From: Summas [summas@centrin.net.id] Sent: Sunday, July 06, 2003 1:35 AM To: fdadockets@oc.fda.gov Cc: gapmmi@indosat.net.id Subject: Comments on Docket No. 02N-0275 - Detention GABUNGAN PENGUSAHA MAKANAN DAN MINUMAN SELURUH INDONESIA INDONESIAN FOOD AND BEVERAGES MANUFACTURERS ASSOCIATION Dutamas Fatmawati Blok DI/30 Jl. Fatmawati No. 39, Jakarta 12150 Tel : (62-21) 7230091/7230391 Fax : (62-21) 7230090/7230391 email: gapmmi@indosat.net.id No : 470/DPP/GAPMMI/VII/03 July 4, 2003 Docket No. 02N-0275 - Detention; Docket No. 02N-0277 – Record Keeping Docket Management Branch (HFA-305) FOOD & DRUG ADMINISTRATION 5630 Fishers Lane Room 1061 Rockville, MD 20852 Dear Sir/Madam: We, The Indonesian Food and Beverage Association, on behalf of our industry members consist of food and beverage industry and trading companies would like to send some comments and questions on The Bioterrorism Act, Section 303 and Section 306. The following are questions and comment : 1. SECTION 303 - We understand that FDA has been implementing the detention to imported foodstuff of inferior quality, though regarded as unintentional contaminations. How does FDA differentiate the intentional from uncontentional contaminations which may occurs in the agriculture products of inappropriate handling? The term of Credible Evidence is very ambiguous to the exporters. The USFDA should make clear definition of Credible Evidence. - If detention occurs and that the goods is not contaminated. Who will pay for the cost occurs during the detention? 2. SECTION 306 - Existing records are in local language. Shall these records satisfy the requirement of establishing records? - Documents needed for product traceability are very difficult for small businesses and very small businesses, especially those who manufacture foodstuffs with various mixed ingredients from various suppliers. We request that FDA will also provide guidance and training for capacity building of small/very small business in foreign countries, especially in developing countries, to comply with requirements of the Act. We thank you on your consideration of our comments and questions. We hope that the implementation of the Bioterrorism Act will bring benefit to the developing countries in improving our capacity. Yours truly, Ir. THOMAS DARMAWAN Executive Director