CLA-2 CO:R:C:S 556800 WAS

District Director
U.S. Customs Service
Otay Mesa Border Station
2500 Paseo Internacional
Entry Control, Protest Rm. 317
San Ysidro, CA 92073

RE: Application for Further Review of Protest No. 2501-92100023; eligibility of breathing circuits from Mexico for duty-free treatment under the GSP; set; GRI 3(b); T.D. 91-7; Superscope; 556797; 556798; 9802.00.80; assembly

Dear Sir:

This is in response to your memorandum forwarding an Application for Further Review of Protest No. 2501-92-100023 made by Sandler, Travis & Rosenberg, P.A., on behalf of Kendall Healthcare Products Co., concerning the eligibility for duty-free treatment under the Generalized System of Preferences (GSP) (19 U.S.C. 2461-2466), with respect to breathing circuits imported from Mexico. A sample of the breathing circuits was submitted for our review. We had an opportunity to meet with counsel on November 3, 1993, to further discuss the above-referenced protest. In addition, counsel submitted additional information in support of its position by letter dated November 23, 1993.

FACTS:

The imported merchandise is described as an anesthesia breathing circuit. A breathing circuit is comprised of a breathing bag and a hose. In use, one end of the hose is connected to an anesthesia machine and the other end is connected either to an endotracheal tube inserted into a patient's mouth or onto a face mask. Oxygen, air, nitrous oxide and other anesthetic gases are delivered from the anesthesia machine to the patient through the hose. In addition, the patient's exhaled gases are transported away from the patient through the hose.

The breathing bag, which is made of vulcanized rubber, is mounted on another part of the anesthesia machine. The bag permits manual ventilation of the patient. That is, squeezing the bag permits the anesthesiologist to force the gas mixture into the patient's lungs. In addition, squeezing or observing the bag permits the anesthesiologist to estimate the function of the patient's lungs.

Some hoses have a filter and/or a sampling port attached. The hoses, filters and sampling ports are products of Mexico. Some of the breathing bags are made in Malaysia and some are made in the U.S. For purposes of this protest, we are only addressing GSP eligibility for those breathing circuits which contain bags of U.S. origin. (Protestant has conceded that breathing circuits which contain Malaysian-origin bags are not eligible for duty-free treatment under the GSP.) In Mexico, a bushing is placed around the opening of each breathing bag and secured with a rubber band. The bushing is of Mexican origin and the rubber band is of U.S. origin. The hoses and breathing bags are packaged together in Mexico and are resold in the U.S. in the same packaging as imported.

The protest concerns the liquidation of the entries of the merchandise, without benefit of duty-free treatment under the GSP, under subheading 9019.20.00, HTSUS, which provides for ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus, and parts and accessories thereof. The protestant contends that the breathing circuits comprised of a bag of Malaysian origin and a hose of Mexican origin are classifiable as follows: both the bag and hose should be classified under subheading 9020.00.60, HTSUS, which provides for other breathing appliances and gas masks.

Similarly, the protestant contends that the breathing circuits comprised of a bag of U.S. origin and a hose of Mexican origin are classifiable as follows: the hose is eligible for duty-free entry under GSP, and the bag (and rubber band) are eligible for the duty allowance in subheading 9802.00.80, HTSUS, which provides for duty-free treatment of the U.S. components of articles assembled abroad in whole or in part of fabricated U.S. components. The protestant argues that the breathing circuits are not classifiable as "composite goods" or "goods put up in sets for retail sale," and as such, are separately classifiable.

As an alternative matter, protestant states that if Customs determines that the breathing circuits are classified as a set, the presence of U.S.-origin components in the set which are entitled to a duty allowance under subheading 9802.00.80, HTSUS, should not defeat GSP eligibility for Mexican-origin hoses in the sets containing the U.S.-origin bags.

ISSUES:

1) What is the proper tariff classification of the breathing circuits? 2) Whether the breathing circuits are eligible for duty allowances under subheading 9802.00.80, HTSUS, and/or duty-free treatment under the GSP.

LAW AND ANALYSIS:

I. Classification of the breathing circuit

The General Rules of Interpretation (GRI's) to the HTSUS govern the classification of goods in the tariff schedule. GRI 1 states in pertinent part that "for legal purposes, classification shall be determined according to the terms of the headings and any relative section or chapter notes and, provided such headings or notes do not otherwise require, according to the [remaining GRI's]."

