Note: The revision of this Import Alert (IA) dated 07/16/2026 updates the reason for alert, guidance section, agency contacts, product description and charge section. Changes to the import alert are bracketed by asterisks (***). *** There is a well-documented history of botulism associated with uneviscerated, salt-cured fish. In the United States between 1981 and 1987, kapchunka, an uneviscerated, salt-cured, air-dried, whole fish, which may or may not be smoked, was implicated in three outbreaks causing 3 deaths and 11 illnesses. Usually produced from whitefish, kapchunka is also known as rybetz, ribeyza, or rostov. Two additional outbreaks occurred in 1991, where faseikh was implicated in causing at least 91 illnesses and 18 deaths in Egypt. Faseikh is a traditional product made by fermenting uneviscerated fresh mullet for up to one day and then salt-curing it in barrels, which may be tightly sealed from one week to one year. In 1991, an outbreak involving four family members in New Jersey was caused by moloha, which is an uneviscerated, salt-cured fish product similar to faseikh. The risk of botulism associated with salt-cured uneviscerated fish continues to be a concern. In April of 2012 three persons were involved in an outbreak of botulism in Canada after consuming fesikh (i.e., faseikh). The fesikh was purchased at a retail store in Toronto. The fesikh was prepared from uneviscerated grey mullet, shad, and sardines that was salted in plastic buckets at room temperature for 5-6 hours, then refrigerated for 20 days and vacuum packaged and offered for sale in refrigerated display cases. On October 25, 2018, two women were hospitalized in the intensive care unit for botulism after consuming fesikh purchased from a local Asian market in New Jersey. The fesikh was salt-cured and fermented by wrapping uneviscerated mullet in plastic and leaving it in the kitchen for 20 days at ambient temperature. The Centers for Disease Control and Prevention (CDC) tested a leftover sample of the consumed fesikh and found it to be positive for botulinum type E toxin. Bloaters prepared by salt-curing uneviscerated, whole herring, which may or may not be smoked, can also pose a hazard. Bloaters may be transformed into other products, such as fillets or bloater paste. Uneviscerated whole fish that are dried, smoked, pickled, or fermented can also pose a public health hazard. Clostridium botulinum (C. botulinum) spores are known to be present in the internal organs of fish, especially the gills and viscera. The internal organs create a reduced oxygen environment that can support C. botulinum growth and toxin formation. Fish that will be salted, dried, pickled, smoked or fermented should be eviscerated prior to these types of processing. Without evisceration, toxin formation is possible during processing even with strict control of temperature. Evisceration should be thorough and performed to minimize contamination of the fish flesh. All internal organs, including viscera, gonads and gills, should be removed for complete evisceration, not just the intestinal tract. If even a portion or contents of the internal organs are left behind, the risk of toxin formation by C. botulinum during these types of processing remains. The FDA is not currently aware of any safe processing procedures for uneviscerated large fish (5 inches or more, including head and tail) that are processed via salt curing, drying, smoking, pickling or fermenting. Small Fish (less than 5 inches) that are too small to be completely eviscerated properly should be processed in a manner that controls the potential of C. botulinum growth and toxin formation. The problem with these processed uneviscerated large fish and fishery products is the difficulty in controlling C. botulinum inside the internal organs of the fish such as attaining sufficient levels of salt in all portions of an uneviscerated fish to inhibit the growth of C. botulinum. Therefore, any uneviscerated fish product that is salt-cured, dried, smoked, pickled, fermented, or brined, can pose a public health hazard if not processed properly, under adequately controlled conditions. Toxin may be present in these products even when there are no outward signs of microbiological spoilage or other clear indications to alert the consumer of a hazard.***
***Salt-cured, dried, smoked, pickled, fermented, or brined fish (i.e., excluding LACF and Acidified products processed in accordance with 21 CFR part113 or 114) that are whole (uneviscerated or partially eviscerated); headless (uneviscerated or partially eviscerated); or fish with internal organs remaining such as gills or gonads. The products of concern may be frozen, refrigerated, or in shelf-stable market forms in either oxygen permeable packaging or reduced oxygen packaging.***
***The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions. [INSANITARY MANUFACTURING, PROCESSING OR PACKING, Section 801(a)(1)] OASIS charge code: MFR INSAN AND The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that such article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4)] OASIS CHARGE CODE: MFR INJ***
***Divisions may detain without physical examination, the product(s) from firms identified on the Red List of this alert. Products from firms identified on the Green List have demonstrated acceptable processing controls. Additionally, following field examination, Divisions may recommend detention of the following products: Small Fish (less than 5 inches): Shipments of small fish which are: salt-cured, dried, smoked, pickled, fermented, or brined. These fish may be assumed to be uneviscerated or partially eviscerated. Large Fish (5 inches or more, including head