CLA-2-30:OT:RR:NC:2:238
Ms. Lindsay B. Meyer
Venable® LLP
575 Seventh Street NW
Washington, DC 20004
RE: The tariff classification of Non-toxigenic Clostridium difficle micro-organisms in bulk form, from Italy and Israel
Dear Ms. Lindsay:
In your letter dated March 1, 2012 you requested a tariff classification ruling on behalf of your client ViroPharma Incorporated. We apologize for the delay as the information submitted was sent to our Laboratory for analysis.
Clostridium difficile is a Gram-positive, spore-forming, anaerobic bacterium, and is the causative agent of Clostridium difficile-associated disease. There are two types of Clostridium difficile, toxigenic and non-toxigenic. Non-toxigenic strains of Clostridium difficle have no ability to produce Toxin A or Toxin B. In your letter, you state that you will only be importing specific strains of Non-toxigenic Clostridium difficle micro-organisms as raw materials for the development of a new investigational drug.
You suggest classification in subheading 3002.90.5150, HTSUS, which provides for cultures of micro-organisms. We agree that Non-toxigenic Clostridium difficle strains are cultures of micro-organisms for tariff classification purposes.
The applicable subheading for the Non-toxigenic Clostridium difficle in bulk form will be 3002.90.5150, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products.” 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).
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.
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 Judy Lee at (646) 733-3033.
Sincerely,
Thomas J. Russo
Director
National Commodity Specialist Division