CLA-2-90:OT:RR:NC:N1:105
Mr. Damon Pike
Smith, Gambrell & Russell, LLP
1230 Peachtree St, N.E.
Promenade II, Suite 3100
Atlanta, GA 30309
RE: The tariff classification of vascular microspheres from Germany.
Dear Mr. Pike:
In your letters dated September 29, 2008, and September 30, 2008, for CeloNova Biosciences, Inc. (CNBS), you requested a tariff classification ruling. No sample was provided.
The microspheres, with a special coating, are injected, typically via a syringe, into the patient “specifically for vascular embolization.” Multiple spheres will travel via the bloodstream to clog the chosen, very small blood vessel(s) by forming artificial embolism(s) to stop or reduce blood flow, for example, to control hemorrhaging or to starve tumors. While it is injected into the patient in the same manner as many drugs, it is not a drug since the microspheres are solid spheres and are not designed to react chemically with the blood or body tissue. In fact, like artificial hip joints and many other artificial body parts, they are designed to be as inert as possible.
You note that CNBS has applied Harmonized System heading 9021.90 to these microspheres for its internal purposes. We agree with you that that does not apply. Following Headquarters Ruling Letter 966555 AM, 9-9-03, it is our position that “other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability” does not apply to ostomy pouches and wafers since they are not “precision electronic devices that actively compensate for the defect or disability” like all the examples in Harmonized System Explanatory Note V to 90.21. That reasoning applies, a fortiori, to exclude these microscopic spheres. As indicated in your Exhibit 3, the US Food and Drug Administration refers to these microspheres as an “implant,” but they are not interpreting the Harmonized System heading language or its Explanatory Notes.
You propose classification in HTSUS 9018.90.80. However, while the microspheres are clearly used in conjunction with medical equipment such as medical grade syringes, they are not the “Instruments and appliances used” by doctors, nurses, etc. “in medical, surgical, dental or veterinary sciences” in performing their therapeutic and diagnostic tasks, e.g., scalpels or MRIs. Rather, they are themselves items that stay indefinitely inside the patient’s body to achieve their benefit, closer to being the reverse of the artificial blood vessels cited in HS EN III-C to 90.21 than in any way to any of the scores of examples in HS EN to 90.18.
New York Ruling Letter E89824 - 105, 11-19-99, classified similar microspheres in HTSUS 9021.30 (essentially replaced by HTSUS 9021.31-.39)
The applicable subheading for these vascular microspheres will be 9021.39.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Other artificial parts of the body and parts and accessories thereof. The rate of duty will be Free.
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 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 J. Sheridan at 646-733-3012.
Sincerely,
Robert B. Swierupski
Director
National Commodity Specialist Division