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  1. Seafood Guidance Documents & Regulatory Information

Aquacultured Seafood

More on Seafood

Seafood Aquaculture

Items of Interest:

FDA has recently received inquiries as to whether salmon from Canada that have been exposed to the infectious salmon anemia (ISA) virus, but are not necessarily diseased, would be allowed entry in to the U.S.

FDA’s Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Safety, Division of Seafood Safety (DSS) works to ensure the safety of aquacultured seafood.

In order to promote overall safety of aquacultured seafood, DSS develops regulations, guidance policy, programs, position papers and advisory opinions and recommends research priorities for issues related to the safety of aquaculture. DSS also facilitates and examines the implementation of regulations; domestic and foreign programs; bilateral agreements related to aquaculture. Additionally, DSS provides scientific and technical support, training, evaluation and certification for State and international aquaculture programs.

This page provides access to content about aquacultured seafood, including consumer information, guidance documents, and education and outreach.

Facts about Aquacultured Seafood 

Aquaculture is the farming of aquatic organisms; such as finfish, molluscs, crustaceans, amphibians, reptiles, turtles and aquatic plants. The term farming implies that there has been some type of intervention in the breeding and rearing process to enhance production; such as stocking, feeding, protection from predators, improvement of water quality, and improvement of animal health conditions including prophylactic and treatment activities (FAO, CWP Handbook of Fishery Statistical Standards, Section J: Aquaculture, 2016).

Aquaculture can occur in freshwater, coastal and marine environments, including: inland ponds, tanks, reservoirs, rivers, lakes, estuaries, bays, fjords, and open sea. While the main purpose of aquaculture is to produce animals and plants for human consumption, it can also be used for numerous other purposes including: replenishing and strengthening stocks of wild populations; producing sport fish, bait fish, ornamental fish, and fish eggs; and growing plant species to be used in a range of food, pharmaceutical, nutritional and biotechnology products. 
Aquaculture is an important industry in many regions of the world. It supports global food and nutrition security by contributing to the reduction of poverty and improving the social wellbeing for millions of people worldwide. For more than 30 years increased aquaculture production has contributed to the overall global fisheries supply and helped sustain wild captured fisheries.

The graph below shows the rapid growth in aquaculture production compared to wild captured fisheries (FAO 2014).

Graph of FAO global seafood production 2012

Aquaculture comprises diverse systems of farming with small-scale, often one-family owned operations and large-scale vertically integrated, comprehensive systems where all production stages and inputs are centrally managed.

Depending on the production intensification and degree of intervention during operation, farming systems are classified as:

  1. Extensive - adopt traditional methods depending on natural productivity with low stocking density and minimal intervention during rearing;

  2. Semi-intensive - rely on both natural productivity and supplementary fertilization and feeding with medium stocking density; or

  3. Intensive – employ culture techniques including pond design, fertilization, supplemental feeding, stock manipulation, disease control involving use of animal drugs for prophylactic and treatment purposes. This system is characterized by a high stocking density and high rate of production.

Aquaculture is vulnerable to the impact of constantly changing environmental conditions and stress factors that make fish more susceptible to diseases. Diseases pose one of the most significant constraints to aquaculture development. Good aquaculture management practices that improve safety and optimize production parameters are necessary to prevent and minimize the impact of diseases on aquaculture products.

Imports account for 91 percent of all seafood products sold in the U.S., with aquaculture accounting for about 50 percent of those seafood imports. Seafood consumption in the U.S. has not significantly increased in the recent years; however, six of the top 10 seafood products that consumers prefer are farm raised species, with farm raised shrimp, salmon and tilapia accounting for more than half of all seafood consumed in the U.S. (U.S. Census Bureau 2014).

All domestic and imported fish and fishery products must comply with provisions of the Hazard Analysis Critical Control Point (HACCP) regulation for Fish and Fishery Products published in Title 21 of the Code of Federal Regulations Part 123. Under this regulation, processors of aquaculture fish are required to understand the hazard(s) associated with aquaculture (e.g., animal drugs used in aquaculture operation) and implement preventive controls to ensure that aquaculture products on the market do not contain hazards (e.g., ensuring that drug usage is legal and appropriate). Unapproved drugs administered to aquaculture fish may pose a potential human health hazard. The legal marketing and use of animal drugs in the U.S. is determined by the Federal Food, Drug and Cosmetic Act and its amendments.

Foreign Country Assessments

Foreign Country Assessment Lab Workers

The assessment determines if safety programs and strategies established by foreign governments meet the FDA’s HACCP requirements, regulations and other relevant laws to control risks and reduce potential hazards (i.e., animal drug residues) of aquaculture products imported into the U.S.

The assessments determine if safety programs and strategies established by foreign governments meet the FDA’s HACCP requirements, regulations and other relevant laws to control risks and reduce potential hazards (i.e., animal drug residues) of aquaculture products imported into the U.S.

