CUSTOMER ADVISORY
Yang Ming Line Chassis Policy in New York/New Jersey Area
Effective May 1, 2012, Yang Ming Marine Transport Corporation ["Yang Ming"] will no longer provide chassis for import and export shipments to and from facilities located in the New York and New Jersey Area. Shippers and Consignees are advised to secure chassis at their expense prior to picking up their container at Yang Mings nominated facility. All motor carriers, either performing merchant haulage or serving as Yang Ming house truckers, are required to secure chassis for these shipments. In case of merchant haulage, Customers are encouraged to contact their motor carriers to make arrangements in advance. Chassis providers, including chassis leasing companies and neutral chassis pools, offer chassis rental and leasing.
Please contact the below providers directly for availability and rates.
TRAC Connect - www.traconnect.com
Direct Chassis Link − www.chassislink.com
Flexi−Van − www.flexi−van.com
Colombia Trade Promotion Agreement to Take Effect on May 15, 2012
Grunfeld, Desiderio, Lebowitz, Silverman & Klestadt LLP / www.gdlsk.com
In a recent press release, the U.S. Trade Representative confirmed that the U.S. - Colombia “Trade Promotion Agreement” (“Colombia TPA”) will take effect on May 15, 2012. The Agreement itself was signed in November 2006 but was not passed into law until October of 2011.
The Colombia TPA (also referred to as the Colombia FTA) extends duty-free or reduced duty treatment to articles satisfying various eligibility rules. As with other recently implemented FTAs, the Agreement, like the NAFTA, is “tariff shift based”. What that means is that, depending upon the commodity, the use of certain foreign inputs may be permitted but they must undergo a specified change in tariff classification as a result of production in Colombia. The applicable tariff shift eligibility rule varies from commodity to commodity depending upon its tariff classification. The Colombia TPA also borrows certain substantive provisions from the DR-CAFTA (such as imposing additional requirements in the textiles and apparel chapters with respect to the origin of narrow elastic fabrics, sewing thread and pocket bag fabrics).
A very important point of which to be aware is that the Agreement provides for a phase-out of duties on qualifying articles. Depending upon the “staging category” applicable to a particular commodity, a qualifying article may become duty-free immediately on May 15, 2012 or have its duty rate phased-out over a period from two to seventeen years. It is critical that any sourcing strategies be informed not only by a commodity’s eligibility rule but its staging category as well. Separate and apart from duty considerations, the Agreement also provides that the U.S. is to eliminate the Merchandise Processing Fee on originating goods of Colombia.
The Agreement is rife with additional eligibility rules addressing such things as the impact of any non-Colombian/non-U.S. processing, the presence of de minimis amounts of non-originating materials, and the importation of retail sets incorporating foreign components that do not satisfy the Agreement rules, just to name a few. As with other Free Trade Agreements, requirements regarding recordkeeping and eligibility verifications (audits) figure prominently.
C-TPAT
C-Air LA / jrc@cairla.com
The C-Air Los Angeles office is currently going through their tri-annual validation process with Customs & Border Protection. C-Air has been a proud member of C-TPAT since 2003 and, over the years, has updated their operations to meet the needs of a secure service provider to Importers. This will be the first in a series to bring attention and assistance to Importers concerning C-TPAT.
C-Air encourages their Importers to become members of C-TPAT. Through this partnership with Customs, the program gives excellent guidelines for importers to secure their supply chain from supplier to receiving warehouses. Customs is better able to assist Importers that are members, since their security systems have already been reviewed by Customs. Importers can view the C-TPAT minimum security criteria by right-clicking and opening the following website:
http://www.cbp.gov/xp/cgov/trade/cargo_security/ctpat/ctpat_application_material/ctpat_security_guidelines/
For those Importers that have already joined C-TPAT, we ask that you provide us with your SVI number so that we can update our partner's status within Customs' system. Your Customer Service Representative will be asking for your number in the future or you can email it to jrc@cairla.com. All SVI numbers are kept confidential. C-Air's SVI number is caiBro02412.
Some Importers are participating in a supply chain security program adminstrated by a Foreign Customs Administration. Customs & Border Protection requests that you advise us of any such programs you are a member of and the Identification Number.
