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IMPORTS OF INTEREST TO FDA
In general FDA
(Food & Drug Administration)
controls imports of goods that; are
ingested, put on the skin, hold edible goods, concern the eyes,
medicines, surgical instruments etc. and articles offering relief
of a medical condition.
All FDA-regulated products are
conditionally released pending FDA's determination of
admissibility. The conditional release period is 30 days. In some
instances, FDA will need
additional
time to determine admissibility. The FDA must issue a written or
electronic notice of sampling, detention or other FDA action to
the importer of record within 30 days of the release of the
merchandise in order for the extension of the conditional release
period to be valid.
Unless extended by FDA, the
conditional release period will terminate upon the occurrence of
one of the following events.
1. Issuance by FDA of a notice of
refusal of admission;
2. Issuance by FDA that the merchandise may proceed; or
3. Expiration of the 30-day period after release of the goods.
In plain English, FDA has the power
to order the redelivery of goods subject to their review
EVEN AFTER Customs release is obtained. Goods released by
Customs may be denied entry into the United States for up to 30
days after entry. Under certain conditions this time period may
even be extended.
The practical commercial realties
notwithstanding, failing to redeliver goods back to Customs as a
result of an order of FDA can result in a penalty against the
Importer equal to three times the value of the cargo.
M.E.
Dey can help you control your FDA shipments and ensure
compliance. It is our policy to hold the goods intact before
delivery, awaiting FDA “may proceed”. At your request we will
deliver the merchandise awaiting FDA approval, but remind you of
the risks of doing this should FDA later issue a redelivery. You
can monitor the status of your FDA release and other entry data at
any time by logging on to our Internet tracking program. We can
also send automatic email notifications to individuals at your
company with FDA status updates. If you are having challenges
with FDA, or other entry processes, remember M.E. Dey can manage
your import clearances in any U.S. Port of Entry. Contact our
office for details. |
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U.S. Customs and Border Protection Mandates
Electronic Manifests Nationwide
Jan 7, 2008
Truck carriers will be required to electronically submit manifests
detailing cargo and carrier information to U.S. Customs and Border
Protection prior to arrival at Alaska land border ports beginning
Feb. 11, marking nationwide implementation of mandatory e-manifest
filing.
CBP Modernization Web
site.
more...
U.S. Customs and Border Protection Announces Container Scanning
Standards
The U.S. Customs and Border Protection Service (CBP) released its
anticipated technical standards required of container scanning
devices. The specifications constitute a roadmap for device
manufacturers to achieve the goals of the container scanning
mandate. CBP stated that all such devices must; detect door
openings after it has been armed, utilize a
non-proprietary/interoperable radio frequency wireless platform,
and are able to provide reads at the point of origin, a
pre-determined intermediate point and the destination point. The
devices must also offer a high probability of detection and a low
probability of false alarms or critical failure.
Excluded from the standards are the electronic seals of the type
that attach to the locking mechanism on the outside of the
container.
Top U.S. ports to get
RFID upgrades
By
Alice Lipowicz
The U.S. Customs and Border Protection agency has awarded Unisys
Corp. a task order worth as much as $62.2 million over five years
to deploy readers and other technologies to support the use of
radio frequency identification tags on new identification cards at
the U.S. borders.
more...
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CBP Canine Alerts to Prohibited Fruits in Sealed Cans at Chicago
O'Hare Airport
Wednesday, January 16, 2008
Chicago
— On January 9, 2008, at Chicago O'Hare International Airport,
U.S. Customs and Border Protection agriculture specialists canine
handler, with the assistance of her canine partner discovered
guavas, a prohibited food product, that were enclosed in sealed
tin cans.
more...
CBP Unveils New
Message System
Tuesday, January 15, 2008
Washington
— Users of all
U.S. Customs and Border Protection automated trade processing
systems can now obtain the latest system-related information via a
new administrative message capability, the Cargo Systems Messaging
Service. CSMS is the first CBP message database with an electronic
mailing service.
more...
CBP Issues Proposed 10 + 2 Rule Requiring Additional Cargo Information
Applies to Moves by Marine Vessel Only At This Time
January 02, 2008
U.S. Customs and Border Protection (CBP) published on January 2,
2008 a Notice of Proposed Rulemaking (NPRM) requiring importers
and carriers to electronically submit additional information on
cargo before it is brought into the United States by vessel. The
Security Filing, also known as the "10 + 2" is another step in the
Department of Homeland Security's (DHS) strategy to better assess
and identify high-risk shipments to prevent terrorist weapons and
materials from entering the United States.
more...
