CLA-2 RR:CR:GC 966555AM
Ms. Amy Johannesen
Coudert Brothers, LLP
1114 Avenue of the Americas
New York, N.Y. 10036-7703
Re: One and two piece ostomy pouches and wafers
Dear Ms. Johannesen:
This is in reference to your letter dated May 14, 2003, on behalf of your client, ConvaTec, Inc., regarding the classification of one and two piece ostomy bags and wafers, pursuant to the Harmonized Tariff Schedule of the United States (HTSUS). We have also considered the arguments made in your supplementary submission, dated August 27, 2003, and those made in a telephone conference on the same date.
FACTS:
One and two piece ostomy pouches and wafers are supplies adhered to the abdomen to collect bodily waste following surgical removal of parts of the intestine or urinary tract. In colostomy surgery, a diseased or damaged portion of the colon is removed and the remaining large intestine is rerouted to a stoma created in the abdomen. In ileostomy surgery, the disease or damage is in the ileum necessitating the small intestine to be rerouted. In either case, the stoma bypasses the anal sphincter so the ostomate (a person with a stoma) no longer has control of the excretion of bodily waste. Urostomy surgery functions in much the same way after the urinary bladder is removed. Either the ureters are rerouted to the side of the body, or they are attached to a small portion of the small intestine and rerouted through the abdomen. Again, the ostomate no longer has control of urination. Ostomates therefore must wear a waterproof receptacle around their stoma to catch the urine or feces draining from the stoma. Additionally, because bodily fluids can be a caustic medium for bacterial growth, the ostomate must wear a protective barrier around the stoma to decrease the instance of infection of the peristomal (around the stoma) skin.
Ostomy pouches and wafers, whether in one or two pieces, are just such a barrier collection system. The wafer is composed of approximately 80% hydrocolloidal mass containing sodium carboxymethylcellulose, gelatin, pectin and polyisobutylene, and sometimes, additional elastomeric polymers. The remaining approximately 20% of the wafer consists of polyethylene film/foam and a plastic flange. The wafer is used both to protect the skin surrounding the stoma from irritating bodily fluids and to provide the base on to which the pouch is attached. On a two piece system, the wafer has a flange device for attachment of the pouch. The pouch is also made of plastic material of various shapes with a tail or drain so that the ostomate can periodically empty the contents of the bag. These ostomy supplies come in boxes of 5 to 30 pieces each.
In NY A86340, dated August 26, 1996, and NY 804864, dated December 28, 1994, we ruled that ostomy pouches and wafers were classified in subheading 3926.90.20, HTSUS, the provision for "Other articles of plastics and articles of other materials of headings 3901 to 3914: Other: Ice bags; douche bags, enema bags, colostomy bags, hot water bottles, and fittings therefor; invalid and similar nursing cushions; crutch tips and grips; dress shields; finger cots; pessaries; prophylactics; sanitary belts; bulbs for syringes; syringes (other than hypodermic syringes) and fittings therefor, not in part of glass or metal." However, we also ruled that the merchandise was correctly entered duty-free under subheading 9817.00.96, HTSUS, the provision for "Articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles: Other," because the merchandise is specially designed for use by physically handicapped persons.
ISSUES:
1. Whether one and two piece ostomy pouches and wafers are appliances worn on the body to compensate for a defect of disability.
Whether wafers imported separately are dressings.
LAW AND ANALYSIS:
Merchandise imported into the U.S. is classified under the HTSUS. Tariff classification is governed by the principles set forth in the General Rules of Interpretation (GRIs) and, in the absence of special language or context that requires otherwise, by the Additional U.S. Rules of Interpretation. The GRIs and the Additional U.S. Rules of Interpretation are part of the HTSUS and are to be considered statutory provisions of law.
GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule and any relative section or chapter notes and, unless otherwise required, according to the remaining GRIs taken in order. GRI 6 requires that the classification of goods in the subheadings of headings shall be determined according to the terms of those subheadings, any related subheading notes and mutatis mutandis, to the GRIs.
In interpreting the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. See T.D. 89 80, 54 Fed. Reg. 35127 (August 23, 1989).