and tail): Shipments of uneviscerated or partially eviscerated large fish which are: salt-cured, dried, smoked, pickled, fermented, or brined. FDA is not currently aware of any safe processing procedures for uneviscerated large fish. Importers may submit relevant testimony to FDA if they believe their products are not violative. The following fish are not associated with the same risk of botulism in that the processing for these types of products either are not expected to have the hazard or can control the hazard of C. botulinum growth and toxin formation; therefore, this Import Alert does not apply to: -Fully eviscerated fish; -LACF and Acidified products produced in accordance with 21 CFR Part 113 or 114; -Raw uneviscerated whole fish (i.e., in the round) including frozen raw uneviscerated fish not in reduced oxygen packaging (ROP) (raw uneviscerated fish in ROP are subject to Import Alert #16-125, as described in that import alert); -Fish sauce and fish pastes; -Fillets, parts, or other products derived from fish that are properly eviscerated prior to preservation. In addition, for the fish and fishery products listed on the Green List, FDA does not believe that there is an appearance of a violation. Entries of fish product coded as 16A[]H[], 16A[]P[], 16I[][][], 16S[][][], 16X[][][], 16Y[][][] should be reviewed to determine if they are subject to this Import Alert. Some examples of fish species or other descriptors that may be encountered at entry and considered for review include but are not limited to the following: Bloaters Boiled and dried anchovies Dried anchovies Dried sardines Dried headless fish Dry salted fish Dried whole fish Dry whole fish Cured fish Cured salted fish Half-dried fish Herring sprats Matjes herring Milker herring Ordinary cure fish Partially dried fish Pickled whole fish Roasted small fish Salted corvina Salted, in brine/whole fish Salted smoked fish Schmaltz herring Seasoned smoked fish Semi dried fish Semi dry salted fish Small fish Small light salted fish Smoke dried fish Smoke fish Soused herring Recommendations for addition to the Red List of this IA may be submitted to the Division of Import Operations (DIO) when FDA examination and/or laboratory analysis determines a product is an uneviscerated fish or partially eviscerated fish which is: salt-cured, dried, smoked, pickled, fermented, or brined; and is either a large fish (5 inches or more, including head and tail) or small fish (less than 5 inches) that, based on available information, does not appear to be processed in a manner that controls the hazard of C. botulinum growth and toxin formation. Those recommendations will be referred to the Human Foods Program (HFP) for case-by-case evaluation and concurrence. Removal from Detention Without Physical Examination (REMOVAL FROM THE RED LIST): In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (the Act). For further guidance on removal from DWPE, refer to FDA�s Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)." Processors of large uneviscerated fish longer than 5 inches (including head and tail) may submit documentation of corrective actions (such as analytical results for complete evisceration, procedures for complete evisceration, and monitoring records). Processors of small uneviscerated fish less than 5 inches in length may submit documentation of corrective actions (such as evidence that the uneviscerated fish are processed in a manner that controls the potential of C. botulinum growth and toxin formation). In addition, after reviewing these submissions, an FDA, foreign competent authority, or third-party inspection of the manufacturing facility may be recommended to verify the validity of the information submitted to FDA, before considering removal from DWPE. Addition to the Green List: Processors may apply for addition to the Green List of this Import Alert to show the fish are processed in a manner that controls the hazard of C. botulinum growth and toxin formation. This request can be provided as part of the removal from the Red List petition or done in preparation for shipping these products. This documentation should be submitted to FDA's Division of Import Operations, at either of the addresses given below. LACF and Acidified Products that are manufactured in accordance with Parts 113 and 114 are not covered under this import alert and should not apply for exemption from DWPE. To request addition to the Green List, the firm may submit documentation to FDA demonstrating that the fish is processed in a manner that the Agency will have confidence that future entries will be in compliance with the Act. Examples of such documentation that may be provided to assist FDA review may include: 1. A flowchart, hazard analysis, and/or a complete concise description of the process flow and process steps (e.g., what is done at that step with time and temperature exposures). The process for the salt-curing, drying, smoking, pickling, fermentation, or brining should be fully described with explanations about how the critical limits were established and/or any specific information to explain the basis for the limits. 2. Controls to eliminate pre-formed toxin such as a boiling step (e.g., boiling for 10 minutes at 212�F) to be conducted immediately (i.e., at the same facility) before the start of the drying or other process such as salt-curing, drying, smoking, pickling, fermenting, or brining. FDA recommends that the processing steps beginning with elimination of pre-formed toxin through to achieving a final water activity or water phase salt sufficient to control C. botulinum growth and toxin formation take place within the same processing facility. 