting the EU’s safety requirements. Moreover, that government  becomes the single point of contact to address any identified problems,  such as seafood products with drug residues above the EU’s accepted  MRLs, and is expected to take regulatory actions across that country’s  supply chain, from farm to processing facility, as necessary.

The EU generally conducts an on-site audit of a country’s food safety  system governing the product that country seeks to export to the EU. The  audit focuses on the ability of the competent government authority  responsible for food safety to carry out its tasks and provide the  necessary guarantees for the safety of food to be exported to the EU. The  EU’s on-site audits include visiting fish farms and processing facilities as  well as reviewing the capabilities and quality of the country’s food testing  laboratories. In addition, to ensure continuous compliance with EU  requirements, the EU periodically conducts follow-up audits of a country’s  food safety system for specific food products, such as seafood.

Countries that export food to the EU also are required to implement  national residue monitoring plans, which include sampling and testing of  food products for residues of specific drugs of concern to the EU. The EU  must approve a country’s residue monitoring plan as a prerequisite for  export of food of animal origin, such as seafood, from that country to the  EU. Countries exporting food to the EU must submit their residue  monitoring plans to the EU for approval each year. The EU can prohibit  a country from exporting seafood to the EU if drugs of concern to the EU  are not included in the country’s national residue monitoring plan or the  country does not otherwise fully implement its plan.

section_title: FDA Takes Steps to Help Ensure the Safety of Imported Seafood from Unsafe Drug Residues and Could Strengthen Its Efforts with Foreign Country Agreements
paragraphs: To help ensure the safety of imported seafood from unsafe drug residues,  FDA generally depends on the actions of foreign processors and U.S.  importers. Specifically, FDA requires processors and importers to follow  its Hazard Analysis and Critical Control Point (HACCP) regulations to  identify hazards and the critical control points where the hazards, such as  pathogen contamination, are likely to occur and to take corrective action.  FDA also performs a limited number of (1) inspections of processors and  importers each year to ensure HACCP compliance, and (2) samples and  tests of imported seafood for contaminants, including unsafe drug  residues. However, FDA has not entered into agreements with other  countries requiring that they test seafood exported to the United States  for the specific drugs the agency tests for—drugs of concern to FDA.
subsections: section_title: FDA Requires Seafood Processors and Importers to Follow HACCP and Conducts a Limited Number of Inspections to Assess Compliance
paragraphs: Since 1997, FDA has used HACCP as its main safety oversight tool 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,  such as pathogens or chemicals, are reasonably likely to occur. Under  HACCP requirements, processors are also responsible for addressing  hazards that may have been introduced before the seafood reached their  facilities, including hazards from unsafe drug residues. FDA inspects a  limited number of foreign seafood processing facilities each year to (1)  identify potential seafood safety problems before seafood products arrive  in the United States, (2) help the agency make admissibility decisions  when seafood products are offered for importation into the United States,  and (3) help ensure that imported seafood products under FDA’s  jurisdiction meet U.S. safety requirements, among other things.

In fiscal year 2016, FDA inspected 144 foreign seafood processer  facilities for HACCP compliance, or nearly 2 percent of the 7,669 total  processors that exported seafood to the United States that year.  According to FDA officials, limited resources dictate the number of  inspections the agency can conduct. Similarly, in our January 2015  report, we found that FDA was not keeping pace with FSMA’s mandate  for increasing the number of these inspections of foreign food facilities.  According to FDA officials, the agency did not plan to meet this FSMA  mandate because of limited funding. Regarding potential drug residues,  FDA’s inspections of foreign seafood processor facilities are limited.  These inspections involve reviewing the processors’ HACCP plans and  other records to ensure that the processors considered drug residues as  a hazard that is reasonably likely to occur if the seafood products it  receives are from fish farms. However, the inspections do not include  visiting the fish farms that supply the processor facilities to evaluate drug  use or controls; it is at these farms where drugs are introduced. FDA’s  inspections also do not include visiting laboratories that may be asked by  processors to test for unsafe drug residues in seafood to assess the  laboratories capabilities and competence.

According to FDA officials, neither fish farms nor laboratories are subject  to the HACCP regulations and therefore are not part of FDA’s processor  inspections. Our review of a random sample of 74 foreign processor  inspection reports prepared by FDA for fiscal years 2013 through 2015  generally confirmed that FDA’s processor inspections did not include  visiting farms that supply the fish to the processor and laboratories that  conduct testing for the processor. From the 74 reports, we found only one  case where the FDA inspectors also visited a fish farm supplying the  processor. In that case, the farm was located near the processing facility.

FDA also requires U.S. importers to verify that foreign processing facilities  are HACCP compliant. HACCP regulations require all importers of  seafood to the United States to demonstrate that the seafood they import  has been processed in accordance with HACCP requirements. For  example, under HACCP requirements, importers of seafood products  must (1) obtain seafood products from processing facilities in foreign  countries that have an agreement with FDA documenting that the  country’s food safety system complies with or is equivalent to the U.S.  system; or (2) maintain written verification procedures that include  product specifications designed to ensure that products are not  adulterated and take at least one of six affirmative steps to document that  the foreign processing facilities supplying their seafood products comply  with HACCP requirements. These steps may include, for example,  maintaining on file a copy of the foreign processor’s HACCP plan and a  written guarantee from the processor that the imported seafood is  processed in accordance with HACCP requirements, or obtaining a  certificate from a foreign government inspection authority or competent  third party certifying that the imported fish was processed in accordance  with HACCP requirements.

As of June 2017, FDA had no equivalence agreements with other  countries, according to FDA officials, precluding importers of seafood  products from using the first of the two options noted above. Instead,  according to FDA officials, U.S. seafood importers generally comply with  HACCP regulations by obtaining (1) a copy of a foreign processor’s  HACCP plan and an attestation that the firm processes its seafood  products in compliance with HACCP regulations and (2) lot-by-lot  certifications from either a foreign government authority or third-party  auditor attesting to the foreign processor’s compliance with HACCP  regulations. However, according to FDA officials, under HACCP  regulations, importers are not required to either visit foreign seafood  processors to ensure that these processors implement their HACCP  plans or assess the competence or ability of foreign governments or third- party auditors to issue lot-by-lot certifications.

Each year FDA inspects a small number of U.S. seafood importers to  determine if they have obtained the appropriate documentation from  foreign seafood processors indicating that the processors had met  HACCP requirements. For fiscal years 2010 through 2015, FDA  inspected, on average, 178 seafood importers annually, or about 4  percent of the average number of seafood importers (4,009) registered  with FDA each year during that period. As with processing facility  inspections, FDA officials stated that the number of importer inspections  was affected by limited resources. Our review of nine random—a non- generalizable sample—FDA reports of importer inspections for fiscal year  2015 showed various problems with importer compliance with HACCP  requirements. For example, of the nine reports, five noted that the  importer inspected did not identify the affirmative step taken to document  that the foreign processors supplying some or all of that importer’s  seafood products were in compliance with HACCP requirements. In some  cases, the inspection report also noted that an earlier FDA inspection had  also found that the importer had failed to identify an affirmative step that  was required in order to comply with HACCP regulations.

section_title: FDA Conducts a Limited Number of Port-of-Entry Examinations and Tests a Small Sample of Seafood Imports to Identify Unsafe Drug Residues
paragraphs: FDA uses a computerized tool for admissibility screening and to  determine, in part, which seafood products to examine. This tool is  called the Predictive Risk-based Evaluation for Dynamic Import  Compliance Targeting (PREDICT). We previously reported on FDA’s  use of PREDICT in May 2016. Examinations may include physical  inspection (e.g., appearance and smell) of the seafood; inspection of the  label; or sampling and laboratory testing of the seafood to identify any  contaminants, including unsafe drug residues, that may render the  seafood adulterated. FDA tests imported seafood for all drugs of concern  to the agency and compares results to its corresponding MRL if one  exists, according to FDA officials. FDA uses a multi-residue method  (MRM) that tests for 26 drugs. FDA also uses other methods to test for  drug residues. In cases in which the MRL is exceeded, the imported  seafood is adulterated under FFDCA and subject to refusal.

If FDA finds adulterated seafood through testing or examination, the  agency can refuse the shipment’s entry into the United States. From fiscal  years 2010 through 2015, FDA refused entry (import refusal) into the  United States of 1,726 seafood products for drug-related violations. The  majority of the refusals were of exports from four countries: China (37  percent), Malaysia (28 percent), Indonesia (12 percent), and Vietnam (11  percent). Shrimp represented 54 percent of all FDA refusals; other  seafood, 32 percent; tilapia, 7 percent; catfish, 6 percent; and salmon,  less than 1 percent. FDA officials said that import refusals may also occur  based on FDA inspections of foreign processors but that they were not  aware of a refusal based on FDA inspectional findings related to the use  of an unsafe drug. Appendix II provides our analysis of FDA’s drug testing  results for fiscal years 2010 through 2015.

