The Country of Origin Marking of the PMP Prep Tray

N251416 April 9, 2014 MAR-2 OT:RR:NC:N1:405 CATEGORY: MARKING Mr. Donald S. Stein Greenberg Traurig, LLP 2101 L Street, N.W. Suite 1000 Washington, D.C. 20037 RE: The Country of Origin Marking of the PMP Prep Tray Dear Mr. Stein: This is in response to your letter dated March 6, 2014, on behalf of Kimberly-Clark Corp., requesting a ruling on the marking of a PMP Prep Tray, which is used to perform medical procedures for peripheral nerve blocks. A marked sample was not submitted with your letter for review. The PMP Prep Tray consists of 17 different components which will be made into kits (“kitted”) in the United States. Fifteen of the items in the PMP Prep Tray are of U.S. origin. The items consist of steri-strip adhesive skin closures, ultrasound gel, ultrasound probe covers, syringes, local injection needles, etc. The imported items are a 24 inch extension set which is made in Taiwan and the gauze pads which are made in China and in the U.S. You state that the imported 24 inch extension set and imported gauze pads are not individually marked with their country of origin but are shipped to Kimberly-Clark Corp. in cartons with the outermost containers properly marked with their country of origin. The various items are consolidated at Kimberly-Clark’s facility in Tucson, Arizona, into the PMP Prep Trays and then sent to customers in the U.S. market. All of the items which comprise the PMP Prep Tray are either of U.S. origin or have previously been legally imported into the US with lawful marking on the outermost containers. Kimberly-Clark seeks guidance with respect to the proper country of origin marking of the PMP Prep Tray once it is completely assembled and packaged (kitted) in the U.S. Specifically, you request a ruling on whether the county of origin of each individual non-U.S. origin component must be stated on the packaging label. The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article. The country of origin of the items which are non-U.S. origin must be stated on the packaging label of the PMP Prep Tray, in a conspicuous, legible and permanent manner. The marking of the packaging of the sealed trays, rather than the individual imported components of the trays, is sufficient provided the ultimate purchaser receives the trays in the marked packaging. The doctor or medical professional is considered the ultimate purchaser of the PMP Prep Trays, not the patient. The name of both the component and its country of origin should be shown on the packaging. This marking will satisfy the marking requirements of 19 U.S.C. 1304 and 19 CFR Part 134. Note that 19 U.S.C. 1304 does not require labeling of U.S. origin articles; however, whether or how retail containers may be marked to indicate the U.S. origin of an article is a matter to be decided by the Federal Trade Commission. Questions may be directed to the Federal Trade Commission, Division of Enforcement, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. For your information, drugs and medical devices are subject to special labeling requirements by the U.S. Food and Drug Administration (FDA). Such merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the FDA. Information regarding the requirements (including labeling) of the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, may be addressed to the Food and Drug Administration, Division of Regulatory Guidance, 10903 New Hampshire Ave., Silver Spring, MD 20993. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 CFR Part 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported in the future. If you have any questions regarding the above, contact National Import Specialist Barbara Kiefer at Barbara.J.Kiefer@cbp.dhs.gov. Sincerely, Gwenn Klein Kirschner Acting Director National Commodity Specialist Division