On October 26, 2015, US Customs and Border Protection released a message from the Food and Drug Administration (FDA) updating the FDA’s scope of increased surveillance of certain FDA regulated products transited through the Binhai New Area Industrial Center and Xiditou Township of Beichen in Tianjin, China.
The message comes in the wake of a second blast, occurring on October 12, 2015, in a chemical warehouse owned by Tianjin Yong Sheng Fine Chemical Co., Ltd.; the blast site is suspected to have contained 3,000 kilograms of alcohol, 1,000 kilograms of acetic acid, 800 kilograms of glycerinum, and 500 kilograms of both sodium and potassium hydroxide. Other chemicals that may be associated with the explosion remain unknown.
In accordance with the previous FDA regulations, importers will be required to submit 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 warehouses.
In order to verify that products are not contaminated from the explosions, 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 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 either the August 12, 2015, or October 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. Instructions on how to use ITACS can be found on the FDA’s website. For additional information or assistance regarding this process, please send an email to compliance@anderinger.com.
In the aftermath of the Tianjin port explosions, China’s top eight container ports continue to feel the after-effects.Three ports, Shenzhen, Dalian, and Tiajin have seen modest falls in September. Tianjin, site of the explosions and China’s sixth-largest container port, dropped by more than 25 percent year-over-year in September to 922,00020-foot-equivalents units; the port was down almost 28 percent in August. The remaining five ports, Shanghai, Ningbo-Zhoushan, Qingdao, Guangzhou, and Xiamen showed minimal gains over last September. On a year-to-date basis, the top eight ports are showing an increase of 3.71 percent over the first nine months of 2014, to 111.56 million TEUs.
If you have any questions about your particular shipment, please send an email to marketing@anderinger.com.
