MAR-2 OT:RR:NC:2:238
Mr. Michael Nordstrom
Scantibodies Laboratory, Inc.
9336 Abraham Way
Santee, CA 92071
RE: THE COUNTRY OF ORIGIN MARKING OF IMPORTED IN VITRO DIAGNOSTIC IMMUNOFLUORESENCE KIT; ARTICLE 509
Dear Mr. Nordstrom:
This is in response to your letter dated August 7, 2013, requesting a ruling on the country of origin marking requirements for the Sofia® RSV FIA kit packaged in Mexico from various materials exported from the United States. A sample was submitted and will be returned to you.
Sofia® RSV FIA is an immunofluorescence kit that is indicated for the detection of respiratory syncytial virus (RSV) nucleoprotein antigen directly from nasopharyngeal swab, nasopharyngeal aspirate or wash specimen from symptomatic patients. It is intended as an aid in the rapid diagnosis of acute RSV infections. The Sofia RSV Test employs immunofluorescence technology that is used with the Sofia Analyzer only. The kit consists of the following: (25) individually foil wrapped plastic test cassettes containing mouse monoclonal anti-RSV antibodies, (25) reagent tubes containing lyophilized buffer with detergents and reducing agents, (25) reagent ampoules with salt solution, (25) sterile nasopharyngeal swabs, (25) pink plastic pipettes, (25) clear plastic pipettes, (1) RSV positive control swab coated with non-infectious RSV antigen, (1) negative control swab coated with heat-inactivated, non-infectious Streptococcus C antigen, (1) package insert, (1) Quick Reference Instructions, (1) QC Card, (1) Translations on CD-ROM and (1) small roll of printer paper. This kit is put up ready for retail sale inside a printed box with the outer surface of the box labeled with the name of the manufacturer, Quidel Corporation of San Diego, CA.
In your letter, you indicated that all of the components that make up the Sofia® RSV FIA kit are manufactured in the United States except for the clear plastic pipettes (item # 1184002), pink plastic pipettes (item #1216200), which are from Mexico and the small roll of printer paper (item # 1200800), which is from Italy. The remaining items of the kit, including the materials for packaging the tests are from the United States. In your letter, you also stated that everything inside the kit is exported to Mexico from the United States for packaging operation only. In Mexico, all of the components that make up the Sofia® RSV FIA Test kit will be placed into the printed box, labeled with a lot number, expiration date, sealed and packaged. Afterwards, Scantibodies Laboratory, Inc. will import the kit into the United States directly from Mexico for distribution.
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. Part 134, Customs Regulations (19 CFR Part 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304.
The country of origin marking requirements for a “good of a NAFTA country” are also determined in accordance with Annex 311 of the North American Free Trade Agreement (“NAFTA”), as implemented by section 207 of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat 2057) (December 8, 1993) and the appropriate Customs Regulations. The Marking Rules used for determining whether a good is a good of a NAFTA country are contained in Part 102, Customs Regulations (19 CFR Part 102). Section 102.11 of the regulations, sets forth the required hierarchy for determining country of origin for marking purposes.
Applying the NAFTA Marking Rules set forth in Part 102 of the regulations to the facts of this case, we find the imported In Vitro Diagnostic Immunofluoresence Kit is a good of the United States for marking purposes.
If a good is determined to be an article of U.S. origin, it is not subject to the country of origin marking requirements of 19 U.S.C. §1304. Whether an article may be marked with the phrase "Made in the USA" or similar words denoting U.S. origin, is an issue under the authority of the Federal Trade Commission (FTC). We suggest that you contact the FTC Division of Enforcement, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580 on the propriety of proposed markings indicating that an article is made in the U.S.
This ruling is being issued under the provisions of Part 181 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. If you have any questions regarding the ruling, contact National Import Specialist Judy Lee at (646) 733-3033.
Sincerely,
Myles B. Harmon
Acting Director
National Commodity Specialist Division