FAT Seafood Research Series · Paper No. 4

How Imported Fish Is Regulated

An interactive map of FDA’s import oversight architecture — from foreign farm to U.S. retail. Click any stage to explore what oversight exists, who’s responsible, and where the documented gaps are.

Agencies involved FDA USDA FSIS NOAA / NMFS USDA AMS CBP / Customs Follow the fish — click a stage 🌊 Foreign Farm
& Harvest 🏭 Foreign
Processing 🚢 Port of Entry
& Sampling 📋 Import
Monitoring 🛒 Retail &
Labeling Inspection intensity — what FDA actually examines Catfish imports (Siluriformes)USDA FSIS — same as domestic catfish Continuous — FSIS inspection at U.S. port or plant Mandatory Shipments physically examinedAll non-catfish imports at port of entry ~1.2% Shipments tested for drug residuesGAO finding, FY2009 ~0.1% Foreign facility inspections completedvs. FSMA-mandated 19,200/yr target 917/yr avg ~5% NOAA-enrolled importsFee-for-service voluntary grading ~17% of all seafood consumed Voluntary GAO (Government Accountability Office) key findings 98.8% of imports entered without physical examination GAO-04-246 / SeafoodSource 0.1% of imports tested for drug residues (FY2009) GAO-11-286 ~5% of mandated foreign facility inspections completed (FY2018–2023) GAO-25-107571 95% of import-alert removal decisions made without required prior audit GAO-20-62 432 FDA food safety investigators on staff for all domestic and foreign food (July 2024) GAO-25-107571 13 specific high-risk species covered by SIMP traceability — not all imports FDA SIMP Rule Country of Origin Labeling (COOL) — same exemptions as domestic fish ✅ Grocery Stores Fresh & frozen imported fish at PACA-licensed retailers must show country of origin and farm-raised/wild-caught status. ❌ Restaurants & Food Service Fully exempt. No federal right to know whether fish is imported or domestic, or where it came from, at a restaurant. ❌ Processed Seafood Breaded, canned, marinated, or multi-ingredient fish products — all exempt. A large share of packaged seafood carries no origin disclosure. ⚠️ Enforcement Transparency USDA stopped publishing data on how many retail establishments it reviews for COOL compliance annually (noted by Southern Shrimp Alliance, 2025). ⚠️ Substantial Transformation If imported fish undergoes substantial transformation in the U.S. (e.g., breading, smoking), it may lose its import origin designation under CBP rules. ⚠️ Font & Visibility No federal minimum font size for COOL labels. Some states (MS, LA, TX, AL) have enacted their own requirements. System strengths and limitations

Dimension	✔ Strength	⚠ Limitation
Legal Standard	Imported fish must meet the same safety requirements as domestic product — clear statutory mandate under FDCA and FSMA	The verification mechanism falls materially short of what the legal standard implies; enforcement capacity has not kept pace with import volume
HACCP Equivalence	Foreign processors must document HACCP plans equivalent to U.S. requirements; FSVP requires importers to actively verify supplier compliance	Verification is primarily documentation review; FDA generally does not visit foreign farms or observe production conditions firsthand
Port-of-Entry Sampling	PREDICT risk-scoring system directs limited examination resources toward higher-risk shipments	~98.8% of shipments enter without physical examination; ~0.1% tested for drug residues; FDA does not test for all drugs of concern
Import Alerts	Firms with documented violations can be placed on automatic detention — a meaningful enforcement tool when properly administered	GAO found 95% of removal decisions made without required prior audit; 31 of 32 public health hazard firms removed without required follow-up inspection
Foreign Inspections	FSMA expanded FDA authority to inspect foreign facilities and refuse entry from non-cooperating facilities	FDA averaged 917 foreign food inspections/year (FY2018–2023) against a mandated target of 19,200 — approximately 5% completion rate
Traceability	SIMP (Seafood Import Monitoring Program) requires chain-of-custody records from harvest through first U.S. sale for 13 specific high-risk species	SIMP covers only 13 species; most imported fish species have no equivalent federal chain-of-custody traceability requirement
EU Comparison	U.S. has entered Regulatory Partnership Arrangements with key exporting countries; established permanent FDA overseas offices	EU applies system-equivalence standard — reviewing foreign government structures, visiting farms, assessing lab capacity. U.S. has not adopted a comparable framework