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US - New travel procedures for border crossers
DHS Press Release Date: January 18,
2008
The U.S. Department of Homeland Security (DHS) reminds travelers
that beginning January 31, 2008, border crossers will be asked to
present documents denoting citizenship and identity when entering
the United States through land and sea ports of entry. This change
primarily affects United States and Canadian citizens, who have
previously been permitted entry by oral declaration alone, and
marks the transition toward standard and consistent documents for
all travelers entering the country.
more...
Refresher on Export Regulations
Exporters need to remember that the Export Administration
Regulations (EAR) are not the only set of rules that can affect
their ability to sell to foreign customers. The International
Traffic in Arms Regulations (ITAR) cover military products,
defense services (consulting services to the military in any way),
and technical data.
more... |
THE WHITE HOUSE
Office of the Press Secretary
For Immediate Release January 22, 2008
STATEMENT BY THE
PRESS SECRETARY
U.S. Export Control
Reform Directives
The President signed a package of
directives that will ensure the United States' export control
policies and practices support the National Security Strategy of
2006, while facilitating the United States' continued
international economic and technological leadership. These new
directives will advance a more efficient and transparent export
licensing process and enhance dispute resolution mechanisms. They
will also help ensure proper levels of control for continued U.S.
economic competitiveness and innovation while protecting national
security. The Directives are intended to clarify and strengthen
the ability of the U.S. Government to monitor and deny U.S.
controlled goods, services or technologies to a potential enemy.
The United States
continues to face unprecedented security challenges, including
terrorist threats from the proliferation of weapons of mass
destruction and advanced conventional weapons to unstable regions
of the world. The United States also faces economic challenges
from the increasing worldwide diffusion of high technology and
global markets. As a result, the Administration will continue to
ensure that our export control system is focused to meet these
challenges. |
Fact Sheet:
Dual-Use Export Control Initiative
131 violations of the Export
Administration Regulations
WASHINGTON
– The Commerce Department’s Bureau of Industry and Security (BIS)
announced today that Northrop Grumman Corporation (Northrop) of
Los Angeles, Calif., has agreed to pay a $400,000 civil penalty to
settle allegations that it committed 131 violations of the Export
Administration Regulations, both in its own capacity and as
successor to Litton Industries, Inc., which Northrop acquired in
April 2001.
“This settlement is a reminder that comprehensive export control
compliance is vital and obligatory. The Bureau of Industry and
Security will continue to work with industry to increase awareness
of the importance of comprehensive export control due diligence in
corporate transactions, particularly in the post-9/11
environment,” said Mario Mancuso, Under Secretary of Commerce for
Industry and Security.
The allegations primarily involved unlicensed exports of specially
designed components for navigation equipment and module
manufacturing data that were to destinations in the Philippines,
Singapore, Malaysia, Italy, and the United Kingdom between January
1998 and September 2002.
Northrop voluntarily self-disclosed the violations and cooperated
fully in the investigation. BIS considers voluntary
self-disclosures to be a significant mitigating factor when
negotiating settlements of administrative cases.
Under Secretary Mancuso praised the Office of Export Enforcement's
Washington Field Office for its work on this case.
BIS
controls exports and re-exports of dual-use commodities,
technology and software for reasons of national security, missile
technology, nuclear non-proliferation, chemical and biological
non-proliferation, crime control and regional stability. Criminal
civil and administrative sanctions can be imposed for violations
of the Export Administration Regulations. For more information,
please visit
www.bis.doc.gov. |
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S H I P P I N G /
T R A D E |
 Take
the Time Before You Ship to Canada
Canada is our largest trading partner and offers a market of roughly
25 million people within 100 miles of the USA/Canadian border.
Canadian culture, business practices, attitudes and conditions are
similar to the USA making trading relatively simple. Transportation
costs are also considerably less due to the proximity of the market. If you are thinking of shipping to Canada
be sure you address the following questions which routinely come up.
more...
