This record is a partial extract of the original cable. The full text of the original cable is not available.

UNCLAS  ROME 000731 
 
SIPDIS 
 
 
HHS FOR FDA - LUMPKIN, PLAISER, FRASER 
 
E.O. 12958: N/A 
TAGS: ETRD EAGR ECON IT EUN EXPORT CONTROLS
SUBJECT: ITALY'S ONGOING CONCERNS REGARDING U.S. 
BIOTERRORISM ACT 
 
REFTEL:  03 ROME 4872 
 
¶1. Summary. GOI officials continue to raise concerns 
about the U.S. Bioterrorism Act (BTA), in particular the 
burden it places on Italian small- and medium-size 
exporters, whose products make up a significant portion 
of Italys food exports.  Officials from three ministries 
emphasized  to Embassy officials in two meetings February 
4 their close attention to the ongoing implementation of 
BTA. In addition, Embassys DHS/Bureau of Immigration and 
Customs Enforcement office has fielded numerous inquiries 
s 
from both exporters and shipping companies regarding the 
potentially negative impact of BTA on their activity. The 
GOI has requested additional seminars on BTA by 
DHS/Bureau of Customs and Border Protection (DHS/BCBP) 
officials in Italy to follow-up the successful seminars 
held in Rome and Milan last October. End summary. 
 
¶2. The Italian Agriculture Ministry called a meeting on 
February 4, attended by MFA and Foreign Trade officials, 
as well as Embassy Rome offices involved with outreach - 
FAS and DHS/Bureau of Immigration and Customs Enforcement 
(DHS/BICE). MinAg officials said that the BTA has placed 
a heavy burden on SME exporters. Italys numerous small- 
and medium-size food exporters are concerned about the 
costs associated with contracting a U.S. agent. FAS 
pointed out that the U.S. Government does not collect 
fees associated with contracting for agents, and 
suggested that Italian trade organizations might work out 
ways to reduce such costs. The GOI also views the 
application of the BTAs provisions to individuals 
shipping items to relatives and friends in the U.S. as 
excessively bureaucratic. 
 
¶3. Italian exporters have also expressed to the GOI their 
confusion regarding the timing of full implementation of 
the BTA. Embassy explained that while the prior notice 
provision became effective on Dec. 12, 2003, the U.S. 
Food and Drug Administration had agreed to phase-in full 
enforcement of the new rules by August 12, 2004. 
Notwithstanding the current leniency on enforcement, 
exporters should now make every effort to comply with the 
rules. Repeat offenders are more likely to be subject to 
penalties. 
 
¶4. Officials of the MFAs Directorate General for 
European Integration (which handles EU affairs) noted 
that the BTAs provisions on records maintenance could be 
seen as unduly interfering in an area beyond U.S. 
jurisdiction, by imposing a traceability system on non- 
U.S. entities.  FAS suggested that governments in fact 
ct 
may require foreign producers to comply with certain food 
safety standards in the production of foods to be 
consumed by its citizens. FAS recalled the example of the 
EU certified slaughter houses in the U.S., for the 
production of meat to be exported to member states. 
 
¶5. After answering other routine questions raised by the 
GOI, FAS and DHS/BICE offered cooperation with GOI 
authorities on future questions or clarification. The GOI 
MinAg offered to put together a list of specific 
questions that would be forwarded to FDA through US 
Embassy Rome. 
 
¶6. In a separate meeting February 4 with econoffs, 
Ministry of Productive Activities - Foreign Trade 
officials Sandro Fanella and Stefano Santacroce 
underscored their ministrys continued close attention to 
BTA implementation.  Supporting Italian SMEs is a prime 
concern of the Ministry, given these firms relatively 
high importance (by EU standards) to the Italian export 
sector.  Such GOI support has been manifested for years 
s 
by its keen interest in expanding the protection of 
geographic indications, also for the benefit primarily of 
SME exporters. 
 
¶7. DHS/BICE officials in Italy have registered a variety 
of concerns about BTA from Italian exporters. Small 
manufacturers have experienced difficulty because of the 
language barrier (none of the instructions are available 
in Italian), and are often unfamiliar with the processing 
 
 
of electronic paperwork on the Internet, such as 
obtaining prior notice confirmation numbers.  We have 
also heard complaints about U.S. law firms offering their 
services as U.S. agents for exporters, often at great 
expense.  Some exporters are wary of disclosing business 
confidential information to agents with whom they are 
 
SIPDIS 
largely unfamiliar. The Italian trade promotion agency 
ICE (Istituto Commercio Estero) has attempted to help 
Italian exporters in this regard by screening some of the 
companies offering their services as agents, and by 
making available to exporters a list of such agents. 
 
¶8. Shipping/forwarding companies have also raised a 
variety of concerns with us. Some are unsure about their 
legal responsibility in case a shipment is rejected 
(especially when such rejection or delay is due to 
missing or incomplete information), as well as the costs 
to be borne for a rejection or delay.  A shipping company 
could find itself responsible for the problems deriving 
from a blocked shipment even if such problems are due to 
another companys errors.  Shippers worry they will bear 
the brunt of security costs imposed on them by the BTA, 
since security burdens are not equitably shared among the 
various entities in the export chain.  The 
shipping/forwarding industry is highly competitive. With 
the cost of retrieving information in Europe higher than 
in many other parts of the world, European firms believe 
theyre at a competitive disadvantage versus firms in 
such places as Hong Kong. 
 
¶9. Another major concern is the role and responsibility 
y 
of the U.S. agent.  Many manufacturers complain that 
having a single U.S. agent could discriminate against 
exporters, since there are geographically distinct 
distribution systems in the U.S., especially between the 
east and west coasts. In addition, a manufacturer might 
not want to disclose details of its sales practices to 
different U.S. distributors. 
 
¶10. Comment. Recent meetings have underscored the GOIs 
attention, if belatedly, to the BTA and its potential 
impact on Italian food exporters.  Despite Embassys 
outreach in the last year, the GOI until recently had not 
substantively engaged the Embassy on its concerns 
regarding BTA.  Italian exporters, on the other hand, 
have long sought information on BTA, as seen by their 
heavy attendance at the two BTA seminars given by 
DHS/BCBP last October. (Embassy would welcome additional 
such seminars this year if possible).  Given the GOIs 
particular interest in protecting its small- and medium- 
sized agricultural exporters (as evidenced by its strong 
ng 
stand on expanding protection of geographic indications), 
we expect Italy would strongly support any EU-level 
approaches to the U.S. on the trade implications of BTA 
on European exporters. End comment. 
 
Sembler 
 
 
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 2004ROME00731 - Classification: UNCLASSIFIED