In fiscal year 2015, FDA examined 2.2 percent of all imported seafood  entry lines for a variety of food safety issues. The number of  examinations is limited by available resources, according to FDA officials.  Further, regarding drug residues, in fiscal year 2015 FDA tested 0.1  percent of about 1 million seafood entry lines for drugs of concern to FDA  in an effort to detect unsafe residues. Of the imported seafood tested, the  percentage that tested positive, by type of seafood was as follows:  catfish, about 9 percent (3 of 33 samples); salmon, 0 (0 of 86); shrimp,  about 12 percent (67 of 550); tilapia, about 11 percent (28 of 258); and  “other” seafood, about 7 percent (14 of 213). Based on this level of  testing, seafood shipments from a foreign processing facility would have a  roughly 1 in 1,000 chance of being selected by FDA for drug residue  testing, unless other information in PREDICT, such as the results of  sampling of prior shipments, processing facility inspection records, and  country of origin, among other factors, elevated or lowered that facility’s  risk score. According to FDA officials, the level of testing of seafood  imports for drug residues is affected by the availability of resources.  Figure 3 shows fiscal year 2015 data for FDA’s examinations and  sampling of imported seafood, including sampling specifically for drug  residues.

Regarding imported catfish specifically, FDA’s sampling and testing for  unsafe drug residues generally increased from fiscal years 2010 through  2012, but then dropped significantly in the following 3 fiscal years, even  as the volume of catfish imports remained relatively the same. For  example, as shown in figure 4, from fiscal years 2012 through 2015,  FDA’s sampling and testing of imported catfish for unsafe drug residues  declined by 75 percent, even as the volume of catfish imports averaged  about 250 million pounds annually during this period.

Further, in comparison to FDA’s sampling and testing of other popular  imported seafood species, such as salmon, shrimp, and tilapia, for unsafe  drug residues, FDA’s sampling and testing of imported catfish showed the  greatest drop relative to import volume for fiscal years 2010 through  2015. For example, as shown in figure 5, FDA’s sampling and testing of  imported catfish experienced the greatest drop per 10 million pounds of  imports, particularly from fiscal years 2012 through 2015. However, as  shown in the figure, the level of sampling and testing per 10 million  pounds of imports is limited for all of the seafood species depicted.  Appendix II provides information on the total number of imported seafood  samples, including for catfish, FDA tested for fiscal years 2010 through  2015.  require FDA to address that outbreak and potentially reduce resources for  drug residue testing.

section_title: FDA Could Strengthen Its Efforts by Pursuing Agreements with Other Countries Requiring That They Test Seafood Exported to the United States
paragraphs: FDA is not pursuing agreements with other countries requiring that they  test seafood exported to the United States for unsafe drug residues,  according to FDA officials, as the EU does. Establishing such agreements  is a practice that we have previously recommended to FDA.  FSMA  requires FDA to develop a comprehensive plan to expand the technical,  scientific, and regulatory capacity of foreign governments and their  respective food industries in countries that export foods to the United  States. To meet FSMA’s requirement, in 2013 FDA developed its  International Food Safety Capacity-Building Plan. This plan states, in part,  that FDA will (1) coordinate with other countries to, among other things,  increase their capabilities related to the safety of the food they export to  the United States and (2) better leverage other countries’ resources. Such  leveraging may enable FDA to perform its work to ensure food safety  more efficiently. Further, the plan states that agreements and other  arrangements with foreign regulatory authorities or other entities are  useful in ensuring the safety of food products and avoiding duplication of  oversight efforts.

Even with the development of this plan in 2013, as of June 2017 FDA had  not entered into any agreements or other arrangements to involve  another country in ensuring the safety of the seafood it exports to the  United States from unsafe drug residues, according to FDA officials.  Further, as of that time, FDA was not actively pursuing such agreements  or other arrangements. When asked why, agency officials said that it  might be worthwhile for FDA to pursue agreements with some countries,  but the agency would have to carefully consider a number of factors in  determining which countries would be appropriate and has not done so.  According to these FDA officials, some countries exporting seafood to the  United States might not be ready for such agreements. For example, they  said that these countries may lack the laboratory infrastructure and  capabilities needed to test for the drugs of concern to FDA, including at  the corresponding MRLs that the agency established for these drugs, and  their laboratory staff may need additional training and education.

According to EU officials, the foreign laboratories that test seafood  products exported to the EU for drug residues should ideally be  accredited and have the required methods included in the scope of  accreditation. Further, these officials stated that those methods must be  validated or the residue monitoring plan will not be approved by the EU.  Countries seeking to export seafood to the EU must either demonstrate  that their seafood safety systems meet EU or equivalent requirements or  comply with specific requirements established in an agreement between  the EU and the exporting country. The United States may still be a market  for at least some seafood that did not meet the seafood safety standards  of the EU because FDA does not have agreements with these  countries.

Moreover, precedent exists for FDA’s use of country agreements in  another area. Specifically, the agency has used them with respect to  pathogen hazards in molluscan shellfish intended for export to the United  States. For example, FDA entered into an agreement with Mexico in 2012  in which Mexico committed that its sanitation program guidelines for  harvesting, processing, transporting, and labeling molluscan shellfish  would comply with U.S. requirements to reduce potential pathogen  hazards. In addition, under the agreement, Mexico committed that its  competent government authority would restrict the harvest of molluscan  shellfish from unapproved growing areas and take enforcement action  against persons or companies harvesting from unapproved areas.

In addition, in the course of doing work for our September 2012 report,  officials from three major seafood exporting countries described the  benefits of countries entering into agreements with them. Noting that they had such agreements with the EU, these officials said that their  countries would be open to establishing similar agreements with the  United States. For example, see the following:

Thai officials said that because Thailand has a formal (government-to- government) agreement with the EU, the Thai government can better  ensure that its seafood processing facilities meet the EU’s safety  standards for seafood exported to EU countries. These officials also  said that, because of this agreement, their government can more  efficiently address problems with Thai seafood exports identified by an  EU country, including any drug residue problems.

Noting that their country has a formal agreement with the EU,  Ecuadoran officials said staff from their government inspect and  certify processor facilities that export seafood products to the EU.  Further, these officials said the Ecuadorian government developed a  national control plan to address specific EU requirements and  standards for seafood exports, including those related to drug  residues.

Noting that Indonesia has formal agreements with other countries,  including the EU, Indonesian officials said that all Indonesian  processing facilities that export seafood to those countries must meet  HACCP certification requirements; obtain a health certificate; and  meet any additional requirements of the importing country, which may  include requirements related to drug residues.

Further, the results of FDA’s “country assessments” of other countries  exporting seafood to the United States point to the potential benefit of  having formal agreements with these countries. FDA conducts these  assessments to provide the agency with a broad view of a country’s  regulatory infrastructure and the capacity of its seafood industry to control  unsafe drug residues. According to FDA guidance, when the agency  determines there is a significant risk that a country may be exporting  seafood with unapproved drug residues to the United States, FDA may  undertake an assessment of the country’s drug residue control program.  FDA has conducted 10 foreign country assessments focused on the use  of drugs in aquaculture in eight countries from 2006 through December  2016. The most recent assessments of China and Indonesia, major  exporters of seafood, were conducted in 2006 and 2007, respectively.  According to the guidance, FDA’s determination may be based on the  results of its own sampling and testing of seafood exported from that  country or on other information, such as a significant change in a  country’s competent government authority responsible for seafood safety  oversight. As described in the guidance, in the course of doing an  assessment, FDA officials may visit seafood processors, fish farms, drug  testing laboratories, feed mills, and veterinary drug distributors and  retailers in the country.

At the conclusion of a country assessment, FDA may offer suggestions or  recommendations to government officials and seafood industry  representatives for improving the country’s seafood safety program.  However, as noted in some of these assessments, the country involved  reported that it could not act on these suggestions or recommendations in  the absence of a formal agreement with the United States, or it was  otherwise apparent that the absence of an agreement was likely an  impediment. For example, see the following:  In its 2012 assessment of Vietnam, FDA recommended that the  Vietnamese government reinstate a requirement that its processors  test all farmed seafood consignments intended for the U.S. market for  unsafe drug residues until such testing showed that unsafe drug  residues were no longer a problem. However, according to the  assessment, Vietnam responded that under its new food safety law, it  can only conduct mandatory consignment testing when required by a  formal agreement with the receiving country. Vietnam noted that it has  such agreements with other countries, such as Canada, the EU,  Japan, and Korea, but does not have an agreement with the United  States.

In its 2013 assessment of Ecuador, FDA strongly suggests that the  competent government authority require that seafood processors  exporting to the United States meet all requirements in Ecuador’s  drug residue plan. However, according to the assessment, Ecuador  responded that its plan is voluntary and thus the country cannot  require that its processors comply with the plan’s requirements except  in cases where Ecuador has a formal agreement with another country.  Ecuador noted that it has such agreements with Argentina, Brazil,  China, the EU, and Russia but not with the United States. Those  countries that have agreements with Ecuador are regulated by EU  standards, according to the assessment. As a result, shrimp or tilapia  that cannot be shipped to EU countries because of concerns about  violative drug residues may be shipped to the United States.

In its 2011 assessment of Malaysia, FDA said that Malaysian testing  of seafood exported to the United States was limited to three drugs  and it was not possible to verify that this seafood met U.S.  requirements and was free of unsafe drug residues. In response to  FDA’s concerns, the competent government authority declined to  make changes in its testing, stating it is the responsibility of U.S.  importers to ensure that seafood imports comply with U.S.  requirements. In contrast, FDA determined that the Malaysian  seafood safety control system underwent major changes in response  to an EU audit, and the country is on the list of countries approved to  export fishery products to the EU.

