Importing Seafoods

Hazard Analysis and Critical Control Points

Hazard Analysis and Critical Control Points (HACCP) regulations for seafood describe a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement, and handling to manufacturing, distribution, and consumption of the finished product. The FDA's multifaceted and risk-informed seafood safety program depends on various measures of compliance with these regulations.
These precautions for imported seafood include:

  • inspections of foreign processing facilities,
  • sampling of seafood offered for import into the United States,
  • domestic surveillance sampling of imported products,
  • inspections of seafood importers,
  • evaluations of filers of seafood products,
  • foreign country program assessments, and
  • relevant information from our foreign partners and FDA overseas offices.
Importing Seafoods

Foreign Inspections and Global Presence:

In recent years, the FDA has increased the number of foreign site inspections and is working globally to better accomplish its domestic mission of promoting and protecting the food supply public health of the United States. FDA has strengthened and better coordinated its international engagements by establishing permanent FDA posts abroad in strategic locations. The posting of FDA staff in certain overseas regions is a key part of the agency's strategy for expanding oversight of imported food.


Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT), a new import screening system being implemented by the FDA, will enhance the current electronic screening system by focusing on higher risk products for examination and sampling and reducing the delays of shipments of lower risk products. The agency's capacity to identify trends and look into patterns will be enhanced through PREDICT. As a result, FDA will be able to deploy its import resources more effectively and change the import sampling thresholds for seafood items over time as necessary.

Foreign country assessments:

Foreign country assessments are system reviews that give the FDA a comprehensive understanding of how well the nation's industry and regulatory framework can manage pharmaceuticals used in aquaculture. Through these evaluations, the FDA can get to know the restrictions that each nation's competent authority has put in place for the sale, accessibility, and usage of animal medications. The FDA employs country assessments to review each nation's regulations and methods for preventing the presence of animal medication residues in the aquaculture products it exports to the US. The FDA may work directly with nations to address drug residue issues thanks to the country assessment program, which also helps FDA direct its overseas inspection and border surveillance resources more effectively and efficiently. Data from country evaluations are used by the FDA to:

  • improve the targeting (increase or decrease) of surveillance sampling of imported aquaculture products;
  • inform its decisions on what new analytical methods it needs to develop and what drugs or chemicals it should target for surveillance sampling;
  • inform its planning of foreign seafood HACCP inspections;
  • provide additional evidence for potential regulatory actions, such as an import alert;
  • improve collaboration with foreign government and industry contacts to achieve better compliance with FDA’s regulatory requirements; and
  • better understand the causes for significant changes in a country’s drug residue problems, such as a sudden spike in noncompliant samples.

Result of Country Assessments:

An important factor in the decision to issue the country-wide import alert for specified aquaculture goods from China in 2007 was the assessment trip to China in 2006. The national assessments for China in 2006, Chile in 2008, and India in 2010 were taken into consideration, and as a result, the compliance program's sampling and testing were enhanced, and these nations' aquaculture goods were given particular assignments (e.g., eel from China, salmon from Chile, and shrimp from India).

The Food Safety Modernization Act of 2011:

The Food and Drug Administration has lately broadened the FDA's statutory authority, which it uses to carry out its regulation of seafood safety. Act Modernizing Food Safety (FSMA). The FDA's food safety program will change as a result of FSMA, which is the agency's first significant revision of the legislation governing food safety in more than 70 years. With additional measures to prevent, rather than react to, food safety problems, FSMA eliminates large and persistent loopholes in the FDA's food safety jurisdiction. It also offers the FDA significant new capabilities to verify that imported seafood is as safe as domestic seafood.

Integrated Food Safety System:

In order to modernize food safety, the FDA collaborates with the President's Food Safety Working Group by forming alliances with stakeholders in the consumer, business, and regulatory sectors. In carrying out their respective regulatory and service activities, the FDA and the National Marine Fisheries Service (NMFS) Seafood Inspection Program, for instance, have some common and related objectives that lend themselves to cooperation under a Memorandum of Understanding (MOU) that outlines the working arrangements between the agencies and facilitates each agency's efforts to carry out its obligations related to the inspection of fish and fishery products.

National Residue Monitoring Program:

The FDA will continue the nationwide residue monitoring program and recognizes the value of such a program to ensure that foods are not contaminated with illicit animal medication residues in addition to implementing the new FSMA authorities. The FSMA requires the FDA to create a program for accredited laboratories to test food, and in some cases, such as in support of the admission of imported food, will mandate that food be tested by accredited laboratories. A program for laboratory accreditation is being developed by the FDA as part of its FSMA implementation efforts.

Consumer Information:

A widget on the federal government's website shows the most recent FDA and USDA food safety alerts and recalls. By visiting, you may be able to download an app that will allow you to receive recall notifications directly to your Android phone if you have a mobile device.

From Thailand, shrimp (U.S. customs records show the shrimp made its way into the supply chains of major U.S. food stores and retailers such as WalMart, Kroger, Whole Foods, Dollar General, and Petco, along with restaurants such as Red Lobster and Olive Garden)

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