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HQ 965366

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September 24, 2002

CLA-2 RR:CR:GC 965366 BJB

CATEGORY: CLASSIFICATION

TARIFF NO.: 8419.89.90; 8419.90.80

Port Director
U.S. Customs Service
555 Battery Street
San Francisco, CA 94126

RE: Protest 2809-01-100717; Polymerase Chain Reaction Machine (PCR machine); Thermal cycler; DNA replication; and Heating/cooling apparatus

Dear Port Director:

This is our decision regarding Protest 2809-01-100717, filed on behalf of Applied Biosystems (“protestant”) concerning the classification, under the Harmonized Tariff Schedule of the United States (“HTSUS”), of polymerase chain reaction machines and parts. In preparing this decision, consideration was given to protestant’s additional submission submitted on May 20, 2002, and telephone conferences held with Applied Biosystems’ personnel and a member of my staff on September 24, 2002.

FACTS:

Protestant describes the subject merchandise as “a machine which duplicates DNA or RNA by a process known as ‘polymerase chain reaction’ (“PCR”).” The subject entries were filed on June 13, 2001, and liquidated on July 13, 2001. The protest was filed on October 11, 2001. The entries contained polymerase chain reaction machines, models “GeneAmp PCR System” 9700, 9600, 2400, and 1000, and parts. Protestant provided descriptions, schematics, specifications, and marketing materials in support of its protest.

Protestant claims that the subject machines are “PCR machines and parts,” that function to provide “millions of copies of genetic material from a specimen of DNA or RNA material placed in the machine[s.]” The subject goods are advertised and described on protestant’s website as “thermal cyclers.” See www.appliedbiosystems.com.

The Office of Science Education and Outreach of the National Human Genome Research Institute, of the United States National Institutes of Health, provides that the PCR process, “sometimes called ‘molecular photocopying,’ . . . is a fast and inexpensive technique used to amplify or copy, small segments of DNA.” The entire cycling process of PCR is automated and “is directed by a machine called a thermocycler, which is programmed to alter the temperature of the reaction every few minutes to allow DNA denaturing and synthesis.” www.nhgri.nih.gov/DIR/VIP/Learing_Tools/Fact_Sh /pcr. htm.

To perform the PCR process, a thermal cycler machine only requires “a reaction tube, reagents, and a source of heat.” Insofar “as different temperatures are optimal for each of the three steps” of PCR, “machines now control these temperature variations automatically.” Each cycle takes only 1-3 minutes, thus, “repeating the process for just 45 minutes can generate millions of copies of a specific DNA strand.” The rapid cycling and copying that can be accomplished in a week used to take a year of laboratory work. The Polymerase Chain Reaction, Tabitha M. Powledge, www.faseb.org/opar/ bloodsupply/pcr.html, August 6, 2002.

Protestant provides that all of the subject thermal cyclers are substantially similar to the “GeneAmp PCR System 9700,” in terms of purpose and function[.]” Model 9700 relies upon solid state thermoelectric devices (“TEDs”) for “accomplishing both heating and cooling.” Protestant provides that “TEDs provide the same heating and cooling functions that are performed in the compressor type refrigeration units” in the other thermal cycler models. (Exhibit A, at 1-17).

Model 9700’s sample block assembly consists of a sample block well plate, heated cover assembly, TEDs, sample block temperature sensor, heat sink, heat sink temperature sensor, and a TED interface board. The heating and cooling in a TED device is a function of thermal conductivity, semiconductor resistance, and current. Individual thermal couplers are connected to make a module. Each module is electrically connected in a series and then stacked parallel to each other to create a larger heating and cooling surface area. Model 9700 relies upon the use of the four TEDs to cover the majority of the sample platform which is thermally connected with thermal compound and a power amplifier.

Model 9600 is heated by a film heater and is cooled by an internal refrigeration unit that circulates cooled liquid through the sample block. This model holds the DNA sample material in small reaction tubes.

Model 2400 uses cartridge heaters and an internal refrigeration unit that circulates cooled liquid through the sample block. Like models 9700 and 9600, the DNA sample material is held in small reaction tubes.

