Note: The revision of this Import Alert (IA) dated 10/17/2023 updates the guidance section including agency contacts and product description. Changes to the import alert are bracketed by asterisks (***). Fresh (Raw) or Fresh Frozen Shrimp: In 1979, as a result of a high violation rate in Indian shrimp (fresh (raw) or fresh frozen), an Import Alert was issued placing all shrimp firms from India on detention without physical examination. In January 1980, a Certification Program was agreed upon by FDA and the Indian government as an assurance that more stringent testing and export controls would be implemented by the Indian government for filth and decomposition. A list of firms exempt from detention without physical examination for filth and decomposition (when accompanied by certificates) was developed. These firms remained on detention without physical examination for Salmonella. Review of the Indian certificates since 1989 by New York District disclosed a pattern of certificate alterations. This resulted in the implementation of an intensive FDA audit and surveillance sampling program demonstrating a high violation rate and further undermining agency confidence in the Indian Certification Program. Accordingly, FDA repealed the Certification Program in 1992. Cooked Shrimp: Between April and September 1994, 10 of 11 entries of cooked shrimp from India sampled by FDA were detained because of decomposition (91%). Between December 1993 and September 1994, 15 of 18 entries (83%) of Indian cooked shrimp that were sampled by FDA were detained because of decomposition.
***Fresh (Raw), Fresh Frozen Shrimp, and Cooked Shrimp***
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food. [Adulteration, Section 402(a)(3)] OASIS charge code: FILTHY and/or The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health. [Adulteration, Section 402(a)(1)] OASIS charge code: SALMONELLA
Divisions may detain, without physical examination, all fresh (raw), fresh frozen, and cooked shrimp from India, except shipments from those firms listed as exempt in the Green List to this alert. The Green List to this alert lists firms whose fresh (raw), and fresh frozen shrimp are exempt from detention without physical examination. The Green List also identifies and lists firms whose cooked shrimp are exempt from detention without physical examination. Fresh (raw), and fresh frozen shrimp should be detained for filth, decomposition, and Salmonella. Cooked shrimp should be detained for decomposition only. For cooked shrimp, the Green List for alert 16-35 applies only to decomposition. Processors of cooked shrimp that have tested positive for Salmonella are listed separately on the Red List under alert 16-81 "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella". Prior to releasing cooked shrimp listed on the Green List of this alert, cross reference alert 16-81, to determine if the processor is listed on the Red List for that import alert. It is critical that entries of cooked shrimp on the Red List under alert 16-81 due to Salmonella are not mistakenly released. Release of Articles Subject to Detention Without Physical Examination under This Import alert: ***In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product is not decomposed. Such evidence could include Private laboratory analysis of a representative sample (s) collected from the affected article. Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. Third-party laboratories may use any methods that are found acceptable to FDA. The private laboratory can check the Import Seafood Products Compliance Program, 7303.844 for analytical methods generally used by FDA.*** 1. Fresh (raw) and fresh frozen should be tested for filth, decomposition, and Salmonella by a private laboratory. 2. Cooked shrimp should be tested for decomposition by a private laboratory. 3. Should be audit sampled for filth, decomposition, and Salmonella as appropriate at a rate consistent with the divisions knowledge of the firm and private laboratory. Removal from Detention without Physical Examination (ADDITION TO THE GREEN LIST) In order to remove a firm's product from DWPE, information should be provided to the Agency to adequately demonstrates 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 (FD&C Act). 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 involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@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 10/17/2023 updates the guidance section including agency contacts and product description. Changes to the import alert are bracketed by asterisks (***). Fresh (Raw) or Fresh Frozen Shrimp: In 1979, as a result of a high violation rate in Indian shrimp (fresh (raw) or fresh frozen), an Import Alert was issued placing all shrimp firms from India on detention without physical examination. In January 1980, a Certification Program was agreed upon by FDA and the Indian government as an assurance that more stringent testing and export controls would be implemented by the Indian government for filth and decomposition. A list of firms exempt from detention without physical examination for filth and decomposition (when accompanied by certificates) was developed. These firms remained on detention without physical examination for Salmonella. Review of the Indian certificates since 1989 by New York District disclosed a pattern of certificate alterations. This resulted in the implementation of an intensive FDA audit and surveillance sampling program demonstrating a high violation rate and further undermining agency confidence in the Indian Certification Program. Accordingly, FDA repealed the Certification Program in 1992. Cooked Shrimp: Between April and September 1994, 10 of 11 entries of cooked shrimp from India sampled by FDA were detained because of decomposition (91%). Between December 1993 and September 1994, 15 of 18 entries (83%) of Indian cooked shrimp that were sampled by FDA were detained because of decomposition.
This alert covers products from: INDIA.
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