In its 2010 assessment of India, FDA noted that drug residue testing  required by the Indian government for seafood exports to the EU and  the United States differed. Specifically, a greater level of testing was  required for seafood exports to the EU. According to FDA’s  assessment, the Indian government said the type of testing done on  seafood intended for the EU would also be done on seafood intended  for the U.S. market if FDA required that seafood exports be  accompanied by a health certificate, as is required by the EU, Japan,  and South Korea. However, FDA does not require health certificates  and took no action to require them after completing this assessment,  according to FDA officials.

As of June 2017, FDA had not entered into any agreements or other  arrangements with any country for ensuring the safety of the seafood  exported to the United States from unsafe drug residues.

In light of FDA’s limited inspections of foreign seafood processors and  U.S. importers, its limited sampling and testing of imported seafood for  unsafe drug residues, and the limitations of FDA’s country assessments  to obtain other countries’ voluntary cooperation in ensuring that their  seafood exports to the United States are free of unsafe drug residues,  FDA not pursuing formal country agreements is counter to the agency’s  International Food Safety Capacity-Building Plan. Under the plan, FDA is  to coordinate with other countries to, among other things, increase their  capabilities related to the safety of food exported to the United States and  better leverage other countries’ resources. Such leveraging may enable  FDA to more efficiently perform its work to ensure food safety. However,  FDA has not pursued formal agreements with countries exporting seafood  to the United States that commit the countries to take actions, such as  testing for drugs of concern to FDA and the corresponding MRLs, that  would leverage those countries’ resources, according to FDA officials.  The EU and other countries have successfully pursued such agreements.

By pursuing formal agreements with countries exporting seafood to the  United States that commit these countries to test for drugs of concern to  FDA and the corresponding MRLs that the agency established for these  drugs, FDA could strengthen its efforts toward ensuring that imported  seafood does not contain unsafe drug residues. Further, such  agreements would allow FDA to leverage other countries’ resources to  improve imported seafood safety and further protect U.S. consumers from  unsafe drug residues. FDA officials acknowledged that such agreements  would be helpful in protecting U.S. consumers from unsafe drug residues.

section_title: FSIS Takes Steps to Help Ensure the Safety of Imported Catfish from Unsafe Drug Residues and Could Strengthen Its Efforts
paragraphs: In assuming responsibility for inspecting imported catfish, FSIS provided  for an 18-month transition period—March 1, 2016, through September 1,  2017—to provide foreign countries, importers, and other stakeholders  time to transition to the full implementation of the agency’s catfish  inspection program for imports. Following the transition period, a foreign  country seeking to continue exporting catfish to the United States after  September 1, 2017, is to request an equivalence determination and  provide documentation showing that its catfish safety inspection system is  equivalent to that of the United States. However, FSIS has not made farm  visits a routine part of initial equivalence determination and verification  on-site audits. FSIS also does not plan to require other countries to test  catfish exported to the United States for the same drugs it tests for—the  drugs of concern to FSIS—at the agency’s MRLs.
subsections: section_title: Upon Assuming Responsibility for Catfish Oversight, FSIS Allowed an 18-Month Transition Period
paragraphs: As of March, 1, 2016, countries exporting catfish to the United States and  intending to continue those exports after September 1, 2017, were  required to provide FSIS with documentation demonstrating that their  food safety systems generally comply with U.S. requirements, including  the use of HACCP. In addition, by that date, these countries were to  provide FSIS with a list of processors intending to continue exporting  catfish to the United States. As of June 2017, 13 countries submitted the  documentation required to continue exporting catfish to the United States  during the transition period.

In April 2016, FSIS assumed responsibility for inspecting imported catfish  at ports of entry. FSIS refers to this as re-inspection, and it generally  included (1) physical examinations and (2) collecting samples for testing  for unsafe drug residues or other contaminants. During the transition,  FSIS targeted shipments for re-inspection on at least a quarterly basis.  As part of the re-inspection, FSIS tested for unsafe drug residues,  including for all drugs of concern to the agency and their corresponding  MRLs. FSIS used, in part, an MRM that tested for 61 drugs. In cases in  which an MRL was exceeded, FSIS considered the imported catfish to be  adulterated and subject to refusal. For drugs approved by FDA for use in  catfish, FSIS’s MRLs are based on FDA’s tolerances for these drugs. For  unapproved drugs, FSIS’s MRLs are based on levels determined by the  agency.

According to FSIS re-inspection data, from May 1, 2016, through July 9,  2017, the agency collected and tested 382 samples from 195 shipments  of imported catfish for unsafe drug residues. Those shipments totaling  over 4.4 million pounds came from 57 processors. FSIS found unsafe  drug residues in 20 of the shipments and refused their entry into the  United States. Together, these 20 shipments included about 422,000  pounds of catfish and came primarily from processors either in China or  Vietnam. The drugs involved included dyes used as anti-fungal agents  and antibiotics that are not approved for use in catfish in the United  States.

section_title: Through Its Equivalence Determination Process, FSIS Relies on Other Countries to Ensure the Safety of the Food They Export to the United States
paragraphs: As discussed, under FSIS’s December 2015 final rule for its catfish  inspection program, a country wanting to continue exporting catfish to  the United States after September 1, 2017, is to submit specified  documentation and information to FSIS by that date. According to an  FSIS document, the agency will use a country’s documentation and  information to begin assessing whether the country’s sanitary measures  for catfish provide an equivalent level of public health protection as found  in the United States. According to FSIS documents, a country is expected  to provide information about its food safety laws and regulations;  inspection procedures, including manuals and directives; enforcement  and compliance programs and policies; and inspection training  programs. According to FSIS documents, the equivalence determination  process may take several years to complete. During that time, FSIS  may ask the country for additional information, as needed, and FSIS  officials are to conduct an on-site (in-country) audit, and in many cases  more than one to verify the information provided by the country. FSIS  conducts an on-site audit at least once during an initial equivalence  determination and again periodically during subsequent verification  audits. According to agency officials, FSIS will conduct periodic on-site  audits in countries with equivalence determinations to verify that their  food safety systems remain equivalent. FSIS uses a data analysis tool,  known as the Country Performance Algorithm, to prioritize the countries  subject to these audits. The agency also publishes the related audit  reports on its website. In the course of an on-site audit, FSIS officials  generally visit government offices, commercial food processing facilities,  and food testing laboratories in the country.

In essence, FSIS intends to use the same equivalence determination  process for imported catfish that it currently uses for imported meat,  poultry, and processed egg products, according to agency officials. As  part of the equivalence determination, FSIS also requires a foreign  country to develop a residue monitoring plan that includes testing for drug  residues. According to FSIS documents, these plans must include, in  part, random sampling of food products at slaughter and the use of  approved sampling and testing analytical methods. We also discussed, in  part, FSIS’s equivalence determination process in an April 2017 report.

In October 2016, FSIS finalized its Self-Reporting Tool (SRT), a  standardized questionnaire that the agency provides to countries that  request an equivalence determination for catfish. The SRT describes the  types of documentation and information that the country must provide to  FSIS for the agency to initiate the equivalence determination process. In  general, this documentation and information relates to the country’s food  safety system and regulatory infrastructure. For example, the SRT asks  for documentation and information on the following six equivalence  components of a country’s food safety system  statutory authority for food safety and other consumer protection  regulations,  chemical residue testing programs, and microbiological testing programs.

According to FSIS officials, as of May 2017, 10 countries had requested  an equivalence determination and FSIS provided them with the SRT.  These countries were Bangladesh, China, the Dominican Republic, El  Salvador, Guyana, Jamaica, India, Nigeria, Thailand, and Vietnam.  Furthermore, as of June 2017, Guyana and Thailand had provided  sufficient information for FSIS to begin the equivalence determination  process.

According to FSIS documents, once it has completed its review and  analysis of a country’s documentation and information, including the  results of its own on-site audits, if deemed satisfactory, FSIS is to then  publish a proposed rule in the Federal Register indicating its intention to  add the country to FSIS’s list of countries eligible to export a particular  food commodity to the United States. After receiving and reviewing any  public comments on the proposed rule, FSIS will make a final equivalence  determination decision and, as appropriate, publish a final rule in the  Federal Register regarding the country’s eligibility to export the  commodity to the United States. As discussed, the equivalence  determination process can take several years from the time a country  completes and submits the SRT until FSIS makes its final determination.  According to agency officials and FSIS documentation, FSIS will allow a  country that submitted an SRT to continue exporting catfish to the United  States pending completion of its equivalence determination as long as  that country continues to respond to FSIS’s requests for additional  information within the timeframe indicated.

According to FSIS officials and documents, after an equivalence  determination is completed, the country reviewed is authorized to export  the related food product to the United States. Thereafter, on an annual  basis, FSIS expects the country’s government to review and update its  SRT responses, as appropriate, and notify FSIS of any changes to the  country’s food safety system. SRT revisions may be necessary because  of country-initiated changes, or revisions may be needed because of new  policies adopted by the United States. FSIS will also require the country  to submit, on an annual basis, specific documents, including an updated  list of all certified food processing facilities eligible to export to the United  States, and an updated description of the country’s residue monitoring  plan, including the previous year’s test results and any actions taken in  response to unsafe drug residue test results.