New Rules Impacting Trademarked Goods
Grunfeld, Desiderio, Lebowitz, Silverman & Klestadt LLP / www.gdlsk.com
U.S. Customs and Border Protection (“CBP”) is seeking comments on an interim rule that amends its regulations governing the importation of merchandise bearing recorded trademarks or recorded trade names. That interim rule becomes effective on publication in the Federal Register -- April 24, 2012.
The interim rule provides CBP with expanded authority to disclose to an intellectual property rights holder information appearing on merchandise or its packaging for the purpose of assisting CBP in determining whether the merchandise bears a counterfeit mark. CBP will now be able to share with the rights holder photographs or a sample of the goods, serial numbers, dates of manufacture, lot codes, batch numbers, universal product codes, and/or other identifying marks appearing on the merchandise or its retail packaging. The interim rule further establishes a new timeline for CBP’s detention and seizure of goods bearing potentially counterfeit marks that are recorded with CBP:
1) Within 5 days of determining to detain, CBP must issue a detention notice.
2) The importer, prior to release of the information to the rights holder, has 7 days excluding weekends and holidays to demonstrate that the marks are not counterfeit.
3) If the importer fails to demonstrate that that the goods are genuine within the 7 day period, CBP will release the information to the rights holder.
4) Customs has a 30-day period from the date on which the merchandise is presented for examination (and any extension, if requested by the importer for good cause) to make a determination with respect to admissibility. If after the 30-day detention period and any authorized extension periods the article is not released, the article will be deemed excluded.
Missing from the notice is a set time frame in which CBP must make its initial determination to detain the goods after entry. The lack of a set time frame could cause delays in the issuance of a detention notice. The Interim Rule also fails to address the consequences of the trademark holder not responding within the 30-day detention period or situations in which a rights holder may withhold authorization for legitimate gray market goods. Left unanswered is how CBP will treat goods bearing potentially counterfeit marks, where such marks are not recorded with CBP.
Comments are due by June 25, 2012
Detroit CBP Agriculture Specialists Intercept Khapra Beetle
Invasive Pest Threatens U.S. Farming Industry
U.S. Customs & Border Protection / www.cbp.gov
Detroit – U.S. Customs and Border Protection agriculture specialists (CBPAS) from the Fort Street Cargo Facility in Detroit intercepted live larvae of the invasive species Trogoderma granarium (Everts), commonly known as the Khapra Beetle.
Agriculture specialists identified for inspection an incoming sea container from the Ivory Coast destined for Washington State containing wood veneer. Upon arrival on April 5, the container was examined for possible wood packing pests. Discovered within a rodent nest inside cardboard packing were several live larvae feeding on corn seed. CBP agriculture specialists suspected the larvae were Khapra Beetles, one of the world's most feared stored-product pests, nominated as one of the 100 worst invasive species worldwide. Wheat, peanuts, barley, oats, corn, and dried orange pulp are just a few of the items this pest destroys. The larvae and images were submitted to the USDA and on April 16, and the larvae were confirmed as Khapra Beetle.
“Khapra Beetle can cause serious economic damage to our agricultural interests,” said Roderick Blanchard, port director for the area port of Detroit. “CBP agriculture specialists are committed to protecting our nation’s agriculture industry.”
The shipment was quarantined and an Emergency Action Notification (EAN) was issued. The USDA will treat the container by fumigation and afterwards will allow it to proceed to its final destination.
CBP Officers at Dulles Seize 4 lbs Cocaine in Chocolate Bars, Juice Boxes
U.S. Customs & Border Protection / www.cbp.gov
Sterling, Va. – Customs and Border Protection (CBP) officers at Washington Dulles International Airport seized more than four pounds of cocaine hidden inside chocolate bars and drink boxes in a Guatemalan woman’s luggage shortly after 11 p.m. Sunday.
CBP officers at Washington Dulles International Airport seized more than 4 pounds of cocaine hidden inside chocolate bars and drink boxes Sunday.
Officers identified the woman as a legitimate courier. She was not charged criminally, but CBP officers removed her from the United States and she faces a five-year ban from returning to the United States.
