Mr. Hans Buegl
One Bay Plaza
1350 Old Bayshore Highway
Burlingame, CA 94010
RE: The tariff classification of Extracted Pure Plasmids and Plasmids Introduced into Bacterial Cells from Germany
Dear Mr. Buegl:
In your letter dated January 15, 2009, you requested a tariff classification ruling. As you know, we presented your initial submission to our laboratory for assessment and comment. Their response was delayed. Subsequently, we had a number of telephone discussions with your attorney. We also received additional facts and arguments from you and your associate through Email. These circumstances caused the delay in our response for which we apologize.
You state that the subject articles, extracted pure plasmids and plasmids introduced into bacterial cells, are manufactured by biological processes. In general, plasmids are always manufactured by biological processes. A specific gene sequence can be inserted into a plasmid so that the plasmid becomes a carrier of the sequence. As a carrier, it is inserted into the bacterial cells. The bacteria can then generate many copies of the sequence. The bacteria are harvested and the pure plasmids can be extracted and isolated from the rest of the bacterial cellular material. Your importations will be of the pure extracted plasmids and also of the bacteria with the plasmids still within them. Both products are used by the pharmaceutical and bio-tech industries and in research for pharmaceutical purposes.
You opine that classification of both the extracted pure plasmids and the plasmids introduced into bacterial cells should be in subheading 3002.90.5150, Harmonized Tariff Schedule of the United States, which provides for “Human blood; …; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Other: Other: Other.” You claim that plasmids are similar products to the vaccines, toxins, cultures of micro-organisms of that subheading. We respectfully disagree.
Based on a number of technical sources, the World Customs Organization (WCO) has distinguished plasmids from viruses based on their method of reproduction. Plasmids are `independently reproduced in a host cell without involving the chromosomal DNA of the cell. Viruses reproduce by injecting their DNA into the host cell, causing that cell to produce copies of the virus while eventually leaving the cell wall and seeking out other possible host cells. Viral DNA is integrated with the chromosomal DNA of the host cell. Furthermore, while the classification of viruses as living material is still in dispute, viruses do occupy a special taxonomic position. They are generally placed in their own Order (“-virales”), while plasmids are never considered to be living materials and are not classified in any family of viruses.
The plasmids within the bacteria are not similar to the Bacterial Artificial Chromosome (BAC) Library which we ruled upon in NY R01773 of April 20, 2005. This was a library of E. coli bacterial cells in a culture medium. They were active cultures. It is our understanding that the plasmids introduced into bacterial cells will simply be isolated from the bacterial detritus.
The applicable subheading for both the Extracted Pure Plasmids and Plasmids Introduced into Bacterial Cells will be 2934.99.9000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Other: Other: Other.” The rate of duty will be 6.5 percent ad valorem.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.
This merchandise may be subject to the rules and regulations of the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, located at 1600 Clifton Rd., Atlanta, GA 30333. You may contact them, by telephone, at: (404) 639-3534 / (800) 311-3435.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at (646) 733-3033.
Robert B. Swierupski
National Commodity Specialist Division