FDA « CustomsNow Blog

FDA

For FDA import detentions, better to submit electronic lab reports

Thursday, April 18th, 2013

The US Food & Drug Administration recently issued CSMS# 13-000181, providing guidance for importers of products subject to detention without physical examination (DWPE). In the case of such detention, FDA accepts private laboratory analysis reports in support of an importer’s case to address any alleged violation. Although the agency accepts both paper and electronic versions of these reports, it prefers that the analysis be submitted in an electronic format for faster review and processing by FDA.

Unfortunately, importers cannot submit the lab reports via ITACS, FDA’s current system that allows electronic submission of other documents related to import entry (and it’s not clear when, if ever, that will be the case). Instead, the agency requires that importers make any such electronic submissions in accordance with the rules of the specific FDA District having jurisdiction, which may, for example, have a special email account established for this purpose.

Posted in FDA | Add Comment »

FDA: Ensure renewal of foreign food facility registrations

Monday, February 18th, 2013

Importing food into the US from a foreign food facility? Make sure that facility has a valid — and renewed — registration with the US Food & Drug Administration. Otherwise, FDA may hold the imported food at the port, or even refuse import of that food.

Last year, FDA experienced a delay with the registration renewal process, and thus had issued a grace period from enforcement for “late” registration renewals submitted prior to January 31, 2013. Now, however, enforcement will commence. To that end, FDA offers the following guidance:

…[I]mport filers who file prior notices for food shipments [should] take proactive action and contact clients with high-volume food shipments, inquire about the FSMA food facility registration renewal status of foreign manufacturing facilities associated to their shipments, and confirm any new registration numbers. Doing so could greatly mitigate any prior notice shipment delays related to registration on or after February 1, 2013.

See CBP’s CSMS# 13-000044 for more details.

Posted in FDA | Add Comment »

Entry cancellation for FDA merchandise at LA/LB Seaport

Monday, November 19th, 2012

At a trade forum last week, CBP’s Entry Division at the Los Angeles/Long Beach seaport provided instructions for entry cancellations for FDA-regulated merchandise:

All cancellations for FDA-refused merchandise must be processed through Team Federal Drug Redelivery (FDR)
- Exception – You may cancel your entry only if instructed by FDA to re-transmit the data
- At no other time should you present a cancellation to entry with an outstanding FDA notice of sampling
Team FDA will refund any duties and fees due if the product was found to be prohibited
If all imported product was prohibited and subsequently exported or destroyed under CBP supervision, the entry will be submitted to the CBP Entry Team for cancellation by Team FDR

Additionally, US Customs’ procedures for general entry deletion and entry summary cancellation can be found here.

Posted in Customs & Border Protection, FDA, Ports, Post-Entry | Add Comment »

DATE/TIME CHANGE – Trade forum on FDA refusal/redelivery updates

Friday, September 7th, 2012

In follow up to our post of September 4, please note these important changes to the date and time of the forum and deadline by which to reserve your spot (changes in bold):

Date/Time: Tuesday, September 25, 2012 @ 9:30 AM
Location: Port of Long Beach Administrative Building, 925 Harbor Plaza, Long Beach, CA 90802
Reservations: Call Marissa Flores or George Sebastian, CBP Office of Port Director @ (562) 366-5700 (deadline Sept. 21)
Questions: Call Supervisory Import Specialist Harout Barsoumian @ (562) 366-5710

Posted in Events, FDA, Ports | Add Comment »

Trade forum: FDA refusal and redelivery process updates

Tuesday, September 4th, 2012

Next week, the Port of Long Beach will be hosting a trade forum for the importing community on planned updates to the FDA and CBP refusal/redelivery process. Topics will include:

FDA exams and entry review
Exports and destructions
New CBP/FDA joint redelivery process
CBP refund and cancellation policy
Refusal process for merchandise entered at LAX

Details are as follows:

Date/Time: Wednesday, September 12, 2012 @ 9:30 AM
Location: Port of Long Beach Administrative Building, 925 Harbor Plaza, Long Beach, CA 90802
Reservations: Call Marissa Flores or George Sebastian, CBP Office of Port Director @ (562) 366-5700 (deadline Sept. 10)
Questions: Call Supervisory Import Specialist Harout Barsoumian @ (562) 366-5710

(For more about the Port of Long Beach, please see our blog post about its Middle Harbor “green” project.)

