MAR-2 OT:RR:NC:N2:238
Mr. Michael Nordstrom
Scantibodies Laboratory, Inc.
9336 Abraham Way
Santee, CA 92071
RE: COUNTRY OF ORIGIN MARKING OF IMPORTED IN VITRO DIAGNOSTIC IMMUNOASSAY KIT AND SPECIMEN COLLECTION AND RETURN KIT; ARTICLE 509
Dear Mr. Nordstrom:
This is in response to your letter dated May 8, 2012, requesting a ruling on the country of origin marking requirements for QuickVue® iFOB (Immunochemical Fecal Occult Blood) Test and QuickVue® iFOB Specimen Collection and Return Kit, packaged in Mexico from various materials exported from the United States. Samples were submitted with your letter for review.
The first product, QuickVue® iFOB (Immunochemical Fecal Occult Blood) Test, is a one-step lateral flow chromatographic immunoassay kit. It is an immunochemical diagnostic test that is intended for the qualitative detection of fecal occult blood. This kit contains two components of the test: 20 individually foil wrapped plastic test cassettes and 20 individually wrapped specimen collection and return kits. Each plastic test cassette contains a burgundy colored conjugate pad containing mouse anti-hHb antibodies conjugated with colloidal gold and a nitrocellulose membrane strip containing a Test line (T-line) coated with anti-hHb antibodies and a Control line (C-line) coated with goat anti-mouse IgG antibodies. Each specimen collection and return kit contains a specimen collection plastic tube with 2 ml FOB buffer and patient identification label, specimen collection paper with adhesive, specimen pouch, absorbent sleeve, return mailer, and patient instructions. The specimen collection and return kit is specifically intended to be used with the plastic test cassettes. It is available in quantities of 25 tests and 2 tests. The QuickVue® iFOB Test 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. According to the product literature submitted to this office, the test is intended for use by laboratories and physician’s offices.
The second product, QuickVue® iFOB Specimen Collection and Return Kit, consists of 10 individually wrapped kits, each containing a specimen collection plastic tube with 2 ml FOB buffer and patient identification label, specimen collection paper with adhesive, specimen pouch, absorbent sleeve, return mailer and patient instructions. The 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 first product, QuickVue® iFOB (Immunochemical Fecal Occult Blood) Test, are manufactured in the United States except for the specimen collection and return kits (item # 1113006) which are manufactured in Mexico. You also indicate that all of the materials for packaging the tests are from the United States and everything inside the in vitro diagnostic immunoassay kit is exported to Mexico from the United States for simple packing. In Mexico, the individually wrapped test cassettes, specimen collection and return kits and the instructional leaflet will be placed into the 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.
You also indicate that all of the components that make up the second product, QuickVue® iFOB Specimen Collection and Return Kit, are manufactured in Mexico except for the packaging materials which are from the United States. In Mexico, the specimen collection and return kits and the instructional leaflet will be placed into the box, labeled with a lot number, expiration date, sealed and packaged. The kit will then be exported to 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 immunoassay kit is a good of the United States for marking purposes and the imported specimen collection and return kit is a good of Mexico for marking purposes.
19 CFR 134.41 (b), provides that country of origin marking is considered conspicuous if the ultimate purchaser in the U.S. is able to find the marking easily and read it without strain. