Gas sterilization as incidental to assembly of medical products

HQ 555154 March 20, 1989 CLA-2-CO:R:C 555154 RA CATEGORY: Classification TARIFF NO: 9802.00.80, HTSUS Mr. William F. Joffroy, President William F. Joffroy, Inc. P.O. Box 698 Nogales, Arizona 85628-0698 RE: Gas sterilization as incidental to assembly of medical products Dear Mr. Joffroy: This is in response to your letter of October 11, 1988, on behalf of Superior Healthcare Group, Inc. of Cumberland, Rhode Island, requesting a ruling that a gas sterilization process would be considered as incidental to assembly for purposes of subheading 9802.00.80, Harmonized Tariff Schedule of the United States (HTSUS). FACTS: Medical products, such as specimen collector sets and suction catheters, are assembled in Mexico from components of U.S. origin and subjected to a gas sterilization process before exportation to this country. This process requires exposure to a sterilant gas of a precise concentration at certain temperature, humidity, and pressure levels. ISSUE: Whether the sterilization process may be considered as an operation incidental to assembly under the provisions of subheading 9802.00.80, HTSUS. LAW AND ANALYSIS: As you know, the HTSUS replaced the Tariff Schedules of the United States (TSUS), effective January 1, 1989. Item 807.00, TSUS, was carried over into the HTSUS without change as subheading 9802.00.80. Subheading 9802.00.80, HTSUS, applies to articles assembled abroad in whole or in part of fabricated components, the product of the U.S., with no operations performed thereon except the attachment of the components to form the - 2 - imported merchandise and operations incidental thereto. An article classified under this tariff provision is subject to duty upon the full appraised value of the imported article, less the cost or value of such products of the U.S. You note that section 10.16(b), Customs Regulations (19 CFR 10.16(b)), provides that operations such as cleaning are considered incidental to the assembly process, and that in our ruling 554338 dated November 5, 1986, we indicated that sterilization was comparable to cleaning. That ruling and a previous ruling dated July 3, 1984 (553055), concerned the applicability of item 807.00, TSUS, to the foreign assembly and sterilization of cotton-tipped applicators or swabs used for medical testing purposes. We stated that sterilizing assembled components for "ultimate use in surgical operations or prospective care" is comparable to a cleaning process and, as such, can be considered incidental to the overall assembly process. We have also held in ruling 071442 dated July 19, 1983, that the sterilization of assembled hospital articles such as surgical gowns and packs is comparable to a cleaning process and, therefore, is considered incidental to the foreign assembly process. HOLDING: Consistent with the above-referenced rulings, the gas sterilization of the assembled medical products before exportation to the U.S. is considered comparable to cleaning and, in our opinion, is an operation incidental to assembly under the provisions of subheading 9802.00.80, HTSUS. Sincerely, John Durant, Director Commercial Rulings Division