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

By Reynaldo Roman for Marken

On December 21, 2012, the U.S. Fish and Wildlife Service (FWS) 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 “cell”, “cell cultures” and “cell lines” are regulated by the agency and require an import/export license for trade.  

Since the approval of the first therapeutic product synthesis from Chinese Hamster Ovarian (CHO) cell cultures in 1987, CHO cell cultures have been among the top methods to produce recombinant proteins. They are considered to be the system of choice for monoclonal antibody therapeutics expression, which explains why the annual sales of biologics that have used CHO cells are in the billions (Jayapal, 2007). Since CHO cells are expected to continue to be the most important cell line for production of biopharmaceuticals, it is important for any importer of CHO cell cultures to understand the specific requirements for their import shipments.

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. Despite the fact that hamsters may often be thought of as domesticated animals, in their notice, FWS indicated that for their purposes hamsters are not considered domesticated animals 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”, “cell cultures” or “cell lines” require importers and exporters to 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” and 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 cell shipments 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 of regulations that 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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References

Jayapal KR, Wlaschin KF, Hu WS, Yap MGS (2007) Recombinant protein therapeutics from CHO cells - 20 years and counting. Chemical Engineering Progress 103: 40–47.