CLA-2: RR:CTF:TCM H030420 KSH
Port Director
U.S. Customs and Border Protection
10 Causeway Street
Room 603
Boston, MA 02222
RE: Application for Further Review of Protest 0401-08-100096; Parietex® and Parietex Composite® surgical mesh products.
Dear Port Director:
This is in reply to your correspondence forwarding Application for Further Review of Protest (AFR) 0401-08-100096, filed by Drinker, Biddle & Reath, on behalf of its client, Sofradim and Surgical Devices (f/k/a United States Surgical).
FACTS:
The merchandise at issue, identified as Parietex® and Parietex Composite® (Parietex), is two types of sterile parietal surgery implants that are used principally for the treatment of hernias and incisional hernias. As imported they are in finished form, sterilized and ready for sale and surgical use. Parietex is designed to be surgically sutured or stapled to tissue to provide reinforcement for weak or torn abdominal walls during hernia repair surgery. To shorten surgery time and assist in ease of placement on the wound, Parietex is cut to shape during surgery to snugly fit within the affected area. The Parietex is composed of woven polyester fabric and the Parietex Composite is composed of the same woven polyester fabric bonded to a resorbable hydrogel anti-adhesive composed of polyethylene glycol, glycerol and oxidized collagen. The polyester encourages cells to adhere and spread, establishing fast and complete tissue in growth including between the fibers for rapid and complete tissue integration. The knit technology of the polyester creates large pores for connective tissue differentiation, flexibility and elasticity.
On June 20, 2005, protestant entered the merchandise subject to this protest in heading 9018, HTSUS, which provides for: " Instruments and appliances used in medical, surgical, dental or veterinary sciences.” A Notice of Action was issued on March 25, 2008, to rate advance the entry. On April 11, 2008, the Parietex was liquidated in heading 6003, HTSUS, which provides for “Knitted or crocheted fabrics of a width not exceeding 30 cm, other than those of heading 6001 or 6002” and the Parietex Composite was liquidated in heading 5907, HTSUS, which provides for: “Textile fabrics otherwise impregnated, coated or covered; painted canvas being theatrical scenery, studio back-cloths or the like.”
On May 29, 2008, protestant filed a protest and application for further review against the classification and liquidation of the merchandise in headings 5907 and 6003, HTSUS.
ISSUE:
Whether the Parietex® and Parietex® Composite surgical mesh products are classified in heading 3005, HTSUS as wadding, gauze and bandages, Section XI, HTSUS, as textile fabric, heading 9018, HTSUS, as instruments and appliances used in medical, surgical, dental or veterinary sciences or heading 9021, HTSUS, as orthopedic appliances.
LAW AND ANALYSIS:
Under 19 U.S.C. §1514(a)(2), a protest may be filed against decisions on the classification of the liquidated merchandise. The instant protest was timely filed within 180 days of liquidation of the entry made on June 20, 2005. (Miscellaneous Trade and Technical Corrections Act of 2004, Pub.L. 108-429, § 2103(2)(B)(ii), (iii) (codified as amended at 19 U.S.C. § 1514(c)(3) (2006)).
Further review of the protest is warranted pursuant to 19 CFR §§174.24(b) and 174.25 as the protest is alleged to be inconsistent with a ruling of the Commissioner of Customs or his designee, or with a decision made at any port with respect to the same or substantially similar merchandise.
Classification under the HTSUS is made in accordance with the General Rules of Interpretation. 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 GRIs may then be applied.
GRI 3(a) provides in relevant part that when classification of goods is under two or more headings "the heading which provides the most specific description shall be preferred to headings providing a more general description.”
The 2005, HTSUS, headings at issue are as follows:
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.
5907 Textile fabrics otherwise impregnated, coated or covered; painted canvas being theatrical scenery, studio back-cloths or the like.
6003 Knitted or crocheted fabrics of a width not exceeding 30 cm, other than those of heading 6001 or 6002.
9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences.
9021 Orthopedic 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.
Note 2 to Section VI, states:
Subject to note 1 above, goods classifiable in heading 3004, 3005, 3006, 3212, 3303, 3304, 3305, 3306, 3307, 3506, 3707 or 3808 by reason of being put up in measured doses or for retail sale are to be classified in those headings and in no other heading of the tariff schedule.
