The tariff classification of EmbryoGlue® from Sweden

N038902 September 26, 2008 CLA-2-38:OT:RR:E:NC:2:238 CATEGORY: Classification TARIFF NO.: 3821.00.0000 Mr. James M. Seufert Vitrolife Inc. 3601 S. Inca Street Englewood, CO 80110 RE: The tariff classification of EmbryoGlue® from Sweden Dear Mr. Seufert: In your letter dated September 19, 2008, you requested a tariff classification ruling. You describe EmbryoGlue® as a buffered liquid medium designed for embryo transfer and implantation. It is packed in 10 mL plastic bottles. According to literature found on your company’s website, EmbryoGlue® is formulated to first provide safe transfer of the embryo and then to support it through the various stages of implantation. It contains Hyaluronan, which assists in rapid diffusion with the viscous hyaluranon-rich uterine fluid. It contains Recombinant Human Albumin to ensure safety, efficacy and consistency. It also has nutrients, such as carbohydrates, amino acids, vitamins, etc., required to support later stage embryo development. Pharmaceutical grade Penicillin G is present as a preservative. You suggest that classification in subheading 3004.90.1000, Harmonized Tariff Schedule of the United States (HTSUS), may be correct. This subheading provides for “Medicaments…consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses…or in forms or packings for retail sale: Other: Containing antigens or hyaluronic acid or its sodium salt.” We respectfully disagree. This product is not a medicament. It is not used to treat or prevent a human or animal ailment. It is our opinion that EmbryoGlue® fits the description of heading 3821. It is designed, at least in part, to maintain the integrity and development of human cells during in vivo fertilization (IVF) transfer and implantation procedures and processes. The applicable subheading for the EmbryoGlue® will be 3821.00.0000, HTSUS, which provides for “Prepared culture media for development or maintenance of micro-organisms (including viruses and the like) or of plant, human, or animal cells.” The rate of duty will be 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 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 National Import Specialist Harvey Kuperstein at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division