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T-850 t3018270003 From-FDA s’ Oct.-22-2002 05:44pm P. 002/005 F-340 3616 International Court NW Washington DC 20008 Tel: (202) 672-971019734 Fax (202) 5728782 FAX lo: Froth: Seng Foo Wang E-mall: eerols.com Mr Matthew Eckd Office of InternaUonal Programs Food and Drug Administration Fax: 301 - 627 0003 Pages; 4 Phone: 361- 827 0807 Date: October l&2002 C.C. MS Julia Ho, Director for Asia and Pacific, US FDA (Fax: 3MBioterrorism 927 0033) Act 2002 We are pleased to forward herewith a COKBVof tie letter from Hon. Rafidah Arir the Minister of International Trade and lndustw of Mal_avsia to Hon. Ambassador Zoel& the USTR outlining Malavsia’s concerns on vdoue aspects of the Bioterroristn Act 2002 whi.ch can have serious imolications on Malavsia’s food CtXbOrtS to the United States of America IWalayaia understands the need for the Biotsrrorism Act. However, in developing the regulations to implement the Acf it is our hope that the US Administration oaticularlv thb FDA and the Denarbnent of Health and Human Services would address the s~eclfic areas of Goncarn raised by Malaysia. The Embassy of MalaysPia is particularhr anpretlative.. of the recea ~~ortunitv to DarticiDate in the FDA discussions with tireinn embassies &d stakeholders. We certainly look forward to future consultations and discussions with the FDA in flnaliring the guidelines and regulations in implementing the Act Thank YOU, I cap 10/22/2002 TUE 16:56 [TX/RX NO 65591 @lo02 L oc t.-22-2002 0 5: 4 5 p m 4. ’ _ . T-350 t3016270003 From-FDA f’. 0 0 3 / 0 0 5 F - 3 4 0 I . . . 1 w o u ld like to & a w your a tte n tio n to th e B Io te n o r l s n ~ A ti s l g n e d b y P r e s i d e n t B u a r h In J u n e 2 0 0 2 . I a tn ~ o n & e ~ e d w ith th e u l e m e n ta tio n o f th e A ct th a t m a y h a v e serious & # k a tio n s o n N lalaysfa % fo o d e x p o r ts to th e Urlited S ta te s . M a taysla% 2. concerq o n rpeciflc sectio n s o f th e ’ Act Include: L & tJ& 3 0 3 - T h e d u m ticm a f d e te n tio n o f i m p o m d g o o d s s h o u l d b e a s shart a s p o s s tb l e to a v q i d a d d i tto n a l c o & s a n d d e l a y e d e n try o f p r o d u c ts into th e U S m a r k e t i9. & + cti~ n 3 0 4 - T h e d e b a r r e d U S fo o d i m p o r ters s h o tA b e m a d e k n o w n to M a laysian ~ ~ o rte = to a v o l d d e te n tio n o f s h i p m e n ts. . 10/22/2002 TUE 16:56 [TX/RX N O 6 5 5 9 1 kti003 act-22-2002 .I 05:45~m From-FDA t3018270003 T-350 P.004/005 F-340 _ . . . 10/22/2002 TUE 16:56 [TX/RX NO 65591 @IO04 1 Ott-22-2002 05:45pm From-FDA T-850 t3018270003 P. 005/005 F-340 a’ c the need for the BiObrrOrbm should not impede trade betwem our two countries. ComIWat@d and j3xWivek ’strict inspectIon process would affbct the cawvoetfthr@n~ of Malay&m producb and may disqpane US tradem from 4. IVlalsysSa understands Act 2002. However, the Act ImpMing MalaysIan products. I--., 5. I hdpe the United Sates would consider concerns and ensum that the lmplemfwrtdion bade and @J timer Ma,~ys$‘s of the Ati tachiyg to lntwnatlona1 mat of dohg business hrv0 countries. 10/22/2002 b&menI TUE 16:56 our’ , [TX/RX NO 65591 kilo05