CLA-2 OT:RR:CTF:TCM H035574 ARM
TARIFF NO: 2844.40.00
Ms. Helen Mestas
Beckman Coulter Inc.
4300 Harbor Blvd.
Fullerton, CA 92835
RE: Modification of New York Ruling Letter N019762; Classification of Reagent kit IM1579 RIA Free T3
Dear Ms. Mestas:
This is in reply to your electronic request, of July 2, 2008, for reconsideration of New York Ruling Letter (NY) N019762, dated December 10, 2007, regarding the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of Reagent kit IM1579 RIA Free T3. In NY N019762, Customs and Border Protection (“CBP”) classified the Reagent kit in subheading 3002.10.01, HTSUS, which provides for "Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes." The rate of duty is free. You state that you have received a copy of a ruling issued by the Australian Customs Service that classifies the product in heading 2844, of its Tariff, and ask that we reconsider our ruling. Your request has been forwarded to this office for reply. We have reviewed NY N019762 and find it to be it error with respect to Reagent kit IM1579 RIA Free T3.
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 was published on February 27, 2013, in Volume 47, Number 10, of the CUSTOMS BULLETIN, proposing to revoke NY N019762, dated December 10, 2007, and proposing to revoke any treatment accorded to substantially identical transactions. No comments were received in response to the proposed notice.
FACTS:
NY N019762 describes the instant merchandise as follows:
Reagent Kit IM 1579 RIA Free T3, is intended for in vitro diagnostic use. This kit contains Ligand coated tubes and is radioactive labeled monoclonal antibody in bovine serum albumin and dye. It is used for the quantitative determination of triiodothyronine (T3) in human serum by the principle of the competitive protein binding analysis.
A page entitled “Direction for Use” is submitted with your request. It states, in pertinent part, the following:
Principle of the Assay
The radioimmunoassay of free triiodythyronin (T3) is a competition assay based on the principle of labeled antibody. Samples and calibrators are incubated with 125I-labeled monoclonal antibody specific for T3, as tracer, in tubes coated with an analog of T3 (ligand). There is competition between the free triiodothyronine of the sample and the ligand for the binding to the labeled antibody. After incubation, the content of tubes is aspirated and bound radioactivity is measured. A calibration curve is established and unknown values are determined by interpolation from the curve.
Reagents Provided
2.1 Kit for determination of free T3, 100 tubes (Cat #1579)
2.1.1 Ligand-coated tubes: 2x50 tubes (ready-to-use)
2.1.2 125I-labeled monoclonal antibody: one 45 ml vial (ready-to-use)
The vial contains 225 kBq, at the date time of manufacture, of 125I-labeled immunoglobulins in liquid form with bovine serum albumin and sodium azide (parenthetical omitted) and a dye.
2.1.3 Calibrators: five 1 ml vials (ready-to-use)
The calibrator vials contain from 0 to 44pM of free T3 in human serum. . . 2.1.4 Control serum: one 1 ml vial (ready-to-use) . . . .
ISSUE:
Whether the vial of 125I-labeled monoclonal antibody, bovine serum albumin, sodium azide and a dye in the Reagent Kit IM1579 RIA Free T3 is classified as a monoclonal antibody reagent of heading 3002, HTSUS, or as a chemically undefined organic compound of Iodine contained in a solution of heading 2844, HTSUS.
LAW AND ANALYSIS:
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. When interpreting and implementing the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System may be utilized. The ENs, while neither legally binding nor dispositive, provide a guiding commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. Customs and Border Protection (CBP) believes the ENs should always be consulted. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
GRI 2(b) requires that goods consisting of different materials be classified according to the principles of GRI 3. GRI 3(a) requires that amongst competing headings, the most specific heading be used, but headings which refer to part only of the goods are equally specific. GRI 3(b), provides that sets put up for retail sale and composite goods consisting of different materials or made up of different components, shall be classified as if they consisted of the material or component which gives them their essential character, insofar as this criterion is applicable. Explanatory Note 3(b)(VIII) to GRI 3(b) states that essential character may be determined by "the nature of the material or component, its bulk, quantity, weight or value, or by the role of a constituent material in relation to the use of the goods." Explanatory Note (X) (page 5) to GRI 3(b) states that the term "goods put up in sets for retail sale" means goods which:
(a) consist of at least two different articles which are, prima facie, classifiable in different headings; (b) consist of products or articles put up together to meet a particular need or carry out a specific activity; and (c) are put up in a manner suitable for sale directly to users without repacking.
The Section VI Notes state, in pertinent part, the following:
1. (a) Goods . . .answering to a description in heading 2844 or 2845 are to be classified in those headings and in no other heading of the tariff schedule.
