Archives from month » March, 2011

FDA Seeks to Facilitate Import Entry Review Process for Medical Devices

(World Trade Interactive)

Responding to increasing concerns with the number of imported medical devices that do not have sufficient entry data to allow prompt admissibility decisions at U.S. ports of entry, the Food and Drug Administration issued to industry members last week a letter providing specific recommendations designed to facilitate the import entry review process for these goods. It is essential, FDA states, that the appropriate personnel associated with the import process (e.g., regulatory affairs, import personnel, brokers/filers, etc.) receive and understand this information and that individual company procedures are updated accordingly.

The letter explains that when an imported product arrives in the U.S., certain information must be provided or transmitted electronically to U.S. Customs and Border Protection. If the product is or may be regulated by FDA, CBP sends the import entry information to FDA for verification to ensure that the product meets FDA requirements. Without the proper information, FDA may initiate a manual review of each line of an entry, which may lead to delays in its release to the importer or consignee.

To increase the likelihood that shipments will be processed based on import system screening and not held for further entry review, FDA recommends the submission of not only consistent and accurate identifiers for firms and correct product codes for the products being imported but also affirmations of compliance (AofC) codes along with their appropriate qualifier. FDA has developed new AofC codes and revised old ones appropriate for use when transmitting entries of imported medical devices, and the letter contains an appendix listing AofC codes with their associated descriptions and qualifiers for medical devices. According to FDA, each entry line should contain an AofC code for the following.

• device foreign manufacturer (DEV) or device foreign exporter (DFE)

• device listing (LST)

• device initial importer (DII)

• premarket application (PMA) (can be a PMA, a humanitarian device exemption (HDE) or a product development protocol (PDP) number), premarket notification number (PMN) or investigational device exemption (IDE)

FDA emphasizes that the use of these codes affirms that the product identified in an FDA import entry line meets FDA requirements specific to the product.


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Europe Moves to Ban Imports of Tar Sands Oil from Canada

(Ecologist – William McLennan)

An attempt to classify tar sands oil as more environmentally-damaging than conventional oil would effectively ban its sale within European Member States

The European Union is moving to prevent tar sands oil from entering the European market due to the greenhouse gas emissions (GHG) associated with its production.

Oil from the tar sands industry is set to be classified as having greater GHG emissions than conventional oil in a review of the European Union’s Fuel Quality Directive. Recognising the greater environmental impact of tar sands oil will effectively ban its use in EU states, where fuel providers are legally bound to aim for 6% reductions in GHG emissions by 2020. Read more here.


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China Experiences Shortages in Wake of Japanese Quake

(International Freighting Weekly – Mike King)

Supply chain disruption causing semi-shutdowns of manufacturers

China is the latest country to experience electronic and automotive parts shortages in the wake of the Japanese earthquake on 11 March. Xianfang Ren, IHS Global Insight Senior China Economist, said supply chain disruption was causing semi-shutdowns of some manufacturers dependent on components from Japan.

“Supply chain disruption is the main concern at this moment, and the slower the production in Japan recovers, the larger the impact will be in the future as inventories are being drawn down quickly to meet demand,” said Xianfang.

The Dongfeng-Nissan Auto Company’s facility in Hubei province is currently running at just one-third of normal capacity, while in Jiangsu province a number of companies have reported 8-10 week delays in component delivery from Japan and some have partially closed. Read more here.


IMPORTANT REMINDERS

(CFIA)

Plant Import Permit Validation

Please be advised that commencing April 1, 2011 CFIA will be ELECTRONICALLY validating Plant Protection Import Permits for commodities regulated under the Plant Protection Act.

For more information please view this link.

Destination Address Validation

Please be informed as of April 1, 2011, clients that transmit The Accelerated Commercial Release Operations Support System (ACROSS) data in the Customs Automated Data Exchange System (CADEX) message map will now be required to provide the destination city, destination province and destination postal code in addition to the destination name and address currently provided for all Canadian Food Inspection Agency (CFIA) transactions. These data elements must be transmitted in the RR30, RR31 and RR32 records.

Clients that transmit ACROSS data in the EDIFACT message map will be required to provide the destination city, destination province and destination postal code in addition to the destination name and address in the NAD + DP segments for all CFIA transactions.