The HTSUS provisions under consideration are:
3005 Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes:
3005.10 Adhesive dressings and other articles having an adhesive layer:
3005.10.50 Other
* * * * * * * * * * * *
Other articles of plastics and articles of other materials of headings 3901 to 3914:
3926.90 Other:
3926.90.20 Ice bags; douche bags, enema bags, colostomy bags, hot water bottles, and fittings therefor; invalid and similar nursing cushions; crutch tips and grips; dress shields; finger cots; pessaries; prophylactics; sanitary belts; bulbs for syringes; syringes (other than hypodermic syringes) and fittings therefor, not in part of glass or metal
* * * * * * * * * * * *
9021 Orthopaedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof:
9021.90 Other:
9021.90.80 Other
We have already recognized that the instant merchandise is classified in subheading 9817.00.96, HTSUS, which provides for duty-free treatment for articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons and parts and accessories of such articles. See NY A86340 and NY 804864. However, the heading text of 9817 and 9021, HTSUS, is not synonymous. Although the “defect or disability” language of heading 9021, HTSUS, is very close to the terms “physically . . . handicapped” in heading 9817, HTSUS (and we need not attempt to ascertain any differences here), the “articles specially designed or adapted” language of heading 9817 could refer to a much larger set of goods than the “high precision” “appliances” of heading 9021, HTSUS, that "compensate for a defect or disability."
In describing the general content and arrangement of Chapter 90, the EN states in pertinent part that: "[t]his Chapter covers a wide variety of instruments and apparatus which are, as a rule, characterised by their high finish and high precision." The EN also lists the following exceptions to the general rule that the instruments and apparatus of this Chapter are high precision types: "ordinary goggles (heading 90.04), simple magnifying glasses and non-magnifying periscopes (heading 90.13), divided scales and school rules (heading 90.17) and fancy hygrometers, irrespective of their accuracy (heading 90.25)." Colostomy bags and ostomy supplies in general are not listed as one of the exceptions to the high precision rule. Ostomy supplies are disposable plastic articles packaged in boxes of 5 to 30, worn for a day, emptied occasionally, and discarded. Therefore, we do not believe they are characterized by high finish and high precision.
Furthermore, the ENs to heading 9021, HTSUS, state, in pertinent part, the following:
(IV) HEARING AIDS
These are generally electrical appliances with a circuit containing one or more microphones (with or without amplifier), a receiver and a battery. The receiver may be worn internally or behind the ear, or it may be designed to be held in the hand against the ear.
This group is restricted to appliances for overcoming deafness; it therefore excludes articles such as headphones, amplifiers and the like used in conference rooms or by telephonists to improve the audibility of speech.
(V) OTHER APPLIANCES WHICH ARE WORN OR CARRIED, OR IMPLANTED IN THE BODY, TO COMPENSATE FOR A DEFECT OR DISABILITY
This group includes:
Speech-aids for persons having lost the use of their vocal cords as a result of an injury or a surgical operation. These consist essentially of an electronic impulse generator. When pressed against the neck, for example, they generate vibrations in the cavities of the throat which are modulated by the user to produce audible speech.
(2) Pacemakers for stimulating defective heart muscles. These are roughly the size and weight of a pocket watch and are implanted beneath the skin of the patient’s chest. They incorporate an electric battery and are connected by electrodes to the heart, which they provide with the impulses necessary for its functioning. Other types of pacemakers are used to stimulate other organs (for example, the lungs, the rectum or the bladder).
Electronic aids for the blind. These consist essentially of an ultrasonic transmitter-receiver powered by an electric battery. The frequency variations resulting from the time taken for the ultrasonic beam to travel out to an obstacle and be reflected back enable the user, through an appropriate device (e.g., an internal ear-piece), to detect the obstacle and judge its distance.
(4) Appliances implanted in the body, used to support or replace the chemical function of certain organs (e.g., secretion of insulin).
The ostomy pouches and wafers are nothing like either the hearing aids of the heading text or the listed examples in the above cited portion of EN 90.21. First, all of the appliances listed in the relevant portions of EN 90.21 are precision electronic devices that actively compensate for the defect or disability. Second, all of the examples compensate for the disability by assisting or replacing the function of a failed organ: they amplify sound when the ears have failed, they stimulate the vocal cords or the heart muscle when the larynx or heart has failed, or they pump insulin when the pancreas has stopped working. As counsel states, aids for the blind, a sonar device, which emits a series of beeps to assist a blind person in judging the distance of objects, does not aid the physiological function of the eyes. We agree. However, the appliance replaces a function of the eyes by allowing a blind person to perceive obstacles in his or her path. In other words, the appliances described by the heading text of 9021, HTSUS, actively assist or replace a function of an organ after its failure. The instant goods do not actually do anything to assist or replace the function of an organ after its failure. The intestine or urinary tract still functions to eliminate waste from the body, albeit without a sphincter. Ostomy supplies simply receive the waste until it can be properly disposed of, functioning much like a diaper.