GRI 3(b) states that "[w]hen, by the application of rule 2(b) or for any other reason, goods are, prima facie, classifiable under two or more headings, classification shall be effected as follows:

Mixtures, composite goods consisting of different materials or made up of different components, and goods put up in sets for retail sale, which cannot be classified by reference to 3(a), shall be classified as if they consisted of the material or component which gives them their essential character, insofar as this criterion is applicable [underlining added]."

The Harmonized Commodity Description and Coding System Explanatory Note (EN) to GRI 3(b), pg. 4, states that "[f]or the purposes of this Rule, the term 'goods put up in sets for retail sale' shall be taken to mean goods which:

(a) consist of at least two different articles which are, prima facie, classifiable in different headings . . .; (b) consist of products or articles put up together to meet a particular need or carry out a specific activity; and (c) are put up in a manner suitable for sale directly to users without repacking (e.g., in boxes or cases or on boards) [emphasis in original]."

According to part (a) of the above test, the articles comprising the "breathing circuit" -- the breathing bag and hose -- must be classifiable under two different headings.

With regard to the classification of the breathing bag, heading 9018, HTSUS, provides for instruments and appliances used in medical and surgical sciences, and includes parts and accessories thereof. EN 90.18, pg. 1487, states that heading 9018, HTSUS, "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 an illness or to operate, etc." The notes, pg. 1490, further provide that the instruments and appliances for human medicine or surgery include "[a]naesthetic apparatus and instruments (face masks, face-piece harness, intratracheal tubes, etc.)," as well as, parts thereof. Accordingly, the breathing bag, which is used exclusively for anesthesiology purposes, is prima facie classifiable (i.e., classifiable under this heading in the absence of a legal or chapter note that requires otherwise) as a part under heading 9018, HTSUS.

However, note 1(a) to chapter 90 states that chapter 90 does not cover "[a]rticles of a kind used in machines, appliances or for other technical uses, of vulcanized rubber other than hard rubber (heading 4016) .... " Thus, if the breathing bag is classifiable under heading 4016, HTSUS, it cannot be classified under heading 9018, HTSUS.

Heading 4016, HTSUS, provides for "[o]ther articles of vulcanized rubber other than hard rubber." EN 40.16, pg. 599, states that heading 4016, HTSUS, "covers all articles of vulcanized rubber (other than hard rubber) not covered by the preceding headings of this Chapter or by other Chapters [underlining added]." The breathing bag, which is mounted onto an anesthesia machine, is made of non-hardened, vulcanized rubber. It is our opinion that the bag, which is not covered by any other heading in the tariff schedule, is classifiable under heading 4016, HTSUS, and therefore, excluded from chapter 90 and heading 9018, HTSUS.

With regard to the classification of the hose, counsel for the protestant states that the hose can be used for two equal functions. In the operating room, the hose is used to administer anesthesia from an anesthesia machine. In the intensive care unit, the hose is used to administer oxygen from a respirator. Therefore, the hose is prima facie classifiable under both heading 9018, HTSUS, as a part of an anesthetic instrument, and heading 9019, HTSUS, as a part of artificial respiration apparatus. Note 2 to chapter 90 states that parts and accessories for articles of this chapter are to be classified as follows:

(a) Parts and accessories which are goods included in any of the headings of this chapter or of chapter 84, 85 or 91. . . are in all cases to be classified in their respective headings; (b) Other parts and accessories, if suitable for use solely or principally with a particular kind of machine, instrument or apparatus, or with a number of machines, instruments or apparatus of the same heading . . . are to be classified with the machines, instruments or apparatus of that kind; (c) All other parts and accessories are to be classified In heading 9033 [emphasis added].

The hose is not a "good included" in any chapter 84, 85, 90 or 91 heading, nor is it suitable for use solely or principally with a particular kind of machine, or with a number of machines of a single heading. Therefore, according to note 2(c) to chapter 90, the hose is classifiable in the "basket" provision for parts of chapter 90 under subheading 9033.00.00, HTSUS.

The articles in question meet part (a) of the above stated GRI 3(b) test, as the breathing bag and the hose are classifiable in separate headings -- heading 4016 and 9033, HTSUS, respectively. The articles also meet part (b) of the test, as the breathing bag and hose, which represent the disposable portion of an anesthesia machine (both are discarded after each use), are put up together to meet a particular need or carry out a specific activity. They also meet part (c), as they are packaged together in plastic for direct sale without repacking.

Because the articles are "goods put up in sets for retail sale," it is necessary to determine the component that gives the set its essential character. It is our opinion that the essential character of the breathing circuit is imparted by the hose, which performs the primary function of the breathing circuit. The hose connects to an endotracheal tube inserted in the patient's mouth or to a face mask, and delivers the anesthetic gases from the anesthesia machine to the patient. Therefore, the breathing circuits are classifiable under heading 9033, HTSUS, specifically under subheading 9033.00.00, HTSUS.