Posted in Events, FDA, Ports | 1 Comment »

FDA system upgrades improve import process

Wednesday, April 18th, 2012

The US Food & Drug Administration has been working for several years to replace their legacy import system (OASIS) with a more intelligent, risk-based application which will benefit both FDA and the trade. The new system actually consists of three systems:

Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) allows FDA to use risk-based algorithms when targeting import shipments for inspection of the documents and/or cargo. It also automates the lookup function on their side to the various Centers’ databases to validate that Affirmation of Compliance numbers are valid which should speed up the review and approval process.
Import Trade Auxiliary Communications Systems (ITACS) allows importers or “anyone that knows the entry number” to submit their documents electronically to the FDA, check on the current status of their entry, and notify the FDA of the preferred exam site. ITACS can be found here.
Mission Accomplishments and Regulatory Compliance Servers (MARCS) allows FDA to view documents and exam information sent to them via ITACS.

To learn more about these programs, you can view the agency’s FAQs.

For those direct filing with the CustomsNow system, these changes do not require any updates to our application or the way in which you declare entries to FDA. Rather, they are stand-alone applications which augment the ABI data feeds to and from the FDA.

We encourage you to contact the FDA offices with which you work to determine if they are operational on these systems so that you can take advantage of this enhanced process.

Posted in FDA, News | Add Comment »

Highlights from the 2012 ICPA Conference

Friday, March 23rd, 2012

CustomsNow recently attended and exhibited at the 2012 International Compliance Professionals Association (ICPA) conference in Atlanta. As usual, there was a terrific exchange of information among the attendees. Some key takeaways were:

ACE

Customs’ new system for the filing of entries, ACE, is on a fast track and CBP anticipates completely turning off the legacy system (ACS) in approximately 2 years. Before then, certain functionality within ACS will be turned off if no longer necessary. For instance, when the transition of Rail and Sea e-Manifest filings to ACE is completed by October of this year, AMS will be decommissioned in the Automated Commercial System (ACS).

Cindy Allen, who heads up the ACE project for Customs, explained that CBP is already working in ACE and it is their “system of record.” Even if you’re filing in ACS today, your entry summary data is transferred to ACE for processing by CBP. Cindy strongly encouraged brokers and self-filers to transition to ACE as soon as possible. Her favorite quote on this topic is “I’d rather be on the bus and not under it.”

Simplified Entry

This simplified entry pilot process is a game-changer and makes a lot of sense. Entry filers will be able to file their entries as soon as the bill of lading information is available and CBP will make their admissibility decision. (Currently they will only provide a release notification 5 days before ETA.)

While your shipment is en-route, you will be able to work with CBP or any Other Government Agencies (OGA) to resolve any issues or concerns they may have (Often the only “issue” is just that that CBP or an OGA must verify that the importer has the necessary permit/document that is required for importing their product) and obtain a full release before the cargo arrives in the US. This will provide more predictability and lead to less delays at the port. Simplified entry may eventually allow for the entry summary information to be filed on an aggregate basis, perhaps once a month.

Direct Filing

There was a presentation on direct filing entries versus using a broker. The pros and cons for each option were discussed in a fair and balanced way. In the end, the consensus seemed to be that direct filing is a compelling option, due to the savings and increased control that accrue to the importer, if the importers has a solid understanding of the entry process. Importers of complicated products (special trade programs, FDA-regulated, etc.) that are interested in direct filing should consider hiring at least one individual familiar with the entry process who can then document and train the entire department. In addition, self-filing entries remotely brings greater uniformity to the process and reduces the need for port-specific entry knowledge.

