IA #20-05, 2/13/02, IMPORT ALERT #20-05, "DETENTION WITHOUT PHYSICAL EXAMINATION AND SURVEILLANCE OF GRAPE JUICE DUE TO LEAD CONTAMINATION" TYPE OF ALERT: Detention Without Physical Examination (DWPE) Surveillance (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: Grape juice, grape juice concentrate PRODUCT CODE: 20D[][]09 PROBLEM: Excessive levels of lead PAC FOR COLLECTION: 04019A PAF: MET (Metals in Products) COUNTRY: Argentina (AR) MANUFACTURER FEI#: Buenaventura O. Rodriguez Dir Postal 9 De Julio 427 Mendoza, Argentina FEI# 1000377025 IMPORTER'S ID#: N/A CHARGE: "The article is subject to refusal of admission to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance, lead, which may render it injurious to health [Adulteration, Section 402(a)(1)]." OASIS CHARGE CODE: POISONOUS RECOMMENDING OFFICE: SAN-DO (HFR-PA140) FLA-DO (HFR-SE240) REASON FOR ALERT: SAN-DO analyzed a shipment of grape juice concentrate and found elevated levels of lead. The average level of lead found in the concentrate was of 0.076mg/l. The calculated exposure to lead from a single 8 oz. serving prepared from this concentrate would be more than three times the Provisional Total Tolerable Intake of Lead for children. As a result of these findings, CFSAN supported a seizure of the shipment based on the excessive levels of lead. GUIDANCE: Districts may detain without physical examination shipments of grape juice concentrate from the manufacturer identified above. Surveillance of grape juice and grape juice concentrate from other Argentinean sources is warranted. For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 827-7605. PRIORITIZATION GUIDANCE: I FOI: No purging required KEYWORDS: Lead, poisonous, metals, juice, grape juice PREPARED BY: Ted Poplawski, DIOP, (301) 443-6553 DATE LOADED INTO FIARS: February 13, 2002