Farm Animal Transparency · Seafood Research Series, Paper No. 4 · Published March 17, 2026 · Source: FDA, USDA FSIS, NOAA NMFS, USDA AMS, GAO-04-246, GAO-11-286, GAO-20-62, GAO-25-107571, 21 CFR Part 123, 7 CFR Part 60 · Interactive visualization by FAT Research Library

← FAT Research Library

📅 Published March 17, 2026

✍️ Dirk Adams

⌛ 12 min read

SEAFOOD RESEARCH SERIES | PAPER NO. 4

How Imported Fish Is Regulated:

FDA’s Import Safety Program, HACCP Equivalence, and the Documented Inspection Gaps

The United States imports between 75 and 90 percent of the seafood Americans consume. The FDA is responsible for the safety of all of it. In practice, FDA’s primary tool is a HACCP-based documentation review — not physical product testing or farm-level inspection. GAO has issued repeated findings that FDA’s import oversight is materially limited: as of the most recent detailed analysis, fewer than 2 percent of import shipments were physically examined, foreign inspection targets were missed by roughly 95 percent, and 95 percent of import-alert removal decisions were made without the required prior audit.^1,2,3,4,5

Prepared for publication by Farm Animal Transparency | March 17, 2026

“The FDA requires that imported seafood meet the same safety standards as domestic product. The mechanism for verifying that equivalence — HACCP documentation review, limited physical sampling, and periodic foreign facility inspections — falls materially short of what the EU applies to the same imports.”

At a glance

• The FDA is the primary federal authority for the safety of all imported fish and fishery products; it uses HACCP documentation review, periodic foreign facility inspections, and port-of-entry product sampling as its main oversight tools.1

• GAO found that FDA tested approximately 0.1 percent of imported seafood for drug residues in fiscal year 2009 — the most recent year examined in detail — and independent analysis estimated that 98.8 percent of imported seafood entered the country without physical examination.2,3

• FDA averaged 917 foreign food facility inspections per year from fiscal years 2018 to 2023, against a FSMA-mandated target of 19,200 — a completion rate of approximately 5 percent.4

• In a review of 274 import-alert removal decisions, GAO found that FDA failed to conduct the required pre-removal audit in 95 percent of cases; for 31 of 32 firms flagged for potential public health hazards, FDA did not conduct the required follow-up inspection.5

• The EU applies a stricter equivalence standard to imported seafood than the U.S., including foreign government structure reviews, farm-level visits, and laboratory assessments — a benchmark the U.S. has not adopted.2

Executive Summary

The legal standard for imported seafood in the United States is clear: it must meet the same food safety requirements as domestically produced product. The enforcement mechanism is a HACCP-based system in which foreign processors and importers are required to document that they operate under a food safety plan equivalent to U.S. requirements. FDA verifies this primarily by reviewing importer records and periodically inspecting selected foreign processing facilities. It physically tests a small fraction of shipments at ports of entry.

That architecture has been the subject of repeated critical findings by the U.S. Government Accountability Office, beginning in the early 2000s and continuing through at least 2025. The consistent finding is that FDA’s actual inspection activity is a small fraction of what its own targets require, that its sampling program does not test for all drugs of concern, that import-alert administration has not followed the agency’s own audit requirements, and that FDA does not routinely visit foreign farms to observe the conditions under which fish are raised and treated.

This post documents the architecture of that system and the specific gaps the government’s own auditors have identified.