Model 1000 uses cartridge heaters and an internal refrigeration unit that circulates cooled liquid through the sample block. This model holds the genetic sample material in situ, in 10 parallel rows of closely spaced vertical slots in the sample block, each of which holds a glass slide tightly for proper thermal contact. The slides completely encapsulate the reagent materials.

Generally, the thermal cyclers’ sample block (container) assemblies hold the tubes that contain the PCR sample. The heated cover of the sample block assembly is placed over the PCR samples during a reaction and thereby prevents sample evaporation, condensation buildup, and increases heat transfer by pressing (forcing) the sample tubes firmly into the wells of the sample platform. In the more recent models, the sample container is heated and cooled by a Peltier type thermoelectric heat pump. The user interface of the electrical system allows the user to enter the thermal cycler run conditions including time and temperature parameters. The electrical system and temperature sensors located in the sample container insure that the temperature of the sample container corresponds to the user-programmed information.

In Model 9700 the top of the sample container block assembly is either a gold-plated silver, or an aluminum well-plate. The well-plates help distribute heat evenly between the 384 sample wells. Beneath the well-plates are four thermo-electric pads. These pads heat and cool the metal plates. They are composed of small pairs of dielectric metal plates sandwiched between ceramic pads. An electric current runs through the metal pairs, causing either heating or cooling, depending on the direction of the current.

There are three basic steps in the PCR process. First, the target genetic material must be “denatured;” the strands of a DNA helix must be unwound and separated. This is done by heating the sample material to 90-96 degrees Celsius. Second, the material goes through a process of hybridization or annealing, by being cooled at a measured rate to a precise temperature, in which the primers bind to their complementary bases on the now single-stranded DNA. The third step is the DNA synthesis by a polymerase. These enzymes are employed in nature by living cells to replicate their own DNA or RNA. The result is two new helixes in place of the first, each composed of one of the original strands plus its newly assembled complementary strand. Supra.,Powledge, at 3.

Upon entry, protestant classified the subject thermal cyclers under subheading 9032.89.90, HTSUS, as “[a]utomatic regulating or controlling instruments and apparatus; parts and accessories thereof: Other instruments and apparatus: Other: Other[.]” The subject machine parts were entered under subheading 9032.90.00, HTSUS, as “[a]utomatic regulating or controlling instruments and apparatus; parts and accessories thereof: Parts and accessories[.]”

The entries were liquidated under subheading 8419.89.90, HTSUS, as “[m]achinery, 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, 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: Other: Other[,]” and under subheading 8419.90.80, HTSUS, as “. . . Parts: Other[.]”

ISSUE:

What is the classification under the HTSUS of the subject thermal cycler machines and parts?

LAW AND ANALYSIS:

We note initially that the protest was timely filed under the statutory and regulatory provisions for protests, 19 U.S.C. 1514(c)(3)(A) and 19 CFR 174.12(e)(1).

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 on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRI’s may then be applied.

The Harmonized Commodity Description and Coding System Explanatory Notes (“EN’s”) constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the EN’s provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of these headings. See T.D. 89-80.

The HTSUS (2001) provisions under consideration are as follows:

8419 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, 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:

Other:

8419.89.90 Other . . . .

9032 Automatic regulating or controlling instruments and apparatus; parts and accessories thereof:

Other:

9032.89.60 Other . . . .

I. Thermal Cyclers:

Protestant claims the subject thermal cyclers should be considered “[a]utomatic regulating or controlling instruments and apparatus[,]” under heading 9032, HTSUS, as they regulate and control multiple temperatures at specific exposure times, including the constant monitoring of reaction well temperatures, in precise sequences over numerous cycles, necessary to conduct the PCR process and DNA replication. Protestant claims the machines are not described under heading 8419, HTSUS, as laboratory equipment for treatment of materials by a process involving a change of temperature.”

EN 84.19, in pertinent part, provides for 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[.]”

