Pharmaceutical and trade groups urged FDA to tread lightly as it puts in place new requirements for drug importers under the Food and Drug Administration Safety and Innovation Act (FDASIA). The National Customs Brokers and Forwarders Association of America (NCBFAA), American Association of Exporters and Importers (AAEI), and the Pharmaceutical Research and Manufacturers of America (PhRMA) each submitted comments in favor of an FDA definition of importer that recognizes that trade services firms like customs brokers can’t be responsible for compliance. They also said FDA should be careful not to impose new data submission requirements that are too onerous. AAEI and PhRMA pushed FDA to establish a trusted drug importer program based on the Customs-Trade Partnership Against Terrorism (C-TPAT), and NCBFAA cautioned against a repeat of the U.S. agent dilemma caused by FDA’s foreign food facility registration requirements.
Automated Commercial Environment (ACE)
The Automated Commercial Environment (ACE) is the CBP's electronic system through which the international trade community reports imports and exports and the government determines admissibility.
Capitol Hill appropriators and the House Ways and Means and Senate Finance Committees are "pleased there's an end in sight" and are supportive of CBP's effort to deploy the long-discussed Automated Commercial Environment (ACE), said Brenda Smith, executive director of the ACE Business Office. Smith met with reporters Aug. 8 to discuss movement on ACE. Still, some lawmakers are "a little skeptical," she said. Continued cuts under sequestration or otherwise would "be a risk for the program," she said. The ACE program lost about $10 million as a result of the sequestration order and related furlough mitigation in FY 2013, she said.
The Department of Homeland Security gave CBP its approval for a three-year plan to implement the Automated Commercial Environment, said CBP Acting Commissioner Tom Winkowski Aug. 7 during the CBP Advisory Committee on Commercial Operations (COAC) meeting. The plan makes use of "agile development," allowing for the addition of incremental capabilities within ACE (see 12082729). Under the three-year plan, all electronic import and export manifest data will have to be transmitted in ACE by May 1, 2015. All data associated with the release of cargo will have to be transmitted in ACE by Nov. 1, 2015, and ACE will be required for all filing by Oct. 1, 2016, CBP said.
Customs broker A.N. Deringer signed an agreement with Kewill to transition to Kewill Customs' technology platform, Kewill said July 30. Kewill called Kewill Customs “a next generation customs brokerage solution” that will offer “enhanced visibility, functionality, and robust ad hoc reporting capabilities to service both Deringer and its clients.” Sandy Mayotte, senior vice president of Deringer, said Kewill Customs’ platform design was easy to use, resulting in less time training logistics professionals to use the system “so that they can dedicate more time to renewing files and ensuring compliance for customers.
The Consumer Product Safety Commission’s proposed new requirements for certificates of compliance would impose a heavy burden on importers and customs brokers, said several companies and trade associations in response to the proposed rule (here). CBP hasn’t implemented CPSC compliance data in the Automated Commercial Environment (ACE), so electronic filing would likely take the form of complicated and time-consuming PDF submissions, said industry groups. And the proposal’s definition of importers brings customs brokers under the new requirements, even though they’re not in a position to certify compliance with product safety regulations, the National Customs Brokers & Freight Forwarders Association of America (NCBFAA) said.
CBP will add post summary corrections abilities within the Automated Commercial Environment (ACE), providing summary data to all filers of all version of the entry summary effective July 27, the agency said in CSMS message (here). CBP on Aug. 10 will also deploy changes to ACE Reports making the latest entry summary information details available to current or previous owners of the entry summary, it said in a separate notice (here). As a result, "no separation of information between owner and semiprivate owner will occur," said CBP. The agency will publish notices in the Federal Register in the near future to announce the changes, it said.
CBP is unable provide further information as to the data elements and conditions through which CBP can share data from the Automated Commercial Environment (ACE) with the Federal Maritime Commission (FMC), said a CBP spokesman. "We are not able to provide more detail regarding the data elements and the conditions under which the FMC may use them beyond what is contained in the release," he said.
The Federal Maritime Commission signed a memorandum of understanding with CBP on July 19 agreeing to share trade data within the International Trade Data System (ITDS), said CBP in a press release (here). The sharing of Automated Commercial Environment (ACE) data will help "strengthen the balance of facilitation and enforcement regarding the regulation of ocean carriers and other entities involved in trade," said CBP. The agreement means that CBP can transfer ACE data directly to the FMC to help it fulfill its "statutory and regulatory duties and responsibilities" and conserve resources within both agencies, said CBP. The agreement "specifies the specific data elements to be shared, the legal authority of FMC to receive the data and the conditions under which FMC may use, store or share the information," said CBP
CBP released the agenda for the Aug. 7 meeting with the Advisory Committee on Commercial Operations of U.S. Customs and Border Protection (COAC) in Washington, D.C. CBP also said the meeting will be available online and registration is available (here).
CBP has finished some of the initial work that will allow for entry summary quality control checks, known as edits, within the Automated Commercial Environment (ACE), said CBP in its June "ACEopedia." CBP started with Harbor Maintenance Fee (HMF) validations to lay a foundation for additional validations and "developed a business rules engine that enables development teams to more easily capture, update, and maintain the business rules that govern how the validations work within the system," it said. "As development progresses and CBP gains more experience with Agile development, increasingly complex validations will be added. The second development Increment is focused on coding validations related to Classification. CBP plans to deploy Increments 1 and 2 in October 2013."