US embassy cable - 03ROME930

UNCLAS ROME 000930 
 
SIPDIS 
 
HHS FOR FDA VEEK, CARNEVALE, CARSON, BREWER 
USDA FOR DRITCHIE/FAS/EKUS 
 
E.O. 12958: N/A 
TAGS: EAGR, ETRD, TBIO, KPAO, IT, EUN 
SUBJECT: ITALY - OUTREACH ON NEW BIOTERRORISM REGULATIONS 
AND AGRICULTURE TRADE 
                       UNCLASSIFIED 
 
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REF: A. STATE 36401 
     B. ROME 812 
 
1. USING THE TALKING POINTS PROVIDED IN REF A, ON FEBRUARY 25 
ECONOFF RAISED THE PROPOSED FDA REGULATIONS TO IMPLEMENT THE 
BIOTERRORISM ACT WITH SANDRO FANELLA, WTO OFFICE DIRECTOR AT 
THE FOREIGN TRADE OFFICE, MINISTRY OF PRODUCTIVE ACTIVITIES. 
WHILE APPRECIATING THE MOTIVATION BEHIND THE U.S. 
LEGISLATION, FANELLA NOTED THAT THE GOI HAD CONCERNS 
REGARDING THE POTENTIAL OBSTACLES TO TRADE THAT THE PROPOSED 
REGULATIONS COULD ENGENDER.  HE RAISED THE FINANCIAL 
DIFFICULTY THAT SMALL-SCALE EXPORTERS MIGHT FACE IN ADHERING 
TO THE PROPOSED RULES, SPECIFICALLY THE REQUIREMENT REGARDING 
PRIOR NOTICE.  ECONOFF NOTED THAT OUR PROPOSAL ATTEMPTS TO 
SIMPLIFY THE PROCESS BY ALLOWING BOTH REGISTRATION AND PRIOR 
NOTICE TO BE PERFORMED VIA THE INTERNET.  WE ALSO EMPHASIZED 
THAT THE RULES ARE STILL JUST PROPOSALS, AND THAT THE U.S. 
WELCOMED COMMENTS FROM ANY INTERESTED PARTIES DURING THE 
PUBLIC COMMENT PERIOD.  FANELLA FURTHER COMMENTED THAT, TO 
HIS KNOWLEDGE, THE EUROPEAN COMMISSION HAD NOT YET DISCUSSED 
THIS ISSUE WITH THE U.S., THOUGH HE HOPED SUCH TALKS WOULD BE 
FORTHCOMING. 
 
2. AS REPORTED REF B, EMBASSY HAS DELIVERED INFORMATION 
PACKETS ON THE PROPOSED REGULATIONS TO A VARIETY OF 
GOVERNMENT, INDUSTRY, AGRICULTURAL AND COMMERCIAL 
REPRESENTATIVES. WE HAVE ALSO CREATED A LINK ON THE EMBASSY'S 
WEBPAGE TO THE FDA WEB ADDRESS PROVIDED IN REF A. 
SEMBLER 
 
                       UNCLASSIFIED 
 
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                       UNCLASSIFIED 
 
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 2003ROME00930 - Classification: UNCLASSIFIED