IA #52-11, REVISED 2/3/97 - IMPORT ALERT #52-11, "***DETENTION WITHOUT PHYSICAL EXAMINATION*** OF ENAMELWARE FROM SHANGHAI LIGHT INDUSTRIAL PROD. AND INTENSIFIED COVERAGE OF ENAMELWARE FROM ALL OTHER SOURCES IN THE PEOPLE'S REPUBLIC OF CHINA" NOTE: This revision updates the alert into the current format and PAC code. Additional changes are bracketed by asterisks (***). TYPE OF ALERT: ***Detention without physical examination*** Intensified Coverage ***NOTE: This import alert contains guidance to FDA field personnel only. It does not establish any requirements, or create any rights or obligations on FDA or on regulated entities.*** PRODUCT: Enamelware PRODUCT CODE: 52A[][]10 PROBLEM: Excessive cadmium residues (HMCD) PAC FOR COLLECTION: ***04019B*** ***PAF FOR COLLECTION: MET (Metals in products)*** COUNTRY: China, Peoples Republic of (CN, 280) MANUFACTURER/ SHIPPER: List of Manufacturers/Shippers and Products under Automatic Detention Firms Product MANUFACTURER: Shanghai Light Industrial Bumper Harvest Product 1/E Corp. Pattern 209 Yuan Ming Yuan Road Shanghai 200002, China FEI# 1000109461 MID# CNSHALIG209SHA SHIPPER: New Intertrade Co. Room 5018 Queens Rd Hong Kong FEI# 1000128328 MID# CNNEWINT5HON CHARGE: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain excessive cadmium residues, an unsafe food additive within the meaning of Section 409 [Adulteration 402(a)(2)(C)]." RECOMMENDING OFFICE: SAN-DO (HFR-PA152) REASON FOR ALERT: In October and November 1991, San Francisco district analyzed a sample of enamelware dishes with "Bumper Harvest" pattern. Laboratory analyses revealed cadmium levels ranging from 0.55 ppm to 0.71 ppm. The MOU with the Peoples Republic of China specifically covers houseware items known as "ceramicware." Enamelware is produced by a different process than items commonly known as ceramicware. Therefore, all recommendations for detention of enamelware should be submitted to ***CFSAN, DE, Imports (HFS-306)*** for review on a case by case basis. ***GUIDANCE: Districts may detain, without physical examination,*** entries of the specific pattern of enamelware from the specified manufacturer. Increased surveillance of all other patterns from the manufacturer/shippers identified. Chemical analysis for cadmium is performed using ***AOAC 984.19 Cadmium and Lead in Cookware (WHO- AOAC Method), AOAC 16th edition 9.1.03.*** ***For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact DFS at (301) 443-3320.*** PRIORITIZATION GUIDANCE: I FOI: No purging required KEYWORDS: Enamelware, cadmium, Shanghai Light PREPARED BY: Ted Poplawski, DIOP, 301-443-6553 DATE LOADED INTO FIARS: February 3, 1997