CLA-2 RR:CR:GC 961705 gah
Port Director
U.S. Customs Service
JFK Airport, Building 77
Jamaica, New York 11430
RE: Protest 1001-97-106205; ophthalmic apparatus
Dear Port Director:
This is a decision on protest 1001-97-106205 timely filed by counsel, on behalf of Topcon America Corporation, on October 3, 1997, against your decision regarding the classification of ophthalmic apparatus. All entries were liquidated on June 27, 1997. Descriptive marketing literature was submitted to this office for examination. In preparing this ruling, consideration was given to arguments presented by counsel in a meeting on January 12, 1999, and in submissions made on February 10, April 26, July 30, and August 23, 1999.
FACTS:
The merchandise is a variety of ophthalmic apparatus produced by Topcon in Japan. Specifically, they are: slit lamps, tonometers; retinal cameras, ophthalmometers (also known as keratometers); screenscopes, lensmeters, vision testers, auto chart projectors; operation microscopes; and parts thereof.
Customs classified the subject merchandise at entry in subheading 9018.50.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for other ophthalmic instruments and appliances. With one exception, the protestant advocates classification of the subject merchandise in subheading 9018.19.9550, HTSUS, which provides for other electro-diagnostic apparatus. Protestant contend that the ophthalmic surgical microscopes are classifiable in subheading 9817.00.96, as other articles specially designed or adapted for the use or benefit of the handicapped.
ISSUE: Is the merchandise more specifically classified as electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters), and therefore classifiable in subheading 9018.19, or other ophthalmic instruments and appliances, and therefore classifiable in subheading 9018.50? If they are electro-diagnostic apparatus, are they for functional exploratory examination? Are the surgical microscopes classified as designed or adapted for the use or benefit of the handicapped?
LAW AND ANALYSIS:
Slit lamp microscopes, tonometers, retinal cameras, ophthalmometers
Classification of merchandise under the Harmonized Tariff Schedule of the United States (HTSUS) is in accordance with the General Rules of Interpretation (GRI). GRI 1 provides that classification shall be determined according to the rules of the headings and any relative section or chapter notes, taken in order. Merchandise that cannot be classified in accordance with GRI 1 is to be classified in accordance with subsequent GRI.
Heading 9018 provides for instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments.
GRI 6 states, in summary, that classification at the subheading level is determined according to the terms of the subheadings, on the understanding that only subheadings at the same level are comparable. The applicable competing subheadings within heading 9018 are:
Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters)
and
Other ophthalmic instruments and appliances
A diagnosis is the identification of a disease by careful investigation of its symptoms and history. 1 Compact Edition of the Oxford English Dictionary 714 (1987).
Slit lamps are microscopes that examine the cornea, lens and clear fluids in layer-by-layer detail, and can also be used to measure the extent of damage caused by glaucoma. Tonometers measure intra-ocular pressure to aid in the diagnosis of glaucoma as well. Retinal cameras are used to examine and document the condition of the retina, choroid, optic disk and posterior pole. Ophthalmometers (keratometers) examine the cornea to obtain measurements of the corneal curvature and to detect and measure astigmatism. All of the apparatus use electricity to function in one way or another.
These four apparatus are therefore accurately described as electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters), in subheading 9018.19, HTSUS.
The Harmonized Commodity Description and Coding System Explanatory Notes (EN) constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the ENs 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, 54 FR 35127, 35128 (August 23, 1989).
The Explanatory Notes (EN) for heading 9018 lists three categories of ophthalmic instruments: surgical, diagnostic and orthoptic or sight testing apparatus. This is an indication that the drafters of the EN believed that diagnostic apparatus are an identifiable category of ophthalmic instruments. Further, within the diagnostic category, EN (I)(C)(2), two of the four apparatus, slit lamp microscopes and tonometers, are specifically enumerated.
Subheading 9018.50 describes other ophthalmic instruments and appliances. Thus, other ophthalmic instruments and apparatus in subheading 9018.50 can include only ophthalmic apparatus which are other than those provided for at the same subheading level in heading 9018, including ophthalmic instruments or apparatus which are electro-diagnostic apparatus, within subheading 9018.11 through 9018.19. Since we have determined that the four instruments mentioned are specifically described as electro-diagnostic, they are classifiable as electro-diagnostic apparatus, in subheading 9018.19.
Within subheading 9018.19, the competing provisions for consideration are subheading 9018.19.40, apparatus for functional exploratory examination and subheading 9018.19.95, other apparatus.