According to FSIS officials, after the transition period, all shipments of  imported catfish from countries that the agency has determined to have  an equivalent food safety system will have to be presented to FSIS  inspectors for reinspection. In addition, a subset of reinspected shipments  will be sampled. According to FSIS officials, after the 18-month transition  period, the agency will update the sampling program based on sampling  results and findings from the transition period. Furthermore, according to  agency officials and FSIS documents, shipments of imported catfish may  be subject to the same three levels of sampling used for imported meat  and poultry: (1) normal sampling, which is based on random sampling; (2)  increased sampling, which is above-normal sampling resulting from an  agency management decision; and (3) intensified sampling, which is  additional sampling undertaken when a previous sample failed to meet  U.S. requirements, such as drug residues that are above the  corresponding MRL. According to FSIS officials and documents, after  equivalence determinations have been done, the intent of the  reinspection process is to verify the effectiveness of the foreign country’s  food safety system, not to evaluate the performance of individual catfish  processing facilities or as the primary effort/point to identify unsafe drug  residues in imported catfish.

section_title: FSIS Could Strengthen Its Efforts to Ensure the Safety of Imported of Catfish
paragraphs: As discussed, during FSIS’s on-site audits, which the agency conducts at  least once to verify the accuracy of the documentation and information a  foreign country seeking an equivalence determination has provided in an  SRT, FSIS generally visits government offices, commercial food  processing facilities, and food testing laboratories in the foreign country.  However, FSIS has not made farm visits—where catfish exported to the  United States are grown and where drugs are potentially first introduced  into catfish—a routine part of initial equivalence determination and  verification on-site audits. In addition, although FSIS will require foreign  countries to develop and implement residue monitoring plans, the agency  will not require these countries to test for drugs of concern to FSIS. In  contrast, the EU requires countries to test for drugs of concern to the EU.

The 2014 Farm Bill directs USDA to consider the conditions under which  catfish are raised and transported to the processing establishment for  examination and inspection. According to agency officials, this directive  allows FSIS to visit catfish farms in exporting countries as part of its on- site audits related to an initial equivalence determination or a subsequent  verification audit. However, these officials said FSIS has not made farm  visits a routine part of initial equivalence determination and verification  on-site audits, because the agency has not yet decided whether to make  visits to fish farms routine like visits to foreign laboratories or processing  facilities.

It is at the fish farms where drugs are first introduced and used. Other  seafood regulators conduct such visits to fish farms, including FDA and  the EU. For example, according to FDA’s procedures for conducting  country assessments, visiting fish farms is a critical element in evaluating  a country’s seafood safety oversight program because farms are where  the potential hazard of unsafe drug residues originates. At such farms,  FDA officials said they review (1) preventive controls to guard against  unapproved drug use; (2) water quality or other factors that may lead  farmers to use drugs; (3) drug use records, including drug withdrawal  times (4) information on countries’ fish farm oversight programs (e.g.,  registration, inspection, and sampling); (5) data that can be compared to  seafood processor records to determine the accuracy and reliability of  these records; and (6) biosecurity measures meant to prevent the spread  of disease and keep fish healthy. According to FDA documents, FDA  officials visit farms that supply the products to the seafood processing  facilities scheduled to be visited by FDA during the assessment. This is  done to verify the controls stated in the processors’ seafood HACCP  plans. Further, by visiting fish farms, FDA gathers useful information  about any foreign government oversight of the farms, as well as the drugs  that are actually being used on the farms in that country, according to  agency documents. For example, as part of FDA’s country assessment  for Ecuador, FDA staff visiting two fish farms in that country discovered  that the farms were using an antibiotic on shrimp that FDA had not  approved for that product.

The EU also visits fish farms in foreign countries during its initial  equivalence determinations and periodic verification audits. According to  EU officials, by visiting these farms and other locations in a country, the  EU audit team occasionally learns of drugs being used by farms that are  not included in the country’s residue monitoring plan. For example, during  the EU’s 2012 verification audit of Ecuador, EU inspectors visited fish  farms and found them using a hormone that the Ecuadorian government  could not verify it had approved for use in aquaculture. In addition, the  information on the drug label did not indicate that it was authorized for  use in Ecuador. Furthermore, one of the farms visited had barrels of an  antibiotic that did not bear numbers or labels, indicating that the antibiotic  was authorized for use in Ecuador.

It is not clear how FSIS could consider the conditions under which  imported catfish are raised, as directed by the 2014 Farm Bill, without  visiting foreign catfish farms. In addition, the agency will already have its inspectors in the foreign country for an on-site audit. Without visiting at  least a sample of farms whose catfish are exported to the United States,  FSIS may be missing an opportunity to fully understand the conditions  under which the catfish are being raised. For example, FSIS could  choose to visit farms that supply catfish to seafood processing facilities  that the agency plans to visit during its on-site audits, like FDA does.

FSIS also does not plan to require countries exporting catfish to the  United States to test for drugs of concern to FSIS as part of a country’s  drug residue monitoring plan, according to agency officials. Instead, as  part of an equivalence determination, FSIS will require a country to have  a national residue monitoring plan. Further, the officials said that FSIS will  expect this plan to include such information as the (1) chemicals,  including drugs, that will be tested for; (2) proposed number of samples to  be taken; (3) testing methods to be used for screening and confirming the  presence of chemicals, including drugs; (4) MRLs to be used; (5)  chemicals, including drugs, newly approved or banned in the past year;  and (6) corrective actions to be taken when a residue violation is found.  However, while agency officials said that FSIS expects another country to  provide an overall level of sanitary protection similar to that in the United  States, the country has flexibility regarding its regulatory practices,  including the specific drugs included in its national residue monitoring  plan.

Even if a country allows its catfish farmers to use drugs not approved for  use in the United States, that country’s catfish exports must still comply  with FSIS’s requirements (i.e., MRLs) for allowable drug residues. As  noted by agency officials, FSIS expects imported catfish to be subject to  the same level of scrutiny as domestic catfish. However, while FSIS will  test domestic catfish for at least 61 drugs using its MRM and other  methods, it is not clear how many drugs or which drugs other countries  will test for in catfish exported to the United States because FSIS will not  have such specific requirements for a foreign country’s residue monitoring  plan after the transition period. Further, FSIS will assess the safety of  drug residues found in domestic catfish against MRLs determined by the  agency, although other countries may use their own MRLs in their drug  residue monitoring plans. For example, Vietnam, the largest exporter of  catfish to the United States, developed its drug residue monitoring plan  and MRLs to meet the EU’s requirements. In comparing FSIS’s MRLs to  Vietnam’s levels for 14 drugs that could be used in catfish, we found 9  drugs for which Vietnam had higher MRLs than FSIS’s. For one antibiotic,  the residue level that Vietnam considers a violation is 30 times greater  than FSIS’s level.

The first time imported catfish may be subject to drug residue testing  similar to the testing done of domestic catfish, including the same 61  drugs and associated MRLs, is likely to be when, and if, the imported  catfish is selected for sampling by FSIS in U.S. ports of entry. As a result,  even after equivalence determinations are completed, FSIS’s sampling  and testing of imported catfish shipments will become the primary  mechanism for identifying the potential presence of unsafe residues of  drugs of concern to FSIS. According to FSIS officials, as of July 2017, the  agency has not yet documented the size of the samples that it will test for  during fiscal year 2018.

In contrast, the EU requires countries exporting seafood to the EU to  include drugs of concern to the EU in their residue monitoring plans.  Although FSIS officials said that the agency expects imported catfish to  be subject to the same level of scrutiny as domestic catfish and that  reinspection is to verify the effectiveness of the exporting country’s food  safety system, the agency is not requiring that the foreign countries test  for the drugs of concern to FSIS and the corresponding MRLs, which  would qualify as the initial foreign country inspection. By having countries  exporting catfish to the United States include in their national residue  monitoring plans the drugs of concern to FSIS and the corresponding  MRLs, as a precondition for an equivalence determination, FSIS would  have better assurance that U.S. food safety requirements were being met  and that U.S. consumers were being protected.

section_title: FDA and FSIS Took Key Steps to Coordinate the Transfer of Catfish Oversight, but They Have Not Fully Coordinated on Drug Residue Testing Methods
paragraphs: FDA and FSIS took steps to accomplish the transfer of catfish oversight  from FDA to FSIS, as called for in the 2014 memorandum of  understanding (MOU) that both agencies signed. However, they generally  have not coordinated on drug residue testing methods, resulting, in some  cases, in differences in MRLs—specifically for unapproved drugs. FDA  and FSIS agreed in their 1984 MOU to exchange information on their  drug testing methods and ensure the comparability of their results.
subsections: section_title: FDA and FSIS Took a Number of Steps to Coordinate the Transfer of Catfish Oversight
paragraphs: In April 2014, FDA and FSIS entered into an MOU to improve interagency  cooperation on food safety and fraud prevention and maximize the  effectiveness of personnel and resources related to examination and  inspection, and to plan for an orderly transition of catfish safety oversight  from FDA to FSIS. The 2014 Farm Bill, which required the agencies to  develop this MOU, directed that the MOU should build upon any prior  agreements between the agencies to improve interagency cooperation.  Pursuant to this MOU, FDA and FSIS took a number of steps to  coordinate the transfer, including the following:

According to FDA officials, in January 2015, FDA established an  internal FDA work group that compiled a list of questions and answers  for FDA and FSIS management officials on topics related to the  transfer.

