CLA-2 OT:RR:CTF:TCM H053758 MG
Eleanore Kelly-Kobayashi, Esq.
Rode & Qualey
Attorneys at Law
55 West 39th Street
New York, New York 10018
Re: Request for Prospective Ruling; BD Vacutainer®; Glass Tube
Dear Ms. Kelly-Kobayashi:
This is in response to your request for a ruling, dated January 27, 2009, and your subsequent submission, dated April 9, 2009, on behalf of your client, Becton Dickinson & Company, and addressed to the National Commodity Specialist Division (NCSD), U.S. Customs and Border Protection (CBP). The NCSD forwarded your request for a binding ruling on the classification of a “BD Vacutainer®” glass tube under the Harmonized Tariff Schedule of the United States (HTSUS), and we received it on March 6, 2009. A meeting was held telephonically, on August 24, 2009 and a sample was received on August 31, 2009. A request for confidentiality was filed with the ruling request and the same was withdrawn in a letter, dated August 24, 2009.
FACTS:
The merchandise at issue is identified as the BD Vacutainer® tube (“the BD tube”) imported from the United Kingdom. According to your submission, the BD tube is an evacuated and sterile glass tube which enables the collection of a pre-defined amount of blood. The BD tubes have a BD Hemogard™ closure which seals the BD tubes. The BD Hemogard™ tube closure is recessed within and covered by a plastic shield to help protect laboratory personnel from contact with blood on the stopper or around the outer rim of the tube. The BD Hemogard™ tube closure also helps prevent blood from splattering when the BD tube is opened.
The BD tube is available coated or uncoated with a silica gel with or without chemicals additives, which cause the blood to clot in a significantly reduced timeframe from normal. The chemicals additives in the BD tube are dosed in predetermined amounts depending on the volume of the draw. The BD tube is used by trained professionals in a medical setting to draw blood specimens for analysis.
The BD tube contains a Hemogard™ closure which acts as a syringe, by enabling the collection of a pre-defined amount of blood, while protecting the person drawing the blood. A sample BD tube containing the additive, acid citrate dextrose (a citrate dextrose solution used as an anticoagulant to preserve blood), was submitted.
ISSUE:
Whether the “BD Vacutainer®” glass tube described above is classified under heading 7017, HTSUS, as “laboratory glassware,” or heading 9018, HTSUS, as “instruments used in medical sciences”?
LAW AND ANALYSIS:
Classification of goods under the HTSUS is governed by the GRI. 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 GRI may then be applied.
The HTSUS provisions under consideration are as follows:
7017 Laboratory, hygienic or pharmaceutical glassware, whether or not graduated or calibrated:
* * *
9018 Instruments and appliances used in medical, surgical, dental or
veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof:
Syringes, needles, catheters, cannulae and the like; parts
and accessories thereof:
* * *
9018.39.00 Other. . . .
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 Customs and Border Protection (CBP) practice to follow, whenever possible, the terms of the ENs when interpreting the HTSUS. See, T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
Chapter 70 Note 1(d) excludes: “optical fibers… hypodermic syringes, artificial eyes, thermometers, …hydrometers or other articles of Chapter 90.” The heading 7017 ENs also exclude: glass instruments and appliances for example, “hypodermic syringes, special cannulae, and other articles being medical, surgical, dental or veterinary instruments or appliances.” Note 1-e to Chapter 90 excludes goods of heading 7017. therefore, we must first determine whether the goods are described by heading 7017, HTSUS.
Heading 7017 covers “Laboratory glassware, hygienic or pharmaceutical glassware whether or not graduated or calibrated.” The ENs to heading 7017 are very specific about the types of articles covered by the heading. With regard to laboratory glassware the ENs state that:
This heading covers glass articles of a kind in general use in laboratories (research, pharmaceutical, industrial, etc.), including special bottles (gas washing, reagent, Woulf’s, etc.), special tubes (gas washing, drying, condensation, filter, gas burettes, test-tubes, etc.), stirrers, distilling flasks, graduated jars, culture flasks (Kolle, Roux, etc.), burettes of all kinds…
The ENs provide concrete examples of the types of articles considered “hygienic or pharmaceutical glassware, ” such as, inter alia, irrigators, nozzles (for syringes, enemas etc.), urinals, bed pans, chamber pots, spittoons, cupping-glasses, breast-relievers (with or without rubber bulb), eye-baths, inhalers and tongue depressors, Spools and reels for winding surgical catgut are also included.