Functional in the medical sense means that which relates to the normal physiological activity or vital functioning, of an organ, but not the structure, or anatomy, of that organ. See Dorland’s Illustrated Medical Dictionary 667 (1994). The instant slit lamp microscopes, tonometers, retinal cameras, and ophthalmometers permit the operator to observe and record the structural effects of a disease or disorder of the eye, but not the activity going on in the eye. The goods do not meet the definition of functional.
Exploratory in the medical sense means that which relates to an active examination, usually involving endoscopy or a surgical procedure, to ascertain conditions present as an aid in diagnosis. Stedman’s Medical Dictionary 550 (1990). While the instant slit lamp microscopes, tonometers, retinal cameras, and ophthalmometers certainly aid in describing the condition of the eye, they do so through visual examination from outside the body cavity, that is, without invasive procedures. We do not believe the goods are exploratory in nature.
The four enumerated apparatus are therefore classifiable in subheading 9018.19.95, other electro-diagnostic apparatus.
Screenscopes, vision testers, auto chart projectors, lensmeters; operation microscopes
Screenscopes and other vision testers are visual acuity testers, and allow examination of a patient’s visual acuity, astigmatism and other vision problems by trained health care professionals. Auto chart projectors electronically project eye testing charts onto a wall for the patient to read. Lensmeters hold a pair of glasses or contact lenses and measure the focus or degree of refraction in the lens. The readings obtained provide a benchmark for the amount of correction a patient currently uses and allows for duplication of that level of correction in another pair of lenses. Ophthalmic surgical microscopes perform microscopic surgery on the eyes. These five apparatus are not diagnostic in nature because they do not identify a disease. The first four are sight-testing apparatus, while the last one is used to correct the effects of disease.
Vision testers and auto chart projectors are specified within the heading 9018 EN (C)(3) category for orthoptic or sight-testing apparatus, as distinct from diagnostic ophthalmic apparatus and because they are not diagnostic, fall to be classified in subheading 9018.50.00, other ophthalmic instruments and appliances. Counsel argues that screenscopes and lensmeters are medical apparatus used by medical professionals to make physical examinations to detect diseases and defects of the body. Counsel notes that the EN (IV) to heading 9018 covers such devices, even though not specifically named, and that if they are medical, they are electro-diagnostic.
We disagree. Screenscopes, for example, may detect visual acuity, but they do not detect the underlying cause of the impairment, and are therefore not diagnostic. Further, electro-medical apparatus are specified in the heading 9018 legal text but they are not entirely captured by any one subdivision of the heading. Rather, electro-diagnostic apparatus include some medical instruments of the heading but not all. Those used in ophthalmic related endeavors that are not electro-diagnostic fall to be classified in the residual provision of other ophthalmic apparatus, 9018.50.00.
Operation microscopes and subheading 9817.00.96
Counsel advises that the ophthalmic operation microscopes at issue are compound optical microscopes, stereoscopic and without a means for photographing an image, classifiable in subheading 9011.10.8000. However, the goods are specially designed or adapted for the use or benefit of handicapped persons other than the blind, and therefore should be classified in subheading 9817.00.96, duty free. Chapter 98, Subchapter XVII, U.S. Note 4(a) defines the term blind or other physically or mentally handicapped persons to include any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one's self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working. Subpart (b)(iii) of that U.S. Note excludes from the scope of subpart (a), therapeutic and diagnostic articles. Persons requiring ophthalmic surgery are physically handicapped within the meaning of this provision since the condition substantially limits a major life activity--seeing.
Customs has set forth certain requirements for an article to receive duty-free treatment in this provision. T.D. 92-77, 26 Cust. B. & Dec. 35. The facts in this case raise three issues, 1) whether the instant microscopes are specially designed or adapted, 2) whether they are for the use and benefit of the handicapped, and 3) whether the goods are therapeutic in nature.
First, as to the specially designed or adapted requirement, Customs has ruled on ophthalmic surgery microscopes, classifying them in subheading 9011.10.80, where the issue of whether they also are classifiable in subheading 9817.00.96 was not raised. HQ 954855, dated December 7, 1994. However, counsel states that the merchandise in that ruling had physical properties similar to the instant microscopes.
In particular, the Topcon sales literature indicates that the microscope is designed to facilitate ophthalmic microsurgery. It delivers three dimensional images using a coaxial illumination standard, and aids in the observation of red reflex. The unit is capable of fine focusing adjustment within a range of 36mm, at a speed of 2.2mm per second. There are five different magnification lens settings. The unit is capable of five different field of view settings. The supporting arms have a range of motion more limited than other surgical microscopes. The axis of the optical path remains fixed over the eye, resulting in an observation angle set at a limited operating rate (generally 45 degrees to the optical axis).