Note 1 to Chapter 90, HTSUS, reads, in relevant part:
This Chapter does not cover:
* * *
(b) Supporting belts or other support articles of textile material, whose intended effect on the organ to be supported or held derives solely from their elasticity (for example, maternity belts, thoracic support bandages, abdominal support bandages, supports for joints or muscles) (Section XI);
Note 6 to Chapter 90, HTSUS, provides the following:
6. For the purposes of heading 9021, the expression “orthopaedic appliances” means appliances for:
(a) Preventing or correcting bodily deformities; or
Supporting or holding parts of the body following an illness,
operation or injury.
* * *
Protestant argues pursuant to GRI 3(a), heading 9018, HTSUS, or alternatively, heading 9021, HTSUS, most specifically provides for the merchandise at issue. Protestant correctly notes that heading 9018, HTSUS, is a use provision which is generally more specific than an eo nomine provision. See Carl Zeiss, Inc. v. United States, 195 F.3d 1375 (Fed. Cir. 1999). Although, heading 9021, HTSUS, is an eo nomine provision, protestant argues that it more narrowly describes the merchandise than either heading 5907, HTSUS, or heading 6003, HTSUS.
Merchandise within the terms of heading of 9018, HTSUS, is classified by the merchandise’s principal use. For articles governed by principal use, Additional U.S. Rule of Interpretation 1(a), HTSUS, provides that, in the absence of special language or context which otherwise requires, such use "is to be determined in accordance with the use in the United States at, or immediately prior to, the date of importation, of goods of that class or kind to which the imported goods belong, and the controlling use is the principal use." In other words, the article's principal use at the time of importation determines whether it is classifiable within a particular class or kind.
While Additional U.S. Rule of Interpretation 1(a), HTSUS, provides general criteria for discerning the principal use of an article, it does not provide specific criteria for individual tariff provisions. However, the CIT has provided factors which are indicative but not conclusive, to apply when determining whether merchandise falls within a particular class or kind. They include: general physical characteristics, the expectation of the ultimate purchaser, channels of trade, environment of sale (accompanying accessories, manner of advertisement and display), use in the same manner as merchandise which defines the class, economic practicality of so using the import, and recognition in the trade of this use. See United States v. Carborundum Company, 63 CCPA 98, C.A.D. 1172, 536 F. 2d 373 (1976), cert. denied, 429 U.S. 979 (hereinafter Carborundum).
In understanding the language of the HTSUS, the Harmonized Commodity Description and Coding System Explanatory Notes (ENs) may be utilized. The ENs, though not dispositive or legally binding, provide commentary on the scope of each heading of the HTSUS, and are the official interpretation of the Harmonized System at the international level. CBP believes the ENs should always be consulted. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
The General EN to Chapter 90, HTSUS, provides the following in relevant part:
This Chapter covers a wide variety of instruments and apparatus which are, as a rule, characterised by their high finish and high precision. Most of them are used mainly for scientific purposes (laboratory research work, analysis, astronomy, etc.), for specialised technical or industrial purposes (measuring or checking, observation, etc.) or for medical purposes.
* * * *
There are certain exceptions to the general rule that the instruments and apparatus of this Chapter are high precision types. For example, the Chapter also covers 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).
The EN to heading 9018, HTSUS, places the instruments and appliances used in medical, surgical, dental or veterinary sciences into different categories. Category (A) identified as “Instruments which may be used under the same names for several purposes lists as examples: “needles, lancets, trocars, surgical knives and scalpels of all kinds, sounds, specula, mirrors and reflectors, scissors, shears, forceps, pliers, chisels, gouges, mallets, hammers, saws, scrapers, spatulae, cannulae, catheters, suction tubes, etc., cauteries, tweezers, dressing, swab, sponge or needle holders, retractors, dilators, clips, syringes of all kinds.
The aforementioned instruments and appliances are characterized by their hardy construction and reusability in the clinical setting. Even those items that are not typically reused are of a type of merchandise that could withstand sterilization and reuse. For instance, most needles, catheters, cannulae and syringes are currently disposed of after use, but some are sterilized for reuse depending on the material of which they are constructed (i.e., plastic syringes are disposed of after use, but glass or metal syringes are sterilized and reused). Further, these items are only used in hospitals, clinics and by practitioners in direct contact with a patient.
