CLA-2-38:OT:RR:NC:N3:139
Nicholas Kypros
Life Technologies
5781 Van Allen Way Carlsbad, CA 92008
RE: The tariff classification of microarray cartridge from Singapore
Dear Mr. Kypros:
In your letter dated September 16, 2024, you requested a tariff classification ruling. We referred the information you provided to our laboratory for review.
The products under consideration are identified as Applied Biosystems Axiom and Clariom and Affymetrix GeneChip microarray cartridges and plates that are designed to bind specific sequences of target RNA to measure its relative amount across sample groups.
Each cartridge consists of probes on a glass substrate glued into a plastic cartridge composed of three pieces with two septa in the back cover. Each microarray plate consists of probes on a glass substrate glued onto a plastic post. The product is produced by synthesizing oligonucleotide probes onto quartz glass (fused silica substrate) using a photolithographic process. After that, the wafer is cut into smaller sections which become chips that are then glued into the appropriate cartridges or plates which are in turn packaged and labelled for sale. The cartridges and plates are different formats for the same type of scientific process. At the time of importation into the United States, each probe consists of nucleotides as well as a silane linker molecule. After importation, in a laboratory, the ultimate customer will process a DNA sample which will be isolated from cells or tissue and amplified. The DNA sample will be labeled with a fluorescent material. Then the sample will be hybridized to the microarray by binding the sample to the probes. Next, the microarray is washed to remove any unbound sample nucleic acids. Finally, the microarray is imaged by the GeneChip or GeneTitan instrument to determine gene expression levels.
In your letter, you state “whether the microarrays can be considered reagents on a backing depends on whether they meet the definition of a reagent as set forth by Customs in various rulings. To meet this definition, the nucleic acids synthesized on the glass within the plastic housing of the array must undergo a specific, detectable chemical reaction. Indeed, the nucleic acids on the chip bind with their target in a chemical reaction, which is then measured by the respective instrument.” You opine that the instant microarray plates and cartridges are classified in heading 3822, Harmonized Tariff Schedule of the United States (HTSUS), as laboratory reagents on a backing. We disagree. According to the Customs and Border Protection’s laboratory report, they are not considered reagents of heading 3822. When the DNA samples are hybridized to the microarray where they bond to the complementary probes, these binding interactions are non-covalent interactions that do not involve the breaking and forming of covalent bonds. They are chemical interactions and are not considered chemical reactions. Once the microarray plates or cartridges have been saturated with the sample, the plates or cartridges are analyzed using instrumentation. The instant microarray plates or cartridges themselves do not undergo a measurable or observable change. As such, they are not reagents of heading 3822 HTSUS.
In your letter, you state the microarray cartridges should be classified as an accessory in subheading 9027.90, HTSUS, which provides for “Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories thereof: Microtomes; parts and accessories: Parts and accessories.” We disagree. In order for the cartridges to be considered an accessory they must enhance the use of the equipment or improve the operation of equipment. In this case, upon importation, the cartridges only contain the nucleotide silane molecule probes. After the cartridge is imported, the sample is placed on the probe to see the reaction by utilizing the analytical equipment. The microarray cartridges do not enhance the usability of the analysis equipment and are not required for the analysis equipment to operate. Therefore, heading 9027, HTSUS, is excluded from consideration.
The applicable subheading for the microarray cartridges will be 3824.99.9397, HTSUS, which provides for Prepared binders for foundry molds or cores; chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included: Other: Other: Other: Other: Other: Other: Other. The rate of duty will be 6 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 at https://hts.usitc.gov/.
The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection 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, please contact National Import Specialist John Bobel at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division