Are you in the seafood import business or planning to enter this lucrative market? Understanding the FDA’s stringent regulations can feel overwhelming, but we’re here to break it down for you in simple terms. As someone who’s guided numerous companies through these regulatory waters, I’ll walk you through everything you need to know about importing seafood into the United States safely and legally.

How the FDA Safeguards America’s Seafood Supply?

The FDA doesn’t take seafood safety lightly, and for good reason. Every piece of shrimp, fillet of salmon, or can of tuna entering the U.S. must meet the same safety standards as domestically produced products. Let’s dive into how the FDA accomplishes this monumental task.
The FDA employs a comprehensive approach guided by their Strategy for the Safety of Imported Food. This strategy rests on four pillars that work together to ensure what ends up on American plates is safe to eat.

The Four Pillars of FDA’s Import Strategy

The FDA has developed a robust framework to protect consumers while facilitating legitimate trade. This framework consists of four key goals that drive all their seafood import activities:

1. Ensuring imported food meets U.S. safety requirements
2. Preventing unsafe foods from crossing the border
3. Responding rapidly to unsafe imported food
4. Maintaining an efficient import program

These aren’t just lofty goals on paper—they translate into real programs and technologies that protect public health every day.

Key Programs in FDA’s Seafood Safety Arsenal

The FDA doesn’t rely on just one approach to ensure seafood safety. Instead, they deploy a variety of complementary tools and programs. Here’s a closer look at the major components of their system:

1- HACCP: The Foundation of Seafood Safety

HACCP (Hazard Analysis and Critical Control Points) forms the backbone of the FDA’s seafood safety program. But what exactly is it? Simply put, it’s a preventive approach to food safety that identifies, evaluates, and controls hazards throughout the entire supply chain.
For seafood importers, HACCP isn’t optional—it’s mandatory. Your foreign suppliers must implement HACCP systems, and you must verify they’re doing so correctly.

2- PREDICT: Smart Screening for Seafood Imports

Have you ever wondered how the FDA decides which shipments to inspect? Enter PREDICT—the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting system. This intelligent screening tool has revolutionized how the FDA monitors imports.

What PREDICT Improves	How It Works	Benefit to Importers
Targeting high-risk products	Uses algorithms to identify risky shipments	Lower-risk products face fewer delays
Data analysis capabilities	Detects trends and investigates patterns	More consistent and predictable inspections
Resource management	Directs FDA resources where needed most	More efficient clearance process
Sampling adjustments	Allows for dynamic sampling levels	Reduced burden on compliant importers
Overall efficiency	Streamlines the import review process	Faster market access for safe products

This risk-based approach means that if you consistently import safe products and maintain good compliance records, you’ll likely experience fewer inspections and delays.

What Are FDA’s International Initiatives

The FDA recognizes that ensuring seafood safety starts long before products reach U.S. borders. That’s why they’ve expanded their presence internationally with several key programs:

1- Foreign Inspections and Global Presence

FDA inspectors don’t just stay stateside—they travel worldwide to inspect foreign processing facilities. The agency has strategically established permanent posts abroad to strengthen oversight and coordination. This global approach helps catch problems at the source rather than at the border.

2- Country Assessments: Understanding Foreign Systems

When the FDA conducts a country assessment, they’re taking a deep dive into that nation’s regulatory infrastructure for controlling things like aquaculture drugs. These assessments provide invaluable information that helps the FDA:

Assessment Outcome	Example Countries	Practical Impact
Target surveillance sampling	China, Chile, India	Increased testing of high-risk products
Develop analytical methods	All exporting countries	Better detection of potential contaminants
Plan foreign HACCP inspections	Major seafood exporters	More focused facility inspections
Support regulatory actions	China (2007 import alert)	Import restrictions when necessary
Improve international collaboration	Ecuador (2023 partnership)	Better compliance with FDA requirements

These assessments have real consequences. For example, following a 2006 assessment in China, the FDA issued a country-wide import alert for certain aquaculture products from China in 2007.

