ITALY - OUTREACH ON NEW BIOTERRORISM REGULATIONS

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

PAGE 02 ROME 00930 061629Z

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