OT:RR:CTF:CPMM H259355 APP
Andrea Abraham, Esq.
Meeks, Sheppard, Leo & Pillsbury
1735 Post Road, Suite 4
Fairfield, CT 06824
RE: Request for a ruling; Classification of reference materials used in VITROS systems
Dear Ms. Abraham:
This is in response to your request for a binding ruling dated June 30, 2014, which was filed on behalf of Ortho Clinical Diagnostics, Inc. (“requestor” or “OCD”). You request a ruling concerning the classification of eight reference materials used to calibrate, verify the calibration range, and monitor the performance of OCD’s VITROS Immunodiagnostic Systems under the Harmonized Tariff Schedule of the United States (“HTSUS”).
FACTS:
OCD requests a classification ruling on the following eight items: Intact PTH Control #6802895, Folate Range Verifiers #6800873, Troponin I ES Range Verifiers
#6802303, Ferritin Calibrators #6800378 or #1158864, Anti-HIV 1+2 Calibrators #6801862, VITROS Immunodiagnostic Products Testosterone Calibrators #1306026, VITROS Immunodiagnostic Products Testosterone Verifiers #6800661, and VITROS Immunodiagnostic Products Testosterone Controls #6800660. These calibrators, controls, and verifiers represent materials of known analyte concentration that can be run in OCD’s VITROS systems to ensure they meet the quality and performance requirements prior to and/or after the testing of a patient sample. The products contain specific analyte levels and matrix composition.
Calibration is “the process of testing and adjusting the instrument or test system readout to establish a correlation between the instrument’s measurement of the substance being tested and the actual concentration of the substance.” A calibrator is the “material that has been manufactured or assayed to have known, measured values of one or more characteristics. The assayed values are provided with the material.” A control sample is defined as a “sample prepared in the same or nearly same way as a test or unknown sample and which should give an expected, predetermined result.” Calibration verification means “testing materials of known concentration in the same manner as patient specimens to assure the test system is accurately measuring samples throughout the reportable range.”
U.S. Customs and Border Protection’s (“CBP”) Laboratories and Scientific Services, New York Laboratory reviewed the information submitted by requestor for the various products and issued two laboratory reports (CBP Laboratory Report No. NY20141081, dated October 10, 2014, and CBP Laboratory Report No. NY20170004, dated April 5, 2017). These two CBP laboratory reports determined the following:
The product, Intact PTH Control, consists [of] a set of three calibrators containing different concentrations of a mixture consisting of a hormone and bovine serum albumin prepared for diagnostic use only. The product is not accompanied by a certificate which indicates the values of the certified properties, the methods used to determine the values and the degree of certainty associated with each value, and the certifying authority.
The product, Troponin I ES range verifier, consists of a set of two calibrators containing different concentrations of a mixture consisting of a protein in human serum prepared for diagnostic use only. The product is not accompanied by a certificate which indicates the values of the certified properties, the methods used to determine the values and the degree of certainty associated with each value, and the certifying authority.
The product, Folate range verifier, consists of a set of two calibrators containing different concentrations of a mixture consisting of folic acid in a buffer solution containing human serum albumin prepared for diagnostic use only. The product is not accompanied by a certificate which indicates the values of the certified properties, the methods used to determine the values and the degree of certainty associated with each value, and the certifying authority.
The product, Ferritin calibrators, consists [of] a set of three calibrators containing different concentrations of a mixture consisting of a protein in human plasma prepared for diagnostic use only. The product is not accompanied by a certificate which indicates the values of the certified properties, the methods used to determine the values and the degree of certainty associated with each value, and the certifying authority.
The product, Anti-HIV 1+2 calibrators, consists of a calibrant containing antisera derived from human blood and prepared for diagnostic use only. The product is not accompanied by a certificate which indicates the values of the certified properties, the methods used to determine the values and the degree of certainty associated with each value, and the certifying authority.
Product: VITROS Immunodiagnostic Products Testosterone Calibrators, Catalogue Code: 130 6026 [Ingredients: Testosterone in human serum with antimicrobial agent. Use: For the quantitative measurement of testosterone in human serum and plasma (EDTA or heparin)]. The documents provided by the importer that will accompany the product at importation do not describe the method used to determine the product values and the degree of certainty associated with each value. As per Note 2(a) to Chapter 38, the product does not meet the definition for certified reference material.
Product: VITROS Immunodiagnostic Products Testosterone Controls, Catalogue Code: 680 0660 [Ingredients: Freeze-dried, human serum with antimicrobial agent. Use: For the measurement of testosterone in human serum and plasma (EDTA or heparin)]. The documents provided by the importer that will accompany the product at importation do not describe the method used to determine the product values and the degree of certainty associated with each value. As per Note 2(a) to Chapter 38 the product does not meet the definition for certified reference material.
Product: VITROS Immunodiagnostic Products Testosterone Range Verifiers, Catalogue Code: 680 0661 [Ingredients: Freeze-dried, testosterone in human serum with antimicrobial agent. Use: For the measurement of testosterone]. The documents provided by the importer that will accompany the product at importation do not describe the method used to determine the product values and the degree of certainty associated with each value. As per Note 2(a) to Chapter 38 the product does not meet the definition for certified reference material.