Please be advised that the full destination address for CFIA shipments cannot be sent in a single string in either the CADEX or EDIFACT message map as the CFIA system will reject the transaction. Additionally, CFIA will introduce additional edits on this requirement. The CFIA edits will return the following messages for invalid information:

• Postal Code wrong format = CFIA-POSTAL CODE INVALID FORMAT
• Postal Code for wrong province = CFIA-POSTAL CODE INVALID FOR THIS PROVINCE
• Province blank = CFIA-FINAL DESTINATION PROVINCE MISSING
• Province spelled wrong = CFIA-FINAL DESTINATION PROVINCE
• Both Blank = CFIA-FINAL DESTINATION PROVINCE MISSING
• Both spelled Wrong = CFIA-FINAL DESTINATION PROVINCE INVALID

This new requirement for destination city, destination province and destination postal code may require a change to your current software. Further clarification on the message structure may be obtained by contacting the Electronic Commerce Unit at 1-888-957-7224.


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Canadian Wood and Housing Exporters Benefiting from Home Build in Japan

(Winnipeg Free Press – Ross Marowits, The Canadian Press)

Canadian wood and pre-manufactured housing companies are beginning to benefit from a pickup in demand resulting from the devastating earthquake and tsunami in Japan. The quake and tsunami two weeks ago caused an estimated US$310 billion of damage. More than 10,000 people have been confirmed dead and 17,000 are missing. Those who survived have been living in schools and other facilities.

Viceroy Homes Ltd. is preparing to build and ship 200 pre-engineered temporary shelters to victims displaced by the world’s costliest natural disaster. Ontario-based Viceroy hopes to win orders from Japanese partner Selco Homes for up to 2,000 of the 30,000 very basic units requested by the Japanese government. The initial order for 200 units is expected to be shipped in two weeks, Viceroy president Daniel Fox said Friday. Read more here.


Strong Loonie Should Spur Productivity: Bank of Canada

(Reuters – Leila Lemghalef)

The strong Canadian dollar should spur businesses to boost their productivity, the Bank of Canada said on Monday as it warned that pressures on exporters would not necessarily dissipate as the economy recovers.

“The fact that we have recently seen a strong dollar has played an important role in the performance of exports,” Jean Boivin, deputy governor of the central bank, said in French after a speech in Montreal. He spoke of “the importance of becoming more productive … in a world where we are faced with an appreciation of the dollar.” The slow recovery of exports was due partly to the sluggish global economy and partly to the erosion of competitiveness over the last decade, due to the Canadian dollar’s rise and to poor productivity, Boivin said during his speech. Read more here.


Canada Bridge Building Nearly Ready

(Paul Morden —The Observer/TimesHerald)

Tenants are expected to move into Blue Water Bridge Canada’s new $68 million building in the next six weeks.

The five-story building that will be home to Canada Border Services, customs brokers, the Canada Food Inspection Agency and Blue Water Bridge Canada’s offices, is on schedule and on budget, said Chuck Chrapko, president and chief executive officer of Blue Water Bridge Canada.

An additional $20 million in infrastructure work on the Canadian side is expected to be finished this month. The work includes new electronic signs and three stormwater pumping stations. Read more here.


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New ICTS Import Inspection Report (IIR) for Meat Consignments

(CFIA)

Please be informed that effective March 29, 2011 the ICTS will generate a new IIR for all the Meat consignments being imported into Canada. The new IIR will have few additional fields which are as follows:

1. Replaced Certificate No.
2. Seal Number
3. Exporting Est. No.
4. Processing Establishment
5. Foreign Slaughter Establishment
6. Product Grade
7. Shipping Marks
8. Stamp :
INSPECTED AND RELEASED

Establishment No.___________________ Date____________________

___________________________________________________________
Inspector (Signed and Printed Name)

A copy of the new IIR form can be found here (page 1) and here (page 2). Should you need more information, please contact:

Dr. Elham Guirguis DVM, MSc.
National Specialist, Import Programs / International Programs,
Meat Programs Division
Canadian Food Inspection Agency
Room T1-4-316, 1400 Merivale Rd., Ottawa, ON K1A0Y9

Tel:(613) 773–6164 Fax:(613) 773–5692 Elham.Guirguis@inspection.gc.ca


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Reliability is Metro Vancouver Port’s ‘Achilles Heel’

(The Vancouver Sun – Scott Simpson)

Threat of strike discourages investment, drives customers elsewhere: CEO

Chronic uncertainty about the threat of a labour shutdown at Port Metro Vancouver is restraining the potential growth of Canada’s largest seaport, Robin Silvester, president and CEO of the port, said Thursday.

Silvester told The Vancouver Sun editorial board that recent successes in fostering collaboration among port participants including terminal operators, truckers, shippers and railways, has improved the efficient movement of goods – and attracted glances of envy from rival North American ports. About $200 million worth of goods move through the port daily including grain, fertilizer, metals and minerals, forest products and manufactured goods.

Over the last 10 years only a handful of days have been lost for the port, particularly with federal governments showing a willingness to order shore labourers back to work within a couple days of going on strike.

However, Silvester said, the port forfeits business – as much as 10% of potential cargo over the past decade from some shippers – and discourages investments in efficiency upgrades by its stakeholders because of potential threats of strike. Read more here.


U.S. Builds Surveillance Facility to Watch Ontario Border

(CTV.ca)

A new surveillance centre at Michigan’s Selfridge Air National Guard base will be keeping an eye on both sides of the border. The base along Lake St. Clair is operated by Homeland Security but has a full-time Mountie helping scan the waterways, shorelines and the air. Ontario Provincial Police and Canadian Border Security Agency officials will have access to the information gathered on the premises. Read more here.

Related: Mountie Joins U.S. Frontier-Surveillance Centre Team (London Free Press)


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U.S. Recordkeeping and Record Access Requirements for Food Facilities Under Review

(World Trade Interactive)

The Food and Drug Administration is inviting public comments by April 27 on the proposed extension of the recordkeeping and records access requirements for food facilities under the Bioterrorism Act. This law requires that persons who manufacture, process, pack, hold, receive, distribute, transport or import food in the U.S. establish and maintain records identifying the immediate previous sources and immediate subsequent recipients of food.

Records for non-transporters must include the name and full contact information of sources, recipients and transporters; an adequate description of the food, including the quantity and packaging; and the receipt and shipping dates.
Required records for transporters include the names of the consignor and consignee, points of origin and destination, date of shipment, number of packages, description of freight, route of movement and name of each carrier participating in the transportation, and transfer points through which the shipment moved.


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WTO Says U.S. Illegally Taxes Brazilian Orange Juice [Zeroing]

(Bloomberg BusinessWeek – John Heilprin, The Associated Press)

The World Trade Organization ruled Friday that the United States is illegally taxing about $2 billion a year of imported Brazilian frozen orange juice.

Brazil’s victory comes after similar U.S. losses in trade disputes over how it applies its complex “zeroing” methodology – calculations that are used to determine how much to punish imports suspected of being “dumped” at unfairly low prices. Read more here.


The Weekly Scope: Technical Bulletins from GHY at a Glance

An updated list of recently published government memorandums, notices, regulations and decisions for the week ending March 25, 2011 is now available on our website here.


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EDC Facilitates Record CAD 10 billion in Canada-Latin America Trade

(Export Development Canada)

Export Development Canada (EDC) [has] announced a 40% increase in its Latin American business volumes in 2010, reaching a record CAD 10 billion.

“Latin America’s supply chain needs match well with Canadian expertise, particularly in key Canadian sectors like infrastructure, power, oil and gas and mining,” said Benoit Daignault, Senior Vice-President, Business Development, EDC, who will speak tomorrow at a Canada-Latin America forum, being held in conjunction with the Inter-American Development Bank Annual General Meeting in Calgary.  Read more here.


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Biodiesel Costs to Outweigh Benefits by $2.4 Billion

(Materials Management & Distribution)

The costs of the federal biodiesel mandate set to come into effect on July 1 this year outweigh the benefits by $2.4 billion over 25 years. This finding is part of a regulatory impact analysis published in the Canada Gazette.

The 4,500 member Canadian Trucking Alliance (CTA) says based on this fact the Government of Canada needs to re-think its approach to the national biodiesel mandate. The CTA wants the government to introduce measures to protect consumers of biodiesel from higher fuel prices, a loss of fuel efficiency and engine and warranty problems from sub-standard fuel. Read more here.


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EDC Facilitates Record CAD 10 billion in Canada-Latin America Trade

(Export Development Canada)

Export Development Canada (EDC) today announced a 40% increase in its Latin American business volumes in 2010, reaching a record CAD 10 billion.

“Latin America’s supply chain needs match well with Canadian expertise, particularly in key Canadian sectors like infrastructure, power, oil and gas and mining,” said Benoit Daignault, Senior Vice-President, Business Development, EDC, who will speak tomorrow at a Canada-Latin America forum, being held in conjunction with the Inter-American Development Bank Annual General Meeting in Calgary.  Read more here.


