Mr. Maher M. Shomali
Thomsen and Burke LLP
Two Hamill Road, Suite 415
Baltimore, MD 21210
RE: The tariff classification of DNA collection kits from Canada
Dear Mr. Shomali:
In your letter dated October 15, 2013, on behalf of 23andMe, Inc., California, you requested a tariff classification ruling.
The product is described as the Oragene Dx (OGD-500) DNA collection kit. The kit is designed to facilitate the collection of a saliva sample and provide for a stable and safe transportation of the sample. The kit includes a plastic collection tube, a plastic funnel that is screwed into the collection tube, a plastic funnel cap that contains a stabilizing liquid (ethyl alcohol), a plastic bag and an absorbent pad. After importation customers use the kits to collect saliva and then return the collection tube with the saliva specimen to a contracted laboratory. The laboratory analyzes the DNA in the specimen to arrive at a profile that indicates factors of genetic ancestry, health conditions and traits.
You are also requesting a ruling on the collection tube when imported with collected saliva for testing in the laboratory.
You suggest classification of the kit in subheading 9018.90.80, Harmonized Tariff Schedule of the United States (HTSUS), which provides for other instruments and apparatus used in medical, surgical, or veterinary sciences, and parts and accessories thereof. This office does not agree. The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of the headings. It is CBP’s practice to consult, whenever possible, the terms of the ENs when interpreting the HTSUS. See T.D. 89–80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
The ENs to heading 9018 state that the instruments and appliances of that heading are used “in professional practice (e.g., by doctors, surgeons, dentists, veterinary surgeons, midwives), either to make a diagnosis, to prevent or treat an illness, or to operate, etc.” The Oragene DNA collection kit is marketed as a personal genome service to aid individuals in gaining insights into their ancestry and inherited traits. The specimen is collected by the individual, at home, by spitting multiple times into the collection tube. The alcohol keeps the saliva in a stable condition until it reaches the laboratory. The analysis of the sample collected will be performed using equipment which would presumably not be classified in 9018, HTSUS, even if the analysis was primarily to diagnose an illness. Exclusion q to the ENs to heading 9018 excludes, “Instruments and appliances used in laboratories to test blood, tissue fluids, urine, etc., whether or not such tests serve in diagnosis…”
The applicable subheading for the Oragene Dx (OGD-500) DNA collection kit will be 3926.90.9910, HTSUS, which provides for other articles of plastics…other…laboratory ware. The general rate of duty will be 5.3 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/.
Your inquiry does not provide enough information for us to give a classification ruling on the collection tubes when imported with the collected saliva samples. Your request for a classification ruling should include specific details regarding the saliva in the condition as imported. Provide a complete component breakdown by weight of all of the ingredients. Include CAS numbers. Explain the purpose and function of each ingredient. Confirm whether the saliva will already have been mixed with the alcohol at the time of importation. Explain how the human saliva is stabilized or preserved. Explain in detail exactly how the mixing affects the saliva. Indicate whether there is a chemical reaction when the human saliva is mixed with the ethanol. Specify whether the ethyl alcohol is consumed in the course of a chemical reaction with the human saliva. Is there still natural/unaltered saliva within the resulting combination/mixture? If so, can the natural saliva itself be subsequently separated or removed from the rest of the fluid? Will this in fact be done?
When this information is available, you may wish to consider resubmission of your request. We are returning any related samples, exhibits, etc. If you decide to resubmit your request, please include all of the material that we have returned to you.
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 on the empty collection kit, contact National Import Specialist Joan Mazzola at (646) 733-3023. If you have any questions regarding the information requested for the collection kit with the saliva specimen, please contact National Import Specialist Judy Lee at 646-733-3033.
Gwenn Klein Kirschner
National Commodity Specialist Division