CLA-2 RR:CTF:TCM 967856 JAS
Port Director, U.S. Customs and Border Protection
610 S. Canal Street, Room 306 Chicago, IL 60607
RE: Protest 3901-05-100414; Steam-Heated Sterilizing Machine
Dear Port Director:
This is our decision on Protest 3901-05-100414, filed by counsel on behalf of Pharmacia & Upjohn Company, against your classification of the Huber DS 250 S machine under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA).
The device was entered under a provision of heading 8419, HTSUS, as medical, surgical or laboratory sterilizers that are machinery, plant or laboratory equipment, whether or not electrically heated, for the treatment of materials by a process involving a change of temperature. It was reclassified under a provision of heading 8479, as other machines and mechanical appliances, having individual functions, not specified or included elsewhere in chapter 84, and the entry liquidated on March 11, 2005, under this provision. This protest was timely filed on April 22, 2005.
In lieu of a conference with Headquarters personnel in the event a decision contrary to the position it advocated was contemplated, counsel presented additional information in a submission, dated November 23, 2005.
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FACTS:
The Huber DS 250 S is a double door pass-through machine used in the pharmaceutical and technical industries to clean elastomer rubber and plastic stoppers and plastic caps, screw caps and aluminum caps. The machine performs a combination of washing, rinsing, siliconizing, sterilization and air-drying.
In sequence, the articles to be processed are washed with detergent in the machine’s rotating inner drum. The wash water is then drained off and the outer cylinder and inner drum cleaned by high pressure jets. The articles are then rinsed with hot water and siliconized, an optional step which involves the application of diluted aqueous emulsions of medical grade silicone oils cured by the application of dry heat at temperatures of up to 300 degrees C. Silicone reagents are typically used to reduce surface tensions and to prevent non-specific binding. Sterilization is then achieved by injecting steam up to 121 degrees C to remove the oxygen-rich atmosphere from the pressure vessel. This kills bacteria and disinfects the articles while the final step, drying, is achieved by blowing pre-filtered air into the chamber. The articles are then allowed to cool to unloading temperatures and removed.
The HTSUS provisions under consideration are as follows:
Machinery, plant or laboratory equipment, whether or not
electrically heated…, for the treatment of materials by a
process involving a change of temperature such as
heating,…, sterilizing,…drying,…;…; parts thereof:
Medical, surgical or laboratory sterilizers
* * * *
Machines and mechanical appliances having individual
functions, not specified or included elsewhere in [chapter
84]; parts thereof:
Other machines and mechanical appliances:
8479.89 Other:
Other:
8479.89.98 Other
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ISSUE:
Whether a principal function for the Huber DS 250 S can be determined.
LAW AND ANALYSIS:
Under General Rule of Interpretation (GRI) 1, Harmonized Tariff Schedule of the United States (HTSUS), goods are to be classified according to the terms of the headings and any relative section or chapter notes, and provided the headings or notes do not require otherwise, according to GRIs 2 through 6.
The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the Harmonized System at the international level. While not legally binding, the ENs provide a commentary on the scope of each heading of the HTSUS and are thus useful in ascertaining the classification of merchandise under the System. U.S. Customs and Border Protection (CBP) believes the ENs should always be consulted. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (Aug. 23, 1989).
Chapter 84, Note 2, HTSUS, states that “subject to the operation of note 3 to section XVI, a machine or appliance which answers to a description in one or more of the headings 8401 to 8424 and at the same time to a description in one or more of the headings 8425 to 8480 is to be classified under the appropriate heading of the former group and not the latter.” Section XVI, Note 3, HTSUS, states, in relevant part, that “machines designed for the purpose of performing two or more complementary or alternative functions are to be classified as if consisting only of that component or as being that machine which performs the principal function.”
General EN (VI) to Section XVI states, with respect to multi-function machines and composite machines, that where it is not possible to determine the principal function and where, as provided in Note 3 to Section XVI, the context does not otherwise require, it is necessary to apply GRI 3(c), which requires classification in the last heading from among those which equally merit consideration.