According to FSIS officials, FDA and FSIS established a transition  work group comprising of FDA and FSIS management officials and  subject matter experts. According to FSIS officials, members of this  workgroup met periodically to discuss issues pertaining to the  transition of jurisdiction and regulatory oversight of catfish from FDA  to FSIS. According to FDA officials, the first transition group  conference call was held on May 19, 2015.

According to FSIS officials, from May 2015 through June 2016, FDA  and FSIS held three teleconferences to coordinate activities related to  the transfer. Specifically, agency officials discussed inspection  methodologies, sampling, and laboratory testing; FDA’s previous  strategy for regulatory oversight of imported catfish, including relevant  FDA import alerts; and sharing of FDA’s knowledge of fish farms and  processing facilities in the United States that handle catfish.

According to FSIS officials, before publishing the final rule for its  catfish oversight program in December 2015, FSIS provided a draft of  this rule to FDA for its review and comment.

FDA and FSIS agreed—as FSIS assumed responsibility for domestic  catfish oversight on March 1, 2016, and imported catfish oversight on  April 15, 2016—that there would be no duplication of the inspection  and testing of catfish between the two agencies. Further, FDA agreed  not to inspect domestic or foreign catfish processing facilities or test  catfish products unless FSIS requested such inspections.

Further, after the agencies took these steps and the transfer was  completed, in discussions with FDA and FSIS officials in January 2017,  we mentioned that FDA appeared to have information that might be  useful to FSIS in carrying out its catfish oversight program that FDA had  not shared with FSIS. We suggested that FDA share with FSIS its past  (1) drug residue testing data for catfish, (2) catfish processor inspection  reports, and (3) foreign country assessments for catfish-exporting  countries. For example, we suggested that information in FDA’s foreign  country assessments might be useful to FSIS in doing equivalence  determinations for some of the same countries. After these meetings,  FSIS requested, and FDA provided, this additional information.

section_title: FDA and FSIS Have Not Fully Coordinated on Drug Residue Testing Methods
paragraphs: Although FDA and FSIS took steps to implement the 2014 MOU and  ensure the smooth transfer of catfish oversight responsibility from FDA to  FSIS, the agencies have not fully coordinated on drug residue testing  methods. For example, the agencies generally did not coordinate in  developing drug residue testing methods and the corresponding MRLs— specifically, for unapproved drugs—that define unsafe drug residues in  imported seafood, including catfish. As a result, the agencies are not  leveraging each other’s knowledge and resources to develop drug  residue testing methods.

As discussed, FDA and FSIS staff held three teleconferences from May  2015 through June 2016 to discuss the transfer of catfish oversight to  FSIS. According to agency officials, the sampling and testing of catfish for  drug residues was among the topics discussed, including the drug testing  methods being used by each agency. Nevertheless, during the course of  our work, we found examples where FDA and FSIS officials, including  program directors and laboratory officials, said that they were unaware of  the other agency’s development and use of more efficient methods to  detect drug residues in seafood, including catfish. These examples  include the following:

FDA officials first learned from us in May 2016 about an MRM used by  FSIS that could identify a significantly greater number of drug  residues present in food, including catfish, than the MRM being used  by FDA for other seafood. Specifically, at that time, FSIS’s MRM could  identify 61 drug residues, and FDA’s MRM could identify 26 residues.

FDA had not informed FSIS that it was developing a new MRM for  testing shrimp, although according to agency officials FDA also  expected to adapt the MRM for use in other seafood, including finfish  such as catfish. FSIS officials said that they became aware of FDA’s  work on this new MRM after hearing FDA officials discuss it at a  public workshop (the North American Chemical Residue Workshop) in  July 2016.

At the time of our work, FDA was developing two new MRMs that  would test for, among other drugs, the antibiotics flumequine,  naladixic acid, and oxolinic acid—drugs that do not have FDA  approval for use in aquaculture. Pending development of these  MRMs, FDA had been using other methods—such as the MRM that  tests for 26 drugs—to test for these drugs, including in catfish when  FDA had this responsibility. According to FDA officials, the agency  tested for these drugs because they were of high enforcement priority  based on human food safety concerns and on the extent of use in the  aquaculture industry. However, FSIS officials told us in May 2016 that  FDA had not informed them of its efforts to develop these two new  MRMs, and FSIS did not have its own method to test for these drugs,  meaning imported catfish had not been tested for these antibiotics  since FSIS assumed responsibility for their safety in April 2016.

As these examples illustrate, neither FDA nor FSIS was aware of MRMs  or other testing methods that the other agency was using or developing  that might have been helpful for carrying out its oversight program. As we  have previously reported, when responsibilities cut across more than one  federal agency—as they do for the safety of imported seafood—it is  important for agencies to work collaboratively. Taking into account the  nation’s long-range fiscal challenges, we noted that the federal  government must identify ways to deliver results more efficiently and in a  way that is consistent with its multiple demands and limited resources.  We also identified key practices that can help enhance and sustain  federal agencies’ collaboration, including identifying and addressing  needs by leveraging resources across agencies to support the common  outcome. Moreover, in 1984, FDA, FSIS, and the Environmental  Protection Agency entered into an MOU committing the agencies, in part,  to coordinate their regulatory activities concerning the presence of drug  and other residues in food. More specifically, under this MOU, the  agencies agreed to exchange information related to analytical methods  for identifying and quantifying residues of drugs, pesticides, and  environmental contaminants in food, and to cooperate in developing and  implementing analytical and statistical methodologies to ensure  comparability of results in the examination of food. Thus, by not  coordinating on testing methods, FDA and FSIS have not fully met the  terms outlined in the 1984 MOU.

Lack of coordination in developing drug residue testing methods has  resulted, in some cases, in differences in MRLs for unapproved drugs.  These are the levels or thresholds at which the agencies will take  regulatory action. In some cases, particularly for an unapproved drug, the  MRL may correspond to the limits of detection associated with an  agency’s particular testing method. In the course of our work, we noted a  number of cases where the agencies were using different MRLs for the  same unapproved drug. For example, for one antibiotic, the MRL that  FSIS considers unsafe is 20 times higher than FDA’s level, yet FDA  considers anything above its MRL to be a human health concern. In  essence, this means that FSIS does not consider catfish with residue  levels greater than FDA’s MRL, but less than FSIS’s MRL, to be  adulterated. However, when FDA had oversight of catfish, the same level  would have rendered the product adulterated. We discussed this and  other cases with FSIS officials, and they said that FSIS uses FDA’s  tolerances for drugs that FDA has approved. However, FSIS developed  its own MRLs for unapproved drugs, as according to FSIS officials, the  agency has the discretion to do so using its own testing methods.

According to FSIS officials, the agency was not aware of FDA’s MRLs for  unapproved drugs. FSIS officials acknowledged that the agency had not  requested information from FDA on its MRLs for unapproved drugs used  on finfish, including catfish. For their part, FDA officials said that they do  not make public their MRLs for unapproved drugs out of concern that  some fish farmers may use these drugs if they believe they can do so in a  way that results in residues below FDA’s MRLs. Under federal standards  for internal control, management should communicate information  externally through reporting lines so that external parties can help achieve  its objectives. Without coordinating and communicating on their  development of drug residue testing methods and corresponding MRLs  for imported seafood, including catfish, the agencies do not have  reasonable assurance that they are taking a consistent approach to  protecting consumer safety from unsafe drug residues.

section_title: Conclusions
paragraphs: FDA and FSIS face difficult challenges in ensuring the safety of the U.S.  food supply, particularly as that food supply increasingly includes  imported foods such as seafood. Because much of imported seafood is  raised in confined conditions on farms, drugs are used to prevent or treat  disease and increase survival rates. According to FDA, residues of some  drugs can cause cancer or allergic reactions when consumed by humans.  In addition, some drugs administered to food-producing animals may  cause bacteria of human health concern to become resistant to antibiotics  used in humans. It is therefore important that federal oversight is effective  in ensuring that seafood is free of unsafe drug residues  As required in FSMA, FDA developed a plan in 2013 to expand the  capacity of foreign governments and their respective food industries in  countries that export foods to the United States. The plan was to include  recommendations for formal agreements with other countries that would  include provisions to place greater responsibility on these countries for  the safety of their seafood exports. However, while FDA has used such  agreements for addressing pathogen hazards in molluscan shellfish, it  has not done so with respect to drug residues in seafood and has no  plans to do so. Without pursuing formal agreements with countries  exporting seafood to the United States that commit these countries to test  for drugs of concern to FDA and the corresponding MRLs that the agency  established for these drugs, FDA will not have reasonable assurance that  imported seafood does not contain unsafe drug residues.

