CLA-2 RR:CTF:TCM 967591 JAS
Port Director, U.S. Customs and Border Protection
10 Causeway Street, Rm. 603
Boston, MA 02222-1059
RE: Protest 0401-05-100020; Pilot Bioreactor
Dear Port Director:
This is our decision on Protest 0401-05-100020, filed by counsel on behalf of
Applikon, Inc., against your classification, of a bioreactor called the 20 Liter Pilot
System under the Harmonized Tariff Schedule of the United States Annotated
(HTSUSA).
The Pilot System was entered under subheading 9027.80.4530, HTSUSA, as electrical instruments and apparatus for physical or chemical analysis. It was reclassified under subheading 8419.89.9585, HTSUSA, as other machinery, plant or equipment for the treatment of materials by a process involving a change of temperature, and the entry liquidated on December 10, 2004, under this provision.
This protest was timely filed on February 15, 2005.
FACTS:
Materials submitted in support of this protest describe bioreactors in general as apparatus which provide an environment for monitoring and controlling temperatures to permit the growth and cultivation of cells, microbes, yeast and other organisms and thereby obtain certain organism byproducts as, for example, recombinant proteins produced from the cultivation and infection of insect cells. Temperatures are controlled in order to keep the cells in an active state. Sensors transmit signals to analytical instruments in the bioreactor vessel which compare
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the process conditions, such as acidity or pH, dissolved oxygen levels and other variables, with desired conditions. If deviations occur, a control device activates valves and pumps to introduce chemical reagents or gases necessary to return the process to normal.
The Pilot System at issue is of open frame design, measuring 600 mm wide x 1105 mm high, and consists of a bioreactor vessel and basic service unit both mounted on a mobile skid, all of stainless steel construction. The vessel is available in various volume capacities - the one at issue has a 20-liter capacity - but the service unit is the same and consists of a gas flow mixing and control section, liquid pump, temperature control system featuring electric heating elements, magnetically coupled stirring element, cooling water connection for air outlet condenser and water and steam connections. Process temperatures are controlled by the heating elements while sterilization of an organism before its introduction into the process is accomplished by injecting steam into the vessel jacket.
The HTSUSA 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,…or cooling:
Other machinery, plant or equipment:
Other:
Other:
8419.89.95 Other
* * * *
Instruments and apparatus for physical or chemical analysis…;
Instruments and apparatus for measuring or checking viscosity,
porosity, expansion, surface tensions or the like; instruments and
apparatus for measuring or checking quantities of heat, sound or light…:
9027.80 Other instruments and apparatus:
Other:
9027.80.45 Electric
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* * * *
Automatic regulating or controlling instruments and apparatus;…:
Other instruments and apparatus:
9032.89 Other:
9032.89.60 Other
ISSUE:
Whether the Pilot System is apparatus for physical or chemical analysis; whether it is an automatic regulating or controlling instrument or apparatus.
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.
Section XVI, Note 1(m), HTSUSA, excludes articles of Chapter 90. Therefore, if the Pilot System is provided for in heading 9027, 9032, or any other heading of Chapter 90, it cannot be classified in heading 8419. In this respect, Chapter 90, Note 7(a), HTSUSA, states that heading 9032 applies only to instruments and apparatus for automatically controlling the flow, level, pressure or other variables of liquids or gases, or for automatically controlling temperature, whether or not their operation depends on an electrical phenomenon which varies according to the factor to be automatically controlled, which are designed to bring this factor to, and maintain it at, a desired value, stabilized against disturbances, by constantly or periodically measuring its actual value.
The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the Harmonized System at the international level. Though not dispositive, the ENs provide a commentary on the scope of each heading of the HTSUS. 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).
Counsel claims that heading 9027, HTSUSA, represents the correct classification because although temperature is controlled as a constant, the primary function of the Pilot System is to analyze the processes occurring in the bioreactor vessel, including
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dissolved oxygen levels, oxygen uptake and carbon dioxide evolution rates, and nutrient levels, to detect deviations from the desired norm, correct the changes, thereby maintaining a constant environment in which the organisms develop and grow. Counsel maintains the Pilot System is similar in function to, though more complex than, moisture analyzers and water content monitors which CBP rulings NY 860128, dated February 21, 1991, and NY F82942, dated March 3, 2000, classified as instruments and apparatus for physical or chemical analysis, under heading 9027. Alternatively, counsel maintains that the Pilot System is provided for in heading 9032, HTSUSA, as an automatic regulating or controlling instrument because, notwithstanding the ability to maintain temperature as a constant, its primary function is to control the levels of liquids and gases in the bioreactor, within the meaning of Chapter 90, Note 7(a), HTSUSA. Counsel maintains that a basic concept of bioreactor design and function is the automatic control of liquid and gas levels, among other variables, that is, the elemental flow into the system should equal the flow out of the system, corrected for accumulation in the system.
Concerning counsel’s claim under heading 9027, the term “physical or chemical analysis” is not defined in any section or chapter legal note, nor is it discussed in the ENs to heading 9027. Therefore, it is the common and commercial meaning of the term that controls for tariff purposes. See C.J. Tower & Sons v. United States, 69 CCPA 128, 673 F.2d 1268 (1982), and related cases. Webster’s Third New International Dictionary (Unabridged), for example, defines analyze as follows: 1 separation or breaking up of a whole into its fundamental elements or component parts; 2a a detailed examination of anything complex made in order to understand its nature or to determine its essential features.
