This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a revised CPG and will be included in the next printing of the Compliance Policy Guides Manual. It is intended for FDA personnel and is available electronically to the public. This guidance document represents the Agency's current thinking on the enforcement of uneviscerated fish products that are salt-cured, dried, or smoked. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statute, regulation, or both.
Uneviscerated, salt-cured, whole fish products have caused several outbreaks of botulism and death. Botulism is a severe form of food poisoning caused by ingesting foods containing a neurotoxin produced by Clostridium botulinum. C. botulinum spores are ubiquitous in fishery products and the marine environment. The spores represent a public health hazard when conditions are suitable for vegetative cell growth and toxin production.
Three outbreaks of botulism, causing 3 deaths and 11 illnesses, resulted from kapchunka in the U.S.between 1981 and 1987. Kapchunka, an ethnic food usually produced from whitefish, is also known as "rybetz," "ribeyza," or "rostov." Kapchunka is an uneviscerated, salt-cured, air-dried, whole fish, which may or may not be smoked. It is consumed without further preparation, such as cooking. The fish are salt-cured under minimum refrigeration conditions for a minimum of 25 days and then air dried at ambient temperature for 3 to 7 days. Kapchunka may be smoked before packing and are commonly stored under refrigeration.
In 1991 two botulism outbreaks occurred. "Faseikh" was implicated in at least 91 illnesses and 18 deaths in Egypt. Faseikh is a traditional product made by fermenting uneviscerated fresh mullet for up to 1 day and then salt-curing it in barrels which may be tightly sealed from 1 week to 1 year. An ethnic fish product called "moloha" caused a botulism outbreak involving four family members in New Jersey. Moloha is an uneviscerated, salt-cured fish product similar to "faseikh." The preparation steps in the New Jerseyincident were not identified since the source of the "moloha" could not be found.
Other salt-cured products, such as "bloaters," can also pose a public health hazard. Bloaters are prepared by salt-curing uneviscerated, whole herring which may or may not be smoked. Bloaters may be transformed into other products, such as fillets or bloater paste. In addition to the products noted above, whole fish that are dried, pickled, or fermented can also pose a public health hazard. The referenced episodes of botulism are representative of a well-documented history of life-threatening health hazards associated with uneviscerated, salt-cured fish. The problems with these products are compounded by the difficulty in attaining sufficient levels of salt in all portions of an uneviscerated fish to inhibit the growth of the C. botulinum. Consequently, any fish product that is salt-cured and then dried, smoked, pickled, or fermented, can pose a public health hazard. 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.
Control of growth and toxin production from C. botulinum in fishery products is based on spore destruction (e.g., retorting canned foods) or inhibition of vegetative cell growth (e.g., control of water activity, or pH, or use of approved chemical inhibitors). The control measures must be applied rapidly and uniformly throughout the product to protect consumers from this potentially life-threatening toxin.
Control of botulism can also be achieved in salted, dried, or smoked products prepared from small species of uneviscerated fish (generally three to five inches in length). Typically, these products are prepared from small anchovy and herring sprats. As uneviscerated fish under five inches in length are processed, their smaller size helps to ensure complete permeation of the flesh with inhibitory levels of salt or drying to a uniformly low water activity, resulting in the attainment of conditions that prevent the growth of C. botulinum.
FDA considers uneviscerated fish that are salt-cured, dried, or smoked to represent a potentially life-threatening health hazard. In addition, fillets, parts, or other products derived from uneviscerated fish pose the same potential health hazard as the original product. Therefore, with the exception of small, uneviscerated fish as described above, FDA considers uneviscerated fish that have been salt-cured, dried, or smoked, as well as products made from them, to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, in that the product has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. These products are hazardous whether stored at ambient temperature, refrigerated, or frozen, or whether packaged in air, vacuum, or modified atmosphere.
REGULATORY ACTION GUIDANCE:
FDA will consider regulatory action (seizure or detention) against any uneviscerated fish greater than five inches in length that is salt-cured, dried, or smoked, or any product derived from such uneviscerated fish, in interstate commerce.
Submit all available documentation to CFSAN/Office of *Compliance* (HFS-605) for seizure consideration.
*Material between asterisks is new or revised.*
Revised: 8/10/2000, 5/2005
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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