Do Chinese Hamster Ovarian (CHO) Cell Specimens Require An Import/Export License?

By Reynaldo Roman, Marken

On December 21, 2012, the U.S. Fish and Wildlife Service (FWS) finally addressed an issue that has been of significant debate among importers of Chinese Hamster Ovary (CHO) cell specimens and trade experts. FWS informed the trade community that only shipments of actual CHO cells, cell cultures and cell lines are regulated by the agency and require an import/export license for trade.  

FWS regulates the import and export of all wildlife and wildlife products. Shipments containing wildlife and wildlife products must be declared to the agency for clearance, making it necessary for importers and exporters to obtain an import/export license and pay user fees. The only exceptions to this rule are shipments of domesticated animals. Certain domesticated animals, such as white lab mice, European rabbits and white lab rats, when not obtained from the wild, are exempt from FWS import and export requirements. In their notice to the trade community, FWS indicated that hamsters are not considered domesticated pecies and, therefore, are regulated by FWS.

In recent months, importers and trade professionals have questioned FWS’ requirements for importing CHO cell specimens and derived products. By providing a specific distinction between actual CHO cells and CHO cell derived specimens and products, FWS has ended the debate. The agency has clarified that only shipments of actual CHO cells or cell lines require that importers and exporters obtain a FWS license and declare the shipment for clearance. Shipments of specimens or derived products that have been processed to the extent that animal material no longer remains in the specimen (e.g., antibodies or recombinant proteins extracted from CHO cells, cell cultures or cell lines purified to remove all cell material) do not require FWS import/export license, declaration or clearance. See the table below:

Shipments of CHO cell specimens or derived products exempt from FWS import/export license requirements must be accompanied by a document or statement that specifically describes the process the specimens or products have undergone.  The fee for acquiring the import/export license required for shipments of actual CHO cells, cell cultures and cell lines, is $100. The license application process can take up to 90 days. Therefore, importers and exporters should plan their shipments accordingly. Once a license is obtained, shipments of regulated CHO cell specimens must be declared to FWS for clearance.

The import and export of goods to and from the U.S can be a complicated process.  The number or regulations that can impact trade can be overwhelming. When you consider, for example, that Customs and Border Protection (CBP) enforces over 400 regulations on behalf of 40 other government agencies, it is easy to see how the trade community and even experienced professionals like Customs Brokers and trade consultants, will occasionally find it difficult to understand and interpret certain trade rules. In order to help educate and clarify trade requirements, agencies periodically issue trade advisories, guidance documents or bulletins to the trade community. You can review the FWS announcement at: http://www.fws.gov/le/publicbulletin/pb122112-chinese-hamster-ovary-cell-specimens.pdf

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