"Detention without physical Examination of *** Uneviscerated Fish Or Partially Eviscerated Fish that are either Sat-Cured, Dried, Smoked Acidified, Pickled, Fermented or Brined" ***

The revision of this Import Alert, dated 3/14/2011, changes the name of the alert; updates the alert to the current format and terminology; expands the products of interest to include partially uneviscerated fish that are smoked, acidified, pickled, fermented, or brined; updates the Reason for Alert; includes a list of specific products that are subject to this alert; and creates a Red List to include specific product/processors combinations which are subject to DWPE. Changes bracketed by ***

***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 cause by moloha, which is an uneviscerated, salt-cured fish product similar to faseikh.

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, acidified, 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, acidified, 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. ***

*** Districts may detain, without physical sampling and analysis, the products noted in the Red List of this import alert.

Large Fish (5 inches or more, including head and tail): Districts 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.

Small Fish (less than 5 inches): Districts may also detain shipments of uneviscerated or partially eviscerated small fish which are: salt-cured, dried, smoked, acidified, pickled, fermented, or brined; unless the manufacturer is listed in the Green List of this import alert.

Fully eviscerated fish, split head-on, or split headless fish are not indicated for detention under this Import Alert. Products produced in accordance with a scheduled LACF/AF process on file with CFSAN are also not indicated for detention under this Import Alert.

Districts should review entries of fish that are coded as (16A-H-), (16A-P-),
(16 I - - --), (16 S - - --) to determine if they are subject to this Import Alert.

Some examples of fish species or other descriptors that may meet these criteria include:
Bloaters
Boiled and dried anchovies
Dried anchovies
Dried sardines
Cured fish
Cured salted fish
Dried headless fish
Dry salted fish
Dried whole fish
Dry whole 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

For questions regarding these criteria or whether products are covered, contact CFSAN/OC/DE/PAB.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.


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 IA 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, acidified, 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. FDA District Offices will submit a revision to incorporate the product and the foreign manufacturer (processor) on the Red List of this import alert to the Division of Import Operations and Policy.

For removal from DWPE: Foreign processors listed on the Red List of this import alert may request removal from that list by submitting documentation demonstrating the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.

The above documentation should be submitted to FDA's Division of Import Operations and Policy, at the following address:

Food and Drug Administration
Division of Import Operations and Policy
12420 Parklawn Drive
ELEM - Room 3109
Rockville, MD 20857

Or via email at: www.importalerts2@fda.hhs.gov


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 and results in either water-phase salt level of at least 10 percent, a water activity below 0.85, or a pH of 4.6 or less. This documentation can also be submitted to FDA's Division of Import Operations and Policy, at either of the above addresses. ***

*** Salt-cured, dried, smoked, acidified, pickled, fermented, or brined fish 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) of the Act in that it appears to have been manufactured, processed, or packed, under insanitary conditions. [ADULTERATION, Section *** 402(a)(4) ***]

OASIS Charge Code: MFR INSAN