Counsel for the protestant maintains that the DS 250 S is a multi-function machine designed to perform complimentary or alternative functions, and that the washing and drying of the stoppers are subsidiary to sterilization, which constitutes the machine’s principal function. The claim is that the DS 250 S meets the description in the 84.19 ENs under (VI) STERILIZING APPARATUS:
These consist essentially of receptacles or chambers, heated usually
by steam or boiling water, (or sometimes by hot air), in which the articles
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or materials to be sterilized are maintained for a period at a sufficiently high
temperature to kill bacteria, etc., without alteration of the composition or
physical condition of the articles or materials themselves.
Counsel cites NY 871935, dated March 25, 1992, which classified an apparatus for flushing, cleaning and disinfecting utensils used in maintaining patients’ hygiene in subheading 8419.20.00, HTSUS. Disinfection was accomplished utilizing steam at a temperature of at least 85 degrees C (185 degrees F). NY 871935 found that the principal function of the apparatus was to disinfect or sterilize, i.e., subjecting a material to sufficiently high temperatures for a period so as to kill bacteria, because “the greatest part of the device’s three-minute cycle time is consumed by that process.” In addition, with its November 23, 2005, submission, counsel presented an affidavit (“Affidavit”) from an engineer and project manager at Pharmacia & Upjohn with direct knowledge of the Huber machine’s operational capabilities. Counsel concludes that since the Huber DS 250 S is provided for in heading 8419, Chapter 84, Note 2 renders heading 8479 inapplicable.
We agree that the Huber DS 250 S is a multi-function machine under Section XVI, Note 3, HTSUS, that is classifiable according to its principal function. The information from which a principal function determination can be made is limited in this case to the product literature. The literature describes the DS S Sterilizer Series Washer/Sterilizers as “[t]he ideal combination of a washer, sterilizer and drier for washing of rubber stoppers and rubber articles of the pharmaceutical and technical elastomer industry.” They are “dedicated units to wash, rinse, siliconize, sterilize and dry stoppers, ready for deposit into the sterile suite. Only sterilized stoppers are presented to the sterile suite.” (Italics added). While washing with detergent and rinsing are important steps in the cleaning process, it is the sterilization that is repeatedly mentioned in the literature. In addition, sterilization is the last step in the process. This is significant inasmuch as only sterilized stoppers are deposited into the sterile suite. Moreover, the literature indicates that pressure and temperatures associated with sterilization are permanently recorded according to the Food and Drug Administration. Finally, the sterilization phase of the process lasts approximately 100 minutes compared to less than 60 minutes for each of the other phases (Affidavit). This is a fact strikingly similar to that in NY 871935 and was the basis for holding that the flushing/disinfecting apparatus to be classifiable in subheading 8419.20.00, HTSUS. See HQ 961408, dated November 24, 1998, on the probative effect CBP affords affidavits. The evidence of record leads us to conclude that the Huber DS 250 S is a multi-function machine that is to be classified as if consisting only of the sterilizing component, which we find performs the principal function.
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HOLDING:
Under the authority of GRI 1 and Section XVI, Note 3, HTSUS, the Huber DS 250 S is provided for in heading 8419. It is classifiable in subheading 8419.20.0000, HTSUSA.
The protest should be ALLOWED. In accordance with the Protest/Petition Processing Handbook (CIS HB, January 2002, pp. 18 and 21), you are to mail this decision, together with the Customs Form 19, to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry in accordance with the decision must be accomplished prior to mailing of the decision. Sixty days from the date of the decision the Office of Regulations and Rulings will make the decision available to CBP personnel, and to the public on the CBP Home Page on the World Wide Web at www.cbp.gov, by means of the Freedom of Information Act, and other methods of public distribution.
Sincerely,
Gail A. Hamill
Myles B. Harmon, Director
Commercial and Trade Facilitation Division