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Update from FDA’s December 10 ACE webinar

Saturday, December 19th, 2015

Following is a brief overview of the December 10, 2015 webinar on the Food and Drug Administration (FDA) and ACE for Drugs, Devices and Biologics.

  • All FDA filings must be processed through ACE beginning February 28, 2016 (in addition to NHTSA and APHIS (Lacey)).









Process Overview

  • The process will be very similar to current state.  CBP will check for syntax errors and reject the entry if missing or invalid data.  Once it is accepted, FDA will use its PREDICT system to check for admissibility.  However, filers will not receive their determination message until 5 days before ETA.  Filers can make changes if more than 5 days prior to ETA.
  • There was some discussion of upcoming policy changes that would allow a filer to revise a submission within the 5 day window.  FDA is also considering requiring submission for FD0 flagged HTSs.
  • FDA will continue to use the ITACS system for document collection/review until the DIS system has line-level functionality.

FDA/ACE Pilot Status

  • To date, 1,000 entries subject to FDA requirements have been filed in the FDA ACE Pilot.  FDA is still on-boarding new participants, and is working with filers and importers to ensure they understand what data is required by commodity.  They can be found in the FDA Supplemental Guide, which breaks down the requirements by commodity.
  • Four parties will always be required and possibly more depending on commodity:
MF Manufacturer of goods
DEQ Shipper
FD1 FDA Import (Importer of Record)
DP Delivered To Party
  • Federal Establishment Identifier (FEI) numbers and Data Universal Numbering System (DUNS) numbers are encouraged in lieu of Name/Address and can expedite release.
    • DUNS numbers can be found here.
    • FEI numbers can be found here.
  • To participate in pilot e-mail or call FDA’s Division of Import Operations at: 301-796-0356.



ACE: Successful PGA Pilot for entries involving FDA and NHTSA

Thursday, August 27th, 2015

seal_acePer US Customs’ CSMS #15-000623:

Last week, [CBP] initiated the first Phase (I) of the PGA Pilots.  [FDA] and [NHTSA] entry data transactions were successfully transmitted, accepted and processed in [ACE].  The second Phase (II) of the PGA Pilots is scheduled to begin on September 2, 2015, with an expansion to additional ports.

In advance of the November 1, 2015 ACE mandatory filing date, CBP has also published a comprehensive overview of the schedule of PGAs and ports participating in the PGA Pilot.

Food importers: Are your foreign food facilities properly registered?

Tuesday, January 6th, 2015

produceImporting 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.

The Food Safety Modernization Act requires foreign (and domestic) facilities that manufacture, process, pack or hold food for human or animal consumption in the US to register with FDA.  These facilities must renew their registrations with FDA, every other year, by December 31 of each even-numbered year.  If a facility failed to register or renew by December 31, 2014, FDA may issue a hold for any food to be imported into the US.

FDA’s advice, per CSMS #15-000002:

“FDA encourages import brokers who file prior notices for food shipments after January 1, 2015 take proactive action and contact clients with high-volume food shipments, inquire about the renewal status of foreign manufacturing facilities associated to their shipment, and confirm any new registration numbers. Prior notices after January 1, 2015 must have a valid facility registration number. Doing so could greatly mitigate any prior notice shipment delays related to invalid or canceled registration.”



LA/LB Seaport’s new rules for FDA refused merchandise

Tuesday, December 16th, 2014

fdalogoUS Customs’ Los Angeles Field Office has released a Public Bulletin announcing revised port procedures for disposition of merchandise refused by FDA, which will be overseen by the newly created Federal Destruction and Redelivery Team (Team FDR).  Key points are as follows:

  • All merchandise refused by the FDA must be exported or destroyed under CBP and FDA supervision within 90 days of the refusal date.
  • Instead of receiving a separate CBPF 4647 and the Notice of FDA Action (Refusal), the importer will now receive a new combined “Refusal Redelivery Notice” (RRN).
  • The RRN is the Notice of Refusal stamped by CBP to indicated redelivery.  A cover sheet with port specific instructions for exportation or destruction of FDA refused merchandise will be included.

The Public Bulletin also details the specific procedures for merchandise for exportation as well as merchandise for destruction (for both seaport shipments and air shipments).

The Public Bulletin can be found here:  LA15-005 (Updated) Los Angeles Field Office Procedures for CBP-FDA Refused Merchandise



Medical device importers — new AofC qualifiers for De Novo applications

Wednesday, September 3rd, 2014

fdalogoThe Food and Drug Administration (FDA) has begun using a new numbering system for medical device De Novo applications.

Accordingly, the appropriate qualifier for the Affirmation of Compliance (AofC) code PMN will either be K or DEN, followed by 6 digits.

On a related note, previously-granted De Novo applications with 510(k) numbers have been reassigned DEN numbers as well.

Full details are available in US Customs’ CSMS #14-000482.

Also, for a general background, see FDA’s August 2014 draft guidance on the De Novo classification process.

CBP launches Trusted Trader program test

Thursday, June 26th, 2014


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


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.