OT:RR:CTF:CPMM H286756 RGR
Port Director, Service Port of Cleveland
U.S. Customs and Border Protection
6747 Engle Road
Middleburg Heights, OH 44130
RE: Application for Further Review of Protest No. 4110-17-100015; Tariff classification of Immulite 2000 Olive 40T
Dear Port Director:
The following is our decision regarding the Application for Further Review (“AFR”) of Protest Number 4110-17-100015, timely filed on January 13, 2017, on behalf of Siemens Healthcare Diagnostics (“Protestant”). The AFR concerns U.S. Customs and Border Protection’s (“CBP”) classification, under the Harmonized Tariff Schedule of the United States (“HTSUS”), of “Immulite 2000 Olive 40T.”
FACTS:
The protested merchandise consists of a product identified as “Immulite 2000 Olive 40T,” which is an allergen protein extract derived from olive tree pollen. Specifically, the imported merchandise consists of a mixture of potassium chloride, bovine serum albumin, potassium phosphate dibasic anhydrous, potassium phosphate monobasic anhydrous, 2-methyl-3(2H)-isothiazolone and distilled water.
CBP Laboratory and Scientific Services (“LSSD”) issued report number NY20160561 on August 29, 2016. It states, in pertinent part, the following:
The product is a mixture of antigens, derived from olive trees, chemically bound to molecules of biotin. During performance of the test, the antigen portion binds to specific antibodies contained in the patient’s blood. Further purification and treatment of the antibody-antigen complex is required to measure allergenicity; these materials are not imported with the instant product. The instant product itself engages in no chemical reaction and produces no observable change in the analyte being measured.
The instant protein extract is used with the Immulite 2000 series of analyzers. Specifically, it is used with a separately imported in vitro diagnostic test kit called Immulite Olive 2000 3gAllergy Specific IgE for the quantitative measurement of allergen-specific IgE in human serum to aid in the diagnosis of IgE-mediated allergic disorders. According to a manual submitted by the Protestant titled “IMMULITE 2000 3gAllergy Specific IgE Universal Kit: Panel Allergen Application,” the principle of the test procedure involves a solid-phase, two-step chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. Neither the liquid phase nor solid bead phase are provided in the instant merchandise.
The subject merchandise was originally entered on January 22, 2016, under subheading 3002.10.0290, HTSUSA (Annotated) (2016), which provides for “Antisera, other blood fractions and immunological products, whether or not obtained by means of biotechnological processes: Other,” and liquidated on November 25, 2016, by the Port of Cleveland under subheading 3824.90.9295, HTSUSA (2016), 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,” at a duty rate of 5% ad valorem.
Protestant filed this Protest and AFR on January 13, 2017, asserting that the Immulite 2000 Olive 40T allergen protein extract is properly classified under subheading 3822.00.5090, HTSUSA, which provides for “Diagnostic or laboratory reagents on a backing, other than those of heading 3002 or 3006: Other: Other.”
In its March 17, 2016 letter, in response to a request for information on the entry, Protestant states:
The allergen panels are manufactured at Siemens Healthcare Diagnostics’ facility located in Los Angeles, California, then exported to the Siemens Healthcare Diagnostics’ facility in Llanberis, Great Britain where the allergen panels are packaged for sale. In the case of this entry, the material was shipped from Siemens Healthcare Diagnostics’ facility in Marburg, Germany to replenish U.S. inventory.
ISSUE:
Whether Immulite 2000 Olive 40T allergen protein extract is classified under heading 3822, HTSUS, as “Diagnostic or laboratory reagents on a backing, other than those of heading 3002 or 3006,” or under heading 3824, HTSUS, as “Chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included.”
LAW AND ANALYSIS:
The protest was properly filed as a decision on classification under 19 U.S.C. § 1514(a)(2). The protest was timely filed within 180 days of liquidation of the entries. See 19 U.S.C. § 1514(c)(3).
Further Review of Protest Number 4110-17-100015 was properly accorded to Protestant pursuant to 19 C.F.R. § 174.24(a) on the grounds that the decision against which the protest was filed is alleged to be inconsistent with previous rulings issued by CBP with respect to substantially similar merchandise.
Classification under the HTSUS is made in accordance with the General Rules of Interpretation (“GRI”). GRI 1 provides that the classification of goods shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs may then be applied.
The HTSUS provisions under consideration are as follows:
3822 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; certified reference materials:
3824 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:
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The Harmonized Commodity Description and Coding System Explanatory Notes (EN) 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 (Aug. 23, 1989).