Thanks to all who stopped by our booth. We enjoyed meeting you and hearing your ideas.

CustomsNow's booth at ICPA 2012 in Atlanta - L to R: Nic Adams, VP - Client Services; Randy Green, VP - Operations & Support; Karin Smith, CEO

Posted in ACE (Automated Commercial Environment), Customs & Border Protection, e-Manifest, Events, FDA, ICPA (Int'l Compliance Professionals Ass'n), Simplified Entry | 1 Comment »

CBP’s Centers of Excellence working well for CE, pharma importers

Thursday, January 12th, 2012

Under the tenure of former Commissioner Alan Bersin, CBP strived to facilitate trade. In that regard, one of Customs’ significant accomplishments has been the launch of two Centers of Excellence and Expertise (CEE), a collaborative effort between the agency and the trade.

As reported in American Shipper, the CEEs were created to expedite processing of imports in two different industries – consumer electronics in Los Angeles and pharmaceuticals in New York. To develop the program, CPB worked closely with a select group of importers in each industry (who were also enrolled in C-TPAT and ISA).

In the pilot program for pharmaceuticals which lead to the launch of the CEEs,

…small teams of [CBP] commodity specialists trained with leading pharmaceutical companies to learn how their supply chains operate and monitored the way CBP examines cargo from trusted shippers. The units identified which shippers are at risk for regulatory violations or government-caused shipping delays. CBP officials say they found many non-productive exams and document reviews being conducted, or cargo detained for clerical rather than substantive reasons. The experts then educated officers at ports how to make better decisions about whether to hold, examine or release consignments, thereby removing unnecessary holds for low-risk cargo.

Given the success of the pilot, the two CEEs officially launched in LA and NY. Required import documents for these two industries are now routed to the respective industry centers for validation, protest, PEAs/PSCs and more. Revenue collection will still occur in the ports of entry.

Although there are still issues related to legal, policy, personnel and process before the centers “achieve full operational processing capabilities,” CBP plans to roll out additional CEEs for the following industries:

Agriculture and prepared products
Automotive and aerospace
Base metals and machinery
Consumer products
Customs brokers
Industrial and manufacturing materials
Petroleum, natural gas and chemicals
Textiles, apparel and footwear

The full article, “Customer service at the border,” is available here (site registration required).

Posted in C-TPAT, CEEs (Centers of Excellence & Expertise), Customs & Border Protection, FDA, News, Ports, Post-Entry | Add Comment »

Highlights from the Trade Support Network (TSN) plenary session

Tuesday, October 11th, 2011

The Trade Support Network (TSN), a group of trade representatives who provide input to US Customs for the design and development of modernization projects, such as ACE, met in Arlington, VA, for its plenary session last month. Following is a summary of the highlights of the meetings.

Overall Message

In the current economic state, TSN’s priority is to help US Customs drive down costs for both importers and CBP, such as less exams of cargo and simplified entry processing. CBP is under significant pressure from Congress to get ACE up-and-running in order to receive funding to complete the project. Customs must show that entries are being filed in ACE and parts of ACS are being turned off.

Agency Structure

Cindy Allen, formerly with the trade, joined CBP around 1 year ago and is in charge (Exec. Director, ACE Business Office, OIT). She is doing a fantastic job of getting ACE back on track and has a great understanding of how it’s going to work. She has a new boss in Allen Gina, a 29 year veteran of CBP, and a new Exec. Director, Cargo Systems and Program Office, OIT, in LindaJacksta. Rich DiNucci, who headed up 10+2, is also on the team now.