(emphasis added).
Additionally, the importer notes that OCD sells the VITROS immunodiagnostic systems and that the calibrators, range verifiers, and controls are used to calibrate these systems and to certify their performance. The values are assigned by running the controls, calibrators, and range verifiers on the corresponding VITROS system numerous times. The calibration range is traceable to in-house reference calibrators.
ISSUES:
Whether the instant merchandise is classifiable as antisera and other blood fractions of heading 3002, HTSUS, or as diagnostic or laboratory reagents, or certified reference materials of heading 3822, HTSUS.
If the instant merchandise is classifiable in heading 3822, HTSUS, whether it is classifiable as “diagnostic or laboratory reagents … other than those of heading 3002” under subheading 3822.00.50, HTSUS or as certified reference materials under subheading 3822.00.60, HTSUS.
LAW AND ANALYSIS:
Classification of goods under the HTSUS is governed by the General Rules of Interpretation (“GRIs”). GRI 1 provides that classification 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. Pursuant to GRI 6, classification at the subheading level uses the same rules, mutatis mutandis, as classification at the heading level.
The HTSUS provisions at issue are as follows:
3002 Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products:
Antisera, other blood fractions and immunological products, whether or not obtained by means of biotechnological processes:
3002.12.00 Antisera and other blood fractions
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:
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:
3822.00.50 Other
3822.00.60 Certified reference materials
Note 1(h) to Chapter 30 (Pharmaceutical Products), HTSUS, states that this chapter does not cover “[b]lood albumin not prepared for therapeutic or prophylactic uses (heading 3502).”
Note 2 to Chapter 38 (Miscellaneous Chemical Products), HTSUS states:
2. (a) For the purposes of heading 3822, the expression “certified reference materials” means reference materials which are accompanied by a certificate which indicates the values of the certified properties, the methods used to determine these values and the degree of certainty associated with each value and which are suitable for analytical, calibrating or referencing purposes.
(b) With the exception of the products of chapter 28 or 29, for the classification of certified reference materials, heading 3822 shall take precedence over any other heading in the tariff schedule.
The Harmonized Commodity Description and Coding System Explanatory Notes (“ENs”) 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 (August 23, 1989).
EN 30.02 states, in relevant part, that this heading covers:
… (C) Antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes.
These products include:
Antisera and other blood fractions, whether or not modified or obtained by means of biotechnological processes.
Sera are the fluid fractions separated from blood after clotting.
The heading covers, inter alia, the following products derived from blood (including vascular endothelial cells): “normal” sera, human normal immunoglobulin, blood fractions and truncated variants (parts) thereof with enzymatic properties/activity, plasma, thrombin, fibrinogen, fibrin and other blood coagulation factors, thrombomodulin, blood globulins, serum globulins, and haemoglobin. This group also includes modified thrombomodulins and modified haemoglobins obtained by means of biotechnological processes, e.g., sothrombomodulin alfa (INN) and thrombomodulin alfa (INN), as well as cross-linked haemoglobins such as hemoglobin crosfumaril (INN), hemoglobin glutamer (INN) and hemoglobin raffimer (INN).
The heading further includes blood albumin (e.g., human albumin obtained by fractionating the plasma of whole human blood), prepared for therapeutic or prophylactic uses.
Antisera are obtained from the blood of humans or of animals which are immune or have been immunised against diseases or ailments, whether these are caused by pathogenic bacteria and viruses, toxins or allergic phenomena, etc. Antisera are used against diphtheria, dysentery, gangrene, meningitis, pneumonia, tetanus, staphylococcal or streptococcal infections, snake bite, vegetable poisoning, allergic diseases, etc. Antisera are also used for diagnostic purposes, including in vitro tests. Specific immunoglobulins are purified preparations of antisera.
The heading does not cover blood albumin not prepared for therapeutic or prophylactic uses (heading 35.02) or globulins (other than blood globulins and serum globulins) (heading 35.04). The heading also excludes medicaments which are not separated from the blood but which in some countries are described as “sera” or “artificial sera”; they include isotonic solutions based on sodium chloride or other chemicals and suspensions of pollen which are used against allergic diseases ….
EN 38.22 states, in relevant part, that:
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).
With the exception of the products of Chapter 28 or 29, for the classification of certified reference materials, heading 38.22 shall take precedence over any other heading in the Nomenclature.
The certified reference materials of this heading are reference materials prepared for the calibration of an apparatus, the assessment of a measurement method or the assignment of values to a material. These reference materials may consist of the following:
Substrate materials containing added analytes, the concentration of which has been accurately determined;
Unmixed materials, the concentration of certain components of which has been accurately determined (e.g., the protein and fat content of milk powder);
Materials, whether natural or synthetic, certain properties of which have been accurately determined (e.g., tensile strength, specific gravity).
