From: mirna isyanti [mir0305@yahoo.com]
Sent: Tuesday, July 08, 2003 9:28 AM
To: fdadockets@oc.fda.gov
Subject: Comments on Docket No. 02N-0275

GABUNGAN PENGUSAHA MAKANAN DAN MINUMAN SELURUH INDONESIA

(THE INDONESIAN FOOD AND BEVERAGES MANUFACTURERS ASSOCIATION)

Dutamas Fatmawati Blok D1/30

Jl. RS. Fatmawati N0. 39

Jakarta 12150

Tel : (62-21) 7230091/7230391 Fax : (62-21) 7230090/7230392 

E-mail : gapmmi@indosat.net.id


No : 470/DPP/GAPMMI/VII/03 July 4, 2003

Docket No. 02N-0275-Detention Branch (HFA-305)

FOOD & DRUG ADMINISTRATION 

5360 Fishers Lane

Room 1061

Rockville, MD 20852


Dear Sir/Madam:


We, The Indonesian Food and Beverages Manufacturer Association, on behalf of our 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 question and comment :



  a.. 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?



  b.. SECTION 306 

Existing records are in local language. Shall these records satisfy the requirement of establishing records?


Documents needed for products traceability are very difficult for small businesses and very small businessess, 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






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