The EN to 38.22 states, in relevant part:
This heading covers diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents, other than diagnostic reagents of heading 30.02 or diagnostic reagents designed to be administered to the patient and blood grouping reagents of heading 30.06. It also covers certified reference materials. Diagnostic reagents are used in the evaluation of physical, biophysical or biochemical processes and states in animals and humans; their function is based upon a measurable or observable change in the biological or chemical substances constituting the reagent. Prepared diagnostic reagents of this heading may be similar in function to those designed to be administered to patients (subheading 3006.30), with the exception that they are used for in vitro, rather than for in vivo, applications. Prepared laboratory reagents include not only diagnostic reagents, but also other analytical reagents used for purposes other than detection or diagnosis. Prepared diagnostic and laboratory reagents may be used in medical, veterinary, scientific or industrial laboratories, in hospitals, in industry, in the field or, in some cases, in the home.
Reagents of this heading are either on a backing or in the form of preparations and thus comprise more than a single constituent. For example, they may consist of admixtures of two or more reagents or of single reagents dissolved in solvents other than water. They may also be in the form of paper, plastics or other materials (used as backings or support), impregnated or coated with one or more diagnostic or laboratory reagents, such as litmus, pH or pole-finding papers or pre-coated immuno-assay plates. Reagents of this heading may also be put up in the form of kits, consisting of several components, even if one or more components are separate chemically defined compounds of Chapter 28 or Chapter 29, synthetic colouring matter of heading 32.04 or any other substance which, when presented separately, would be classifiable under another heading. Examples of such kits are those for testing glucose in blood, ketones in urine, etc., and those based on enzymes. However, diagnostic kits having the essential character of products of heading 30.02 or 30.06 (e.g., those based on monoclonal or polyclonal antibodies) are excluded.
The reagents of this heading should be clearly identifiable as being for use only as diagnostic or laboratory reagents. This must be clear from their composition, labelling, instructions for in vitro or laboratory use, indication of the specific diagnostic test to be performed or physical form (e.g., presented on a backing or support).
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The subject merchandise can only be classified in heading 3824, HTSUS, if it is deemed excluded from heading 3822, HTSUS. Cargill, Inc. v. United States, 318 F. Supp. 2d 1279, 1278-88 (Ct. Int'l. Trade 2004) (characterizing heading 3824, HTSUS, as a basket provision). Accordingly, we initially consider whether the instant merchandise, a protein extract in a solution without other components of a diagnostic kit, is classifiable in heading 3822, HTSUS.
The tariff term “reagent” is not defined in the HTSUS, but in Headquarters Ruling Letter (“HQ”) H129336, dated July 11, 2011, CBP stated:
A reagent is "a substance employed as a test to determine the presence of some other substance by means of the reaction which is produced. Now, any substance employed in chemical reactions." The Compact Oxford English Dictionary, Second Edition (p. 271, 1991).
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Typically, a reagent is mixed with another chemical, reacts with it, and is consumed in that reaction, creating a different set of chemicals. For instance, silver nitrate is a reagent used for the detection of certain halide ions (chloride, iodide, bromide), particularly for chloride. When clear silver nitrate and sodium chloride solutions are combined, the silver and chloride ions react with one another to form a silver chloride solid precipitate and a solution of sodium nitrate. Hence, the addition of silver nitrate to a clear sodium chloride solution allows one to detect the presence of chloride in the solution, because the white silver chloride precipitate could not have formed without its presence.
Similarly, in HQ H259355, dated December 19, 2017, CBP also relied on dictionary definitions in determining the meaning of “reagent” for purposes of heading 3822, HTSUS: “Hawley's Condensed Chemical Dictionary defines a reagent, in part, as ‘Any substance used in a reaction for the purpose of detecting, measuring, examining, or analyzing other substances.’” Therefore, in order for the subject merchandise to be a reagent within the meaning of heading 3822, HTSUS, it must participate in a chemical reaction when used to detect other substances as part of diagnostic testing.
In Laboratory Report Number NY20160561, LSSD determined that “The instant product engages in no chemical reaction and produces no observable change in the analyte being measured (emphasis added).” Thus, by itself, the subject merchandise does not participate in any reaction or measureable change and therefore is not classified as a reagent of heading 3822, HTSUS, when imported separately.
In fact, CBP has consistently classified certain solutions imported separately, even if intended for inclusion in a reagent kit, outside of heading 3822, HTSUS, when they do not participate in a chemical reaction when used in conjunction with other articles in the kit and a sample of the patient’s blood. For example, in NY N258021, dated December 22, 2014, CBP excluded from heading 3822, HTSUS, a product called R1, consisting of N, N-bis (2-hydroxyethyl) glycine (Bicine) buffer, colipase (porcine pancreas), a detergent and a preservative. This product was imported separately in bulk form to make up an enzymatic in vitro diagnostic test kit. In its condition as imported, R1 is merely used to increase the specificity of the test procedure, and it is not used by itself for the detection of pancreatic lipase and does not undergo an observable or measurable change. However, in that same ruling, CBP classified in heading 3822, HTSUS, another product called R3, consisting of Tartrate buffer, 1,2-O-dilauryl-rac-glycero-3-glutaric acid-(6-methylresofurin) ester (chromogenic lipase substrate), taurodeoxycholate, a detergent and a preservative. Like R1, R3 was imported separately in bulk form to make up an enzymatic in vitro diagnostic test kit. However, unlike R1, R3 participates in a chemical reaction when it reacts with lipase to form a red dye, which is proportional to lipase activity and can be determined photometrically. Moreover, R3 acts as a reagent of heading 3822, HTSUS, as it contains a chromogenic compound which when added to the sample, produces a measurable color change.