Pursuant to Section XVI, Note 1(m), HTSUS (2001), (which includes Chapters 84 and 85), the “section does not cover: . . . [a]rticles of chapter 90.” Therefore, if the thermal cyclers are an instrument or apparatus of heading 9032, HTSUS, or any other heading of chapter 90, they cannot be classified in chapter 84, HTSUS.

Note 6 to Chapter 90 (2001) provides:

Heading 9032 applies only to:

(a) 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; and

(b) Automatic regulators of electrical quantities, and instruments and apparatus for automatically controlling non-electrical quantities the operation of which depends on an electrical phenomenon varying according to the factor to be controlled.

EN 90.32 (2001) provides in pertinent part as follows:

In accordance with Note 6 to this Chapter, this heading covers:

(A) 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, stabilised against disturbances, by constantly or periodically measuring its actual value; and

(B) Automatic regulators of electrical quantities, and instruments and apparatus for automatically controlling non-electrical quantities, the operation of which depends on an electrical phenomenon varying according to the factor to be controlled, which are designed to bring this factor to, and maintain it at, a desired value, stabilised against disturbances, by constantly or periodically measuring its actual value. . . .
Automatic control apparatus for liquids or gases and apparatus for automatically controlling temperature form part of complete automatic control systems and consist essentially of the following devices:

(A) A device for measuring the variable to be controlled (pressure or level in a tank, temperature in a room, etc.) . . .

(B) A control device which compares the measured value with the desired value and actuates the device described in (C) below accordingly.

(C) A starting, stopping or operating device.

Apparatus for automatically controlling liquids or gases or temperature, within the meaning of Note 6(a) to this Chapter, consists of these three devices forming a single entity or in accordance with Note 3 to this Chapter, a functional unit.

Some instruments and apparatus do not incorporate devices which compare the measured value with the desired value. They are directly activated by means of a switch, e.g., when the predetermined value is reached.”

Protestant claims that the subject thermal cyclers meet all of the above requirements under heading 9032, HTSUS, because these machines regulate and control the temperatures necessary for the PCR process. Protestant relies upon evidence provided that the thermal cyclers automatically control the temperature of DNA samples in a liquid solution by electronic means, minimize temperature variations and ramp times, monitor exposure times, and track the number of cycles performed to replicate the sample DNA or RNA. The control settings vary temperature over 3-step cycles and automatically correct temperature variations, of plus or minus .25 of a degree Celsius, through a precise temperature sensor feedback system. Protestant claims that “[t]he precise coordination and regulation of these temperature changes and cycles make it possible for the polymerase enzymes to replicate the DNA or RNA.”

Further, protestant claims that the cyclers’ contain an integrated RTD (Resistive Temperature Device) temperature sensor and a heat sink temperature sensor in the interchangeable block assembly module supported by a CPU board control system which compares the measured value (temperature) with the desired value, and regulates the amount of electricity to the TEDs through the power amplifier. Protestant concludes that “[s]tarting, stopping or operation of the instrument is also provided by the CPU board[,]” and the thermal cycler also “calculates the required primer annealing temperatures and selects the proper PCR sequence to run to produce the required results.”

The primary function of the subject machines is to greatly accelerate the replication of DNA and produce high yield output. Heading 9032, HTSUS, is “only” for an instrument that controls and regulates. The significance of the subject thermal cycler machines is their capacity to rapidly heat and cool DNA sample material at precise temperatures, in pre-programmed sequences, and in repetitive, reproducible cycles.

Although protestant claims the thermal cyclers are apparatus for regulating and controlling temperature, protestant’s Exhibit A, in the section entitled “Systems,” provides that Model 9700 consists of the following three main systems: 1) interchangeable sample block (container) module; 2) base module (in which the sample container rests); and 3) electrical system; and that “[t]hese three systems work together to rapidly and uniformly heat and cool the PCR sample. Moreover, protestant’s Exhibit A, in the section entitled: “Theory of Operation,” page 1-5, provides that “[h]eating and cooling of the samples, . . . is essential to the PCR[.]”

These machines do use temperature sensors and other components to regulate temperature control. Together these components primarily function to determine when to issue instructions to change the temperature, not to maintain it, and when to follow the next pre-programmed sequence of heating and cooling essential to the PCR process. Further, the thermal cyclers rely upon and use a lot of additional information for heating and cooling the DNA sample material well beyond the current temperature of that material.

