The tariff classification of Pneumolysin Toxin from Canada

N193018 December 5, 2011 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3002.90.5150 Ms. Deanna Slusher Sanofi Pasteur 1 Discovery Drive Swiftwater, PA 18370 RE: The tariff classification of Pneumolysin Toxin from Canada Dear Ms. Slusher: In your letter dated November 14, 2011, you requested a tariff classification ruling. The subject product, Pneumolysin, is a protein toxin of the gram positive bacteria Streptococcus pneumoniae. You state in your letter that Pneumolysin is a purified recombinant protein derived from Streptococcus pneumoniae and expressed in E. coli (BL21 (DE3) Plasmid pJMS102). The recombinant protein is a wild-type Pneumolysin Toxin (wtPly) which is purified from crude bacterial lysate. Pneumolysin Toxin is an intracellular bacterial protein released on disruption of Streptococcus pneumoniae. You also state that the material is intended for in vitro laboratory testing only, for a Pneumococcal Protein Vaccine development project. The applicable subheading for the Pneumolysin Toxin will be 3002.90.5150, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Human blood; … ; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Other: Other: Other.” 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 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. 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 the National Import Specialist Judy Lee at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division