The EN to heading 9021, HTSUS, lists trusses (inguinal, crural, umbilical, etc., trusses) and rupture appliances as examples of orthopedic appliances. According to Taber’s™ Cyclopedic Medical Dictionary, Edition 15, 1985, orthopedic is defined as "concerning orthopedics; prevention or correction of deformities." A deformity is defined by Taber’s™ Cyclopedic Medical Dictionary as "an alteration in the natural form of a part or organ. Distortion of any part or general disfigurement of the body. It may be acquired or congenital. If present after injury, usually implies the presence of fracture, dislocation or both. May be due to extensive swelling, extravasation of blood or rupture of muscles."
Parietex is not "characterised by its high finish and high precision” as are the goods of Chapter 90 nor does Parietex fall into one of the exceptions to the general rule. Parietex is not reusable, nor is it a type of merchandise that is reuseable. It is not similar to trusses insofar as a truss is generally constructed of padding and elastic material which is worn against the skin and is usually worn only during normal daily activity. See W. Mc Adam Eccles, The Modern Treatment of Hernia by Trusses, The British Medical Journal (July 28, 1928). Furthermore, unlike other orthopedic appliances implanted in the body, Parietex does not actively assist or replace a function of an organ after its failure. Cf. NY C80952, dated November 6, 1997 and NY E89824, dated November 19, 1999. Rather Parietex and Parietex Composite support the surgically repaired tissues and prevent adhesions. This allows new tissue to grow and the hernia to heal. Supporting the hernia during healing encourages tissue regeneration. In this way Parietex is akin to the abdominal support bandages excluded from Chapter 90, HTSUS, by Note 1(b) to Chapter 90, HTSUS. As such, Parietex is excluded from classification in Chapter 90, HTSUS.
Alternatively, protestant argues that pursuant to GRI 1, Parietex is classified in heading 3005, HTSUS. Protestant cites to NY N013820, dated July 10, 2007 (absorbable adhesion barrier designed to separate surgically traumatized opposing tissue surfaces in the peritoneal cavity classified in heading 3005, HTSUS) and NY 833702, dated January 25, 1989, (laporatomy sponges and pre-cut sponges in packings for retail sale for use during surgical procedures and temporarily placed within the body cavity classified in heading 3005, HTSUS) in support of its position.
The HTSUS does not define bandages, however, CBP has defined a bandage as a piece of material applied to a body part to make compression, absorb drainage, prevent motion, retain surgical dressing, or lend support to a wound. See New York Ruling (NY) I84715, dated August 8, 2002 and HQ 963875, dated August 3, 2000. In contrast, items that exclusively lend support to body parts are not classifiable in heading 3005, HTSUS. See HQ 966637, dated October 22, 2003.
Similar to the absorbable adhesion barrier at issue in NY N013820, the instant merchandise functions as a specialized protective designed exclusively to prevent adhesions during the healing process. Furthermore, it is cut to shape to snugly fit within the affected area. In this regard, Parietex is akin to bandages in that Parietex lends support and compression to a wound in the abdominal walls by forming a barrier at the site where adhesions are expected to occur thereby allowing remesothelialization to occur. As such, Parietex is classifiable in heading 3005, HTSUS. In accordance with Note 2 to Section VI, we need not entertain classification of Parietex in Section XI.
HOLDING:
Pursuant to GRI 1, Parietex is classified in heading 3005, HTSUS. It is specifically provided for in subheading 3005.90.50, HTSUS, which provides for “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: Other: Other, Other.” The 2005 general, column one rate of duty is Free. Since the rate of duty under the classification indicated above is lower than the liquidated rate, you are instructed to grant the protest in full.
In accordance with Sections IV and VI of the CBP Protest/Petition Processing Handbook (HB 3500-08A, December 2007, pp. 24 and 26), you are to mail this decision, together with the CBP 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 the decision. Sixty days from the date of the decision Regulations and Rulings of the Office of International Trade 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