FDA to Require Additional Info From Importers Affected by Tianjin Port Explosion
The Food and Drug Administration will require extra documentation from importers of food, drugs and medical devices that have passed through the port of Tianjin, China due to a recent industrial accident that resulted in the release of toxic chemicals, said CBP in a CSMS message dated Sept. 11 (here). Entry and shipping documents such as bills of lading, air waybills and commercial invoices must be submitted to FDA for any entries of human and animal food products, human and animal drug products, and medical devices that are indicated as having originated from, stored in, or transited through the industrial center Binhai New Area in Tianjin, China, said CBP.
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FDA will review the additional documentation to determine whether the imported product was in the affected area at the time of the explosion, said CBP. Products that left Tianjin before the explosion occurred on Aug. 12 will elicit no further FDA action beyond the normal admissibility review process, said the CSMS message. However, for any human and animal food products, human and animal drug products, and medical devices that left the Tianjin area on or after Aug. 12, FDA will require importers or their entry filers to submit additional information, as follows:
- If the importer is not the end commercial user of the product, provide 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 it left the city of Tianjin, including: (a) the geographical location of the product at the time of the explosion and in the aftermath through the present, and (b) how the product was packaged from the time of the explosion to the present.
- Whether the importer conducted a risk assessment to determine the impact of the Aug. 12 explosion on the safety of the product. If so, explain the methodology and the outcome of the assessment.
- Explain what testing has been conducted or is planned to be conducted on the product to identify contamination associated with the explosion.
To speed up the process, importers should provide the required information “in a timely manner” through FDA’s electronic Import Trade Auxiliary Communication System, said CBP. General questions should be directed to FDA’s Division of Import Operations, 12420 Parklawn Drive, ELEM Room 3109, Rockville, MD 20857 telephone: (301) 796-8969. Questions related to the entry processing of specific entries should be directed to the FDA District covering the port of entry, said CBP.