Congress has mandated that on a case-by-case basis decisions under a prior nomenclature are deemed instructive in interpreting provisions under the HTSUSA, particularly where the nomenclature previously interpreted remains unchanged and no dissimilar interpretation is required by the text of the HTSUSA. Such is the case here. Pharmacia Fine Chemicals, Inc. v. United States, 9 C.I.T. 438 (1985), cited with approval Burrows Equipment Co. v. United States, 62 Cust. Ct. 681, C.D. 3848, 300
F. Supp. 455 (1969), in which the Court examined the common meaning of the term “chemical analysis” in item 711.88, Tariff Schedule of the United States, which provided, among other things, for instruments or apparatus for physical or chemical analysis, the predecessor provision to heading 9027. Included were instruments and apparatus which determine one or more ingredients of a substance either as to kind or amount; or those which perform a detailed examination of a complex chemical substance for the purpose of enabling one to understand its nature or to determine an essential feature; or those which determine what elements are present in a chemical substance. The Court then held that the instruments and apparatus of item 711.88 are those which are “[chiefly used] to facilitate physical or chemical determination of the quantity, qualities or composition of a substance.”
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Heading 9027 encompasses a variety of instruments and apparatus whose collective function is to gather information and determine whether or if some action may then be necessary. In NY 860128, the first case counsel cites, a moisture analyzer used to determine the moisture content in a sample by repeatedly weighing the sample, drying it by infrared radiation, then weighing it again, was held to be an instrument or apparatus of heading 9027. Comparing the weight of the sample before and after the drying process, and thereby determining its moisture content, was found to be a type of physical analysis for purposes of heading 9027. In NY F82942, the second case counsel cites, a water content monitor for measuring the water content in oil flowing through a transformer valve was found to perform a type of chemical analysis for heading 9027 purposes. These classifications are correct based on the facts presented.
CBP does not dispute that in utilizing analytical instruments with appropriate software to compare the process conditions in the bioreactor vessel with desired conditions the Pilot System performs a type of physical or chemical analysis for heading 9027 purposes. However, the facts indicate that if deviations occur a control device in the System activates valves and pumps to introduce chemical reagents or gases necessary to return the process to normal. This is a significant additional function that is beyond the scope of instruments and apparatus of heading 9027. Therefore, we conclude that the Pilot System is not described by that heading.
Counsel’s claim under heading 9032 fails for the same reason. The 9032 ENs state, in part, that instruments and apparatus for automatically controlling the flow, level, pressure and other variables of liquids or gases or for automatically controlling temperature are connected to an appliance which carries out the orders (pump, compressor, valve, furnace burner, etc.) [to] restore the variable to the prescribed value. This appliance, generally remote controlled by a mechanical, hydraulic, pneumatic or electric control, is to be classified in its own appropriate heading. For example, thermostats for automatically controlling temperature are named at 90.32 EN (I)(D), but thermostatic steamers, cabinets, etc., in which the temperature is kept constant by means of a thermostat, are expressly excluded and are to be classified in their respective headings. In addition to performing an automatic control function, the Pilot System initiates the necessary corrective actions to return the process to normal, a function that exceed the scope of instruments and apparatus of heading 9032. We conclude that the Pilot System is not described by heading 9032.
As to the liquidated provision, heading 8419 provides, in relevant 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 such as heating…sterilizing…steaming…or cooling. Chapter 84, Note 2(e) excludes from heading 8419 machinery or plant, designed for mechanical operation, in which a change
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of temperature, even if necessary, is subsidiary. The 84.19 ENs elaborate by stating that the 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. 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. The Pilot System contains a magnetically coupled stirrer system incorporating geared-down motors, along with built-in, remote controlled pumps and valves, all of which involve mechanical action.
But certainly, these do not constitute the System’s main function. In the Pilot System temperatures are controlled in order to keep the cells in an active state to facilitate the growing and cultivating of organisms. CBP does not dispute that acidity, dissolved oxygen levels and other process variables affect the transformation of the organisms in the bioreactor vessel. Regardless, heading 8419 provides for machinery and plant for treating materials by a process involving a change of temperature such as heating,…sterilization,…or cooling. The heading only requires that the machinery or plant involve a change of temperature (Emphasis added). See HQ 965366, dated September 24, 2002. Likewise, the literature contains numerous references to temperature, to wit, “The temperature control is a closed loop circulation system with electrical heaters. Steam is only required during sterilization. Temperature can be controlled from 5o C above cooling water temperature to sterilization temperature. Process temperature is controlled by three 1000 W electric heating elements. Sterilization is accomplished by injecting steam into the vessel jacket. An integrated temperature safety switch prevents overheating of the system.” Clearly, the bioreactor can be said to treat materials by a process that involves a change of temperature, even a simple change. Catalytic reactors utilizing heat to initiate a reaction in chemical research have been classified in subheading 8419.89.9585, HTSUSA. See NY J80527, dated March 4, 2003. Also, thermal reactors for chemical or enzyme-mediated reactions requiring accurately controlled thermal cycling, capable of a virtually unlimited number of rapid and accurate temperature changes have been classified in subheading 8419.89.5075, HTSUSA. See NY 868377, dated November 26, 1991.
HOLDING:
Under the authority of GRI 1, the 20 Liter Pilot System is provided for in heading 8419. It is classifiable in subheading 8419.89.9585, HTSUSA. The 2004 column one, general rate of duty under this provision is 4.2 percent ad valorem.
The protest should be DENIED. 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
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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,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division