Post Summary Corrections

As reported in this blog on September 20, PSC functionality was delivered June 4, and it became mandatory to file PSCs instead ofPEAs effective last month. PSCs may be filed 270 calendar days from date of entry, but cannot be filed within 20 calendar days of the scheduled liquidation date. Filers can request “accelerated liquidation” to get a quick bill/refund but then will forfeit an opportunity to file another PSC. It’s a full-replace of the entry and CBP will maintain all versions of entries. Importers should ensure that their ABI applications also keep versions of the entry before filing PSCs in order to keep an adequate record of their transactions with CBP.

Additionally, when the PSC is filed, the entry goes into “customs status” and CBP will remove the scheduled liquidation date. Currently filers can query the entry to get some insight as to the status, but long term there will be a UC message to all filers associated with the entry detailing the status and new liquidation information. Most PSC’s filed to date (around 100) were a “pass through” meaning they did not require CBP involvement. Note to brokers: You should review your powers of attorney to make sure your clients haven’t limited your ability to file PSCs.

Cargo Release

For this project, there is a new approach to requirement gathering – A Concept of Operations (CONOPS) has been created and all requirements mapped back to the CONOPS. Currently they are detailing the system requirement, with input from the trade and CBP field offices. These functional requirements, and the functional decomposition should be completed by June 2012. The goal is to deploy a subset of functionality within the next 18 months (then turn off selectivity in ACS)

E-Manifest: Rail & Sea

Allows holds to be placed/removed at the conveyance, container, master bill level as well as the house bill of lading level. CBP will provide brokers with a “broker download” to assist in populating the entry header. Nine early adopters will begin filing their manifest in this new system in the coming weeks in 3 ports. ETA for full deployment is January 2012, then CBP will begin decommissioning AMS in ACE. This will enable true visibility on which PGA has held merchandise and the reason for the hold.

ACE Technical Discussion (Linda Jacksta)

Remaining In-Scope: E-Manifest, Cargo Processing and release, Remaining Entry Types, Collections (lots of emphasis), and Exports. Trying to leverage existing functionality with ACE or any other federal agency systems.

Entry Simplification

See our blog post of October 4 for details.

PGA Panel Discussion

FDA is replacing OASIS with MARCS at the end of this year. A component of MARCS is PREDICT which allows FDA to automatically validate AoC qualifiers. No more AoC codes will be required in ACE as they will be mapped based on the field definition. Filers will have better visibility to the status and can receive their Notice of Sampling via the system.

Posted in ABI (Automated Brokerage Interface), ACE (Automated Commercial Environment), Customs & Border Protection, e-Manifest, FDA, News, Simplified Entry | Add Comment »

Savvy importers handle their own customs compliance

Thursday, June 30th, 2011

In an opinion piece recently published in American Shipper, “More to brokerage than pushing a button,” the president of the National Customs Brokers and Forwarders Association of America, Jeffrey Coppersmith, attempts to boost the perceived value of customs brokers. He cites the complexities in clearing CBP and other government agencies that have jurisdiction over imports.

There is no doubt that navigating this regulatory maze can be very complex. From the standpoint of a customs brokerage, it has customers that import everything from drugs to medical devices. Food to firearms. Alcohol to cars. Household effects. And everything in between. That’s clearly many different regulatory programs of which to keep track.

Importers, however, have a more narrow focus. They are very knowledgeable of their imported products and the requirements to import. The Mod Act of 1993, which placed more responsibility on importers to know importing regulations and requirements, forced most importers to invest in their customs teams. Compliance manager positions have abounded.

In a short amount of time since the Mod Act, importers were classifying their own import product, determining the correct country of origin for CBP purposes, ensuring their products met the requirements for Free Trade Agreements, and so on. Most also audited some/all of their broker’s entries (and many required correcting.) And they didn’t stop there. Many continued to research and document new processes on how to effectively clear imports through agencies like the FDA, DOT, etc.

Nowadays, most importers have mastered the knowledge relating to the import regulatory schemes to which their products are subject. They train their teams and know the “hot spots” in their import program. It is not out of the question for them to take complete control over their import program by becoming direct filers of their entries and ISFs.

Posted in Direct Filing, FDA, General | Add Comment »