These reference materials must be accompanied by a certificate which indicates the values of the certified properties, the methods used to determine the values and the degree of certainty associated with each value, and the certifying authority.
(emphasis added).
If the instant merchandise is a certified reference material, it is classified in heading 3822, HTSUS, specifically in subheading 3822.00.60, HTSUS, as such. If it is not a certified reference material, but is instead a product of heading 3002, HTSUS, such as antisera and other blood fractions and modified immunological products, then by the exclusionary terms of heading 3822, HTSUS, it is classified in heading 3002, HTSUS. If it does not qualify as a certified reference material of subheading 3822.00.60, HTSUS or as a reagent of heading 3002 HTSUS, it is classifiable in heading 3822, HTSUS, specifically in subheading 3822.00.50, HTSUS.
Pursuant to Note 2(a) to Chapter 38, HTSUS, certified reference materials must be accompanied by a certificate, which indicates the values of the certified properties, the methods used to determine these values, and the degree of certainty associated with each value. CBP has previously classified certified reference materials under heading 3822, HTSUS, specifically under subheading 3822.00.60, HTSUS, provided they complied with the requirements in Note 2(a) to Chapter 38, HTSUS. See New York Ruling Letter (“NY”) N232989, dated October 4, 2012 (the company was a known producer of certified reference materials and had provided a certificate for the certified reference standard used in laboratory analysis in compliance with the requirements in Note 2(a) to Chapter 38, HTSUS); NY L88599, dated January 20, 2006 (the calibration mixtures were accompanied by a certificate of analysis indicating the values of the certified properties, the methods used to determine these values, the degree of certainty associated with each value, and the certifying authority); NY N152405, dated March 18, 2011 (various ISO 17025 liquid density certified reference materials, which were the standard for the calibration of density measuring equipment in compliance with the requirements in Note 2(a) to Chapter 38, HTSUS); NY N109995, dated June 25, 2010 (various ISO 17025 liquid density certified reference materials, which were the standard for the calibration of density measuring equipment in compliance with the requirements in Note 2(a) to Chapter 38, HTSUS); NY N052415, dated March 13, 2009 (calibration and cleaning kit in compliance with the requirements in Note 2(a) to Chapter 38, HTSUS).
However, from an examination of the documents submitted and confirmation in the two CBP laboratory reports, see supra, we conclude that unlike the products in the above-cited CBP rulings, the subject reference materials are not certified reference materials pursuant to Note 2(a) to Chapter 38, HTSUS, because they do not indicate the values of the certified properties, the methods used to determine these values, and the degree of certainty associated with each value. We will next determine the proper classification of the instant reference materials.
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”. The instant products are prepared diagnostic reagents because they are used for the purpose of the in vitro evaluation (detecting, measuring, examining, or analyzing) a specific substance or substances which serve as an indicator of physical, biophysical or biochemical processes and states in humans, they consist of more than a single constituent, and they are dissolved in a solvent matrix other than water (in the cases at hand, serum, serum albumin, or plasma). They are classifiable in heading 3822, HTSUS, as such, provided they are not described by heading 3002, HTSUS (or heading 3006, HTSUS, which is not implicated here). Products of heading 3002, HTSUS, include human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products ...; vaccines, toxins, cultures of micro-organisms … and similar products.
Of the eight products at issue, only the product Anti-HIV 1+2 Calibrators is wholly comprised of products of heading 3002, HTSUS (anti-virus calibrators and antisera) and is thus a product of heading 3002, HTSUS. It is therefore excluded from classification in heading 3822, HTSUS.
The Intact PTH Control and the Folate Range Verifiers do not contain any product of heading 3002, HTSUS. Human and animal albumin prepared for diagnostic use is not listed in the heading text and is specifically excluded by EN 30.02 and Note 1(h) to Chapter 30, HTSUS.
Although, the rest of the calibrators, verifiers and controls include human plasma and human serum, which are products of heading 3002, HTSUS, those products merely serve as the reagents’ solvent matrix. Therefore, the subject Troponin, Ferritin and Testosterone products are not excluded from classification in heading 3822, HTSUS, and are classified there.
HOLDING:
By application of GRIs 1 and 6, the Intact PTH Control, Folate Range Verifiers, Troponin I ES Range Verifiers, Ferritin Calibrators, VITROS Immunodiagnostic Products Testosterone Calibrators, VITROS Immunodiagnostic Products Testosterone Controls, and VITROS Immunodiagnostic Products Testosterone Range Verifiers are properly classified under heading 3822, specifically under 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; certified reference materials: 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: Other.” The 2017 column one, general rate of duty is Free.
By application of GRIs 1 and 6, the product Anti-HIV 1+2 Calibrators is properly classified under heading 3002, HTSUS, specifically under subheading 3002.12.00, HTSUS, which provides for “Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Antisera, other blood fractions and immunological products, whether or not obtained by means of biotechnological processes: Antisera and other blood fractions.” The 2017 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 at https://hts.usitc.gov/current.
A copy of this ruling letter should be attached to the entry documents filed at the time the goods are entered.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division