The legal framework: equal standards, unequal verification

Under the Federal Food, Drug and Cosmetic Act and the Food Safety Modernization Act (FSMA), FDA is responsible for ensuring that imported foods meet the same safety standards as domestic foods. For seafood, the specific regulatory foundation is 21 CFR Part 123, which requires all seafood processors — foreign and domestic alike — to operate under mandatory HACCP programs. Importers must verify, through documentation, that the foreign products they bring into the U.S. have been processed in accordance with HACCP requirements.¹

FSMA (2011) added new tools: the Foreign Supplier Verification Program (FSVP) requires importers to take active steps to verify that their foreign suppliers produce food in a manner that meets U.S. safety standards, rather than simply certifying compliance on paper. FSMA also expanded FDA’s authority to conduct foreign facility inspections and to refuse entry to food from facilities that do not permit inspection. The Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system scores import shipments for risk and directs examination resources toward higher-risk entries.^1,6

These are meaningful structural improvements. But they operate within a system whose underlying capacity — inspector staffing, laboratory capacity, and foreign country engagement — has not kept pace with the volume and complexity of global seafood trade.

How import oversight works in practice

FDA’s practical oversight of imported seafood involves four tools, applied in combination.^1,2,6

Tool	What it involves	Known limitations
HACCP documentation review	FDA inspectors review importer records to confirm the foreign processor has a HACCP plan covering significant hazards. Importers must maintain documentation of supplier compliance.	Verifies that paperwork exists; does not independently test product or observe farm conditions. Foreign farms are generally not visited.
Foreign facility inspections	FDA inspects selected foreign processing facilities to evaluate HACCP implementation. FSMA mandated a target of 19,200 foreign food facility inspections per year.	FDA averaged 917 foreign food inspections per year from FY2018–2023 — approximately 5% of the mandated target. FDA officials have acknowledged the 19,200 target is not realistic given existing staffing.
Port-of-entry sampling	FDA physically examines and tests selected import shipments at U.S. ports of entry, focusing on product presentation, labeling, and laboratory analysis for contaminants and drug residues.	GAO estimated that 98.8% of imported seafood enters without physical examination. FDA tested approximately 0.1% of imports for drug residues in FY2009.
Import alert system	When a foreign firm or geographic region has a history of violations, FDA places it on an import alert, requiring subsequent shipments to be detained pending testing or documentation.	GAO found that 95% of import-alert removal decisions were made without the required prior audit; 31 of 32 firms flagged for public health hazards were removed from alerts without the required follow-up inspection.

Source synthesis based on Endnotes 1–6.

The inspection gap by the numbers

The quantitative picture of FDA’s import oversight capacity is stark and has been documented consistently across multiple GAO reports spanning more than two decades.^2,3,4,5

Metric	Finding	Source
Share of imported seafood physically examined	Approximately 1.2% (FY2002); estimated 98.8% entered without examination	GAO-04-246; SeafoodSource
Share tested for drug residues	Approximately 0.1% (FY2009)	GAO-11-286
FDA foreign food inspections completed per year	Average 917 (FY2018–2023)	GAO-25-107571
FDA mandated foreign inspection target (FSMA)	19,200 per year	GAO-25-107571
Target completion rate	Approximately 5%	GAO-25-107571
FDA food safety investigators on staff (July 2024)	432 (for all domestic and foreign food)	GAO-25-107571
Import alert removals without required prior audit	260 of 274 decisions (95%)	GAO-20-62
Public health hazard findings without required follow-up inspection	31 of 32 firms (97%)	GAO-20-62

The drug residue problem

One of the most significant and least visible risks in imported seafood involves drug residues from aquaculture operations. Fish raised in confined systems are susceptible to bacterial and parasitic infections. Farmers in major exporting countries routinely use antibiotics, antifungals, and other drugs to treat or prevent disease. Some of these substances — including malachite green, chloramphenicol, and certain nitrofurans — are not approved for use in U.S. aquaculture and may not legally be present in food sold in the U.S. at any detectable level. Residues of these drugs can cause cancer or contribute to antibiotic resistance.^2,3