FSIS has not decided whether to include, as part of an initial equivalence  determination or subsequent verification audits, visits to any foreign  catfish farms as part of its on-site audit in another country. However, the  2014 Farm Bill directs FSIS to consider, in part, the conditions under  which catfish are raised, and catfish farms are the place where drugs are  introduced. Without visiting at least a sample of farms whose catfish are  exported to the United States, such as the farms that supply catfish to the  seafood processing facilities that FSIS plans to visit during its on-site  audits, FSIS may be missing an opportunity to fully understand the  conditions under which the catfish are being raised. In addition, FSIS  does not plan to require countries exporting catfish to the United States to  test for drugs of concern to FSIS as part of their drug residue monitoring  plans. By having countries exporting catfish to the United States include  in their national residue monitoring plans the drugs of concern to FSIS  and the corresponding MRLs, as a precondition for equivalence  determinations, FSIS would have better assurance that U.S. food safety  requirements were being met and that U.S. consumers were being  protected.

Finally, FDA and FSIS are independently developing drug testing  methods and MRLs for use in seafood, and lack of coordination and  communication in developing drug residue testing methods has resulted,  in some cases, in differences in MRLs—specifically, for unapproved  drugs. Without coordinating and communicating on their development of  drug residue testing methods and corresponding MRLs for imported  seafood, including catfish, the agencies do not have reasonable  assurance that they are taking a consistent approach to ensuring  consumer safety from unsafe drug residues.

section_title: Recommendations for Executive Action
paragraphs: We are making a total of five recommendations, including two to FDA and  three to FSIS:  The Commissioner of FDA should pursue formal agreements with  countries exporting seafood to the United States that commit these  countries to test for drugs of concern to FDA and the corresponding  MRLs that FDA established for these drugs. (Recommendation 1)

The Administrator of FSIS should ensure that agency staff doing an on- site audit in another country for an equivalence determination visit at least  a sample of farms whose catfish are exported to the United States to  determine the conditions under which the catfish are being raised,  including the drugs being used. (Recommendation 2)

The Administrator of FSIS should require as part of an equivalence  determination that countries exporting catfish to the United States include  in their residue monitoring plans the drugs of concern to FSIS and the  corresponding maximum residue levels. (Recommendation 3)

The Commissioner of FDA should coordinate and communicate with FSIS  in developing drug residue testing methods and corresponding maximum  residue levels for imported seafood that may also be applicable to  imported catfish. (Recommendation 4)

The Administrator of FSIS should coordinate and communicate with FDA  in developing drug residue testing methods and corresponding maximum  residue levels for imported catfish that may also be applicable to other  imported seafood. (Recommendation 5)

section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft of this report to USDA and the Departments of  Commerce, Health and Human Services, and Homeland Security for their  review and comment. In written comments, Health and Human Services’s  FDA agreed with one of the recommendations and partially agreed with  the other. FDA also provided technical comments, which we incorporated  as appropriate. In written comments, USDA’s FSIS partially agreed with  two of the recommendations and stated that its current policy already  addresses the third recommendation. Copies of Health and Human  Services’s and USDA’s comments are presented in appendixes III and IV,  respectively. In an email, the Department of Homeland Security’s GAO- Office of Inspector General Liaison Office stated that, because there were  no recommendations directed to the department, it would forego a formal  management response letter but provided one technical comment, which  we incorporated. Likewise in an e-mail, the Department of Commerce's  National Oceanic and Atmospheric Administration Audits Office stated  that the agency did not have any technical comments.

In its written comments, FDA agreed with our recommendation that it  should coordinate and communicate with FSIS in developing drug residue  testing methods and corresponding maximum residue levels for imported  seafood that may also be applicable to imported catfish. FDA stated that it  has a process in place to notify FSIS of new tolerances and changes in  tolerances for FSIS-regulated products and that it will extend this process  to notify FSIS of concentrations of specific unapproved drugs in catfish  over which FDA has public health concerns. In addition, FDA stated that it  has contacted FSIS about rejoining the quarterly meetings FDA holds on  aquaculture method prioritization and development.

FDA partially agreed with our recommendation that it should pursue  formal agreements with countries exporting seafood to the United States  that commit these countries to test for drugs of concern to FDA and the  corresponding MRLs that FDA established for these drugs. FDA stated  that, while it had not received any requests to establish this type of  arrangement, it concurs that the agency could explore pursuing such  arrangements. FDA also stated that factors outside its control that could  limit robust implementation of this recommendation include the country’s  ability and readiness to comply with the requirements necessary to have  a successful arrangement. FDA added that applicable test methods,  analytical capacity and adequate government oversight would be among  essential criteria. We recognize that there are external factors that could  affect FDA’s implementation of this recommendation, but we do not  believe such factors should prevent FDA from pursuing formal  agreements with other countries related to testing seafood for drugs of  concern and the related MRLs for these drugs, as these factors have not  hindered the EU and other countries that have successfully pursued such  agreements.

In its written comments, FSIS stated that the draft report contains a few  either misleading or inaccurate statements that it believes we use to  support our recommendations directed at USDA. For example, FSIS  points to our statement that "FSIS has not made farm visits a routine part  of initial equivalence determinations and verification on-site audits...."  According to FSIS, this statement is somewhat misleading, because FSIS  has not made any initial equivalence determinations for foreign catfish  fish inspection systems;  therefore, FSIS has not yet had the opportunity  to conduct on-site verification audits of foreign catfish inspection  programs for initial equivalence determinations. FSIS stated that it  partially agrees with the recommendation that FSIS visit at least a sample  of farms whose catfish are exported to the United States to determine the  conditions under which the fish are raised. We are aware that FSIS has  not yet conducted on-site audits, and we discuss in our report the timing  of those audits once the agency receives the required information and  documentation from foreign governments. However, we nonetheless  believe it is important that FSIS visit at least a sample of catfish farms as  a routine matter during its equivalence determination on-site audits,  instead of relying on a review of documentation describing a foreign  country’s fish farm oversight program. We believe that FSIS can best  understand the conditions under which catfish are raised and obtain  information about the drugs actually used on farms through in-person  visits to these farms, as FDA and the EU do as part of their seafood  oversight efforts. As noted in our report, FSIS will already have its  inspectors in the foreign country for on-site audits, so these individuals  could also visit the farms that supply catfish to the seafood processing  facilities that FSIS plans to visit during its on-site audits. FSIS could also  independently verify any foreign country information about its catfish farm  oversight program through visits to catfish farms.

FSIS stated that its current policy already addresses our recommendation  that it require, as part of an equivalence determination, that countries  exporting catfish to the United States include in their residue monitoring  plans the drugs of concern to FSIS and the corresponding maximum  residue levels. FSIS identifies as misleading or inaccurate our statement  that, “while FSIS will test domestic catfish for at least 61 drugs using its  multi-residue method and other methods, it is not clear how many drugs  or which drugs other countries will test for in catfish exported to the  United States.” According to FSIS, this statement is incorrect, as foreign  countries are required to provide drug testing information to the agency  as part of the Self-Reporting Tool (SRT), which is a requirement for an  initial or ongoing equivalence determination. In addition, FSIS stated that  it will also have access to information on a foreign country’s testing for  drug residues through the SRT and the country’s residue monitoring plan.  Further, after reviewing those plans, according to FSIS, the agency can  request changes to the plan for testing for drug residues. We disagree  that FSIS policy already addresses our recommendation. In our report,  we explain the type of information that foreign countries will provide in the  SRT as well as the information that foreign countries will be required to  include in their residue monitoring plan. However, a foreign country will  decide what drugs it will test for. FSIS could question the design of the  residue monitoring plan if it identified unsafe drug residues based on its  own testing. Nevertheless, FSIS does not plan to test all catfish imports  because its reinspection program is not designed to be the primary  means by which the agency identifies unsafe drug residues in imported  catfish. Rather than address potential testing gaps in a foreign country’s  residue monitoring program piecemeal, FSIS should require that foreign  countries test for all drugs of concern to FSIS at the outset of the  equivalence determination, thus ensuring that foreign countries are  demonstrating that their measures are as effective as FSIS’s in  addressing the safety of imported catfish.

FSIS partially agreed with our recommendation that FSIS should  coordinate and communicate with FDA in developing drug residue testing  methods and corresponding MRLs for imported catfish that may also be  applicable to other imported seafood. In its comments, FSIS noted that  while we found examples where FDA and FSIS officials, including  program directors and laboratory officials, were unaware of the other  agency's development and use of more efficient methods to detect drug  residues in seafood, including catfish, they believe that the  characterization of this finding is overstated. FSIS stated that while our  audit work may have found examples where officials were unaware of a  specific activity, the U.S. Agricultural Research Service, FSIS, and FDA  regularly share information related to analytical methods for identifying  and quantifying residues of drugs, pesticides, and environmental  contaminants.  Nevertheless, FSIS stated that it fully intends to implement  the provisions of the MOU with FDA on coordinating on testing methods  and that it also intends to enhance residue testing coordination through  other interagency mechanisms as well, such as the Surveillance Advisory  Team and the Interagency Residue Control Group.