II. Eligibility of breathing circuits for duty-free treatment under the GSP

Under the GSP, eligible articles the growth, product or manufacture of a designated developing beneficiary country (BDC) which are imported directly into the customs territory of the U.S. from the BDC may receive duty-free treatment if the sum of (1) the cost or value of materials produced in the BDC, plus (2) the direct costs of the processing operations performed in the BDC, is equivalent to at least 35% of the appraised value of the article at the time of entry into the U.S. See 19 U.S.C. 2463(b).

General Note 3(a)(iii), HTSUS, states that special rates of duty under one or more of the special tariff treatment programs (including GSP) apply to those products which are classified under a provision for which a special rate is indicated in the "Special" subcolumn and for which all of the legal requirements for such program(s) have been met. In cases where a set is classified by reference to General Rule of Interpretation (GRI) 3(b), the item of the set which imparts its essential character determines the classification of the entire set. Therefore, if the "Special" subcolumn opposite the subheading under which the set is classified contains a special duty rate for a particular tariff preference program, then the entire set would be entitled to that special rate, assuming compliance with the program's requirements.

As stated in General Note 3(c)(ii)(A), HTSUS, Mexico is a designated BDC. Based upon our prior discussion, we believe that the proper tariff classification of the breathing circuit in this case is under subheading 9033.00.00, HTSUS. This subheading is a GSP-eligible provision, and, therefore, the breathing circuits are entitled to duty-free treatment provided that the entire set is considered to be a "product of" Mexico and the 35% value-content and "imported directly" requirements are met.

Prior to August 20, 1990, the GSP program differed from the Caribbean Basin Economic Recovery Act (CBERA) and U.S.-Israeli FTA programs in that the latter programs included a "product of" requirement, while the GSP did not. This requirement means that in order to receive duty-free treatment, an article either must be made entirely of materials originating in the beneficiary country or, if made of materials from a non-beneficiary country, those materials must be substantially transformed in the beneficiary country into a new or different article of commerce. In Madison Galleries, Ltd. v. United States, 688 F. Supp. 1544 (CIT 1988), aff'd, 870 F.2d 627 (Fed. Cir. 1989), the court concluded that, under the GSP statute, it is unnecessary for an article to be a "product of" a GSP country to be eligible for duty-free treatment under that program. However, section 226 of the Customs and Trade Act of 1990 (Public Law 101-382) included an amendment to the GSP statute requiring an article to be a "product of" a GSP country in order to receive duty-free treatment. This amendment was effective for articles entered, or withdrawn from warehouse for consumption, on or after August 20, 1990. See T.D. 91-7 dated January 16, 1991 (25 Cust. Bull. 6).

Protestant claims that those breathing circuits which are imported into the U.S. without Malaysian-origin breathing bags, are comprised entirely of items either the "product of" Mexico or the "product of" the U.S. Protestant further claims that the U.S.-origin components should not be considered for purposes of determining whether a set satisfies the "product of" requirement of the GSP. Counsel argues that since the U.S.-origin components separately receive a duty allowance under subheading 9802.00.80, HTSUS, they cannot be considered for purposes of determining whether merchandise imported into the U.S. is the growth, product or manufacture of the BDC. It is protestant's position that the 9802 items are constructively segregated from the rest of the set for both classification and valuation purposes.

In Superscope, Inc. v. United States, 13 CIT 997, 727 F. Supp. 629 (1989), the court held that certain glass panels of U.S.-origin that were exported, repacked abroad with certain foreign components, and returned to the U.S. as part of unassembled audio cabinets, were entitled to duty-free entry under item 800.00, Tariff Schedules of the United States (TSUS) (the predecessor to subheading 9801.00.10, HTSUS), since the U.S. panel portion of the imported article was "not 'advanced in value or improved in condition. . . while abroad,' but [was] merely repacked." Id. at 631. Although the Superscope case concerned the TSUS, not the HTSUS, the decision is believed to be equally applicable to similar situations arising under the HTSUS, since item 800.00, TSUS, and relevant Schedule 8, TSUS, headnotes were carried over virtually unchanged into the HTSUS.