The verification problem has two components. First, FDA’s sampling program does not test for all drugs of concern. GAO found that FDA does not routinely test for drugs that other countries — including the EU — have approved for aquaculture use. This creates a systematic gap: seafood containing residues of drugs that are unapproved in the U.S. but approved in the country of origin may enter U.S. commerce undetected because the test panels FDA uses do not screen for those substances. Second, FDA inspectors generally do not visit foreign farms to observe drug use practices or evaluate the competence of the laboratories that test fish before export.²

GAO was explicit: the EU reviews foreign government regulatory structures, visits fish farms, assesses the capabilities of exporting countries’ laboratory systems, and requires system-level equivalence. The U.S. has not adopted an equivalent approach.

The import alert system and its administration

When FDA identifies a pattern of violations — contaminated product, banned drug residues, pathogen findings — it places a foreign firm or geographic source region on an import alert. Subsequent shipments from that source are subject to automatic detention pending satisfactory testing or documentation. Import alerts are a key tool for protecting consumers from known violators.⁵

The GAO’s review of 274 removal decisions from October 2011 through July 2018 found significant problems with how FDA manages the removal process. FDA’s own guidelines require the agency to audit samples from at least one shipment used to support each removal decision, to verify the validity of private-laboratory analysis. In 260 of 274 removal decisions — 95 percent — FDA did not conduct any audit within the year prior to removal. FDA officials told GAO they conducted limited sampling because documentary evidence from firms was often considered sufficient. GAO concluded that FDA does not monitor whether it is meeting its own audit goals, and recommended that FDA establish a monitoring process. FDA agreed.⁵

The problem was starker for public health hazard findings. When an inspection identifies that a firm may pose a public health risk, FDA’s directive requires a follow-up inspection within six months before the firm can be removed from an import alert. GAO found that 31 of 32 such firms were removed without the required follow-up inspection occurring.⁵

The EU comparison

The contrast with the European Union’s approach to imported seafood safety is instructive. The EU applies a system-equivalence standard rather than a firm-level HACCP documentation review. To be eligible to export seafood to the EU, a country must demonstrate that its domestic regulatory system — including its government inspection structure, food safety legislation, farm inspection program, and laboratory system — is equivalent to EU standards. EU officials visit farms in exporting countries, evaluate government oversight capacity, and assess the reliability of the testing infrastructure that certifies product before export.²

GAO explicitly identified this divergence as a gap in U.S. consumer protection, recommending that FDA study the feasibility of adopting practices used by the EU and other jurisdictions to better ensure the safety of imported seafood. FDA has not adopted a system-equivalence framework comparable to the EU’s.

Country of Origin Labeling for imported fish: what is required and where the gaps are

COOL applies to imported fish the same way it applies to domestic fish at the retail level: fresh and frozen fish at PACA-licensed grocery stores must be labeled with country of origin and method of production. For imported fish that has not undergone substantial transformation in the U.S., the country of origin is determined by U.S. Customs and Border Protection based on the country where the fish was harvested or farmed.⁷

The same exemptions that limit COOL for domestic fish apply equally to imported fish. Restaurants, food service, fish markets, and processed seafood products (breaded, canned, marinated, combined with another ingredient) are all exempt from COOL disclosure. A consumer buying frozen marinated tilapia fillets — which are imported and processed — has no federal right to origin information on the label. A consumer ordering fish at a restaurant has no federal right to know whether it is domestic or imported, farmed or wild.⁷

Federal COOL enforcement has also faced transparency questions. The Southern Shrimp Alliance noted in 2025 that USDA stopped publishing data on how many retail establishments it reviews for COOL compliance annually, making it difficult to assess how vigorously the existing requirements are enforced.⁸