As agreed with your office, unless you publicly announce the contents  earlier, we plan no further distribution of this report 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 Homeland Security; 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 members have any questions about this report, please  contact me at (202) 512-3841 or morriss@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff members who made contributions  to this report are listed in appendix V.

section_title: Appendix I: Objectives, Scope and Methodology
paragraphs: This report addresses how the Food and Drug Administration (FDA) and  U.S. Department of Agriculture’s (USDA) Food Safety and Inspection  Service (FSIS) ensure the safety of imported seafood from unsafe drug  residues. Specifically, this report examines (1) how FDA helps ensure the  safety of imported seafood from unsafe drug residues and ways the  agency could strengthen its efforts, (2) how FSIS helps ensure the safety  of imported catfish from unsafe drug residues and ways the agency could  strengthen its efforts, and (3) the extent to which FDA and FSIS  coordinate their oversight efforts. Unsafe drug residues may include  residues  from drugs unapproved for aquaculture use in the United States, of approved drugs that exceed allowed levels, or of drugs that are approved for use on one seafood species but are  being inappropriately used on another seafood species.

To review how FDA helps ensure the safety of imported seafood from  unsafe drug residues, we examined FDA regulations, including Hazard  Analysis and Critical Control Point (HACCP) regulations. We also  reviewed information on FDA’s primary oversight mechanism—HACCP  inspections of seafood importers and foreign country processing  facilities—and its seafood import sampling program, including information  on the major components and requirements of these mechanisms. We  reviewed relevant sections of FDA guidance manuals, including its  Compliance Program Guidance Manual, Regulatory Procedures Manual,  Office of Regulatory Affairs Laboratory Manual, and Fish and Fishery  Products Hazards and Controls Guidance - Fourth Edition. We also  reviewed plans and other documents detailing FDA’s drug residue  sampling program and procedures for its import alert and refusal  processes. We analyzed FDA mechanisms for protecting imported  seafood from violative drug residues. Specifically, we analyzed 74  randomly selected foreign facility (e.g., processing) inspection reports  from a total of 318 reports for fiscal years 2013 through 2015. We also  analyzed 9 non generalizable, randomly selected importer inspection  reports out of 232 total reports for fiscal year 2015.

To examine the ways FDA could strengthen its efforts to ensure the  safety of imported seafood from unsafe drug residues, we reviewed  FDA’s use of agreements with foreign countries that address FDA  requirements regarding drug residues in farmed seafood and their  importance, given limitations in other activities FDA undertakes to ensure  the safety of imported seafood. We reviewed legal and planning  documents regarding the use of agreements by FDA, including the FDA  Food Safety Modernization Act and FDA’s 2013 International Food Safety  Capacity-Building Plan. We reviewed a 2012 agreement with Mexico  intended to ensure that all molluscan shellfish exported to the United  States from Mexico are safe. In addition, we reviewed FDA’s foreign  country assessment criteria and reports for Ecuador (2013), India (2010),  Malaysia (2011), the Philippines (2015), and Vietnam (2012) and how any  FDA-identified deficiencies were resolved. FDA conducts foreign country  assessments to provide the agency with a broad view of a foreign  country’s industry and regulatory infrastructure capacity to control  aquaculture drugs. We also compared FDA activities to the activities FSIS  and the European Union (EU) undertake as part of their equivalence  determinations to determine if there are any elements of their activities  that if included in FDA activities, have the potential to enhance FDA’s  oversight process for imported seafood.

In addition, we analyzed FDA’s import refusal data and data on FDA’s  import drug residue test results for fiscal years 2010 to 2015. For FDA’s  import drug residue test data, we corrected the product codes for some  entries for which the code did not match the product description and two  analysts reviewed any changes made to FDA records to ensure that the  revised codes were correct. We also reviewed controls for the systems  that house these data and interviewed FDA officials regarding these  controls and determined that the data were sufficiently reliable for the  purposes of our reporting objectives. We analyzed the National Oceanic  and Atmospheric Administration’s (NOAA) seafood import volume data for  2010 through 2015 that it acquired from the Department of Commerce  and U.S. Customs and Border Protection (CBP) to enable us to identify  how many millions of pounds were imported for each type of seafood so  that we could compare this to FDA sampling data. We reviewed controls  related to the reliability of these data and determined that they were  sufficiently reliable for the purposes of our reporting objectives.  Specifically, we reviewed a document on the data quality assessment of  this information by the U.S. Census Bureau and compared the data to  import data generated by another federal agency—USDA’s Economic  Research Service.

The final year selected for FDA data (foreign processing facility and  importer inspection reports and import refusal data and data on FDA’s  import drug residue test results) and NOAA import volume data was the  most recent year for which complete data were available at the time of  our analysis.

To examine how FSIS helps ensure the safety of imported catfish from  unsafe drug residues, we reviewed information on how the agency was  implementing its catfish inspection program during the program’s  transition period from March 1, 2016, to September 1, 2017, and how it  planned to implement its equivalence determination process for catfish.  Specifically, for the transition period, we reviewed the 2015 final rule that  established the catfish inspection program; FSIS notice and other  information on the catfish inspection program requirements; sampling and  testing guidance during the transition period, including Hold and Test  Protocols; FSIS data on sampling and testing and the results; FSIS data  on catfish import sampling from May 1, 2016, through July 9, 2017; and  FSIS’s Chemistry Laboratory Guidebook, including the Screening and  Confirmation of Animal Drug Residues Method (CLG-MRM1.06). We also  reviewed the agency’s controls for the systems that house these data and  determined that the data were sufficiently reliable for the purposes of our  reporting objectives. For example, we interviewed FSIS officials regarding  supervisory approvals of test results input into their system and controls  included in their efforts to comply with international standards.

For FSIS’s plans for implementing its equivalence determination process  after the end of the transition period, we reviewed FSIS regulations,  guidance, and other documentation related to FSIS’s equivalence  determination process as currently used for meat, poultry, and processed  egg products. Specifically, we reviewed the steps FSIS takes to  determine equivalence, including the Self-Reporting Tool that the agency  provides to the foreign governments that ask for equivalence  determinations, which contains the general information required from the  foreign countries. We reviewed FSIS guidance on the agency’s periodic  audits of countries to verify continued equivalence and two reports  resulting from these audits that FSIS conducted of countries that have  already been determined to be equivalent for meat and poultry. We also  reviewed FSIS’s reinspection program for monitoring the effectiveness of  exporting countries’ inspection systems and overall food safety programs  through imported product examinations and residue testing. We reviewed  an example of how FSIS places responsibility on foreign governments to  take corrective actions when the agency finds that imported products are  adulterated because of contaminants such as violative drug residues.

To examine the ways, if any, FSIS could strengthen its efforts to ensure  the safety of imported catfish from unsafe drug residues, we reviewed  FSIS plans for its on-site equivalence determinations and verification  audits and compared these activities to the activities FDA and the EU  undertake as part of their foreign country assessments and equivalence  determinations, respectively, to determine if there are any elements of  their activities that if included in FSIS activities, have the potential to  enhance FSIS’s equivalence determinations and verification on-site  audits. We also reviewed FSIS’s proposed requirements for foreign  countries’ residue monitoring plans. Lastly, we reviewed the EU’s  requirements for foreign countries’ residue monitoring plans as well to  determine whether there were any specific EU requirements that could  enhance FSIS’s residue monitoring plan requirements. We reviewed the  EU’s equivalence determination process and, in particular, its seafood  import program to determine whether its practices for ensuring the safety  of seafood imports have the potential to enhance the U.S. agencies’  practices. We discussed the EU equivalence determination process and  verification audits with EU officials from the Food and Veterinary Office  (Grange, Ireland) to gain a better understanding of its programs and  oversight controls for seafood imports. We included the EU program in  the scope of our work because the EU is the largest importer of seafood  in the world.

To review the extent to which FDA and FSIS collaborate and coordinate  in imported seafood and catfish safety programs, we reviewed a 1984  memorandum of understanding (MOU) signed by FDA, FSIS, and the  Environmental Protection Agency that was developed to help promote  more effective, efficient, and coordinated federal regulatory activities  concerning drug residues. We reviewed the general activities of the  Interagency Residue Control Group and Surveillance Advisory Team,  which constitute the primary vehicles through which these agencies  coordinate their regulatory activities concerning the presence of drug  residues. We reviewed the April 2014 MOU between FDA and FSIS that  was developed, in part, to improve interagency cooperation on food  safety and fraud prevention with regard to the transfer of catfish  inspection from FDA to FSIS. We reviewed steps FDA and FSIS have  taken to collaborate on transferring responsibility for the oversight of  catfish. We reviewed general information on the multi-residue methods  (MRM) FDA is developing to test for drug residues in seafood and the  MRM FSIS developed for testing catfish for drug residues. We reviewed a  March 2010 USDA Office of Inspector General report on how the  Interagency Residue Control Group and Surveillance Advisory Team  were established and currently functioning. We compared their  coordination activities to key practices that can help enhance and sustain  federal agencies’ collaboration that we previously identified, particularly  the practice of identifying and addressing needs by leveraging resources  when responsibilities cut across more than one federal agency.

We met with FDA and FSIS officials to discuss information for all  objectives, including obtaining their views on the pros and cons of  opportunities to strengthen their programs regarding unsafe drug residues  in imported seafood. We reviewed past GAO reports relevant to this  topic.