3- Regulatory Partnerships: Collaboration for Safety

The FDA doesn’t try to go it alone. They actively establish partnerships with their regulatory counterparts worldwide. A great example is the 2023 Regulatory Partnership Arrangement (RPA) with Ecuador’s seafood regulatory authority to strengthen shrimp safety. These collaborations create a more unified approach to seafood safety.

What Is the Process of Importing Seafood Into the U.S.

Now that we understand how the FDA monitors imports, let’s walk through the practical steps you need to take to import seafood successfully. Consider this your roadmap to compliance.

1- Know the Requirements

Before you import your first shipment, you need to understand the rules of the game. The FDA’s food regulations, including those for seafood, are primarily found in the U.S. Code of Federal Regulations (CFR) Title 21, Parts 1 to 199.
Specific seafood regulations include:

• 21 CFR Part 123 (HACCP requirements)
• 21 CFR Part 101 (Labeling requirements)
• Additional requirements in 21 CFR Parts 1, 110, and subparts A, B, and F of Part 117

Don’t worry if this sounds overwhelming! The FDA provides helpful resources like Seafood Compliance Program Manuals and Compliance Policy Guides on their website (www.fda.gov/seafood).

2- Ensure Your Suppliers Meet Key Regulations

As an importer, you’re responsible for verifying that your suppliers meet FDA requirements. Here are the major regulations they must follow:
Food Facility Registration
Every foreign facility that manufactures, processes, packs, or holds food for U.S. consumption must be registered with the FDA. Make sure each of your suppliers has an active Food Facility Registration number. This registration is free and can be completed through the FDA Industry Systems portal.
Seafood HACCP Compliance
This is absolutely critical! Your suppliers must follow HACCP principles, and you must verify they’re doing so. This verification, called the “Affirmative Step,” requires you to:

2. Establish written verification procedures for each product
3. Define the product’s safety specifications
4. Identify which specific verification method you’ll use
5. Implement at least one verification method each time you import
6. Maintain records of these verifications for up to two years

Verification Option	How It Works	Pros and Cons
Obtain HACCP records	Get records for each shipment	Comprehensive but paperwork-intensive
Get certificates	From foreign authorities or third parties	Easier but relies on others’ assessments
Inspect facilities	Visit your suppliers regularly	Direct control but expensive
Maintain processor guarantees	Written guarantees plus HACCP plans	Balanced approach for ongoing relationships
Test products	Periodic laboratory testing	Evidence-based but can’t catch all issues

Remember: Your verification records must be in English and available for FDA inspection. Failure to produce adequate records can result in FDA enforcement action.

3- Review Import Alerts

Before importing, check FDA’s Import Alerts at fda.gov/import-alerts. These alerts identify products that may violate FDA requirements and are subject to Detention Without Physical Examination (DWPE). Products on these lists will be detained upon arrival unless you can prove compliance.
Import alerts can target specific manufacturers, products, or even entire countries. Staying current with these alerts can help you avoid costly surprises.

4- Declare Your Shipment

When your products are ready to ship, you’ll need to declare them to both U.S. Customs and Border Protection and the FDA. Most importers hire a licensed customs broker to handle this process and electronically submit the required information.
You’ll need to provide details about your shipment, including:

• Product names and descriptions
• Intended use
• Names and addresses of all responsible parties
• Manufacturer’s Food Facility Registration number
• Additional specific information like FCE numbers for canned products

5- File Prior Notice

The FDA requires advance notification of all food shipments entering the U.S. This “Prior Notice”
helps protect against potential threats to the food supply. You can file this information through the Prior Notice System Interface, or your broker can handle it for you.

6- Navigate the FDA Admissibility Process

Once your seafood arrives, the FDA will review it for admissibility. They use risk-based screening tools, may physically examine products, and sometimes collect samples for testing. Compliant products will be released, while non-compliant ones may be refused entry.
You can monitor your shipment status through the Import Trade Auxiliary Communications System (ITACS) at itacs.fda.gov.

