Import Alert Guide
Import Alert 16-81 — Seafood Detained for Salmonella
A plain-language guide to FDA Import Alert 16-81, which allows detention without physical examination of seafood products for Salmonella. What it covers, the charge it carries, and what per-shipment testing evidence typically involves.
The Short Version
What Is Import Alert 16-81?
Import Alert 16-81 permits FDA to detain, without physical examination, shipments of seafood products from firms on its Red List due to the presence of Salmonella. FDA treats seafood as adulterated when Salmonella is detected by its standard methods, regardless of whether the product is intended to be eaten raw or cooked — a zero-tolerance standard. Once a firm is listed, every covered shipment is presumed violative on arrival, and the importer must demonstrate, shipment by shipment, that the specific lot does not contain Salmonella.
- Alert Number
- 16-81
- Products Covered
- Seafood products, and finished products composed in whole or part of listed seafood, from Red List firms
- Charge
- Adulteration — appears to contain Salmonella, a poisonous and deleterious substance (Section 402(a)(1))
- Mechanism
- Detention Without Physical Examination (DWPE), firm-specific Red List
- FDA Standard
- Zero / non-detectable Salmonella by BAM methodology or equivalent
- Official Text
- FDA Import Alert 16-81
The Background
Why Seafood Gets Detained Under 16-81
Salmonella is a leading cause of foodborne illness, and FDA applies a strict standard to seafood: when Salmonella is found by its standard methods, the product is considered adulterated whether it is meant to be consumed raw or cooked. FDA expects zero or non-detectable levels.
Salmonella in seafood is generally traced to fecal contamination of the water environment or to insanitary conditions and temperature abuse in post-harvest handling and processing — it is not naturally present in the intestinal tracts of finfish, crustaceans, or mollusks. Because of that, a single positive finding can lead FDA to refuse the tested shipment and add the firm to the Red List, after which all future shipments of the same or similar products are automatically detained.
This alert exists for seafood products and firms that do not fit within other, more specific seafood import alerts, and it may not be the only alert under which a given seafood product is detained for Salmonella.
The Evidence
What Per-Shipment Testing Typically Involves
To secure release of an individual detained shipment, the responsible party generally provides evidence that the specific product does not contain Salmonella. That evidence commonly rests on private laboratory analysis of a representative sample under documented custody.
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Representative Sampling
Samples are collected from the detained lot under a documented plan and chain of custody. FDA references its Bacteriological Analytical Manual (BAM), Chapter 1, for Salmonella sampling plans.
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LAAF-Accredited Analysis
Salmonella analysis follows BAM Chapter 5 or an equivalent method. As of December 1, 2024, food testing to support admission of detained food must be conducted by a LAAF-accredited laboratory.
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Your Team Submits
Results and custody records are organized into a case file; you and your authorized parties submit to the FDA compliance office identified on the notice. FDA may collect audit samples before deciding, and makes the final admissibility decision.
LAAF matters here. Since December 1, 2024, results from a non-LAAF-accredited laboratory may not be usable to support release of detained food. Whether LAAF applies to your specific case is confirmed during laboratory matching — see our laboratory testing coordination guide.
Be Realistic
What This Alert Means in Practice
Honest limitations
- Perishability is the clock. Raw and fresh seafood is highly perishable; for some shipments, the time to complete sampling and laboratory analysis can approach or exceed the product's shelf life. Speed of coordination matters more here than almost anywhere.
- Release is not removal. Winning release of one shipment does not take the firm off the Red List — every future shipment is still detained until a removal petition succeeds.
- Removal takes more than clean tests. Firms are removed by petitioning FDA with evidence that the conditions causing the violation were resolved; consistent non-violative shipments support the petition but do not by themselves remove a listing.
- No one can guarantee the result. A single positive finding fails the shipment. Disciplined sampling and custody remove avoidable failure modes; they cannot change what is in the product.
Related
Related Alerts & Guides
Food Products — Salmonella
The broad food-side Salmonella alert for products not covered by seafood-specific alerts.
Read the guide IA 16-124Seafood — Unapproved Drugs
The other major seafood alert family — aquaculture drug residues rather than pathogens.
Read the guide IndustrySeafood Detention Testing
Category overview: common seafood detention reasons and the testing they typically require.
View industriesSeafood Detained Under 16-81?
Perishable Cargo Can't Wait — Start the Review Now
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FDA Detention Sampling is an independent private company. We are not affiliated with, endorsed by, or part of the U.S. Food and Drug Administration. This guide is a plain-language summary of Import Alert 16-81; the official alert text published by FDA is authoritative and controls. Sampling, laboratory testing, documentation, and coordination services do not guarantee FDA release, admissibility, acceptance of laboratory results, removal from any import alert, or any specific regulatory outcome. FDA makes the final admissibility decision.