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FDA

CBP launches Trusted Trader program test

Thursday, June 26th, 2014


handshake

US Customs has launched a test of its Trusted Trader initiative, “a new program that will streamline the process through which importers can establish to CBP that they strive to secure their supply chains and strengthen their internal controls for compliance with … existing [customs] laws.”

Working in conjunction with the CPSC and FDA, CBP plans to use the Trusted Trader program to unify the current C-TPAT and ISA programs.  (Non-participating companies will still have the option to participate exclusively in C-TPAT and apply to the ISA program).  In addition, the Trusted Trader program will leverage the expertise of Customs’s CEEs “to manage trusted trader accounts from an industry perspective.”

CBP lists numerous benefits of the Trusted Trader program, including:

  • All the incentives provided by the C-TPAT and ISA programs
  • Reduced FDA targeting/examination risk score
  • Potential for penalty offsets in penalty mitigation decisions
  • Additional benefits if participating in Reconciliation Prototype program
  • Exemptions from on-site visits from Drawback Specialists
  • And much more

The Trusted Trader test is expected to last for 18 months, and the application process is now open.

See last week’s Federal Register announcement for more details.

Attend next week’s Annual State of the LA/LB Port & CBP Update

Thursday, January 2nd, 2014

owit_oc_logo_smOn January 9, Women in Trade – Orange County is hosting the Annual State of the Los Angeles/Long Beach Seaport event with a panel of the following speakers from US Customs LA/LB officials:

  • Todd Owen – Director, Field Operations
  • Carlos Martel – Port Director LA/LB Seaport
  • Elva Muneton – Assistant Port Director, Trade

Also participating in the roundtable will be:

  • Dan Solis, Director of LA District of Import Operations, FDA
  • Hank Tapy, Director, Western Region, Office of Import Surveillance & Inspection, CPSC

Discussion topics will include:

  • Headlines of 2013 — Year in Review
  • Current Updates for Trade Compliance
  • Forecast of Trade Issues, Challenges & Priorities for 2014
  • Expected Operational Changes at National and Port Locations
  • Risk Assessment Methodologies
  • New CPCS and FDA Regulations and Standards
  • Import/Export Exams, Investigations and Inspections
  • Centers of Excellence & Expertise (CEE)

Register for this event to be held in Newport Beach.

ACE: CBP hard at work integrating 47 PGAs

Monday, August 26th, 2013

seal_ace

As importers know, US Customs does not operate in a vacuum in regulating the flow of goods into US ports.  Rather, there are 47 other Participating Government Agencies (PGAs) that have some degree of oversight of shipments for entry.  As CBP gears up for full deployment of ACE in 2016, all PGAs must be integrated with ACE, creating a “single window” for trade processing.

The International Trade Data System (ITDS) is a federal inter-agency program that assists PGAs in identifying, documenting, and executing their plan to leverage ACE to improve business operations and further agency missions.

In a recent presentation for the Trade Support Network (TSN), CBP highlighted its work with the ITDS Task Force and provided a current status of ACE integration for PGAs:

  • CBP meeting with FDA every two weeks to work onboarding plan
  • Near term PGAs:
    • Data:  Census, Nuclear Regulatory Commission
    • Export licensing:  Bureau of Industry and Security, Directorate of Defense Trade Controls
    • Hazardous waste monitoring:  Environmental Protection Agency (EPA)
  • PGAs currently onboard:
    • DIS:  National Marine Fisheries Service, Food Safety Inspection Service (FSIS), Animal and Plant Health Inspection Service, Center for Disease Control and Prevention, EPA, Defense Contract Management Agency
    • Interoperability:  FSIS, Agriculture Marketing Service, U.S. Coast Guard, Consumer Product Safety Commission
    • PGA Message Set (October):  EPA, FSIS

(TSN briefing presentation > Stakeholder Webinar 080813-ALL)

FDA: Importers must vouch for safety of food brought to US

Tuesday, July 30th, 2013

fdalogoUnder the US Food and Drug Administration’s newly proposed regulations, US food importers for the first time must ensure that imported food for humans and animal is as safe as domestically produced food.

Promulgated under the Food Safety Modernization Act (FSMA), the rules, if adopted, would set parameters for foreign supplier verification programs (FSVPs) that importers must create and follow to safeguard the nation’s food supply.  The proposed rules also call for an accreditation program for third-party auditors of imported food.

According to last week’s FDA press release,

[t]he new measures respond to the challenges of food safety in today’s global food system.  Imported food comes into the United States from about 150 different countries and accounts for about 15 percent of the U.S. food supply, including about 50 percent of the fresh fruits and 20 percent of the fresh vegetables consumed by Americans.

If food importers fail to comply with the new rules, they are subject to entry and/or eligibility denials to participate in FDA’s voluntary qualified importer program (VQIP) for expedited review and entry of food, which is currently in development.  The public comment period on the proposed rules closes on November 26.

 

 

 

 

For FDA import detentions, better to submit electronic lab reports

Thursday, April 18th, 2013

fdalogoThe 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.

 

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.

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.

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

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.)

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:

  1. 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.
  2. 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.
  3. 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.