Melamine tainted rice protein.
FDA Import Alert IA9928
IA #99-28, 4/19/07, IMPORT ALERT #99-28, "DETENTION WITHOUT PHYSICAL EXAMINATION OF RICE PROTEIN, RICE PROTEIN CONCENTRATE AND RICE GLUTEN DUE TO THE PRESENCE OF MELAMINE" TYPE OF ALERT: Detention Without Physical Examination (Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public). PRODUCT: Rice Protein Rice Protein Concentrate Rice Gluten PRODUCT CODES: 02D12 Rice protein/rice protein concentrate (human food use) 02D13 Rice gluten (human food use) 71I03 Rice protein/rice protein concentrate (animal food use) PROBLEM: Poisonous or deleterious substance PAF: PES PAC FOR COLLECTION: 04R853 (human food use) 71R853 (animal food use) COUNTRY: See Attachment MANUFACTURER/ FEI#: See Attachment CHARGES: "The article is subject to refusal of admission pursuant to section 801(a)(3)in that it appears to bear or contain a poisonous or deleterious substance, which may render it injurious to health [Adulteration, section 402(a)(1)]" and/or "The article is subject to refusal of admission pursuant to section 801(a)(3)in that it appears to bear or contain a food additive that is unsafe within the meaning of section 409 [Adulteration, section 402(a)(2)(C)(i)]" and/or "The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to unfit for food [Adulteration, 402(a)(3)]" RECOMMENDING OFFICE: Division of Import Operations and Policy (HFC-170)REASON FOR ALERT: On April 15, 2007, a Californian importer/marketer of ingredients for pet food notified FDA of a bag labeled as containing melamine that was included with a shipment of rice protein concentrate. The importer reported that during the week of April 2, they received and unloaded a shipment of rice protein concentrate purchased from Binzhou Futian Biology Technology Co., Ltd., Shandong, China. During the unloading of the white tote bags of rice protein concentrate, the firm's employees observed a pink bag with the word "melamine" stenciled on the side of the bag. The firm isolated the pink bag outside of the warehouse and segregated the remainder of the shipment within the warehouse. Analysis by the firm detected the presence of melamine in the rice protein concentrate in the pink bag, although it was apparently not detected in the accompanying white bags of rice protein concentrate. Subsequent analysis by FDA, however, did reveal the presence of melamine in white bags of rice protein concentrate. On April 16, 2007, an own-label distributor of pet food notified FDA that the firm had recently received complaints of vomiting and renal injury in pets. The distributor attributed the complaints to a formulation change three weeks earlier that included the incorporation of rice protein concentrate received from the Californian importer. Analysis by the firm and FDA revealed the presence of melamine in the finished pet food product. On April 17, 2007, the distributor initiated a voluntary nationwide recall of Venison dog products (dog food and dog treats) and dry Venison cat food. GUIDANCE: Districts may detain without physical examination, products offered for importation from manufacturers and shippers listed in the Attachment to this import alert. Report rice protein, rice protein concentrate and rice gluten samples found positive for melamine for animal food use to Cathie Marshall, CVM, Division of Compliance, HFV-232, at (240) 276-9217 and positive samples for melamine for human food use to Salvatore Evola, CFSAN, Division of Enforcement, HFS-606, at (301)436-2164. Appropriate screening criteria have been set for rice protein, rice protein concentrate and rice gluten from China. Recommendations for detention without physical examination of firms with violative product should be forwarded to DIOP, HFC-170. For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact Tom Savage, Division of Field Science, at (301) 827-1026. To enable the agency to assess whether the firm has identified the source of the problem, and has taken the appropriate steps to correct and prevent future occurrences, FDA recommends that a firm requesting removal from detention without physical examination provide the following information: 1. a. Results of the firm's investigation(s) into the problem of melamine contamination b. Documentation showing corrective action(s)such as: i. a description of the process(es) currently being used ii. verification that the process is adequate iii. measures that have been taken to prevent recontamination c. Copies of three (3) production records showing the process, quantities processed, lot numbers and dates of processing. AND d. Documentation showing that a minimum of five (5) consecutive entries have been released by FDA based on third party laboratory analyses that show the shipments of rice protein and rice protein concentrate do not contain melamine. All requests for removal from DWPE should be forwarded to DIOP,(HFC-170) which in turn will forward the requests to CVM (HFV-230) for evaluation. PRIORITIZATION GUIDANCE: I FOI: No purging required KEYWORDS: Feed, pet food, melamine, rice, protein, concentrate PREPARED BY: Cathie Marshall, CVM, HFV-232, 240-276-9217 and Linda Wisniowski, DIOP, HFC-172, 301-443-6553 DATE LOADED INTO FIARS: April 19, 2007 ATTACHMENT 4/19/07 Firms and products currently under detention without physical examination CHINA (CN) Firm: Date DWPE Product /Code: Binzhou Futian Biology Technology 04/19/07 Rice Protein/gluten Co., Ltd. 71I03 No. 11 Yuanqian Street, Jinsanjiao Development District, Shandong, China FEI No. 2000022765