CFIA: Additional Import Controls in Place for Food Products from Japan

(CFIA)

The Canadian Food Inspection Agency (CFIA), in collaboration with the Canada Border Services Agency (CBSA) and Health Canada, is implementing enhanced import controls on milk products, fruits, and vegetables from areas of Japan affected by the ongoing nuclear crisis (Japanese prefectures of Fukushima, Gunma, Ibaraki, and Tochigi).


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U.S./Canada Pallets Makers Prepare for ISPM 15

Many U.S. wood pallet makers say they are ready for requirements set by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service and the Canadian Food Inspection Agency that will require all wood pallets moving between the countries to be treated in line with international standards against wood-eating pests reports American Shipper.

On Dec. 2, 2010, APHIS proposed regulations to remove an exemption that allows wood packaging materials from Canada to enter the United States without first meeting treatment and marking requirements that apply to these materials from all other countries. The agency said the action is needed to prevent the introduction and spread of pests via wood packaging materials from Canada. In 2004, APHIS amended its treatment regulations for imported wood packaging materials, such as pallets, crates, boxes, and blocking and bracing, to correspond with standards established by the International Plant Protection Convention’s International Standards for Phytosanitary Measures (ISPM) 15.

APHIS said the less restrictive requirements for Canadian wood packaging materials were initially based on the premise that U.S. forests share both a common boundary with Canada and, to a reasonable degree, the same forest pests. However, a recent agency risk analysis found there are unique forest pests and pathogens to Canada that have the potential to be introduced or reintroduced into the United States via the movement of untreated wood packaging materials.

CFIA agrees with APHIS on a need for a “harmonized approach” to ending the exemption from ISPM 15 on wood packaging materials moving between Canada and United States. While APHIS has yet to set its final implementation date for the rule ending the ISPM 15 exemption for Canadian wood pallets, the agency said there will be a period of “informed compliance.” During this time, wood packaging material that is not treated will be allowed to enter. However, the carrier will be notified that the materials will be required to comply once ISPM 15 is fully implemented, which is expected after a period of 32 months.

“What is important for shippers to know is that during the ‘informed compliance’ period, if insect infestation is found, loads will either be refused or treatment required prior to entering,” said Gary Sharon, vice president of Ohio based WPM manufacturer Litco International. “For companies shipping back and forth between Canada and the U.S., now is the time to convert to ISPM 15 approved export pallets and other packaging to avoid unnecessary costs and delays.”


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President’s Export Council Calls for Single Window for Import and Export Data

(World Trade Interactive)

The President’s Export Council approved March 11 a letter to President Obama that urges the federal government to fully establish an automated single shipment information window that works with equal efficiency for both imports into and exports from the U.S. The letter asserts that the absence of a single automated system for export clearance increases costs for U.S. exporters, unnecessarily adding expense and time-in-transit to business transactions. On the other hand, a single window for exports could increase the efficiency and ease of exporting, especially for small and medium-size businesses, and thus help advance the National Export Initiative’s goal of doubling U.S. exports in five years. For example, a one-day improvement in the time it takes to export from and import into the U.S., by means of a single window, could increase U.S. trade by almost $29 billion and help to create thousands of new U.S. jobs.

The letter states that while the International Trade Data System component of the Automated Commercial Environment currently under development by U.S. Customs and Border Protection has thus far focused primarily on U.S. import data, a 2010 Treasury Department report to Congress recommends that export functionality in ITDS be given a higher priority. The PEC therefore recommends that export agencies work with the ITDS board of directors to quickly identify ways to provide a single window that can create a seamless export process. The ITDS board has already engaged the Export Control Reform Task Force created by the president and is preparing to push this initiative forward.


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ATA Truck Tonnage Index fell 2.9% in February

(Transport Intelligence)

The American Trucking Associations’ advance seasonally adjusted (SA) For-Hire Truck Tonnage Index decreased 2.9% in February after increasing a revised 3.5% in January 2011. The latest drop put the SA index at 113.3 (2000=100) in February. In January, the SA index equalled 116.6. During December 2010 and January 2011, the SA tonnage index jumped a total of 6.1%.

The not seasonally adjusted index, which represents the change in tonnage actually hauled by the fleets before any seasonal adjustment, equalled 102 in February, down 2.8% from the previous month. Read more here.


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