FDA Guidance for Products from Tianjin, China
Per CBP – CSMS (Cargo Systems Messaging Service) #15-000676:
FDA is informing US importers of intended increased surveillance of certain FDA-regulated
products imported from the industrial center Binhai New Area in Tianjin, China.
On August 12, 2015 a chemical explosion occurred at the Tianjin Dongjiang Port Rui Hai International Logistics Co., at the industrial center named Bihhai New Area. Tianjin Dongjiang Port Rui Hai International Logistics Co. Ltd. was a storage and distribution center of containers with hazardous chemicals: sodium cyanide (NaCN), toluene diisocyanate (TDI) and calcium carbide (CaC2), all of which pose direct threats to human health on contact. NaCN in particular is highly toxic.
Check out: Explosions at Chinese Container Port -Tianjin
In order to verify the products are not contaminated from the explosion, FDA will be requiring submission of entry and shipping documents (bills of lading, air waybills, commercial invoices, etc.) for entries of human and animal food products, human and animal drug products, and medical devices which are indicated as having originated from, stored in, or transited through the industrial center Binhai New Area in Tianjin, China. FDA will review the documents to determine if the shipment was in the Tianjin, China area on or after August 12, 2015. Products that left the Tianjin, China before August 12, 2015 should need no additional review other than the routine FDA admissibility review.
The FDA is therefore requesting that importers (or their entry filers) 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 disposition of the product at the time of the explosion and for the time between the explosion and when the product left Tianjin, including
- the product’s geographical location at the time of, and since, the explosion, and
- how the product was packaged (primary, secondary packaging, wrapped pallet, shipping container, etc.) at the time of, and since, the explosion
- whether the importer conducted a risk assessment to determine the impact of the explosion 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 explosion
Importers are advised that it may speed FDA’s review process if entry documentation is provided in a timely manner; and, for those shipments indicated for examination or sampling, if location and availability information is provided in a timely manner.
To facilitate receipt and review of information, FDA strongly recommends submission of documents via electronic means. FDA’s Import Trade Auxiliary Communication System (ITACS) is designed to improve communication between FDA and the import trade community and facilitate the electronic submission of documents to FDA.
To view the message: CSMS #15-000676
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