T.D. 91-7 states as follows:

In our opinion, a set or mixed or composite goods can exist, within the meaning of GRI 3(b), even though a portion of the collection consists of American goods returned. This view is consistent with the Superscope decision, in which the court clearly treated the U.S.-origin glass panels as part of the single tariff entity (unassembled furniture) for tariff classification purposes even though the glass panels separately qualified for entry under item 800.00, TSUS. Similarly, the presence of American goods returned in a set (also containing foreign-origin items) should not destroy the identity of the set and frustrate the purpose of GRI 3(b), which is to facilitate the classification of sets, mixtures and composite goods by permitting the components or items to be classified under a single HTSUS heading.

T.D. 91-7 also stated that "the above analysis regarding subheading 9801.00.10, HTSUS, also is applicable, in large part, to situations in which a portion of a set or mixed or composite goods consists of components or items assembled abroad in whole or in part of U.S.-origin fabricated components."

Thus, in determining the classification of a set which includes U.S. components or items assembled abroad in whole or in part of U.S.-origin fabricated components according to T.D. 91-7, the first step is to determine whether the combination of articles qualifies as a set within the meaning of the tariff schedule and the Explanatory Notes in the HTSUS. The next step is to classify the set under a single HTSUS heading by ascertaining which, if any, of the items impart the set's essential character. Then, it is necessary to determine whether any of the items in the set are entitled to a duty allowance under subheading 9802.00.80, HTSUS. An allowance in duty is then made for the value of those components which satisfy the "conditions and requirements" of subheading 9802.00.80, HTSUS. The remainder of the items in the set are assessed duty at the Chapter 1-97, HTSUS, rate applicable to the article which imparts the essential character (whether or not such article is entitled to duty-free treatment under subheading 9802.00.80, HTSUS). The first issue we must address is whether the presence of U.S.-origin components in the set, which may be eligible for a duty exemption under subheading 9802.00.80, HTSUS, will defeat the "product of" requirement under the GSP.

In T.D. 91-7, Customs also held that, as a general rule, a collection classifiable in one subheading pursuant to the GRI's will receive CBERA treatment only if all of the items or components in the collection are considered "products of" the beneficiary country. To illustrate the application of the "product of" requirement to sets under the CBERA, T.D. 91-7 set forth the example of a hairdressing set consisting of a comb, brush, and scissors manufactured in Jamaica from materials originating in Jamaica, and an electric hair clipper manufactured in Taiwan (a non-BC country) which is imported into Jamaica for packaging with the other items of the set. We stated that in cases where the entire imported set is not the "product of" a BDC, as required by the CBERA statute, neither the set nor any part thereof would be entitled to duty-free treatment under this program. The above requirements also exist under the GSP statute with respect to articles entered on or after August 20, 1990.

Consistent with T.D. 91-7, we find that the breathing circuits in the instant case are considered sets within the meaning of the Explanatory Notes relating to GRI 3(b) and they are classified under subheading 9033.00.00, HTSUS, (hose), even though some of the components in the set may be entitled to a duty allowance under subheading 9802.00.80, HTSUS. However, the assembly of the U.S. and Mexican-origin components into a breathing bag in Mexico is not a "complex and meaningful operation" as defined in C.S.D. 85-25 dated September 25, 1984 (HRL 071827). See also HRL 555727 dated January 31, 1991 (attaching cover assemblies and mounting brackets to completed PCBA's in the production of sound amplifiers, intermittend windshield wiper governors, and speed control amplifiers does not result in a second substantial transformation). Therefore, we do not find that the U.S. components of the breathing bag were substantially transformed into a new and different article of commerce in Mexico.

In a case involving a set which consisted entirely of Mexican items and U.S.-origin items which were eligible for duty-free treatment under subheading 9801.00.10, HTSUS, Customs held that the entire set was not precluded from duty-free treatment under the GSP. See HRL 556798, 556797 dated September 23, 1993. In HRL 556798, 556797, we stated that:

the catheter kits are considered sets within the meaning of the Explanatory Notes relating to GRI 3(b), and the set is properly classified pursuant to GRI 3(b) under subheading 9018.39.00, HTSUS, which is a GSP-eligible provision. Second, pursuant to T.D. 91-7, we find that the U.S. components which qualify for duty-free treatment under subheading 9801.00.10, HTSUS, are to be excluded from the set for purposes of determining whether the kits qualify as "products of" Mexico under the GSP.

In HRL 556798, 556797, we found that after removing and separately classifying the U.S. items under subheading 9801.00.10, HTSUS, the remaining items in the set were entirely of Mexican origin. Thus, we concluded that inasmuch as all of the remaining items in the set qualified as "products of" Mexico, those articles were entitled to duty-free treatment under the GSP.