The term “hygienic or pharmaceutical glassware” is described in the ENs to heading 7017 as “articles of general use not requiring the services of a practitioner.” The BD tubes are used exclusively by a phlebotomist or other healthcare practitioner to draw blood. They are not used as general glassware supplies in a laboratory, nor are they similar to the examples provided in ENs to heading 7017, HTSUS. Hence, they do not constitute “hygienic or pharmaceutical glassware.”
Furthermore, the BD tubes are evacuated and sealed sterile tubes, with or without chemicals additives (to preserve the blood and prepare the specimen for analysis) and are specifically designed to be used by trained medical professionals to draw and collect blood. Inasmuch as doctors, nurses and medical practitioners use the BD tubes in a medical setting to collect blood (that is then transported for analysis prescribed by a physician) they are not generally used in a research, pharmaceutical, industrial laboratories setting.
Given the aforementioned, the BD tubes are not described by the terms of heading 7017, HTSUS, as “laboratory glassware.” Therefore, the instant merchandise is not excluded from classification in Chapter 90 by Note 1-e thereto.
Heading 9018 covers “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing.” The ENs to heading 9018 state that:
This heading covers a very wide range of instruments and appliances which, in the vast majority of cases are used only in professional practice, (e.g., by doctors, surgeons, dentists, veterinary surgeons, midwives), either to make a diagnosis, to prevent or treat illness or to operate, etc….
This group includes…[i]nstruments which may be used under the same names for several purposes…[include] cannulae … suction tubes [, and]… syringes… of all kinds, e.g.,… suction (with or without pump…)
The EN further states that the instruments of heading 9018 may be “made of any material.” In HQ H006419, we found that a BD Vacutainer™ RST (plastic tube) having the identical properties and functions as the instant BD glass tube was classified in subheading 9018.39, HTSUS. Citing to the heading 9018 ENs, we concluded that since the RST is used to draw blood and functions similarly to cannulae, suction tubes, and syringes, it is covered by the provisions of heading 9018, HTSUS, and is specifically provided for in subheading 9018.39.00, as an instrument used in medical science, similar to a syringe.
Similar to the BD Vacutainer® plastic tubes in H006419, the instant BD glass tubes are used by medical practitioners to draw and collect blood for testing and function similarly to a syringe. A syringe consists of a barrel and plunger. To draw blood a needle is attached and inserted in a vein. The plunger of the syringe is retracted to create a vacuum so that a certain amount of blood flows from the vein into the syringe. The vacuum in the sealed BD tubes acts like that created in a syringe.
Furthermore, at HSC 39, the Harmonized System Committee of the World Customs Organization (“WCO”) took a decision to amend the Compendium of Classification opinions by insertion of Opinion 901839/1, which may be found at Annexes IJ to Doc. NC1139B1a (HSC/39/March 2007). That opinion involved an article described as “Evacuated tubes, of plastics, with a pre-defined vacuum for exact draw volumes of blood. The tubes are used to collect and, for a limited time, also to transport, preserve and store blood for specific testing of serum, plasma or whole blood in a clinical laboratory. They are suitable for use principally with phlebotomy needles and holders produced by the same manufacturer. They have a sterile interior with (and without) additives dosed in predetermined amounts depending on the draw volumes. The tubes are fitted with colour-coded safety caps having coloured-coded inner rings. The additives can be either chemically inert or a kind of chemically interacting with a taken sample. The chemically inert additives (clot activator, separation gel and polystyrene beads) have mechanical functions. The chemical additives act, for example, as anticoagulating agents (ethylene diamine tetra acetic acid (EDTA)), heparin (ammonium, lithium, sodium), sodium citrate, potassium or ammonium oxalate) or as antiglycolytic agents (sodium fluoride and lithium iodo acetate).”
The HSC determined that the evacuated tubes are to be classified in heading 9018.39, HTSUS, which covers “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Syringes, needles, catheters, cannulae and the like; parts and accessories thereof: Other.” Decisions in the Compendium of Classification Opinions should be treated in the same manner as the EN’s, (i.e., while neither legally binding nor dispositive, they provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of these headings) and “should receive considerable weight.” See T.D. 89-80. Accordingly, the BD tube is classified in heading 9018, HTSUS, specifically, subheading 9018.39.00, HTSUS, as consistent with the WCO opinion cited above.
HOLDING:
On the basis of GRI 1, The BD Vacutainer® glass tube is classified in subheading 9018.39.00, HTSUS, which provides for “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing: Syringes, needles, catheters, cannulae and the like; parts and accessories thereof: instruments; parts and accessories thereof: Syringes, needles, catheters, cannulae and the like; parts and accessories thereof: Other. 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 Internet at www.usits.gov/tata/hts/.
Sincerely,
Gail A. Hamill, Chief
Tariff Classification and Marking Branch