U.S. Losses
During 2007
Catastrophes cost
U.S. property/casualty insurers an estimated $6.5 billion in 2007, the
Insurance Services Office Inc.'s Property Claim Services unit
reported. That was the eighth-lowest catastrophe loss total in a
decade, according to PCS. PCS reported that 23
catastrophes—which PCS defines as an event that causes $25 million or
more in insured property losses and affects a significant number of
policyholders and underwriters—affected 41 states last year.
California sustained the largest loss at $1.23 billion, about $1.1
billion of which stemmed from a wildfire in San Diego County.
PCS estimated that last year's catastrophes resulted in about 1.18
million claims, the bulk of which were personal lines claims.
Business Insurance,
1/21/2008.
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Container shipping industry launches public awareness drive
January 14, 2008
The Container Shipping Information Service was launched January 10
to help people worldwide understand how the humble container box
helps them to enjoy the lives they lead in today’s
world.
more...
Census Posts Updated List of HTS
Numbers that Cannot be Used to Report Exports
The Census
Bureau has posted to its Web site a list of 180 Harmonized Tariff
Schedule (HTS) numbers that are invalid for use in reporting
exports (either via the Automated Export System (AES) or on a
paper Shipper's Export Declaration (SED)) as of January 1, 2008.
Click here for list.
Energy Bill Includes
Short Sea Shipping
Congress sent to President Bush for his signature the "Energy
Independence and Security Act of 2007" (H.R. 6), which contains an
initiative to promote short sea shipping, also known as the Marine
Highway Initiative. more... |
24 shipping lines open website to tell people the container story
TOP container shipping companies have come together to launch the
Container Shipping Information Service (CSIS), a website designed
to raise global public awareness about the "benefits and impact"
the industry has on day-to-day life.
more...
To Prevent Box
Losses
Shipping lines are taking urgent steps to tackle the problem of
containers lost overboard after being heavily criticized by
maritime safety authorities over the absence of any industry
guidelines. more...
U.S. - Korea Free
Trade Agreement
Nearly 95
percent of U.S. exports of consumer and industrial products will
enter Korea duty-free within three years of implementation of the
U.S.-Korea Free Trade Agreement. All remaining tariffs will be
phased out over ten years with the exception of tariffs on four
fish products that will be phased out over either 12 or 15 years. |
Department of Commerce Announces Signing of
‘Guidelines for U.S.-China High Technology and Strategic Trade
Development’
The U.S. Department of Commerce today announced the signing of
“Guidelines for U.S.-China High Technology and Strategic Trade
Development” (‘Guidelines’) by the U.S. Department of Commerce and
China’s Ministry of Commerce (‘MOFCOM’). The Guidelines outline
the importance of working cooperatively to achieve the mutual
benefits of promoting U.S. high technology exports to China.
more... |
Worst storm in 50 years hits China
Soldiers shovel snow on the Yangtze River Bridge in
Nanjing, Jiangsu province January 29, 2008. Millions of Chinese
shivered through power cuts and water shortages on Wednesday and
millions more were stranded by snow that has blanketed parts of
central and southern China. Picture taken January 29, 2008.
REUTERS/China Daily (CHINA) CHINA OUT
more...
China textile export growth dependent on US
07 Jan 2008, CSCB
The
value of China's textile imports grew more than 20 percent in the
first 10 months of 2007, based largely on increasing volumes to the
United States.
The
loosening of textile quotas has helped China's exports grow 20.1
percent, even as the government tried to rein in runaway export
figures through tighter export control measures.
The
growth has largely come from textiles exported to the United States,
China's second-biggest textile export market after the European Union.
The value of exported textiles to the United States rose 23.3 percent
to $21.1 billion, while the value actually went down 0.4 percent to
the EU, where China sold $23.3 billion worth of textiles in the
first 10 months of last year.
$200
Million Dairy Modernization Project in China
A
delegation from Wisconsin's sister-state in China, Heilongjiang
Province, was in Madison on Wednesday, January 9 to meet with
potential suppliers for a $200 million on a dairy improvement project.
Staff from the Wisconsin International Trade Team organized the
meeting held at the Wisconsin Department of Commerce.
more...