The present case, however, is distinguishable from the facts at issue in HRL 556798, 556797. HRL 556798, 556797 involved a set which was created by simply packaging together U.S. and Mexican-origin articles. Pursuant to Superscope, Customs was permitted under the facts in HRL 556798, 556797 to separate out for classification and value purposes those U.S items which were simply packaged together and had not been advanced in value or improved in condition abroad, under subheading 9801.00.10, HTSUS. However, in the instant case, the U.S. breathing bag and rubber band and Mexican-origin bushing are assembled together to create a single article - the breathing bag with bushing. Unlike the catheter kit in HRL 556798, 556797, the entire set here is subject to classification under subheading 9033.00.00, HTSUS, when it is entered into the U.S., and the value of the U.S.-origin components may be subtracted from the full value of the imported set at the time of entry, if the requirements under subheading 9802.00.80, HTSUS, are met. It is the entire assembled article - not just the U.S.-origin components - which is subject to the provisions of subheading 9802.00.80, HTSUS, provided that all of the requirements of this provision are satisfied. This differs from HRL 556798, 556797, where only the U.S. items were separately classified and entered under subheading 9801.00.10, HTSUS. Therefore, we are of the opinion that the presence of the U.S. components in the set which have not undergone a substantial transformation in Mexico, defeats the "product of" requirement for purposes of GSP duty-free treatment.

III. Eligibility of partial duty exemption under subheading 9802.00.80, HTSUS

As we have determined that the set is not eligible for duty-free treatment under the GSP, the next issue to be addressed is whether an allowance in duty may be made for the cost or value of the breathing bags and rubber bands under subheading 9802.00.80, HTSUS.

HTSUS subheading 9802.00.80 provides a partial duty exemption for:

[a]rticles assembled abroad in whole or in part of fabricated components, the product of the United States, which (a) were exported in condition ready for assembly without further fabrication, (b) have not lost their physical identity in such articles by change in form, shape or otherwise, and (c) have not been advanced in value or improved in condition abroad except by being assembled and except by operations incidental to the assembly process such as cleaning, lubrication, and painting. . .

All three requirements of HTSUS subheading 9802.00.80 must be satisfied before a component may receive a duty allowance. An article entered under this tariff provision is subject to duty upon the full value of the imported assembled article, less the cost or value of such U.S. components, upon compliance with the documentary requirements of section 10.24, Customs Regulations (19 CFR 10.24).

Section 10.14(a), Customs Regulations (19 CFR 10.14(a)), states in part that:

[t]he components must be in condition ready for assembly without further fabrication at the time of their exportation from the United States to qualify for the exemption. Components will not lose their entitlement to the exemption by being subjected to operations incidental to the assembly either before, during, or after their assembly with other components.

Section 10.16(a), Customs Regulations (19 CFR 10.16(a)), provides that the assembly operation performed abroad may consist of any method used to join or fit together solid components, such as welding, soldering, riveting, force fitting, gluing, laminating, sewing, or the use of fasteners.

In the subject protest, the operation which consists of manually fitting the bushing into the neck of the bag and placing the rubber band around the neck of the bag in order to securely join the components together is considered an acceptable assembly operation. See 19 CFR 10.16(a). Therefore, as the U.S. components used in the assembly process were exported in condition ready for assembly without further fabrication, did not lose their physical identity in the assembled article, and were not advanced in value or improved in condition except by assembly operations, the returned breathing circuit are eligible for an allowance in duty under subheading 9802.00.80, HTSUS, for the cost or value of the U.S.-origin breathing bags and rubber band.

HOLDING:

The breathing circuits are classifiable, according to GRI 3(b), under subheading 9033.00.00, HTSUS, which provides for parts and accessories for machines, appliances, instruments or apparatus of chapter 90, not specified or included elsewhere. As the set does not satisfy the "product of" requirement, it may not be entered duty-free under the GSP. However, the U.S.-origin breathing bag and rubber band which are assembled with the bushing in Mexico and returned to the U.S. as part of the set are entitled to a duty allowance under subheading 9802.00.80, HTSUS, provided that the documentary requirements of 19 CFR 10.24 are met. This protest should denied in part and granted in part in accordance with this decision.

In accordance with Section 3A(11)(b) of Customs Directive 099 3550-065, dated August 4, 1993, Subject: Revised Protest Directive, this decision together with the Customs Form 19, should be mailed by your office 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 take steps to make the decision available to Customs personnel via the Customs Rulings Module in ACS and the public via the Diskette Subscription Service, Lexis, Freedom of Information Act and other public access channels.

Sincerely,

John Durant, Director
Commercial Rulings Division