Assessment of a foreign country’s seafood safety system for aquaculture products supports the FDA’s enforcement activities and helps the agency determine effectiveness of established operational criteria.

Good Aquaculture Practices

The FDA, in conjunction with the Joint Institute for Food Safety and Nutrition (JIFSAN) has developed Good Aquaculture Practices (GAqP)disclaimer icon a scientifically broad-based training program for countries exporting aquaculture products to the U.S., with the primary goal of providing teaching tools to trainers who can then teach GAqP practices in their countries.  

The program is a scientifically broad-based program, with practical information on aquaculture production, handling, processing, storage, and transportation. The training focuses on risk reduction, not risk elimination. Training needs vary by country, and the time frame and extent of training may also vary.

Frequently Asked Questions

1. Why is there a need for aquacultured seafood?

The output of the world‘s captured fisheries has been either steady or declining in the last decade.  With a growing demand for seafood, aquaculture has become a means to supplement the wild fisheries supply.  Aquaculture has produced more seafood for human consumption, kept the overall price of seafood down, and made seafood more accessible to consumers around the world.  The World Bank Report Fish to 2030 Prospects for Fisheries and Aquaculture predicts that aquaculture will need to provide two thirds of the global fish supply for consumption by 2030.  In 2014, aquaculture accounted for 44% of the world’s total fish production.

2. Is aquacultured seafood as safe and healthy to eat as wild caught?

Yes, aquacultured seafood is safe to eat and is considered a healthy food choice and should be a part of healthy diet.  Both aquacultured and wild caught fish and shellfish are held to the same food safety standards to ensure that only safe and wholesome products are offered to consumers.  Aquacultured and wild caught seafood are a good source of proteins, omega-3 fatty acids, key vitamins and minerals.  The United States Department of Agriculture (USDA) Dietary Guidelines for Americans 2015-2020 recommends that Americans should include at least 2 servings of seafood per week as part of a healthy eating pattern.

3. Is imported seafood held to the same standard as domestically produced seafood?

Yes, the FDA holds domestic and import producers to the same standard. All seafood processors, including processors of aquacultured products, must comply with FDA laws and regulations including the Seafood HACCP regulation.  They are subject to FDA inspections and examinations at the port of entry.  Adulterated products are not allowed to be sold in the U.S., and foreign processors that import a violative product into the U.S. market are placed on the detention without physical examination (also called an Import Alert). 

4. Are animal drugs used in aquaculture? 

Yes, sometimes animal drugs may be used to maintain fish health and welfare.  The use of animal drugs in aquaculture is strictly regulated in the U.S.  Only medicine products approved by the FDA Center for Veterinary Medicine (CVM) are allowed to be administered to aquatic animals, and withdrawal periods and testing are strictly enforced to ensure that no drug residues are present before the fish is sold to consumers.  The list of animal drugs approved for aquatic animals by FDA CVM is available Approved Aquaculture Drugs.

5. Does the FDA publish a list of unapproved aquaculture drugs?

No, the FDA does not publish a list of unapproved drugs. In the U.S., any animal drug not approved by the FDA is considered an unapproved animal drug.

6. How does FDA monitor the safety of imported aquacultured seafood?

Seafood products are among the most internationally traded food commodities.  All imported seafood is screened prior to entering U.S. commerce, and different subsets of entries are inspected at varying rates depending on the potential risks.  FDA is actively engaged in inspection, sampling, and testing seafood products imported to the U.S.

7. How does FDA determine when to sample and test imported aquacultured seafood?

FDA electronically screens all seafood entries into the U.S. and uses a Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system to determine when to conduct physical examination and sample imported seafood products for testing.   PREDICT as a risk-based screening tool assists entry reviewers in targeting higher-risk shipments for examination.  The system uses an extensive database to determine if there are specific health risks associated with a particular product or company and prevent the entry of adulterated, misbranded, or otherwise violative goods.

8. What happens to the imported aquacultured seafood product when unapproved drug residues are detected?

When the imported seafood product tests positive for the presence of residues of animal drugs not approved in the U.S., FDA may take regulatory action against the entry, firm, and/or owner of the goods.  The contaminated product is refused entry and not allowed to be sold in the U.S.  The violative firm is placed on an Import Alert, which results in refusal of admission (detention without physical examination) of all future shipments from this firm.

9. Which countries and regions in the world produce the most aquacultured seafood? 

According to the United Nation’s Food and Agriculture Organization (FAO), The State of World Fisheries and Aquaculture – 2016, approximately 89% of all farmed seafood in the world is produced by Asian countries, followed by Americas (4.6%), Europe (3.9%) and Africa (2.3%).

Additional Resources


Please contact us at:


United States Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Food Safety, Division of Seafood Safety
5001 Campus Drive, HFS-325
College Park, MD 20740

Phone: 240-402-2300

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