* * * *
3. Goods put up in sets consisting of two or more separate constituents, some or all of which fall in this section and are intended to be mixed together to obtain a product of section VI or VII, are to be classified in the heading appropriate to that product, provided that the constituents are:
(a) Having regard to the manner in which they are put up, clearly identifiable as being intended to be used together without first being repacked;
(b) Entered together; and
(c) Identifiable, whether by their nature or by the relative proportions in which they are present, as being complementary one to another.
Chapter 28 note 6 states:
6. Heading 2844 applies only to:
(a) Technetium (atomic No. 43), promethium (atomic No. 61), polonium (atomic No. 84) and all elements with an atomic number greater than 84;
(b) Natural or artificial radioactive isotopes (including those of the precious metals or of the base metals of sections XIV and XV), whether or not mixed together;
(c) Compounds, inorganic or organic, of these elements or isotopes, whether or not chemically defined, whether or not mixed together;
(d) Alloys, dispersions (including cermets), ceramic products and mixtures containing these elements or isotopes or inorganic or organic compounds thereof and having a specific radioactivity exceeding 74 becquerels per gram (0.002 microcurie per gram);
(e) Spent (irradiated) fuel elements (cartridges) of nuclear reactors;
(f) Radioactive residues whether or not usable.
The term "isotopes", for the purposes of this note and of the wording of headings 2844 and 2845, refers to:
(i) Individual nuclides, excluding, however, those existing in nature in the monoiosotopic state;
(ii) Mixtures of isotopes of one and the same element, enriched in one or several of the said isotopes, that is, elements of which the natural isotopic composition has been artificially modified.
Chapter 30 note 2 provides that “For the purposes of heading 3002, the expression "modified immunological products" applies only to monoclonal antibodies (MABs), antibody fragments, antibody conjugates and antibody fragment conjugates.”
The following HTSUS provisions are relevant to the classification of this product:
2844: Radioactive chemical elements and radioactive isotopes (including the fissile or fertile chemical elements and isotopes) and their compounds; mixtures and residues containing these products:
2844.40.00 Radioactive elements and isotopes and compounds other than those of subheadings 2844.10, 2844.20, and 2844.30; alloys, dispersions (including cermets), ceramic products and mixtures containing these elements, isotopes or compounds; radioactive residues
* * * * *
3002 Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products:
3002.10.01 Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes .
* * * * *
The contents of the Reagent Kit IM1579 RIA Free T3 meets the definition of a set under GRI 3(b) as it consists of articles classified in different headings, put up in packings for the end user (laboratory personnel), intended to be used together for the particular activity of determining the level of free T3 in a blood sample. The article of the kit which imparts the kit with its essential character is the vial of 125I-labeled monoclonal antibody, bovine serum albumin, sodium azide and a dye. This vial and its contents constitute a composite good under GRI 3(b). The item that imparts the contents of the vial with its essential character is the 125I-labeled monoclonal antibody. These statements are not in dispute.
The classification of the 125I-labeled monoclonal antibody is at issue. A monoclonal antibody is a modified immunological product classified in heading 3002, HTSUS, by note 2 to Chapter 30. A “labeled” monoclonal antibody is a new chemical compound that is not chemically defined, however, the monoclonal antibody remains intact. The “label”, in this case 125Iodine, is a radioactive isotope of iodine. Hence, the 125I-labeled monoclonal antibody at issue is included in Chapter 28 under note (c) to the chapter. It is contained in a dispersion of bovine serum albumin, sodium azide and a dye having a specific radioactivity exceeding 74 becquerels per gram, which meets the terms of Chapter 28 note 6(d). Therefore, under Section VI, note (a), the merchandise must remain classified in Chapter 28, specifically in heading 2844, HTSUS, as a mixture containing a compound of a radioactive isotope.
HOLDING:
By application of GRIs 1 and 3, the classification of the Reagent kit IM1579 RIA Free T3 is in heading 2844, HTSUS, specifically in subheading 2844.40.00, HTSUS, which provides for: “Radioactive chemical elements and radioactive isotopes (including the fissile or fertile chemical elements and isotopes) and their compounds; mixtures and residues containing these products: Radioactive elements and isotopes and compounds other than those of subheadings 2844.10, 2844.20, and 2844.30; alloys, dispersions (including cermets), ceramic products and mixtures containing these elements, isotopes or compounds; radioactive residues.” The column one general rate of duty is 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 www.usitc.gov.
EFFECT ON OTHER RULINGS:
This ruling modifies NY N019762, dated December 10, 2007, with respect to the classification of the Reagent kit IM1579 RIA Free T3. The classification of Rubella IgG 34430, TBIL reagent 442745, IgG reagent 446400, and GenomeLab™ GeXP Human MetastasisPlex Kit A32712 remains unchanged.
In accordance with 19 U.S.C. 1625(c), this ruling will become effective 60 days after publication in the CUSTOMS BULLETIN.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division