Recent improvements to the import oversight architecture

It is important to note that FDA’s import oversight architecture has improved meaningfully over the past decade, even as gaps persist. FSMA’s Foreign Supplier Verification Program shifted responsibility to importers to actively verify — not just certify — that their foreign suppliers meet U.S. standards. FDA established permanent overseas offices in strategic locations. The PREDICT risk-scoring system focuses limited inspection and sampling resources on higher-risk sources. FDA has entered into Regulatory Partnership Arrangements with exporting countries, including a 2023 agreement with Ecuador focused on shrimp safety. The Seafood Import Monitoring Program (SIMP) expanded documentation requirements for certain high-risk species, requiring chain-of-custody records from harvest through the first point of U.S. sale.^1,6

These are real advances. They have not closed the gap identified by GAO. The 2025 GAO report on FDA inspection performance found that FDA has not met its mandated inspection targets since fiscal year 2018, and that its foreign inspection completion rate remained at approximately 5 percent of the FSMA target through fiscal year 2023 — the most recent year for which data was analyzed.⁴

The FAT perspective

The regulatory gap between what the law requires and what FDA has the capacity to verify is the central transparency issue in imported seafood. The legal standard — imported fish must meet U.S. safety requirements — is clear and appropriate. The verification mechanism — HACCP documentation review, limited physical sampling, and periodic foreign facility inspections conducted at roughly 5 percent of the mandated rate — is materially weaker than the legal standard implies.

What this means concretely for a consumer: a fish labeled “Product of Vietnam” or “Product of Thailand” at a U.S. grocery store has been produced under that country’s food safety system, reviewed by FDA primarily through importer documentation, and has a statistically very small probability of having been physically tested for drug residues before reaching the store. This is not a statement that the fish is unsafe. It is a statement that the assurance of safety rests primarily on the foreign producer’s own practices, the importer’s verification of supplier documentation, and a regulatory system that the government’s own auditors have repeatedly characterized as under-resourced relative to the scale of the task.

Consumers who want a stronger evidentiary basis for the fish they buy have two practical options at retail: look for NOAA voluntary inspection marks (U.S. Grade A or PUFI), which indicate a paying-for-inspection commitment by the processor; or choose fish that carries a credible third-party sustainability and safety certification such as those from the Marine Stewardship Council (MSC) or Aquaculture Stewardship Council (ASC), which have independent auditing requirements. Neither is a substitute for a well-resourced government inspection program. Both are better than no signal at all.

Publishing Package

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Meta description: A plain-English guide to how imported fish is regulated in the United States — covering FDA’s import safety program, HACCP equivalence requirements, documented GAO findings on inspection gaps, the drug residue problem, import alert administration, and the EU comparison.

Endnotes

1. U.S. Food and Drug Administration, “Imported Seafood Safety Program,” fda.gov, accessed March 2026.

2. U.S. Government Accountability Office, “Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources,” GAO-11-286, 2011.

3. SeafoodSource, “FDA Urged to Improve Imported Seafood Oversight,” citing GAO-11-286; SeafoodSource, “FDA Embarks on New Strategy for Imported Food Inspections.”

4. U.S. Government Accountability Office, “Food Safety: FDA Should Strengthen Inspection Efforts to Protect the U.S. Food Supply,” GAO-25-107571, 2025.

5. U.S. Government Accountability Office, “Imported Seafood Safety: Actions Needed to Improve FDA Oversight of Import Alert Removal Decisions,” GAO-20-62, 2019.

6. U.S. Food and Drug Administration, “How FDA’s Strategy Helps Ensure the Safety of Imported Seafood,” FDA Voices, 2023.

7. USDA Agricultural Marketing Service, “Country of Origin Labeling (COOL),” 7 CFR Part 60; USDA AMS FAQ on COOL, ams.usda.gov.

8. Southern Shrimp Alliance, “The LABEL Act: Shrimp Labels You Can Actually Read,” October 29, 2025.

Additional References

1. FDA. “Seafood HACCP and FSMA.” www.fda.gov.
2. 21 C.F.R. Part 123. www.ecfr.gov.
3. GAO. Seafood Safety GAO-11-286. 2011. www.gao.gov.
4. GAO. Imported Seafood Safety GAO-17-443. 2017. www.gao.gov.
5. 7 C.F.R. Part 60. www.ecfr.gov.