7- Consider the Voluntary Qualified Importer Program (VQIP)

If you’re a consistent importer with a strong compliance history, consider applying for the FDA’s Voluntary Qualified Importer Program. This fee-based program offers expedited review and entry for qualified importers.

Special Requirements for Specific Seafood Products

Some seafood products have additional requirements beyond the standard regulations. If you import any of these specialty items, pay close attention:

• Low Acid Canned Foods and Acidified Foods

Products like canned tuna or shelf-stable pickled fish require special registration and process filing. You’ll need to obtain your processor’s Food Canning Establishment (FCE) number and the product’s process filing submission identifier (SID) to provide at import.

• Raw Bivalve Molluscan Shellfish

Oysters, clams, mussels, and roe-on scallops must comply with National Shellfish Sanitation Program (NSSP) requirements. These products can only be imported from countries with FDA cooperative arrangements, and shippers must be on the Interstate Certified Shellfish Shippers List.

The Best Way to Prepare FDA Import License?

Importing seafood into the United States comes with significant responsibilities, but understanding the FDA’s requirements puts you on the path to success. Remember that these regulations aren’t just bureaucratic hurdles—they’re designed to protect consumers and ensure a level playing field for all importers.

By following the steps outlined in this guide, you’ll not only avoid costly delays and refused shipments but also contribute to a safer food supply. The FDA continues to evolve its approach to imported seafood safety, using new technologies and collaborative approaches to balance safety with efficiency.

As your business navigates these regulatory waters, stay informed about changes to requirements and maintain open communication with your suppliers, customs brokers, and the FDA. Success in seafood importing isn’t just about compliance—it’s about building a culture of safety throughout your supply chain.
Have questions about specific aspects of seafood importing? Drop them in the comments below, and we’ll address them in future posts!