Counsel states that Topcon only produces and distributes to the ophthalmic market, representing them as designed specifically for ophthalmic microsurgery. They are in most cases used for cataract surgery or posterior vitrectomy. We find that counsel has established physical properties and marketing information as to the design and use that indicate the apparatus is used principally in ophthalmic surgery.
Second, Customs has held that ophthalmic surgical instruments other than operation microscopes, were specially designed or adapted for the use and benefit of the handicapped because they were used to improve a visually handicapped person’s ability to see. HQ 952465 dated January 27, 1993. In that matter, instruments for cataract surgery, vitrectomy, glaucoma filtration procedures, corneal transplantation and retinal attachment were classified as for the benefit of the handicapped. Topcon’s operation microscopes are an important and indispensable aid to the surgeon in magnifying the area to be operated on and in performing delicate and precise microsurgeries on the eye. These microscopes are used 95 percent of the time for the same five procedures for which the instruments in HQ 952465 were used according to an affidavit of a Topcon executive. Counsel has established that the goods at issue are designed and principally used for the benefit of the handicapped. See HQ 557712, dated June 27, 1994.
Third, Customs and the courts have held that therapeutic articles within the context of this provision are those articles that heal or cure a condition. T.D. 92-77, 26 Cust. B. & Dec. 35; Travenol Laboratories, Inc. v. U.S., 17 CIT 69, (1993). As a result, apparatus that alleviates symptoms of a condition is not excluded as “therapeutic” within the meaning of U.S. note 4(b) and can be classified in subheading 9817.00.96, and given duty-free treatment. In HQ 952465, evidence was shown that the instruments at issue did not heal or cure the underlying eye conditions of the patient, but served to alleviate the manifestations of the degenerative ophthalmic condition. Given that Topcon’s operation microscopes are used in the same procedures, counsel believes that the evidence in HQ 952465 supports a finding that the instant goods are non-therapeutic as well. We agree. The operation microscopes are classifiable in subheading 9817.00.96.
Parts of the above apparatus
Counsel has listed seventeen distinct parts which he believes are parts suitable for use solely or principally with one of the ophthalmic apparatus discussed above. Note 2(b) to chapter 90 indicates that parts and accessories, not classifiable according to note 1 and note 2(a) to chapter 90, 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.
We find that the following parts are designed and shaped and assembled in such a way that they are suitable for use solely or principally with their apparatus, as discussed and classified above. Plates or plate assemblies for ophthalmometers (keratometers) and retinal cameras, head rests for retinal cameras, axis, fixation target and fixation target assemblies for slit lamps are each classified in subheading 9018.19.9560 as parts and accessories of electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters). Holders for lensmeters and spirit levels for vision testers are classified in subheading 9018.50.00 as parts and accessories of other ophthalmic instruments. The lens caps for the camera which is part of the operation microscope is classified as a part in subheading 9817.00.96.
The caster without a brake for attachment to an instrument table is classified as a caster in subheading 8302.20.00.
Counsel has withdrawn its protest as to the following items: retaining rubber for lensmeter, steel ball for retinal camera, remote control unit for chart projector, printer for vision tester, CCD camera for keratometer, and ring for Polaroid attachment.
HOLDING:
The slit lamp microscopes, tonometers, retinal cameras and ophthalmometers imported by Topcon are classified as electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters), other; other; other, other apparatus in subheading 9018.19.9550, HTSUS. Plates, plate assemblies for ophthalmometers (keratometers) and retinal cameras, head rests for retinal cameras, axis, fixation targets and fixation target assemblies for slit lamps are classified in subheading 9018.19.9560 as parts and accessories of electro-diagnostic apparatus...,other, other, other; parts and accessories, in subheading 9018.19.9560. HTSUS.
The screenscopes, vision testers, auto chart projectors, and lensmeters, holders for lensmeters and spirit levels for vision testers are classified as other ophthalmic instruments and appliances and parts and accessories thereof in subheading 9018.50.00, HTSUS.
The operation microscopes and camera lens caps are classified as articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories that are specially designed or adapted for use in the foregoing articles, other, in subheading 9817.00.96.
The protest should be allowed in part and denied in part, as set forth above. In accordance with Section 3(A)(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 counsel for the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to mailing 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.gov, by means of the Freedom of Information Act, and other methods of public distribution.
Sincerely,
John Durant, Director
Commercial Rulings Division