The woman arrived on a flight from San Salvador, El Salvador, and presented herself as a traveler for business. A CBP officer referred her to a secondary inspection for a baggage exam. In her baggage, CBP officers discovered eight chocolate bars, six of which contained a cocaine center, and six small drink boxes that contained plastic bags filled with cocaine. Total weight of the cocaine was 1,877 grams, or four pounds, two ounces. The street value was approximately $130,000.
“Customs and Border Protection officers are very good at finding illicit substances concealed in novel ways,” said Christopher Hess, CBP port director for the Port of Washington. “This narcotics seizure highlights the work of vigilant officers performing a thorough inspection and preventing this deadly poison from finding its way onto our community’s streets.”
Drug smuggling is a serious offense and violators risk being criminally charged.
CBP removed the woman in lieu of criminal charges. The Privacy Act prohibits releasing her name since she wasn’t criminally charged.
“Every day at Dulles we welcome thousands of business travelers to the United States,” said Hess. “But this is one type of business that doesn’t belong here.”
For more on CBP’s border security mission at our nation’s Ports of Entry, please visit the attached website.
( Ports of Entry )
FDA Strengthens International Collaboration to Ensure Quality, Safety of Imported Products
New report presents FDA’s focus on global cooperation for product safety
U.S. Food & Drug Administration / www.fda.gov
The U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. today released the agency’s “Global Engagement Report1,” detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency.
The report describes the steps the agency is taking to ensure that imported food, drugs, medical devices, and other regulated products meet the same rigorous standards for safety and quality as those manufactured domestically.
“As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world,” said FDA Commissioner Margaret A. Hamburg, M.D.
Global production of FDA-regulated goods and materials has exploded over the last decade and continues to grow. FDA-regulated products originate from more than 150 countries, 130,000 importers, and 300,000 foreign facilities. Each year from 2005-2011, food imports have grown by an average of 10 percent, while imports of pharmaceutical products have increased at nearly 13 percent and device imports have grown more than 10 percent. Approximately 50 percent of fresh fruits and 20 percent of fresh vegetables, as well as 80 percent of the seafood consumed in America come from abroad. Similarly, more than 80 percent of the active pharmaceutical ingredients used to make medicines are imported.
The report outlines a variety of engagement strategies the FDA is using in partnership with other agencies, organizations and coalitions around the world to strengthen global, regulatory capacity-building efforts; develop and harmonize science-based regulatory standards; increase awareness about the importance of regulatory systems; and share information and data globally to facilitate rapid identification of and response to public health emergencies.
Through its international offices in Africa, Asia, Europe, Latin America, and the Middle East, the FDA is increasing its knowledge base about local regulatory systems and landscapes. The agency is also increasing the understanding of foreign governments and industry of FDA regulations and standards for products destined for U.S. consumers, and collaborating to strengthen regulatory science and evidenced-based approaches to product safety and quality. All of this furthers the FDA’s implementation of its global strategy, set forth in the agency’s special report, Pathway to Global Product Safety and Quality2, released last year.
To access the Global Engagement Report3, and learn more about the FDA global work please visit the agency’s web page dedicated to its work on globalization: www.fda.gov/global4.
FDA Strengthens Monitoring of Post-Approval Drug Safety
Safety of approved drugs given same priority as premarket drug review
U.S. Food & Drug Administration / www.fda.gov
A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration’s oversight of drugs once they reach the American public, according to a new report released today by the agency’s Center for Drug Evaluation and Research (CDER). The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that give the same priority to postmarket drug safety monitoring as to premarket drug review.
The report says CDER is also delivering earlier, more effective drug safety information to the public to protect patients from harm. In 2011, CDER issued 68 drug safety communications – up from 39 in 2010. The communications provide early information to patients and health care professionals about drug safety issues as they emerge.
“Our oversight of the safety of marketed drugs has changed significantly over the past few years,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This report shows that the quality, accountability, and timeliness of postmarket drug safety decisions have been enhanced, and our public communication of this information is more effective.”
CDER introduced a comprehensive plan to strengthen drug safety in 2004 that was further enhanced with the passage of the Food and Drug Administration Amendments Act (FDAAA) of 2007. FDAAA authorized major changes to how the safety of drugs would be monitored once on the market, giving FDA the authority to require postmarket studies of drug safety concerns and drug labeling changes when new drug safety information is identified.