EN 90.32, in pertinent part, provides that, “[t]he automatic regulators of this heading are intended for use in complete automatic control systems . . . , and maintain it [in this case, the temperature] at, a desired value, stabilised against any disturbances, by constantly or periodically measuring its actual value.” The subject goods are not designed to maintain a single temperature. They are specifically designed to keep temperatures changing at very brief time intervals to achieve rapid heating and cooling of the DNA material. The thermal cyclers have sample blocks in a heat well that is covered to form a heating and cooling chamber or cabinet, and the temperature of the DNA samples is constantly measured. However, this type of regulation and control device is not the kind of automatic regulation or control contemplated by Note 6 to Chapter 90, or EN 90.32.

EN 90.32(I)(E) describes “[t]emperature regulators for setting and maintaining pre-set temperatures on electrical heating appliances” as very simple devices used to operate “a switch to make and break the power circuit,” and “the ‘On’ and ‘Off’ periods (and consequently the temperature of the heating elements) being determined by the position of a manual control dial . . ..” Although the subject machines also have manual controls, they are designed to fully automate the PCR process and through pre-programmed sequences harness automation to perform numerous cycles that provide exact DNA replication. The function performed by the thermal cyclers is not one described by heading 9032, HTSUS. No other headings in Chapter 90, HTSUS, describe the subject goods.

Chapter 84 Note 2, HTSUS (2001), in pertinent part, provides that “Heading 8419 does not, however, cover: (e) Machinery or plant, designed for mechanical operation, in which a change of temperature, even if necessary, is subsidiary.” EN 84.19, in pertinent part, further provides that “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[.]”

Protestant claims that the principal function of the subject machines is to regulate and control the biochemical PCR process and DNA replication. Protestant also claims that the thermal cyclers’ heating and cooling function is secondary to their “main mechanical function,” and are therefore excluded from classification under heading 8419, HTSUS. However, neither the thermal cyclers’ biochemical PCR process, nor its rapid heating and cooling of DNA sample material, used to accelerate DNA replication and yield, are mechanical functions. Thus, the subject thermal cyclers are not excluded under the language of Chapter 84, Note 2(e), or EN 84.19. Support for this interpretation is found in EN 84.19, in pertinent part, which provides that “machinery and plant classified in this heading may or may not incorporate mechanical equipment.”

Protestant also claims that the subject goods are not described in heading 8419, HTSUS, or the ENs, because neither the PCR process, nor the heating/cooling functions, are “simple” changes of temperature or “simple” processes. Protestant further claims that the thermal cyclers’ heating and cooling do not cause a transformation of the DNA material principally resulting from these temperature changes.

However, heading 8419, does provide for “machinery, plant or laboratory equipment, . . ., for the treatment of materials by a process involving a change of temperature such as heating, cooking, roasting, . . . or cooling[.]” (Emphasis added.) The heading only requires that the laboratory equipment or machinery involve a change of temperature.

We note, that EN 84.19 describes many complicated machines which require very careful monitoring and controlling of temperatures, including oil fractionating machinery and laboratory lyophilisation apparatus. See EN 84.19 (II) (B) and (III) (B). Thus, laboratory equipment that changes temperature in sequences, or rapidly heats and cools to precise temperatures, still meets the description provided in this heading.

As noted above, the first step of the PCR process is to heat the DNA sample material to 94-96 degrees Celsius for approximately one minute. Only once the DNA sample material is heated will its helix strands separate. Absent this “denaturing,” the remaining steps of the PCR process cannot take place. This first step is, therefore, fundamental to the entire PCR process. Without a completion of “denaturing,” DNA replication will not take place and accelerated cycling will not achieve a high yield output. The heating and cooling of the DNA sample material, does principally cause the denaturing of the helix’s strands and results in a transformation described under heading 8419, HTSUS.

