CLA-2-90:OT:RR:NC:N1:105

Linda Weinberg
Barnes & Thornburg LLP
1717 Pennsylvania Ave. NW Suite 500
Washington DC 20006

RE: The tariff classification of a Portable Food Allergen Detection Device, Single-Use Pods and a Starter Kit from China and various other countries.

Dear Ms. Weinberg:

In your letter dated August 2, 2019, on behalf of your client DOTS Technology Corp., you requested a tariff classification ruling. Your request involves the classification of a Portable Food Allergen Detection Device, Single-Use Pods and a Starter Kit when imported separately.

The food allergen detection device is a device used by consumers to test food for the presence of certain common food allergens. The food allergen detection device consists of numerous components including a detector unit, which contains an optical detection mechanism, lithium-ion battery and homogenization motor to drive the rotor in the pod. The fluorescent detection mechanism detects signals generated by the Signaling Polynucleotides (SPN) chemical reaction in the pod. The detector includes a light-emitting diode (LED) that excites fluorescent SPN, optical components that guide the LED to the detection chamber, lenses that collect the fluorescence, an imaging printed circuit board assembly, a fluorescence detector for measuring the emitted light, and a signal processor that analyzes fluorescence signals and transmits the identity of the allergen of interest to the visual display panel.

The DOTS’ single-use pod consists of a stadium-shaped plastic base and top, a fluidics panel, a rotor, and other components and is filled with SPN and a buffer solution.  The fluidics panel component contains the assay that binds the active molecule, which detects the presence of the allergen protein.  The chemical reaction between the SPN and assay yields a detectable signal indicating the presence of the target allergen.  In use, the pod is inserted into the food allergen device.  The pod’s rotor “blends” a cut food sample and releases protein from the food.  The protein is then mixed with the SPN and buffer.  When the SPN is bound to the assay via DNA: DNA interactions, a signal is produced that indicates the absence of the allergen protein in the protein extracted from the food sample.  If the allergen protein is present in the protein extracted from the food sample, the binding interaction does not occur and no signal is produced.  The user is alerted to the test results on the device.

The Starter Kits consist of one food allergen device packaged together with one or more pods.

General Rule of Interpretation (GRI) 1, Harmonized Tariff Schedule of the United States (HTSUS), states in part that for legal purposes, classification shall be determined according to the terms of the headings, any relative section or chapter notes and, unless otherwise required, according to the remaining GRI’s taken in order. Goods that are, prima facie, classifiable under two or more headings, are classifiable in accordance with GRI 3. GRI 3(a) states that the heading that provides the most specific description shall be preferred to headings providing a more general description. However, when two or more headings refer to only part of the items in a composite good, those headings are to be regarded as equally specific in relation to the goods, even if one of them gives a more complete or precise description of the good. As such, they are regarded as equally specific and classification of the composite good is to be determined by GRI 3(b) or GRI 3(c) taken in the appropriate order in which they are set out in GRI 3. GRI 3(b) states in part that composite goods, which cannot be classified by reference to GRI 3(a), are to be classified as if they consisted of the component that gives them their essential character. GRI 3(c) provides that when goods cannot be classified by reference to GRI 3(a) or GRI 3(b), they are to be classified in the heading that occurs last in numerical order among the competing headings which equally merit consideration.

After examining the facts concerning the starter kits, this office is of the opinion that the food allergen device and single-use pods, imported together, constitute a set with the food allergen device being the item which provides the essential character, GRI 3(b) noted.

The applicable subheading for the Portable Food Allergen Detection Device and the Starter Kit will be 9027.50.8015, 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: Other instruments and apparatus using optical radiations (ultraviolet, visible, infrared): Other: Other: Chemical analysis instruments and apparatus. The rate of duty will be free.

The applicable subheading for the Single-Use Pods will be 3822.00.5090, HTSUS, which provides for Diagnostic or laboratory reagents on a backing and prepared diagnostic or laboratory reagents, whether or not on a backing, other than those of heading 3002 or 3006: Other: Other. The rate of duty will be free.

In your request, you questioned the applicability of section 301 trade remedies for the Starter Kits. The Portable Food Allergen Detection Device and the Single-Use Pods, when imported separately, would not be subject to the section 301 trade remedies. When applying GRI 3(b) for the Starter Kit, the essential character was determined to be the Portable Food Allergen Detection Device. This item is not subject to the section 301 trade remedies, thus the Starter Kit would also not be subject.

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 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 Jason Christie at [email protected].

Sincerely,

Steven A. Mack
Director
National Commodity Specialist Division