3. The HACCP plan addressing applicable food safety hazards associated with the product. For small fish, a HACCP plan that would assist FDA�s review should, at a minimum, list critical control points (CCPs) for: sizing of the fish to be less than 5 inches (from tip of tail to tip of nose), boiling of fish for at least 10 minutes, the processing step(s) necessary to achieve a finished product with a maximum water activity of 0.85 or a minimum water phase salt of 20% (e.g., brining, salting, curing, smoking, and drying) with testing of finished product. 4. The monitoring records for at least 5 days for processing a single batch from capture to end product to illustrate the implementation of the plan. 5. Product testing results (i.e., to demonstrate adequate water phase salt, or water activity). All documents should be legible and in English. Requests for removal from DWPE under the Red List of this alert will be referred by DIO to the Human Foods Program/ Imports Enforcement Branch. If a firm and/or a representative thereof would like to submit a petition for removal from DWPE under this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov. For questions or issues involving import operations, contact OII, Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to HFP/Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: Note: The revision of this Import Alert (IA) dated 07/16/2026 updates the reason for alert, guidance section, agency contacts, product description and charge section. Changes to the import alert are bracketed by asterisks (***). *** There is a well-documented history of botulism associated with uneviscerated, salt-cured fish. In the United States between 1981 and 1987, kapchunka, an uneviscerated, salt-cured, air-dried, whole fish, which may or may not be smoked, was implicated in three outbreaks causing 3 deaths and 11 illnesses. Usually produced from whitefish, kapchunka is also known as rybetz, ribeyza, or rostov. Two additional outbreaks occurred in 1991, where faseikh was implicated in causing at least 91 illnesses and 18 deaths in Egypt. Faseikh is a traditional product made by fermenting uneviscerated fresh mullet for up to one day and then salt-curing it in barrels, which may be tightly sealed from one week to one year. In 1991, an outbreak involving four family members in New Jersey was caused by moloha, which is an uneviscerated, salt-cured fish product similar to faseikh. The risk of botulism associated with salt-cured uneviscerated fish continues to be a concern. In April of 2012 three persons were involved in an outbreak of botulism in Canada after consuming fesikh (i.e., faseikh). The fesikh was purchased at a retail store in Toronto. The fesikh was prepared from uneviscerated grey mullet, shad, and sardines that was salted in plastic buckets at room temperature for 5-6 hours, then refrigerated for 20 days and vacuum packaged and offered for sale in refrigerated display cases. On October 25, 2018, two women were hospitalized in the intensive care unit for botulism after consuming fesikh purchased from a local Asian market in New Jersey. The fesikh was salt-cured and fermented by wrapping uneviscerated mullet in plastic and leaving it in the kitchen for 20 days at ambient temperature. The Centers for Disease Control and Prevention (CDC) tested a leftover sample of the consumed fesikh and found it to be positive for botulinum type E toxin. Bloaters prepared by salt-curing uneviscerated, whole herring, which may or may not be smoked, can also pose a hazard. Bloaters may be transformed into other products, such as fillets or bloater paste. Uneviscerated whole fish that are dried, smoked, pickled, or fermented can also pose a public health hazard. Clostridium botulinum (C. botulinum) spores are known to be present in the internal organs of fish, especially the gills and viscera. The internal organs create a reduced oxygen environment that can support C. botulinum growth and toxin formation. Fish that will be salted, dried, pickled, smoked or fermented should be eviscerated prior to these types of processing. Without evisceration, toxin formation is possible during processing even with strict control of temperature. Evisceration should be thorough and performed to minimize contamination of the fish flesh. All internal organs, including viscera, gonads and gills, should be removed for complete evisceration, not just the intestinal tract. If even a portion or contents of the internal organs are left behind, the risk of toxin formation by C. botulinum during these types of processing remains. The FDA is not currently aware of any safe processing procedures for uneviscerated large fish (5 inches or more, including head and tail) that are processed via salt curing, drying, smoking, pickling or fermenting. Small Fish (less than 5 inches) that are too small to be completely eviscerated properly should be processed in a manner that controls the potential of C. botulinum growth and toxin formation. The problem with these processed uneviscerated large fish and fishery products is the difficulty in controlling C. botulinum inside the internal organs of the fish such as attaining sufficient levels of salt in all portions of an uneviscerated fish to inhibit the growth of C. botulinum. Therefore, any uneviscerated fish product that is salt-cured, dried, smoked, pickled, fermented, or brined, can pose a public health hazard if not processed properly, under adequately controlled conditions. Toxin may be present in these products even when there are no outward signs of microbiological spoilage or other clear indications to alert the consumer of a hazard.***
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