The US Food and Drug Administration (FDA) announced recently that it will require the submission of entry and shipping documents (bills of lading, air waybills, commercial invoices, etc.) for entries of FDA-regulated goods that originated from, were stored in, or transited through the Binhai New Area industrial center in Tianjin, China. The increased surveillance is one of the steps being taken in the aftermath of the August 12, 2015, chemical explosion that occurred at the Tianjin Dongjiang Port Rui Hai International Logistics Co.
The explosion site, a storage and distribution center for containers with hazardous chemicals, housed sodium cyanide (NaCN), toluenediisocyanate (TDI) and calcium carbide (CaC2), all of which are toxic and pose a direct threat to human health.
In order to verify that products are not contaminated from the explosion, the FDA will review all entry and shipping documents to determine if the shipment was in the Tianjin, China area on or after August 12,2015. Products that left Tianjin before August 12, 2015, should not require additional review outside of the routine FDA admissibility review.
Human and animal food products, human and animal drug products, and medical devices that left the Port of Tianjin on or after August 12, 2015, will require additional information in order for the FDA to make an admissibility decision.
The FDA is,therefore, requesting that importers (or their entry filers) submit the following information related to the products they are importing:
- If you are not the end commercial user of the product, provide information identifying all known recipients of the product.
- Explain the physical disposition of the product at the time of the explosion and for the time between the explosion and when it left the city of Tianjin, including the following: A) Where was the product located (geographical location) at the time of the explosion and in the aftermath of the explosion through the present? B) How the product was packaged (primary, secondary, wrapped pallet, shipping container,etc.) at the time of the explosion and in the aftermath through present.
- Explain whether risk assessment tests were conducted to determine the impact of the August 12, 2015, explosion on the safety of your product. And, if so, explain your methodology and the outcome of your assessment.
- Explain what testing has been conducted or is planned to be conducted on the product to identify contamination associated with the explosion.
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. The FDA strongly recommends the submission of documents via electronic means, such as the agency’s Import Trade Auxiliary Communication System (ITACS). Instructions on how to use ITACS can be found on the FDA’s website.
Deringer will continue to provide updates regarding supply chain effects related to the Tianjin explosion. If you have any questions about your particular shipment, please send an email to email@example.com.