CLA-2-30:RR:NC:2:238 E83756
Mr. Richard A. Rocco
Livingston International Inc.
552 Sonwill Drive
Buffalo, NY 14225
RE: The tariff classification of crude Heparin adsorbed onto ion-exchange-resin beads from Canada
Dear Mr. Rocco:
In your letter dated June 9, 1999, on behalf of your client, Diosynth Inc., you requested a tariff classification ruling.
The subject product for which you are requesting a tariff classification ruling consists of crude Heparin which has been adsorbed onto the surface of ion-exchange-resin beads. Heparin is indicated for use as an anticoagulant.
According to your letter, crude Heparin is extracted from porcine intestinal mucosa and “ribbons” (Heparin-bearing tissue) from an edible-casing operation in Canada. The mucosa and “ribbons” from the casing operation are pumped into processing tanks located in a separate room dedicated to the Heparin extraction process. The material undergoes a “digestion” process, as well as temperature and alkalinity adjustments. Ion-exchange-resin beads (produced in the Netherlands, imported into the U.S., and then exported to Canada by your client) are added to the digested material, which results in the Heparin being adsorbed onto the surfaces of the beads. The beads are then separated from the digested material, cleaned, and put up in 55-gallon drums for shipment to your client in the U.S. Upon arrival in the U.S., the crude Heparin is released from the beads through an elution process. The regenerated beads are then cleaned, repackaged in 55-gallon drums, and shipped back to Canada by your client for reuse.
Pursuant to Rule 3(b) of the General Rules of Interpretation, HTS, we are of the opinion that the subject product constitutes a composite good whose essential character is imparted by the crude Heparin.
With respect to classification at the subheading level, you assert that the subject product should be classified under subheading 3001.20.0000, HTS, which provides for “[E]xtracts of glands or other organs or of their secretions.” However, we note that, within heading 3001, HTS, Heparin and its salts are provided for, by name, separate and apart from extracts of glands or other organs, or of their secretions, for organotherapeutic uses.. Furthermore, we note that the explanatory notes to heading 3001, HTS [see E.N. 3001(A) and (B)], also list Heparin and its salts separate and apart from extracts of glands or other organs, or of their secretions, for organotherapeutic uses. Accordingly, it is our determination, by virtue of the manner in which both the language of heading 3001 and the explanatory note thereto are promulgated, that Heparin and its salts are not intended for inclusion within subheading 3001.20.0000, HTS.
The applicable subheading for the subject product will be 3001.90.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for: "[G]lands and other organs for organotherapeutic uses, … ; extracts of glands or other organs or of their secretions for organotherapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or ." The general rate of duty will be free.
This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.
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 212-637-7068.
Sincerely,
Robert B. Swierupski
Director,
National Commodity
Specialist Division