China Growth Record
Causes Problems
CHINA, 25 January
– CHINA’s 2007 GDP of Rmb25.7 trillion ($3.4 trillion) means its
economy grew 11.4%, again faster than in 2006 (11.1%), according to
Fairplay sources. The rapid pace of growth has left demand for goods
outstripping supply, causing high inflation (almost 5%) and major
headaches to the country’s power industry. Despite China’s huge
reserves (and a very cold winter), more than 90 power stations had to
be temporarily closed because a shortage of coal. According to
commentators, the lack of transport infrastructure in China is
exacerbating the inflation problem, not shipping. Railways simply
cannot cope with demand for goods, despite the massive building
programmes that are in place. Shipping benefited from last year's
events: Cosco saw an 85% rise in profits to more than Rmb1Bn ($150M).
On the ports front, Shanghai handled more than 26M teu, which was up
20% from the year before, while its total throughput of 560M tonnes
gave it first place again. Most other ports showed even faster growth,
surpassing 30% compared to the year before. The growth rates are
slowing, however, as some commentators believe China’s growth will
slow to 10.5%.
Lloyd's Register - Fairplay web links
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E
V E N T S / S E M I N A R S
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 Hong
Kong and China closures for the New Year’s Celebration & Spring
Festival!!!
Most
Hong Kong offices and factories are closed February 7-10
Most
China offices and factories are closed February 6-12
Mark your calendars – The Chinese year 4706 begins on February 7,
2008. The traditional Chinese celebration is 15 days long.
Although the recommended government holiday runs from February 6
to February 12, business is typically slow until the traditional
holiday ends on February 21. In addition, many manufacturing
facilities have longer holidays because of the movement of the
traveling population, estimated to be about one billion people, as
they return home for the holidays. Travelers to China should also
be aware that just prior and just following the holidays, internal
transportation ticket prices will be high and in short supply. It
is easy for travelers to become stranded, especially when
returning to larger cities unless they have purchased tickets in
advance. It is a good idea to send New Year's greetings to Chinese
customers and associates, but do not expect to conduct serious
business during this time period.
This years
holiday follows the worst snow storm in 50 years. Transportation
has all but grinded to a halt. The delays will affect freight
movement for weeks. We will do everything we can to keep freight
moving. Contact out office or check our internet tracking for
updates on your freight status.
China's Industrial Machinery / Equipment
Demands in the Pearl River Delta Webinar February 26, 2008
Learn about industrial machinery needs in China's eastern
region of the Yangtze River Delta. The webinar briefing and
Q&A discussion will be led by the US Commercial Service -
Shanghai office. Additional details to follow.
for more information, please contact:
1-800-USA-TRADE
Deborah Dirr, International Trade Specialist, U.S.
Export Assistance Center, Cincinnati, OH
Tel: 937-259-2522 Email:
ddirr@mail.doc.gov |
Technology entrepreneurs within Wisconsin’s international business
community can get support for their ideas through the Governors
Business Plan Contest. Contestants will have the opportunity to
win seed capital, valuable services that will help them launch
their businesses, and a Grand Prize worth $50,000. The statewide
contest is also a chance to get constructive feedback on a
business plan and to help move it from a virtual business to a
reality.
more...
Wisconsin’s food and beverage companies interested in expanding
their reach into China can benefit from exhibiting at the USA
Pavilion at the SIAL China Food Show. The event is scheduled for
May 14-16, 2008 in Shanghai, China.
more...
 Limited
Space on South America Mission
There are a limited number of spaces still available on a
multi-state trade mission that will travel to Argentina, Brazil,
and Chile April 19-29, 2008. This opportunity to meet agents,
distributors, and customers in three strong and growing markets is
organized by the Council of Great Lakes Governors and the
Wisconsin Department of Commerce. For more information about the
trade mission or South American markets in general, contact our
Latin American specialist, Ms. Susan Dragotta,
susan.dragotta@wisconsin.gov, ph: (262)691-5147.
Susan Dragotta,
Commerce Latin America Specialist and Outreach Consultant for
Southeast Wisconsin
Global Marketplace and South African opportunities
The Business Council Inc. and the Milwaukee World Trade
Association will Host:
Mr. Yusuf Omar
Consul General of South Africa & Other South African Dignitaries
YOU ARE INVITED!
Monday, January 14, 2008 ● 9:00 A.M.
at WE Energies M-7 Business Resource Center, 231 West Michigan
Please RSVP by
Wednesday, January 9 2008:
Lou McGlothian at
lmcglothian@mmac.org or call (414) 287-4119
HURRY SPACE IS LIMITED!!
Save the Date!
Tuesday, May 13, 2008
WI International Trade Conference Italian
Community Center, Milwaukee |
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