CLA-2-38:OT:RR:NC:2:238
Mr. Kayode Modeste
CooperSurgical, INC.
75 Corporate Drive
Trumbull, CT 06611
RE: The tariff classification and country of origin marking of Quinn’s™ Sperm Washing Medium in 12x12 mL (REF Number ART-1005) and 100 mL (REF number ART-1006), from Denmark
Dear Mr. Modeste:
In your letter dated June 8, 2015, you requested a tariff classification and country of origin marking ruling. The information you submitted was sent to our laboratory for analysis and has been completed. A marked sample was not submitted with your letter for review.
The subject product, Quinn’s™ Sperm Washing Medium, is a prepared culture medium that is put up in liquid form (12x12 mL and 100 mL) containing a mixture of several ingredients including Gentamicin and 5.0 mg/mL of Human Serum Albumin. In your letter, you indicated that the medium is a modification of HEPES-buffered Human Tubal Fluid (HTF). The technical literature included with your letter also indicated that the medium is intended for in vitro procedures involving sperm washing and incubation.
The applicable subheading for the Quinn’s™ Sperm Washing Medium in 12x12 mL (REF Number ART-1005) and 100 mL (REF number ART-1006), will be 3821.00.0000, Harmonized Tariff Schedule of the United States (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.
In your letter you suggest subheading 3822.00.5090, HTSUS, which provides for “Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents, whether or not on a backing, other than those of heading 3002 or 3006: Other: Other.” We disagree. According to our laboratory, Quinn’s™ Sperm Washing Medium is a media that is used for the suspension of sperm cells. In a follow-up email to this office, you stated that the sperm washing medium is a suspension of ionic solutes (salts), food source (glucose), and anti-oxidants (albumin). The medium contains an energy source (glucose) for the sperm to survive while awaiting intrauterine insemination. Therefore, this product is correctly classified in heading 3821, HTSUS, as a prepared culture media for the maintenance of human cells (sperm).
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/.
You also requested for the country of origin marking requirements concerning Quinn’s™ Sperm Washing Medium. You stated that the mediums are manufactured via a three part process in Denmark.
The first step involves bulk formulation of approximately 17 different component materials sourced from various countries (USA, Japan, China, India, Germany, and Denmark) that are mixed in large formulation vats (50 to 700 liters) until the components have fully dissolved and the liquid is completely homogeneous. When the components are dissolved, they are no longer separable from one another and each component is essential to the function of the Sperm Washing Medium.
The second step involves sterile filtration where the liquid formulation is passed through a filter cartridge containing a membrane with pore sizes of 0.2 micrometers in diameter. This membrane is validated to remove the smallest microbes (Brevundimonas diminuta), and thus the liquid is considered sterile filtered.
The last step involves aseptic filling where the sterile filtered liquid is aseptically packaged into sterile and pyrogen free containers (plastic or glass bottles). This process takes place in a controlled environment, typically an ISO class 100 filling station. The filled bottles are aseptically capped (sealed without introducing microbes from the outside environment), and labeled and final packaged for quality control testing. When the production batch has completed the quality control testing, it is released for sale to the end user.
The marking statute, section 304 Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the United States the English name of the country of origin of the article. Part 134, Customs Regulations (19 CFR Part 135) implements the country or origin marking requirements and exceptions of 19 U.S.C. 1304.
Section 134.1(b), Customs Regulations (19 CFR 134.1(b)), defines "country of origin" as:
the country of manufacture, production or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the "country of origin" within the meaning of this part;…
A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Association v. United States, 628 F. Supp. 978 (Ct. Int’l Trade 1986).
In the instant case, we find that the blending of multiple ingredients in Denmark results in a new product, Quinn’s™ Sperm Washing Medium, which has an identity distinct from the materials from which it was produced. Based on the facts presented, a substantial transformation has occurred as a result of the operations performed in Denmark. Therefore, the country of origin of the imported Quinn’s™ Sperm Washing Medium is Denmark. Since the solution, is incapable of being marked, it is excepted from being marked (19 C.F.R. Section 134.32(a)).
Accordingly, marking the container with the proper country of origin in which Quinn’s™ Sperm Washing Medium is imported and sold to the ultimate purchaser is an acceptable country of origin marking.
This merchandise may be subject to the rules and regulations of the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, located at 1600 Clifton Rd., Atlanta, GA 30333. You may contact them, by telephone, at: (404) 639-3534 / (800) 311-3435.
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 Judy Lee at [email protected].
Sincerely,
Gwenn Klein Kirschner
Director
National Commodity Specialist Division