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Importer Security Filing
The 10+2 enforcement phase is moving into its second quarter, and Customs will be issuing more severe penalties to violations. As a reminder, please contact your AIT representative or visit the US Customs website to confirm shipment compliance.
CBP Continues Importer Security Filing Outreach
On April 23, Customs announced a new ISF Outreach Program. In order to help the trade community understand how to comply with the Importer Security Filing and Additional Carrier requirements, commonly known as "10+2," CBP will be hosting a series of webinars in the next month specifically focusing on the needs of small to medium-sized companies importing into the United States.
"CBP is committed to working with the trade community to enable successful compliance with ISF," said Kimberly Marsho, Director of Trade Relations. "The Importer Security Filing allows CBP to make earlier and more informed targeting decisions prior to cargo arriving in the U.S. which is an important layer in CBP's efforts to secure the border."
The one-hour webinars are primarily geared towards small and medium-sized importers who have limited familiarity with the Importer Security Filing and Additional Carrier Requirements. The program will consist of a high-level overview of the "10+2" requirements, an update on the statistics and current trends, critical information on enforcement, and will conclude with a question and answer session.
| West Coast Importers |
April 27, 2010 |
1pm - 2pm EDT |
| Gulf States/Mid-West Importers |
May 4, 2010 |
10am - 11am EDT |
| East Coast Importers |
May 13, 2010 |
10am - 11am EDT |
For more information and to register, visit the following link:
http://www.cbp.gov/xp/cgov/trade/trade_outreach/09_outreach_schl.xml
FDA News
Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting
The expected national rollout of FDA's PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) has been delayed indefinitely. FDA is troubleshooting IT infrastructure problems that have resulted in server crashes and overloads. Designed to help uncover adulterated and misbranded imports, the PREDICT system is in full production in the Los Angeles and New York Districts. Importers in LA and NY should be seeing higher "May Proceed" rates. FDA will resume further deployment of PREDICT when all problems have been fixed.
CDRH Transparency Website launched
In a news release dated April 19, 2010, FDA announced the launch of the Center for Devices and Radiological Health (CDRH) Transparency website. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions.
"The Center for Devices and Radiological Health Transparency website gives the public a window into our work," said CDRH Director Jeffrey Shuren, M.D. "It provides a closer and clearer look at what we do and why we do it."
The site includes information related to the following topics:
- Pre-market submissions for approved and cleared products - summaries of FDA's review of the documents and data that companies submit to FDA when requesting clearance or approval to market a new or improved device, and the systems FDA uses to evaluate these submissions.
- Post-market performance and safety - documents and data describing how well devices perform after they are on the market, and information about how FDA monitors medical device safety.
- Compliance and enforcement - official actions that FDA has taken in response to problems with devices or device companies.
- Science and research - research programs at CDRH or sponsored by CDRH.
- Educational resources - information to help industry and others understand CDRH requirements and processes.
- CDRH performance data - metrics about CDRH programs.
In the coming months, FDA will expand the CDRH Transparency website to include pre-market approval and clearance reviews.
The site includes a feedback feature that will allow FDA to collect input and suggestions from the public about the information provided.
For more information:
The FDA's Transparency Initiative
The CDRH Transparency Web site
The HHS Open Government Plan
BIS Issues Final Rule on Issuance of Paper Licenses
On April 5, the Department of Commerce's (Commerce) Bureau of Industry and Security (BIS) published a final rule in the Federal Register that covers Issuance of Electronic Documents and Related Recordkeeping Requirements.
This final rule would eliminate the return of paper versions of certain license related documents and amend the associated recordkeeping requirements.
Here are some of the documents associated with this rule:
- Export licenses
- Reexport licenses
- Notices of denial of export and reexport license applications
- Notices of return of export and reexport license applications without action
- Classification request results
- License Exception AGR notification results
- Encryption review request results.
To view the full text, please click on the following link:
http://edocket.access.gpo.gov/2010/2010-7639.htm
Consumer Product Safety Commission (CPSC)
Per National Customs Brokers & Forwarders Association (NCBFA), CPSC plans to start issuing its own import detention notices to better match its product codes to the Harmonized Tariff Schedule, etc. CPSC plans to finalize the details of these notices in a meeting with U.S. Customs and Border Protection officials in early May and start issuing its own notices by mid-May.
In cases where a shipment is only being detained for CPSC purposes, CPSC sources state that a CPSC detention notice may often be issued in lieu of a CBP detention notice. CPSC's detention notices would have more information than the current detention notices on CPSC issues provided by CBP, as they will state the potential violation(s) for which the product is being detained and include CPSC contact information.
CPSC may allow goods to be picked up by importer pending sample results. CPSC is exploring the possibility of taking samples of detained merchandise and releasing the rest of the shipment to go to the importer while the testing takes place. However, the importer would have to ensure that none of the merchandise is introduced into U.S. commerce until approval to do so is received.
Since CPSC has product codes that do not correspond to HTS numbers, the agency is working to improve this situation. For example, with all-terrain vehicles, the HTS number covers other products, but the agency only needs to target ATVs.
Also of interest are the following links from the CPSC site:
CPSC Compliance Guide Webinar on the Consumer Product Safety Improvement Act (CPSIA) - March 25, 2010
Webinar Video and PowerPoint Slides [PDF]
Bill Introduced to Require Foreign Manufacturers to Have U.S. Agents
"Foreign Manufacturers Legal Accountability Act of 2010," (H.R. 4678) was introduced into the House of Representatives on February 24, 2010. This legislation would require that manufacturers of certain products (and their components) that are being entered into the commerce of the United States must have established a registered U.S. agent located in a state with "substantial connection to the importation, distribution, or sale of the products of such foreign manufacturer or producer." This bill has been referred to the following committees, Energy and Commerce, Ways and Means, and Agriculture.
Manufacturers and producers of the following products governed by the Food and Drug Administration (FDA), Consumer Product Safety Commission (CPSC), and Environmental Protection Agency would be required to establish an agent "authorized to accept service of process against such manufacturers, and for other purposes:
- Drugs, devices, and cosmetics;
- Biological products;
- Consumer products;
- Chemical substances or new chemical substances.
In keeping with transparency mandates, the bill would require that a list of registered agents be made available to the public.
For current information on this bill, go to the legislative information from the Library of Congress website: http://thomas.loc.gov/ and enter "H.R.4678" in the "bill number" search area.
If you have any questions or comments regarding the Compliance eNewsletter,
please contact Paul Codere from the Customs Brokerage Department.
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