CLA-2 OT:RR:CTF:TCM H246715 DSR
Assistant Port Director - Trade Operations
Atlanta Service Port
U.S. Customs and Border Protection
157 Tradeport Drive
Atlanta, GA 30354
RE: Internal advice request concerning the classification of washer-disinfectors
This letter is in reply to your request for internal advice dated August 8, 2013, and initiated by Getinge USA, Inc. (“Getinge”), pertaining to the classification under the Harmonized Tariff Schedule of the United States (“HTSUS”) of three washer-disinfectors collectively referred to as the Getinge 46-Series or “Model 46”. We have also considered your arguments presented in a meeting held on July 7, 2016 with members of my staff.
FACTS:
The subject machines are designated as the Model 46-2, Model 46-4 and Model 46-5. They significantly differ only in capacity and number of spray arms and dockings. The Model 46-2 has three spray arms and one docking. The Model 46-4 has two spray arms and two dockings. The Model 46-5 has two spray arms and three dockings. Each machine utilizes hot water and detergent to clean reusable items by sequentially washing, rinsing, drying and disinfecting those items. Examples of such items include utensils, glassware, bottles, trays, pans, and surgical instruments. The machines are used in hospitals, clinics, laboratories and throughout the pharmaceutical industry. They are not intended for household use.
The washing, rinsing, drying phases must be completed prior to the disinfection phase in order for the disinfection phase to be effective. The phase parameters vary according to the customer’s requirements for temperature treatment, goods to be cleaned and setting where the machine is to be used, e.g., medical or laboratory. The cleaning process does not alter the composition or physical condition of the articles being cleaned.
ISSUE:
Are the machines classified under subheading 8419, HTSUS, which provides, in pertinent part, for machinery, plant or laboratory equipment, whether or not electrically heated, for the treatment of materials by a process involving a change of temperature; heading 8422, HTSUS, which provides, in pertinent part, for dishwashing machines and machinery for cleaning or drying bottles or other containers; or heading 8479, HTSUS, which provides for machines and mechanical appliances having individual functions, not specified or included elsewhere in Chapter 84, HTSUS?
LAW AND ANALYSIS:
Classification under the HTSUS is made in accordance with the General Rules of Interpretation (GRI's). 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 based on GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRI’s 2 through 6 may then be applied in order.
In addition, in interpreting the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System may be utilized. The ENs are not dispositive or legally binding and, as a rule, cannot limit or restrict the scope of the legal texts to which they correspond. Instead, the ENs provide a commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. See T.D. 89 80, 54 Fed. Reg. 35127 (August 23, 1989). The HTSUS provisions under consideration are as follows:
8419 Machinery, plant or laboratory equipment, whether or not electrically heated (excluding furnaces, ovens and other equipment of heading 8514), for the treatment of materials by a process involving a change of temperature such as heating, cooking, roasting, distilling, rectifying, sterilizing, pasteurizing, steaming, drying, evaporating, vaporizing, condensing or cooling, other than machinery or plant of a kind used for domestic purposes; instantaneous or storage water heaters, nonelectric; parts thereof:
* * *
8419.20.00 Medical, surgical or laboratory sterilizers.
* * * *
8422 Dishwashing machines; machinery for cleaning or drying bottles or other containers; machinery for filling, closing, sealing or labeling bottles, cans, boxes, bags or other containers; machinery for capsuling bottles, jars, tubes and similar containers; other packing or wrapping machinery (including heat-shrink wrapping machinery); machinery for aerating beverages; parts thereof:
Dishwashing machines:
* * *
8422.19.00 Other.
8422.20.00 Machinery for cleaning or drying bottles or other containers.
* * *
8479 Machines and mechanical appliances having individual functions, not specified or included elsewhere in this chapter; parts thereof:
* * * *
EN 84.79 indicates that heading 8479, HTSUS is a “basket” provision that is intended to cover merchandise that cannot be classified more specifically in any other heading of Chapter 84. According to the Court of International Trade, “[c]lassification of imported merchandise in a basket provision is appropriate only when there is no tariff category that covers the merchandise more specifically.” Apex Universal, Inc. v. United States, 22 C.I.T. 465, 16 (1998) (quoting Ruth F. Sturm, 2 Customs Law & Administration § 52.8 at 78 (3d ed. 1997)). Thus, if the instant devices are classifiable in headings 8419 or 8422, HTSUS, then heading 8479 is inapplicable.