We interviewed CBP officials in headquarters and at selected U.S. ports  of entry to gain a better understanding of the agencies’ programs. We  interviewed CBP officials at the Port of New York in Newark, New  Jersey—the largest port of entry for seafood products in the United  States—and toured CBP’s facilities to observe its examination of seafood.  We also interviewed FSIS officials at a reinspection facility in Newark and  observed the reinspection process. In addition, we visited and interviewed  CBP officials at the Port of Long Beach in Long Beach, California—the  second largest port of entry for seafood in the United States. Further, we  interviewed CBP officials at the Otay Mesa Land Crossing and Cargo  Facility in Otay Mesa, California, to learn about CBP’s activities related to  ensuring the safety of seafood imports and CBP’s interaction with FDA  and FSIS, and observed CBP’s review process for imported seafood. The  Otay Mesa crossing is in proximity to the Long Beach Port. We selected  the largest and second largest ports of entry for seafood into the United  States and selected a land port that is in close proximity to one of the  seaports. We also interviewed FDA officials at the agency’s Southwest  Import District’s Resident Post at Otay Mesa, California, and at the Los  Angeles District Office and Pacific Regional Laboratory in Irvine,  California, to discuss FDA’s testing of seafood imports for drug residues  with laboratory officials. In addition, we visited an FSIS import inspection  establishment in Vernon, California—close to the Long Beach port—to  learn about the measures FSIS uses to ensure that imported catfish do  not have unsafe drug residues. We also interviewed officials from the  National Marine Fisheries Service in the Department of Commerce to  gather information on their imported seafood inspection services  performed on a fee-for-service basis for private companies, including any  data on sampling of imported seafood for drug residues and associated  results.

For informational purposes, we spoke with representatives from one large  and one medium-sized catfish farm, Tackett Fish Farms and Pentecost  Brothers, respectively; one large catfish processor, Heartland Catfish  Company; a large feed mill that produces medicated feed, Fishbelt Feed,  Inc.; and the National Warmwater Aquaculture Center at the Mississippi  State University Extension Service. To gain stakeholders’ perspectives on  FDA’s and FSIS’s efforts to address the safety of seafood imports, we  also spoke with representatives from the National Fisheries Institute.  According to its website, the institute focuses on education about seafood  safety and other issues, and includes more than 200 member companies  including seafood processors, importers, and exporters. We also spoke  with a representative of the Consumer Federation of America. According  to its website, the Consumer Federation of America is an association of  non-profit consumer organizations that was established to advance the  consumer interest through research, advocacy, and education. Today,  nearly 300 groups participate in the federation and govern it through  representatives on the organization’s Board of Directors.

We conducted this performance audit from January 2016 to September  2017 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’s Drug Residue Testing for Imported Seafood
paragraphs: Table 1 shows the number of seafood samples that the Food and Drug  Administration tested for drugs and the number and percentage of those  samples that contained unsafe drug residues, as well as the volume of  seafood imported, for fiscal years 2010 through 2015.

section_title: Appendix III: Comments from the Department of Health and Human Services

section_title: Appendix IV: Comments from the U.S. Department of Agriculture

section_title: Appendix V: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact

section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Anne Johnson (Assistant  Director), James R. Jones, Jr. (Assistant Director), David Moreno  (Analyst-in-Charge), Beverly Peterson, and Zachary Sivo made key  contributions to this report. Important contributions were also made by  Kevin Bray, John Delicath, Michele Fejfar, Ying Long, Danny Royer, and  Kiki Theodoropoulos.

section_title: Related GAO Products
paragraphs: Seafood Safety: Status of Issues Related to Catfish Inspection.  GAO-17-289T. Washington, D.C.: December 7, 2016.

Imported Food Safety: FDA’s Targeting Tool Has Enhanced Screening,  but Further Improvements Are Possible. GAO-16-399. Washington D.C.:  May 26, 2016.  2015 Annual Report: Additional Opportunities to Reduce Fragmentation,  Overlap, and Duplication and Achieve Other Financial Benefits.  GAO-15-404SP. Washington D.C.: April 14, 2015.

Food Safety: Additional Actions Needed to Help FDA’s Foreign Offices  Ensure Safety of Imported Food. GAO-15-183. Washington D.C.: January  30, 2015.

Food Safety: FDA Can Better Oversee Food Imports by Assessing and  Leveraging Other Countries’ Oversight Resources. GAO-12-933.  Washington D.C.: September 28, 2012.

Seafood Safety: Responsibility for Inspecting Catfish Should Not Be  Assigned to USDA. GAO-12-411. Washington D.C.: May 10, 2012.

Food Safety: FDA Needs to Reassess Its Approach to Reducing an  Illness Caused by Eating Raw Oysters. GAO-11-607. Washington D.C.:  September 8, 2011.

Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood  and Better Leverage Limited Resources. GAO-11-286. Washington D.C.:  April 14, 2011.

Seafood Fraud: FDA Program Changes and Better Collaboration among  Key Federal Agencies Could Improve Detection and Prevention.  GAO-09-258. Washington D.C.: February 19, 2009.

Results-Oriented Government: Practices That Can Help Enhance and  Sustain Collaboration among Federal Agencies. GAO-06-15. Washington  D.C.: October 21, 2005).

Food Safety: FDA’s Imported Seafood Safety Program Shows Some  Progress, but Further Improvements Are Needed. GAO-04-246.  Washington D.C.: January 30, 2004.

Food Safety: Federal Oversight of Shellfish Safety Needs Improvement.  GAO-01-702. Washington D.C.: July 9, 2001.

Food Safety: Federal Oversight of Seafood Does Not Sufficiently Protect  Consumers. GAO-01-204. Washington D.C.: January 31, 2001.

Fast facts: Ninety percent of the seafood eaten in the United States is imported, and about half of that is raised on fish farms. Farmers may treat fish with antibiotics and other drugs because these fish can be susceptible to infections. Misuse of drugs can leave residues in seafood that cause health problems for consumers.

We looked at how the two agencies charged with ensuring seafood safety protect against unsafe drug residues, and made five recommendations to strengthen their efforts. For example, agencies could require foreign governments to do more testing for these drug residues.

Question-summary annotations: questions: question: How does the FDA identify potential hazards in imported seafood?
answer: To help ensure the safety of imported seafood from unsafe drug residues, the Food and Drug Administration (FDA) generally depends on the actions of foreign processors and U.S. importers. FDA requires processors and importers to follow its Hazard Analysis and Critical Control Point (HACCP) regulations to identify hazards and the critical control points where the hazards, such as pathogen contamination, are likely to occur and take corrective action.

question: How does the FDA enforce HACCP compliance?
answer: FDA also performs a limited number of (1) inspections of processors and importers each year to ensure HACCP compliance, and (2) tests of imported seafood for contaminants, including unsafe drug residues.

question: How will FDA improve its efforts to ensure the safety of imported seafood?
answer: FDA could strengthen its efforts to ensure the safety of imported seafood from unsafe drug residues by pursuing agreements with other countries requiring that they test seafood exported to the United States for unsafe drug residues. Under an agency plan, FDA is to coordinate with other countries to increase their capabilities related to the safety of food exported to the United States and better leverage their resources.
child_questions: question: How does FDA choose which countries with which to partner?
answer: According to FDA officials, it might be worthwhile for the agency to pursue agreements with some countries, but FDA would have to carefully consider a number of factors in determining which countries would be appropriate, which it has not yet done.

question: How has FDA used country agreements in the past?
answer: FDA has used country agreements with respect to pathogen hazards in molluscan shellfish intended for export to the United States.

questions: question: Why did FDA transfer catfish oversight to FSIS?
answer: FDA and FSIS took steps to accomplish the transfer of catfish oversight from FDA to FSIS, as called for in the 2014 memorandum of understanding (MOU) that both agencies signed.
child_questions: question: What was lacking from this agreement?
answer: However, they generally have not coordinated on drug residue testing methods, resulting, in some cases, in differences in drug residue levels used to determine if seafood is unsafe—specifically for unapproved drugs—as called for in the 1984 MOU.
child_questions: question: What effect does the FDA and FSIS's lack of coordination have on consumers?
answer: Without this coordination, the agencies do not have reasonable assurance that they are consistently protecting consumers from unsafe drug residues.

questions: question: How is most seafood consumed in the US raised?
answer: Most seafood consumed in the United States is imported, and about half of it is raised on fish farms.

question: Why do farmers use drugs on farmed seafood?
answer: Because farmed seafood is raised in confined areas and susceptible to infections, farmers may use drugs like antibiotics.
child_questions: question: What is the effect on consumers of drugs used on seafood?
answer: The use of unapproved drugs or the misuse of approved drugs may result in unsafe residues in seafood that can cause cancer or allergic reactions, according to FDA, which is charged with ensuring the safety of most seafood.

questions: question: What recommendations did GAO make to FDA and FSIS?
answer: GAO is making five recommendations, including that FDA pursue agreements with other countries to test seafood exported to the United States and that FSIS visit a sample of fish farms as part of foreign country on-site audits; and that FDA and FSIS coordinate in developing testing methods and corresponding residue levels for imported seafood.
child_questions: question: What were FDA and FSIS's reactions to GAO's recommendations?
answer: FDA agreed with or partially agreed with two; FSIS partially agreed with two and stated it already addresses a third.
child_questions: question: How did GAO then respond?
answer: GAO disagrees and believes the recommendations should be implemented.