Note: The revision of this Import Alert (IA) dated 03/26/2024 updates the reason for alert, agency contacts, and charge code language. 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. More recently, 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 Center for Disease Control (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. Because Clostridium botulinum (C. botulinum) spores are known to be present in the viscera, fish that will be preserved by salting, drying, pickling, or fermentation must be eviscerated prior to processing. Without evisceration, toxin formation is possible during the process even with strict control of temperature. Evisceration must be thorough and performed to minimize contamination of the fish flesh. All the organs, including gonads, are required to be removed for complete evisceration, not just the intestinal tract. If even a portion of the viscera or its contents is left behind, the risk of toxin formation by C. botulinum remains. There are no known safe processing procedures for uneviscerated large fish. The problem with these fish and fishery products is the difficulty in 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 registered and filed under 21 CFR 108/113 or 114) that are whole (uneviscerated or partially eviscerated); headless (uneviscerated or partially eviscerated); or fish with gonads remaining in the body cavity. The products of concern may be frozen, refrigerated, or in shelf-stable market forms in either aerobic or oxygen-limiting 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.*** [ADULTERATION, Section 402(a)(4)] OASIS charge code: MFR INSAN
Divisions may detain the product(s) from firms identified in the Red List of this alert and meets the definition of uneviscerated large or small fish: Small Fish (less than 5 inches): Divisions may detain shipments of uneviscerated or partially eviscerated small fish which are: salt-cured, dried, smoked, pickled, fermented, or brined, unless the manufacturer is listed in the Green List of this import alert. Large Fish (5 inches or more, including head and tail): Divisions may also detain shipments of uneviscerated or partially eviscerated large fish which are: salt-cured, dried, smoked, acidified, pickled, fermented, or brined. There are no known safe processing procedures for uneviscerated large fish. Fish and fishery products not indicated for detention under this Import Alert include those listed on the Green list of this alert and the following: Fully eviscerated fish, split head-on, or split headless fish. LACF and Acidified products produced in accordance with a scheduled LACF/AF process on file with CFSAN. Products where the manufacturer has registered under 21 CFR Part 108 and filed the schedule processes under 21 CFR 113 or 114; Raw uneviscerated fish (i.e., in the round) including frozen raw uneviscerated fish; Fish sauce and fish pastes; Fillets, parts, or other products derived from fish that are properly eviscerated prior to preservation are not covered under this import alert. Divisions should review entries of fish that are coded as 16A[]H[], 16A[]P[], 16I[][][],16S[][][],16X[][][],16Y[][][] to determine if they are subject to this Import Alert. Some examples of fish species or other descriptors that may meet these criteria 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 The following procedures apply for the inclusion to or removal from detention without physical examination of foreign processor/product combinations listed in the Red List to this import alert: For inclusion to the Red List: DWPE will be indicated 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 is a small fish (less than 5 inches) not known to be processed in a manner that controls the potential of C. botulinum growth and toxin formation (i.e. the processor is not on the IA Green List). Divisions should forward recommendations through the Division of Import Operations (DIO) to the Center for Food Safety and Applied Nutrition (CFSAN), Office of Compliance, Division of Enforcement for addition to the Red List. Processors of small fish (less than 5 inches in length) such as anchovies and herring sprats may apply for exemption (inclusion on the Green List of this Import Alert), provided the fish are appropriately handled and processed in a manner that controls the potential of C. botulinum growth and toxin formation. Processors of uneviscerated finfish products must demonstrate a process that results in either a water-phase salt level of at least 20% or a water activity of 0.85 or less or a pH of 4.6 or less. LACF and Acidified Products with a filed scheduled process (i.e. under 108 113 or 114) are not covered under this import alert and do not need to apply for exemption or removal from DWPE. This documentation can also be submitted to FDA's Division of Import Operations, at either of the addresses given below. NOTE: Since the article is subject to Refusal of Admission per Section 801(a)(1) of the Act, FDA considers submission of analytical results alone to be insufficient to overcome the appearance of the product having been prepared, packed, or held under insanitary conditions. In addition, the appearance of a violation per Section 801(a)(1) of the Act precludes reconditioning under Section 801(b) of the Act. Petitions for removal of a firm subject to DWPE may be removed from the Red List or added to the green list by submitting verification per 21 CFR 123.12(d) that the fish or fishery product(s) in question has/have been processed in compliance with the seafood HACCP regulation (21 CFR part 123), and should 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). The process for the salt-curing, drying, smoking, acidifying, 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 formation such as a pre-boiling step (i.e., 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, pH, or water phase salt sufficient to control Clostridium botulinum toxin formation take place within the same processing facility. 3. HACCP plan or plans that address all food safety hazards associated with the product. The seafood HACCP regulation requires that plans be specific for each location where fish and fisheries products are processed. When processing of the fish occurs at different and/or multiple locations (e.g. additional drying, or repacking at different locations) and a hazard analysis determines that a food safety hazard may be associated with the product or process, documentation should be submitted for each location and should clearly indicate each processing location (name and address). The HACCP plan should, at a minimum, list critical control points (CCPs) for: sizing of the fish to be less than 5 inches, boiling of fish for at least 10 minutes, the processing step(s) necessary to achieve a finished product with a water activity of ?0.85 or a water phase salt of ?20% or pH ?4.6 (e.g., brining, salt-curing, smoking, and drying) with testing of finished product, and finished product labeling for allergens. Additional CCPs may be needed to control additional hazards such as pathogen growth as a result of time and temperature abuse, and histamine, depending on the species of fish and processing. 4. The monitoring records for at least 5 days for a single batch from capture to end product to illustrate the implementation of the plan. If monitoring records from multiple locations are provided, the processing location should clearly be identified for each record. 5. Product testing results (i.e., to demonstrate adequate water phase salt, or water activity or pH). 6. All documents must be in English. When additional species and/or process-related food safety hazards are associated with an applicant's products and when the information provided does not demonstrate that adequate controls are in place for those hazards, the Agency may consider enforcement action to address control of those hazards. This could result in issuance of a Warning Letter or addition of the firm and its products on to Import Alert #16-120. Removal from Detention without Physical Examination (REMOVE FROM RED LIST): Requests for removal from detention without physical examination under the red list of this alert will be referred by DIO to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch for evaluation. For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)." If a firm and/or a representative thereof would like to request removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forward to the following address: Food and Drug Administration Division of Import Operations 12420 Parklawn Drive, ELEM-3109 Rockville, MD 20857 Or via email to: Importalerts2@fda.hhs.gov *** Questions or issues involving import operations should be addressed to 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 the Human Foods Program 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 03/26/2024 updates the reason for alert, agency contacts, and charge code language. 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. More recently, 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 Center for Disease Control (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. Because Clostridium botulinum (C. botulinum) spores are known to be present in the viscera, fish that will be preserved by salting, drying, pickling, or fermentation must be eviscerated prior to processing. Without evisceration, toxin formation is possible during the process even with strict control of temperature. Evisceration must be thorough and performed to minimize contamination of the fish flesh. All the organs, including gonads, are required to be removed for complete evisceration, not just the intestinal tract. If even a portion of the viscera or its contents is left behind, the risk of toxin formation by C. botulinum remains. There are no known safe processing procedures for uneviscerated large fish. The problem with these fish and fishery products is the difficulty in 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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