Since 2008, the FDA has:
• required 65 safety-related labeling changes, in addition to the safety labeling changes done voluntarily by drug manufacturers
• required manufacturers to implement a variety of Risk Evaluation and Mitigation Strategies (REMS) to ensure that the benefits of a drug or biological product outweigh its risks. FDA has required 64 complex REMS, in addition to a number of less complex REMS. Some of these REMS include plans for restricted access to certain high-risk products
• doubled staff in CDER’s Office of Surveillance and Epidemiology from 123 in 2007, to 245 in 2012. This group of drug safety specialists includes physicians, pharmacists, epidemiologists, and other professionals
• established specific safety positions within each of the Office of New Drugs’ 18 divisions that review applications for new drugs. Each division’s deputy director for safety and safety regulatory project manager helps ensure the appropriate handling of postmarket safety issues related to the drugs approved within their division.
New programs such as Safety First, Sentinel2, and Safe Use3 all demonstrate CDER’s work to strengthen the critical sciences that underpin drug safety monitoring. These new capabilities advance the FDA’s ability to track drug safety concerns, identify potential safety signals early, analyze data for its clinical significance, and determine whether a regulatory change or other solution is needed to further protect patients from drug risks.
Specific examples of the FDA’s use of new drug safety tools include:
• the Mini-Sentinel pilot project that enables FDA to assess medical product safety issues by utilizing secure access to the electronic health care information of more than 125 million patients, provided by 17 data partners nationwide
• a new division in CDER’s Office of Biostatistics that focuses exclusively on postmarket drug safety
• an expanded program that enables FDA epidemiologists and statisticians to work with outside collaborators who have access to both large population-based health care data and the expertise to use those data for drug safety studies
• advances in pharmacogenomics, or personalized medicine, to help doctors use genetic testing to anticipate the safety and effectiveness of a given drug for a given patient.
For information visit:
Report: Advances in FDA’s Safety Program for Marketed Drugs
Drug Safety Communications
Safe Use
Sentinel7
ICE Seizes Nearly $900,000 in Counterfeit Merchandise at El Paso Flea Market
U.S. Immigration & Customs Enforcement / www.ice.gov
EL PASO, Texas – Special agents with U.S. Immigration and Customs Enforcement's (ICE) Homeland Security Investigations (HSI) Sunday seized nearly 20,000 counterfeit items with a manufacturer's suggested retail price (MSRP) of nearly $900,000, at the local Fox Plaza flea market.
The enforcement operation was part of the continuing efforts of HSI's Commercial Fraud Group, and the Southwest Border Financial Operations and Currency United Strike Force (FOCUS) to track down individuals who sell counterfeit and pirated products.
It took HSI special agents a few days to count the following seized items and identify the MSRP:
8,911 DVDs with an MSRP of $122,210.72;
10,669 CDs with an MSRP of $128,454.76; and
1,728 items, including handbags, NFL merchandise and NIKE-brand sneakers with an MSRP of $648,409.15.
A total of 21,308 items were seized with an MSRP of $899,074.63.
The following Border Enforcement Task Force members also participated in the operation; U.S. Customs and Border Protection, the Texas Alcohol and Beverage Commission, and the El Paso Sheriff's Department. Trademark representatives were on site to authenticate merchandise. Representatives of the Recording Industry Association of America and the Motion Picture Association of America also assisted.
"Counterfeiting is a significant problem that affects our economy, impacts American jobs, and puts the public's health and safety at risk," said Dennis A. Ulrich, special agent in charge for HSI El Paso. "Consumers who buy pirated products may also be funding criminal organizations with their purchases."
Operations such as the one conducted at the Fox Plaza Flea Market are coordinated through the HSI-led National Intellectual Property Rights Coordination Center, one of the U.S. government's key weapons in the fight against criminal counterfeiting and piracy. The IPR Center uses the expertise of its 20 member agencies to share information, develop initiatives, coordinate enforcement actions and conduct investigations related to IP theft. Through this strategic interagency partnership, the IPR Center protects the public's health and safety, the U.S. economy and the war fighters. To report IP theft or to learn more about the IPR Center, visit www.IPRCenter.gov.