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FDA Guidance for Products from Tianjin, CN

October 26 2015  |  Related: 15-000676

UPDATE to CSMS# 15-000676 – FDA Guidance for Products from Tianjin, CN

Updates noted with {***} in the information below.

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 AND Xiditou Township of Beichen District 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: NaCN, TDI and CaC2, all of which pose direct threats to human health on contact. NaCN in particular is highly toxic.

***On October 12, 2015, a second explosion occurred at a warehouse owned by Tianjin Yong Sheng Fine Chemical Co., Ltd. at Xiditou Township of Beichen District in Tianjin, China.

The 700 square-meter warehouse, located in the northern suburbs, is reported to have stored about 3,000 kilograms of alcohol, 1,000 kilograms of acetic acid, 800 kilograms of glycerinum, 500 kilograms of sodium hydroxide and 500 kilograms of potassium hydroxide.

Other chemicals that may be associated with the explosion remain unknown.***

In order to verify the products are not contaminated from the explosions, 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 and Xiditou Township of Beichen District 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.

Human and animal food products, human and animal drug products, and medical devices that left the Tianjin, China area on or after August 12, 2015, will require additional information in order to make an admissibility decision.

FDA is requesting importers (or their entry filers) submit the following information related to the products they are importing:

1. If you are not the end commercial user of the product, provide information identifying all known recipients of the product.

2. Explain the physical description and geographic location of the product at the time of the explosions and from the time between the explosions and when it left the city of Tianjin, including the following:

A. Where was the product located (geographical location) at the time of the ***explosions*** and in the aftermath of the ***explosions*** through the present?

B. How was the product packaged (primary, secondary packaging, wrapped pallet, shipping container, etc.) at the time of the ***explosions*** and in the aftermath through the present?

3. Explain whether your firm conducted a risk assessment to determine the impact of the August 12 and ***October 12 explosions*** on the safety of your product. And, if so, explain your methodology and the outcome of your assessment.

4. Explain what testing has been conducted or is planned to be conducted on the product to identify contamination associated with the August 12 and ***October 12 explosions***?

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.

Instructions on how to use ITACS to submit documentation and information to the FDA can be found at the following link.

Questions or comments on how to submit documents, or about ITACS in general, can be directed to itacssupport@fda.hhs.gov

Questions regarding this action by FDA can be directed to 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.
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