OT:RR:CTF:EMAIN: H316429 PF

Linda Weinberg
Barnes & Thornburg LLP
1717 Pennsylvania Avenue, NW, Suite 500
Washington, DC 20006

Re: Modification of NY N305614; 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:

This is to inform you that U.S. Customs and Border Protection (“CBP”) has reconsidered New York Ruling Letter (“NY”) N305614, dated August 30, 2019, which you requested on behalf of your client, DOTS Technology Corp. NY N305614 involves the classification of a Portable Food Allergen Detection Device, Single-Use Pods and a Starter Kit when imported separately. We have determined that this ruling is incorrect with respect to the applicability of the Section 301 remedy set forth in U.S. Note 20 to Subchapter III, Chapter 99, Harmonized Tariff Schedule of the United States (HTSUS). Accordingly, for the reasons set forth below, CBP is modifying NY N305614.

Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C. §1625(c)(1)), as amended by section 623 of Title VI (Customs Modernization) of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057), a notice of the proposed action was published in the Customs Bulletin, Vol. 55, No. 22, on June 9, 2021. No comments were received in response to this notice.

In NY N305614, the Portable Food Allergen Detection Device, Single-Use Pods and a Starter Kit were described as follows:

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.

In NY N305614, CBP classified the Portable Food Allergen Detection Device and the Starter Kit in subheading 9027.50.8015, HTSUS Annotated, 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.” In addition, CBP classified the Single-Use Pods in subheading 3822.00.5090, HTSUSA, 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.”

CBP also determined, without clarifying the country of origin of the subject merchandise, that the Portable Food Allergen Detection Device, the Starter Kits (constituting the Portable Food Allergen Detection Device and Single-Use Pods), and Single-Use Pods, would not be subject to section 301 trade remedies.

ISSUE:

Whether the Portable Food Allergen Detection Device, Single-Use Pods and a Starter Kit are subject to the Section 301 Trade Remedy?

LAW AND ANALYSIS:

Merchandise imported into the United States is classified under the HTSUS. Tariff classification is governed by the principles set forth in the General Rules of Interpretation (“GRIs”) and, in the absence of special language or context which requires otherwise, by the Additional U.S. Rules of Interpretation (“AUSR”). The GRIs and the AUSR are part of the HTSUS, and are considered statutory provisions of law for all purposes.

GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule and any relative section or chapter notes and, unless otherwise required, according to the remaining GRIs taken in order. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the heading and legal notes do not otherwise require, the remaining GRIs 2 through 6 may then be applied in order.

There is no dispute that the Portable Food Allergen Detection Device is classified in subheading 9027.50.80, 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.” There is also no dispute that the Starter Kit, constituting the Portable Food Allergen Device and Single-Use Pods, constitute a set with the Portable Food Allergen Device being the item which provides the essential character pursuant to GRI 3(b). Accordingly, the Starter Kit is also classified in 9027.50.80, HTSUS. Moreover, when imported separately, the Single-Use Pods are classified in subheading 3822.00.50, 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.”

The issue in this case is whether the Portable Food Allergen Detection Device, the Starter Kit and the Single-Use Pods are subject to the 301 Trade Remedy pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS. Since the Portable Food Allergen Device and the Starter Kit are classified in subheading 9027.50.80, HTSUS and goods of subheading 9027.50.80, HTSUS, are expressly included in U.S. Note 20 to Subchapter III, Chapter 99, the subject Portable Food Allergen Detection Device and the Starter Kit are subject to the 301 Trade Remedy if the Portable Food Allergen Device is a product of China. HOLDING:

By application of GRIs 1 and 6, the Single-Use Pods are classified in subheading 3822.00.50, 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.” The general, column one rate of duty for goods of subheading 3822.00.50, HTSUS, is Free.

By application of GRIs 1 and 6, the Portable Food Allergen Detection Device is classified in subheading 9027.50.80, 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.”

By application of GRIs 1, 3(b), and 6, the Starter Kits consisting of one Portable Food Allergen Detection Device and one or more Single-Use Pods are also classified in subheading 9027.50.80, HTSUS. The general, column one rate of duty for goods of subheading 9027.50.80, HTSUS, is Free.

Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 9027.50.80, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty.  At the time of importation, such products must be reported under the relevant Chapter 99 subheading, i.e., 9903.88.01, in addition to subheading 9027.50.80, HTSUS, listed above. The HTSUS is subject to periodic amendment, so you should exercise reasonable care in monitoring the status of goods covered by the Note cited above and the applicable Chapter 99 subheading.  For background information regarding the trade remedy initiated pursuant to Section 301 of the Trade Act of 1974, including information on exclusions and their effective dates, you may refer to the relevant parts of the USTR and CBP websites, which are available at https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and https://www.cbp.gov/trade/remedies/301-certain-products-china, respectively.

EFFECT ON OTHER RULINGS:

NY N305614, dated August 30, 2019, is hereby MODIFIED.

In accordance with 19 U.S.C. 1625(c), this ruling will become effective 60 days after its publication in the Customs Bulletin.


Sincerely,

Craig T. Clark, Director
Commercial and Trade Facilitation Division