In NY N256882, dated February 5, 2015, CBP also excluded from classification in heading 3822, HTSUS, a product called Iron-SL Dissociating Reagent (R1), consisting of an acid buffer solution containing a surfactant, preservatives and stabilizers. This product was imported separately in bulk form to make up an in vitro diagnostic test kit for the determination of iron in human serum. In the condition as imported, R1 was merely used to prepare a serum sample for quantification by reagent R2 and was not used for the detection of iron in human serum and did not undergo an observable or measurable change. On the other hand, a second product called Iron-SL Color Reagent (R2), and consisting of a solution containing ferene and stabilizers, was classified in heading 3822, HTSUS, because the ferene participated in a chemical reaction with ferrous iron to form a blue chromophore. Further, R2 undergoes processes to form a ferrous-ferene complex, which is observable visually and quantifiable.
Similar to the products identified as R1 in NY N258021 and NY N256882, the instant merchandise is also added to an in vitro immunoassay kit after importation, but does not participate in a chemical reaction and does not produce an observable or measurable change when used in conjunction with the kit. Therefore, in its condition as imported, the subject merchandise is not classified in heading 3822, HTSUS.
The Protestant relies on NY 810394, dated June 5, 1995, in support of its argument that the subject merchandise should be classified in heading 3822, HTSUS. In NY 810394, CBP classified an allergen patch test consisting of a thin-layer, rapid-use epicutaneous test system as a diagnostic reagent under subheading 3006.30.10, HTSUS, which provides for “diagnostic reagents designed to be administered to the patient: containing antigens or antisera.” Heading 3006 is not at issue here as Protestant does not state the instant merchandise is designed to be administered to the patient. That case is not dispositive here.
The Protestant also relies on HQ H129336, dated July 11, 2011, in support of its argument that the subject allergen protein extract should be classified in heading 3822, HTSUS. There, CBP classified “Dynabeads M-450 Tosylactivated” and “Dynabeads M-280 Tosylactivated” products under heading 3822, HTSUS. The Dynabeads are polysterene spheres that act as a solid phase for the attachment of antibodies. The Protestant argues that the reaction of the Dynabeads in HQ H129336 is similar to the first steps of the Immulite 2000 3gAllergy IgE specific diagnostic test in that a ligand compound binds to IgE from a patient sample, creating a different material, which is bound to an anti-biotin bead. However, the Dynabeads participate in a chemical reaction by providing “reactive sulphonyl esters that can react covalently with proteins (e.g. antibodies) or other ligands containing primary amino or sulphydryl groups. No further activation is necessary. Dynabeads M450 Tosylactivated will bind proteins physically and chemically with an increasing number of covalent bonds with higher temperature and pH.” Accordingly, CBP classified the Dynabeads as laboratory reagents of heading 3822, HTSUS. In contrast, the subject allergen protein extract, by itself, does not participate in a chemical reaction, nor does it produce an observable or measurable change when mixed with an antibody. Therefore, the subject Immulite 2000 Olive 40T allergen protein extract is not classifiable in heading 3822, HTSUS.
As Immulite 2000 Olive 40T allergen protein extract is not elsewhere specified or included, it is classified in heading 3824, HTSUS, specifically under subheading 3824.90.9295, HTSUSA (2016), 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.”
HOLDING:
By application of GRIs 1 and 6, the subject Immulite 2000 Olive 40T allergen protein extract is classified under heading 3824, HTSUS, specifically under subheading 3824.90.9295, HTSUSA (2016), 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.” The column one, general rate of duty at the time of entry was 5% 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/current.
You are instructed to DENY the protest.
In accordance with Sections IV and VI of the CBP Protest/Petition Processing Handbook (HB 3500-08A, December 2007, pp. 24 and 26), you are to mail this decision, together with the CBP Form 19, to the Protestant no later than 60 days from the date of this letter. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to mailing the decision.
Sixty days from the date of the decision, the Office of Trade, Regulations and Rulings will make the decision available to CBP personnel and to the public online at http://www.cbp.gov, by means of the Freedom of Information Act, and other methods of public distribution.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division