With regard to potential classification in heading 8419, we note the following from EN 84.19:
[T]he heading covers machinery and plant designed to submit materials (solid, liquid or gaseous) to a heating or cooling process in order to cause a simple change of temperature, or to cause a transformation of the materials resulting principally from the temperature change (e.g., heating, cooking, roasting, distilling, rectifying, sterilizing, pasteurizing, steaming, drying, evaporating, vaporizing, condensing or cooling processes). But the heading excludes machinery and plant in which the heating or cooling, even if essential, is merely a secondary function designed to facilitate the main mechanical function of the machine or plant, e.g., machines for coating biscuits, etc., with chocolate, and conches (heading 84.38), washing machines (heading 84.50 or 84.51), …
In support of its position, Getinge cites to New York Ruling Letter (NY) 871935 (March 25, 1992), in which CBP classified a machine identified as a “Model S-206, Getinge Flusher/Disinfector” in subheading 8419.20.00 (HTSUS, 1992) as a medical, surgical or laboratory sterilizer. The machine is described as follows:
It is designed for efficient cleaning and disinfection of the utensils mainly used in the management of patients' hygiene, such as bedpans, urinals, kidney basins and suction bottles. Its principal function is sterilizing based on the fact that the greatest part of the time cycle is consumed by that process. The disinfector has space for, e.g., one bedpan or three urine bottles at a time and is started with a button. The entire process only takes three minutes and comprises flushing, cleaning and disinfection. Disinfection is accomplished with steam at temperature of at least 85 degrees C (185 degrees F).
We then concluded that the “Flusher/Disinfector” met the terms of heading 8422, HTSUS, and was therefore a medical, surgical or laboratory sterilizer of subheading 8419.20.00 (HTSUS, 1992). However, we are currently reconsidering the conclusion reached in NY 871835, as the ruling contained sparse analysis concerning the principal function finding. Without such analysis, and because the machines at issue here differ from the machinery at issue in NY 871935, we cannot assign useful precedential value to that ruling.
Getinge claims that the subject machines are sterilizers, while also stating that the machines “disinfect” by subjecting items to a sufficiently high temperature to kill bacteria without altering the physical condition of those items. Getinge also asserts that the washing function of the machines is ancillary to the disinfection function, and that the machines should therefore be classified within subheading 8419.20.00, HTSUS, as medical, surgical or laboratory sterilizers.
While asserting that there is no distinction in the tariff between “disinfection” and “sterilization,” Getinge also acknowledges that there exists a “technical” difference between sterilization – “killing all microorganisms” – and disinfection (“killing all harmful microorganisms”). See Internal Advice Request memorandum, page 6, fn. 1, dated June 11, 2011. Further, the specifications stated within the document 46-4 Washer/Disinfector Data and Specifications state that the machines are not designed to sterilize. See http://www.getinge.com/us-ca/healthcare/products-within/cleaning-disinfection/washer-disinfectors/getinge-46-series/. To wit:
… Thermal disinfection parameter of this product is exposure of materials to minimum 194ºF (90ºC) moist heat for one minute, and up to 203º (95ºC) for ten minutes. This product is not a substitute for sterilization. Critical items, such as invasive surgical instruments, must be further processed by terminal sterilization before reuse in any procedure. (Emphasis added).
Finally, during the meeting of July 7, 2016, a representative from Getinge, and counsel for Getinge, stated that the 46-Series machines do not sterilize items. Instead, the machines are designed to disinfect items before those items are sterilized elsewhere.
We also note the following excerpt from “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008” (CDC) William A. Rutala, Ph.D., M.P.H.1,2, David J. Weber, M.D., M.P.H.1,2, and the Healthcare Infection Control Practices Advisory Committee (HICPAC):
Sterilization describes a process that destroys or eliminates all forms of microbial life and is carried out in health-care facilities by physical or chemical methods. Steam under pressure, dry heat, EtO gas, hydrogen peroxide gas plasma, and liquid chemicals are the principal sterilizing agents used in health-care facilities. Sterilization is intended to convey an absolute meaning; unfortunately, however, some health professionals and the technical and commercial literature refer to “disinfection” as “sterilization” and items as “partially sterile.” When chemicals are used to destroy all forms of microbiologic life, they can be called chemical sterilants. These same germicides used for shorter exposure periods also can be part of the disinfection process (i.e., high-level disinfection).
