As CBP and the other government agencies get closer to the full implementation of the single-window environment known as the ACE, U.S. importers must have a strong process for validating import documents and making sure complete and accurate information is submitted through ACE upon making entry of imported goods. While the use of ACE is expected to shorten clearance times for compliant, low-risk products; import shipments lacking the necessary import data will certainly be subject to delays or rejections from the relevant regulatory agencies.

 

US Customs and Border Protection (CBP) and other Participating Government Agencies (PGAs) have updated several of their regulations to reflect the new Automated Commercial Environment (ACE) import filing requirements which are part of the trade single-window initiative.  Below is a summary of the updated regulations and highlights of important rule changes.

 

Food and Drug Administration (FDA)

Final rule effective date: December 29, 2016

https://www.federalregister.gov/documents/2016/11/29/2016-28582/submission-of-food-and-drug-administration-import-data-in-the-automated-commercial-environment

  • Import data for FDA-regulated items must be submitted through ACE. (Submission of import data through ACE is expected to facilitate automated “May Proceed “determinations for low-risk products)
  • FDA Product Codes must be consistent with invoice descriptions
  • Mandatory use of Intended-Use Codes

 

Centers for Disease Control (CDC)

Final rule effective date: December 30, 2016

https://www.federalregister.gov/documents/2016/12/30/2016-31750/electronic-filing-of-certain-import-data-into-the-document-image-system-through-the-automated

 

  • Import permit information must be submitted through ACE
  • Import certification must be submitted through ACE

 

Customs and Border Protection (CBP) and Environmental Protection Agency (EPA)

Final rule effective date January 26, 2017

https://www.federalregister.gov/documents/2016/12/27/2016-31055/toxic-substance-control-act-chemical-substance-import-certification-process-revisions

 

  • TSCA Certifications must be submitted through ACE
  • The name, phone number and email contact information for the person providing the TSCA certification must be transmitted through ACE

 

Drug Enforcement Agency (DEA)

Final rule effective date: January 30, 2017

https://www.federalregister.gov/documents/2016/12/30/2016-28966/revision-of-import-and-export-requirements-for-controlled-substances-listed-chemicals-and-tableting

 

  • The DEA import/export declarations (DEA Forms 236, 486 and 486A), will be replaced with an electronic process. Upon receipt of a complete declaration through the Diversion Control Division secure network application, DEA will provide the importer or exporter with the notice of receipt that must then be filed with CBP as part of the CBP import or export filing through ACE, or any successor system. DEA will also transmit the declaration information electronically to CBP so that customs officers can validate importations and exportations subject to DEA regulations.

 

  • The DEA is mandating electronic reporting requirements in § 1310.05 for all regulated transactions involving tableting machines and encapsulating machines, including domestic, import, and export transactions. To standardize and streamline the electronic filing of these reports, the DEA is implementing usage of a new form, DEA Form 452                                                                                                                                                

                               

Marken Trade Compliance                                                                                                                                          
January 11, 2017