CLA-2-30:OT:RR:NC:N1:138
Ms. Karen L. Prouty
IDEXX Laboratories
One IDEXX Drive
Westbrook, ME 04092
RE: The tariff classification of the SNAP Beta ST Plus Test Kit (Product Number 99-0004704), from the United States and other countries
Dear Ms. Prouty:
In your letter dated June 25, 2018, you requested a tariff classification ruling.
The SNAP Beta ST Plus Test Kit (Product Number 99-0004704) is a qualitative test kit used by the dairy industry to detect specific antibiotic residues belonging to the beta-lactam class of antibiotics in milk. The test kit consists of a small plastic device housing a membrane immobilized (spotted) with two different spots representing the detection test system and one control spot. The device also contains a substrate/buffer solution, which reacts with Horse Radish Peroxidase (HRP) enzyme conjugates. Each device in the test kit is bagged with a plastic test tube containing a mixture of three lyophilized enzyme conjugates. The first enzyme conjugate is a penicillin binding protein (PBP) conjugated to HRP. This first enzyme conjugate is used to detect 16 beta-lactam antibiotic residues in the milk sample. The second enzyme conjugate is an antiCephalexin antibody conjugated to HRP. This second enzyme conjugate is used to detect beta lactam Cephalexin in the milk sample. The third enzyme conjugate is a polyclonal goat antiChicken antibody conjugated to HRP that is used as a control and to provide a comparison for the sample spot color development intensity.
In a follow-up email to this office, you indicated the SNAP Beta ST Plus Test Kit consists of individually foil wrapped pouches to conduct 100 tests. Each foil pouch consists of (1) disposable plastic pipet, (1) SNAP Beta ST Plus Test device and (1) plastic vial containing the mixture of lyophilized conjugates. The individual foil wrapped pouches of the SNAP Beta ST Plus Test Kit are packaged together in a box for retail sale along with the product’s instruction pamphlet.
You suggest classification in subheading 3822.00.1090, 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: Containing antigens or antisera: Other.”
In our opinion, the antibody conjugates of the mixture containing three lyophilized enzyme conjugates impart the essential character to the kit. Therefore, the SNAP Beta ST Plus Test Kit is excluded from classification as a diagnostic reagent of heading 3822, HTSUS, by the terms of the language in heading 3822, HTUS, and the Harmonized System Explanatory Note 38.22, 30.02(C) and 30.02(E), HTSUS.
The applicable subheading for the SNAP Beta ST Plus Test Kit will be 3002.15.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antisera, other blood fractions and immunological products, whether or not obtained by means of biotechnological processes: Immunological products, put up in measured doses or in forms or packings for retail sale.” The general 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 the World Wide Web at https://hts.usitc.gov/current.
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 merchandise may also be subject to the requirements of the Toxic Substances Control Act (TSCA), which are administered by the U.S. Environmental Protection Agency. Information on the TSCA can be obtained by contacting the EPA at 1200 Pennsylvania Avenue, N.W., Mail Code 70480, Washington, D.C., by telephone at (202) 554-1404, or by visiting their website at www.epa.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,
Steven A. Mack
Director
National Commodity Specialist Division