Heading 8419, HTSUS, also provides a list of processes recognized as “involving a change of temperature.” This list, which includes processes “such as heating . . . or cooling[,]” is not an exhaustive list. It is not limited to singular or elementary changes of temperature. The heading does not exclude changes of temperature rapidly attained, briefly maintained, arranged in sequences, or pre-programmed to be regularly changed. Therefore, subject machines involve changes of temperature described under heading 8419, HTSUS.

EN 84.19, in pertinent part, also provides that ”[t]he heading covers machinery and plant designed . . . to cause a transformation of the materials resulting principally from the temperature change (e.g., heating, cooking, roasting, distilling, rectifying, sterilising, pasteurising, steaming, drying, evaporating, vaporising, condensing or cooling processes). Protestant claims that genetic copying does not principally result from the temperature change, as PCR is a biochemical process and results from the biochemical enzymes and primers.

However, absent the capacity to heat to a precise temperature, neither denaturing nor DNA copying will take place. Without the accurate and precise fluctuation of heating and cooling temperatures none of the three steps in the PCR process will succeed. The polymerase enzyme activity is a biochemical activity that takes place in nature. The function of the thermocyclers is to rapidly and precisely produce those temperatures according to a precise time and temperature sequence. In terms of heading 8419, HTSUS, the subject machines produce heat which results in a transformation that occurs in the denaturing process.

Therefore, the subject thermal cyclers are classifiable in subheading 8419.89.90, which provides for, “[m]achinery, 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, 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: Other: Other[,]”

II. Parts:

Section XVI, Note 2, HTSUS, provides as follows:

Subject to note 1 to this section, note 1 to chapter 84 and to note 1 to chapter 85, parts of machines (not being parts of the articles of heading 8484, 8544, 8545, 8546, or 8547) are to be classified according to the following rules, in pertinent part:

Parts which are goods included in any of the headings of chapter 84 or 85 (other than headings 8409, 8431, 8448, 8466, 8473, 8485, 8503, 8522, 8529, 8538, and 8548) are in all cases to be classified in their respective headings;

Other parts, if suitable for use solely or principally with a particular kind of machine, or with a number of machines of the same heading (including a machine of heading 8479 or 8543) are to be classified with the machines of that kind or in heading 8409, 8431, 8448, 8466, 8473, 8503, 8522, 8529, or 8538 as appropriate. However, parts which are equally suitable for use principally with the goods of headings 8517 and 8525 are to be classified in heading 8517; . . . .

The entry and protest documents include a reference to “parts” for the subject thermal cycler machines. At entry protestant classified these goods under subheading 9032.90.00, HTSUS, as parts of “[a]utomatic regulating or controlling instruments and apparatus[.]” Classifying these goods under subheading 8419.90.80, supra., you concurred that they were parts suitable for use solely or principally with the subject thermal cycler machines classifiable under heading 8419, HTSUS, Note 2(b), above. Absent any evidence to the contrary, they are classifiable in subheading 8419.90.80, HTSUS, as: “[m]achinery, 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, 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: Parts: Other[.]”

HOLDING:

At GRI 1, the subject thermo cyclers are all classifiable under subheading 8419.89.90, HTSUS, which provides for “[m]achinery, 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, 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: Other: Other. “

At GRI 1, the thermo cycler parts are classifiable under subheading 8419.90.80, HTSUS, which provides for “[m]achinery, 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, 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: Parts: Other[.]”

You are instructed to DENY the protest.

In accordance with Section 3A(11)(b) of Customs Directive 099 3550-065, dated August 4, 1993, Subject: Revised Protest Directive, 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 Customs personnel, and to the public on the Customs Home Page on the World Wide Web at www.customs.treas.gov, by means of the Freedom of Information Act, and other methods of public distribution.

Sincerely,

Myles B. Harmon, Acting Director

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See also:

• Tariff No.: 8419.89.90 - Industrial machinery, plant or equipment for the treatment of materials, by process involving a change in temperature, nesi
• Tariff No.: 8419.90.80 - Parts of machinery, plant or laboratory equipment for the treatment of materials by a process involving a change of temperature, nesi
• Tariff No.: 9032.89.60 - Automatic regulating or controlling instruments and apparatus, nesi