In relevant part, the text of heading 8419, HTSUS, explicitly requires that a good within its purview sterilize items. The instant machines clearly do not “sterilize” judging from the information submitted and from additional information gained during the July 7 meeting. We therefore find that the subject devices are not within the purview of heading 8419, HTSUS.
Heading 8422 covers, in relevant part, dishwashing machines. EN 84.22 illuminates the scope of items covered by the subheadings
This heading covers dishwashing machines (for plates, glasses, spoons, forks, etc.), whether or not incorporating provision for drying, including electrically-operated types, whether or not domestic. The heading also covers machines of different types designed for cleaning or drying bottles or other containers … These include:
(1) Machines (whether or not steam-operated) for cleaning, washing, rinsing or drying bottles, jars, cans, boxes, casks, milk churns, cream separator bowls or other containers. These machines sometimes incorporate provision for disinfection or sterilization. …
The instant machines are used in hospitals, clinics, laboratories and throughout the pharmaceutical industry to clean items such utensils, glassware, trays, pans, and surgical instruments. While the machines are also able to disinfect those items, that is not determinative. See EN 84.22, supra.
Subheading 8422.19.00, HTSUS, covers dishwashing machines other than those of the household type. While EN 84.22 provides exemplars of items that may be covered by “dishwashing machines,” e.g., plates, glasses, spoons, forks, etc., it does not limit the heading’s coverage to those items and does not provide a definition of the term “dish.” The tariff also does not define the term “dish.” When terms are not defined in the HTSUS or the ENs to the HTSUS, they are construed in accordance with their common and commercial meaning. See Nippon Kogasku (USA), Inc. v. United States, 69 C.C.P.A. 89, 673 F.2d 380 (1982). Common and commercial meaning may be determined by consulting dictionaries, lexicons, scientific authorities and other reliable sources. C.J. Tower & Sons v. United States, 673 F.2d 1268, 69 C.C.P.A. 128 (1982). CPB rulings have used the term “dish” to describe items such a soak dish of a manicure set (NY L88026, October 28, 2005) and a soap dish (NY K87240, July 12, 2004). Indeed, the term “dish” can refer to “any of various shallow concave vessels; broadly: anything shallowly concave.” See http://www.merriam-webster.com/dictionary/dish (last visited March 24, 2016). The subject machines are equipped to wash items that may be construed as dishes, i.e., trays and pans, and are prima facie classifiable in subheading 8422.19.99, HTSUS. However, the subject machines are also designed to wash other items, such as bottles, which are specifically listed in the text of subheading 8422.20.00, HTSUS. As such, the instance devices would be prima facie classifiable in subheading 8422.20.00, HTSUS, as multi-function machines.
GRI 6 directs the subheading analysis under GRI 1. Note 3 to Section XVI directs that “machines designed for the purpose of performing two or more complementary or alternative function “ are to be classified as if consisting only of that component that performs the principal function. If a principal function cannot be determined, they are classified in accordance with GRI 3(c). See EN to Section XVI Note 3. GRI 3(c) states that when goods cannot be classified by reference to GRI 3(a) or 3(b), they shall be classified under the heading that occurs last in numerical order among those which equally merit consideration. Here, the subheading that occurs last in numerical order is subheading 8422.20.00, HTSUS. Accordingly, the subject machines are classified in subheading 8422.20.00, HTSUS, as machinery for cleaning or drying bottles or other containers.
HOLDING:
Pursuant to GRI I, the Model 46-2, Model 46-4 and Model 46-5 washer-disinfectors are classifiable under subheading 8422.20.00, HTSUS, which provides for “Machinery for cleaning or drying bottles or other containers.” The rate of duty will be “Free.”
Duty rates are provided for your convenience and subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at www.usitc.gov.
You are to mail this decision to the internal advice requester no later than 60 days from the date of the decision. At that time, the Office of International Trade, Regulations and Rulings, will make the decision available to CBP personnel, and to the public on the CBP Home Page at 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