FAQ

1. What is the HACCP regulation for seafood imports and why is it important?
   The Hazard Analysis Critical Control Point (HACCP) regulation requires processors and importers to identify potential food safety hazards and establish preventive measures. This system is crucial because it shifts focus from reacting to contamination to preventing it in the first place, making seafood safer for consumers.
2. Who needs to comply with the seafood HACCP regulations?
   Any business that processes fish or fishery products for import into the US market must comply with HACCP regulations. This includes foreign processors and US importers. Even storage facilities, distributors, and warehouses handling seafood may need to comply as they fall under the FDA’s definition of “processing.”
3. If I’m just importing seafood but not processing it, do I still need a HACCP plan?
   Yes. While you might not need a full HACCP plan as a non-processor, US importers must still follow verification procedures to ensure that the foreign processors they source from are complying with HACCP regulations. This includes maintaining documentation and verification records.
4. Are there exemptions to the seafood HACCP regulations?
   Retail establishments, fishing vessels (unless they process seafood onboard), and firms that only harvest or transport seafood without processing are generally exempt. Additionally, products exported from the US may be exempt if they meet specific criteria outlined in Section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act.
5. How do the FDA Food Safety Modernization Act (FSMA) and seafood HACCP regulations interact?
   Seafood processors complying with the seafood HACCP regulation (21 CFR part 123) are exempt from the FSMA preventive controls requirements. However, they must still comply with Current Good Manufacturing Practice requirements and may need to follow other applicable FSMA provisions.
   Drug Residue Testing
6. What is FDA doing to prevent unsafe drug residues in imported seafood?
   FDA implements a multi-layered approach including inspecting foreign processors and US importers for HACCP compliance, conducting targeted sampling and testing of imports for drug residues, collaborating with foreign regulatory authorities, and establishing regulatory partnerships with major seafood exporting countries.
7. How much of imported seafood does FDA actually test for drug residues?
   FDA tests only a small percentage (approximately 0.1%) of seafood imports for drug residues. The agency uses a risk-based approach to determine which products to test, focusing on certain high-risk countries, specific drugs of concern, and types of seafood with historically higher violation rates.
8. What drugs does FDA test for in imported aquaculture products?
   FDA tests for both approved and unapproved drugs in aquaculture products. This includes antibiotics like fluoroquinolones and nitrofurans, antifungal compounds, and other veterinary drugs. The agency specifically targets drugs that are not approved for use in US aquaculture or those that exceed established tolerance levels.
9. What happens if FDA finds drug residues in my imported seafood?
   If FDA detects unapproved drug residues or residues exceeding tolerance levels, they may issue an Import Alert placing your products on “detention without physical examination” (DWPE). This shifts the burden to you to prove future shipments are compliant, typically through third-party laboratory testing.
   Import Procedures and Requirements
10. What information must I provide when importing seafood products into the US?
    You must submit prior notice through the FDA’s Automated Commercial Environment (ACE) system before the shipment arrives, including details about the product, manufacturer, shipper, importer, and country of origin. You must also maintain importer verification records showing your foreign suppliers comply with HACCP requirements.
11. How does FDA’s import screening system work for seafood?
    FDA uses the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) screening system to determine which shipments to examine or sample. The system evaluates factors like compliance history, product risk, country of origin, and intelligence data to prioritize higher-risk products for inspection.
12. What are Import Alerts and how do they affect seafood importers?
    Import Alerts inform FDA field staff that certain products may be detained without physical examination due to past violations. If your supplier or product is on an Import Alert, your shipments may be automatically detained until you provide evidence (usually third-party laboratory testing) proving compliance.
13. How do I get my seafood products removed from an Import Alert?
    To be removed from an Import Alert, you typically need to provide evidence of at least five consecutive compliant shipments through third-party laboratory testing. You must also demonstrate that you’ve implemented corrective actions to prevent future violations. The petition process for removal is detailed in FDA guidance documents.
    Food Safety and Compliance
14. What are the most common reasons imported seafood gets rejected?
    Common reasons include filthy, decomposed or otherwise unfit conditions (adulteration), unsafe drug residues, improper labeling, lack of required HACCP documentation, bacterial contamination (particularly Salmonella), histamine (scombrotoxin) formation, and the presence of other prohibited substances.
15. How does FDA handle inspections of foreign seafood facilities?
    FDA conducts limited inspections of foreign processors each year, focusing on countries with significant export volume to the US or a history of compliance issues. These inspections evaluate HACCP implementation and compliance with US requirements. FDA also conducts broader country assessments to evaluate national control systems.
16. What steps should I take before importing seafood to ensure FDA compliance?
    Before importing, verify your foreign supplier has implemented a HACCP plan, establish a verification program, obtain appropriate documentation (including HACCP records and product testing results), ensure accurate labeling, register with FDA if required, and understand the specific requirements for your type of seafood product.
17. Are there special requirements for importing raw molluscan shellfish (clams, mussels, oysters)?
    Yes. Raw molluscan shellfish can only be imported from countries that have a Memorandum of Understanding (MOU) with FDA or are listed on the Interstate Certified Shellfish Shippers List (ICSSL). These agreements ensure the exporting country maintains equivalent safety controls for shellfish harvesting and processing.
    Recent Developments and Resources
18. What are Regulatory Partnership Arrangements and how do they affect seafood imports?
    Regulatory Partnership Arrangements (RPAs) are agreements between FDA and foreign regulatory authorities to strengthen food safety throughout the supply chain. For example, FDA signed an RPA with Ecuador in 2023 to enhance the safety of imported shrimp, which may lead to more streamlined import processes for compliant suppliers.
19. How can I stay updated on FDA seafood import regulations?
    Subscribe to FDA email updates on seafood safety, monitor the FDA website for new guidance documents and regulatory changes, join industry associations that provide regulatory updates, and review FDA’s annual reports on import sampling results and compliance actions.
20. Where can I find guidance on preparing HACCP plans for seafood imports?
    The FDA publishes the “Fish and Fishery Products Hazards and Controls Guidance,” currently in its 4th edition, which provides comprehensive information on seafood hazards and control measures. Additional resources include FDA’s seafood HACCP training programs, guidance documents, and the Seafood HACCP Alliance training materials.