IA #20-03 REVISION - 4/3/97, IMPORT ALERT #20-03, "DETENTION WITHOUT PHYSICAL EXAMINATION OF ***RAISINS DUE TO LEAD***" - ATTACHMENT A - Revised 2/20/98, ATTACHMENT B - REVISED 4/3/97 NOTE: This alert has been reformatted to identify firms from other countries and revise the title. Additional changes are bracketed by asterisks. TYPE OF ALERT: Detention Without Physical Examination (Note: This import alert contains guidance to FDA field personnel only. It does not establish any requirements, or create any rights for, or obligations on, FDA or regulated entities.) PRODUCT: Raisins (sultanas) PRODUCT CODE: 20A[][]10 20B[]H10 PROBLEM: Excessive levels of lead (HMPB) PAC FOR COLLECTION: 04019A ***PAF: MET (Metals in Products)*** COUNTRY: ***See attachment*** MANUFACTURER/ SHIPPER: ***See attachment*** MANUFACTURER/ SHIPPER ID: ***See attachment*** CHARGE: "The article is subject to refusal of admission pursuant 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)]." RECOMMENDING OFFICE: Buffalo District, Import Operations Branch (HFR-NE350) REASON FOR ALERT: In January and February, 1996, BUF-DO sampled two lots of Turkish sultanas, a small, yellow, seedless raisin, based on information received from SEA-DO. Lead analysis revealed levels in excess of 1 ppm in both samples. Screening for lead in other shipments of Turkish raisins indicate lead levels ranging from 0.83 to 0.98 ppm. Additionally, Canada's Health Protection Branch has performed extensive lead testing of Turkish raisins with results frequently indicating lead levels of concern to FDA. FY'96 data for Turkish raisins indicates that 15 of 22 samples analyzed for lead were found to contain levels in excess of 0.250 ppm. This represents a violation rate of 68%. ***In December, 1996, detention without physical examination was extended to all Turkish sultanas.*** ***During January, 1997, BUF-DO collected a sample of Mexican raisins that were transshipped through Canada. Analysis by NERL indicated lead levels of 317 ppb and 270 ppb by original and check analysis respectively.*** GUIDANCE: Districts may detain, without physical sampling and analysis, entries of raisins from the individual firms listed on Attachment A except for the firms identified in Attachment B. Identifying specific growers can be difficult since Turkish shippers frequently purchase raisins at an open market. ***Districts should submit a recommendation for detention without physical examination for any raisin shipment found to contain lead in excess of 250 ppb.*** For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 443-3320 or 3007. PRIORITIZATION GUIDANCE: I FOI: No purging required. KEYWORDS: Raisins, sultanas, lead, poisonous, metals PREPARED BY: Ted Poplawski, DIOP, (301) 443-6553. DATE LOADED INTO FIARS: April 3, 1997 ATTACHMENT A TO IMPORT ALERT #20-03 2/20/98 Firms recommended for detention without physical examination CANADA (CA, 260) Amazin' Raisin International All raisins including 77 Comeau St. flavored raisins Atholville, Canada 2/18/98 FEI# 1000601910 MEXICO (MX, 595) FIRM DATE Grupo Agroindustrial Sonorense S.A. 3/27/97 Carretera a Nogales Km. 5 Hermosillo, Sonora, Mexico FEI# 1000279975 TURKEY (TR, 905) FIRM DATE All firms from Turkey 12/2/96 ATTACHMENT B TO IMPORT ALERT #20-03 4/3/97 Firms exempt from detention without physical examination FIRM DATE There are no firms identified at this time.