In HQ 960056, dated January 30, 1997, we found that adult incontinence diapers were classified in heading, 6211, HTSUS, as cotton garments, a provision describing the material in the diaper. Adult incontinence was found to be a disability so, like for ostomy supplies, duty free status was granted under heading 9817, HTSUS. We reaffirm this approach to incontinence products. Ostomy supplies, like diapers, are not classified as appliances worn to compensate for a disability. See also, NY 893069, dated January 3, 1994, and NY G83304, dated November 3, 2000.
Counsel argues that dicta in Midwest of Cannon Falls Inc. v. U.S., 20 CIT 123, 122 F3d 1423 (Fed. Cir. 1997), does not allow us to rely on the ENs in the manner described above. We disagree. Our analysis flows from the tariff terms themselves. The language “hearing aids and other appliances . . .” indicates that the other appliances must be like hearing aids. The subsequent terms of the heading, “worn . . . on the body” and “to compensate for a defect of disability” tell us the way in which a considered item must be similar to a hearing aid. Ostomy products, while worn on the body, do not compensate for a defect or disability in the active assistance or replacement of functioning flowing from the defect or disability. The relevant portion of EN 90.21 simply confirms that this is the correct conclusion as to the meaning of "appliances" that “compensate for a defect or disability” by only listing precision electronic devices that actively replace or assist the lost function engendered by a defect or disability. We decline to go beyond the scope of the heading, as counsel suggests, by interpreting the phrase “compensates for a defect or disability” to mean anything that helps the disabled person live a more normal life.
Counsel states that this line of reasoning was not apparent in HQ 951654, dated July 2, 1992, classifying tracheostomy covers in subheading 9021.90.80, HTSUS, with duty free treatment under 9817.00.96, HTSUS. We note that HQ 951654 classified a completely different product and is not dispositive here. Replacing the function of the nasopharynx, the tracheostomy covers that were the subject of that ruling, filter and warm the air after a laryngectomy. This surgery reroutes the trachea to an opening in the throat bypassing the nasopharynx. We note, however, that this ruling is being reviewed for correctness.
As to wafers imported separately from the ostomy pouches, explicit consideration has not been given in previous rulings to their possible classification in heading 3005, HTSUS, the provision for “[w]adding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices) . . . put up in forms or packings for retail sale for medical, . . . purposes.” As a primary consideration for classification in heading 3926, HTSUS, we note that the wafer consists essentially of products classified in headings 3901 through 3914, such as carboxymethylcellulose, polyisobutyulene and elastomeric polymers, and polyethylene.
The wafer is made of the same material found in hydrocolloidal dressings. Hydrocolloidal dressings both protect the skin and heal an open wound. The wafers differ from a dressing in that they contain a flange attachment for the ostomy pouch and an area in the middle to be cut to fit the stoma. The skin covered by the wafer is intact and there is no wound to cover. The stoma is a surgically created opening in the skin that is not a wound, per se, but rather fully functioning intestinal or uretal tissue anastamosed to dermal tissue. Hence, the function of the wafer is clearly to protect intact skin rather than to dress a wound, and, more importantly, to provide the fitting on which to attach the ostomy pouch. Although similar in material, the wafer is not similar in function to wadding, gauze or bandages in that it is not applied to a wound with the intent to protect the wound from debris, absorb exudate from the wound, or provide the environment for healing. Therefore, the wafer is not classified in heading 3005, HTSUS.
Counsel argues that NY 894238, dated February, 18, 1994, placing a donut shaped hydrocolloidal dressing in heading 3005, HTSUS, should control the issue. We disagree. The dressing in that case is used to cover excoriated areas, as well as protect healthy tissue, around stomas, fistulas, chest tubes and wounds that necessitate a hole in the middle of the dressing. However, the dressing can not be used as a base for an ostomy bag because there is no fitting on the dressing to attach the bag. Hence, this product is a dressing distinguishable from the ostomy wafers, which chiefly provide a fitting for attachment of an ostomy bag.
HOLDING:
The one and two piece ostomy pouches and wafers are classified in subheading 3926.90.20, the provision for "Other articles of plastics and articles of other materials of headings 3901 to 3914: Other: Ice bags; douche bags, enema bags, colostomy bags, hot water bottles, and fittings therefor; invalid and similar nursing cushions; crutch tips and grips; dress shields; finger cots; pessaries; prophylactics; sanitary belts; bulbs for syringes; syringes (other than hypodermic syringes) and fittings therefor, not in part of glass or metal." NY A86340 and NY 804864 are reaffirmed.
Sincerely,
Myles B. Harmon, Director
Commercial Rulings Division