Documentation Requirements for FDA-Regulated Goods Imported from Chinese Port Expanded
The Food and Drug Administration its expanding its requirement for the submission of entry and shipping documents (bills of lading, air waybills, commercial invoices, etc.) for entries of FDA-regulated human and animal food products, human and animal drug products, and medical devices imported from the Chinese port of Tianjin. This requirement initially applied to such goods that originated from, were stored in or transited through the Binhai New Area industrial center following an Aug. 12 explosion at a hazardous chemical container storage and distribution center there. The FDA is now expanding this requirement to such goods that originated from, were stored in or transited through Xiditou Township of Beichen District in Tianjin following an Oct. 12 explosion at a warehouse reported to have stored alcohol, acetic acid, glycerinum, sodium hydroxide, potassium hydroxide and possibly other chemicals as well.
The FDA will continue to review the entry and shipping documents submitted to determine if a shipment was in the Tianjin area on or after Aug. 12. Products that left the Tianjin area before this date should need no additional review other than the routine FDA admissibility review. However, regulated goods that left the Tianjin area on or after Aug. 12 will continue to require additional information to enable the FDA to make an admissibility decision.
The FDA is therefore requesting that importers (or their entry filers) continue to submit the following information related to the products they are importing.
- if the importer is not the end commercial user of the product, information identifying all known recipients of the product
- the physical description and geographic location of the product at the time of the explosions and from the time between the explosion and when the product left Tianjin, including (a) the product’s geographical location at the time of, and since, the explosions, and (b) how the product was packaged (primary, secondary packaging, wrapped pallet, shipping container, etc.) at the time of, and since, the explosions
- whether the importer conducted a risk assessment to determine the impact of the explosions on the safety of its product and, if so, the methodology used and the outcome of the assessment
- what testing has been conducted or is planned to be conducted on the product to identify contamination associated with the explosions
Importers are advised that it may speed the FDA’s review process if entry documentation and, for shipments indicated for examination or sampling, location and availability information is provided in a timely manner. To that end, FDA strongly recommends the submission of documents via electronic means such as the agency’s Import Trade Auxiliary Communication System. Instructions on how to use ITACS can be found here.
Harry Zhang, vice president, China customs consulting and compliance, for Sandler & Travis, advises that some companies shipping goods through Tianjin have returned them to be destroyed rather than face possible delays in entering the U.S. due to concerns of contamination, while some are seeking certification of non-contamination so their exports may proceed. Others are working to reroute their shipments through other Chinese ports. Zhang states that Sandler & Travis’ Shanghai office staff can help companies determine which option is best for them and deal with vendors, brokers and government agencies to ensure all requirements are met. For more information, please contact Harry Zhang at 86.138.2626.5357 or via email.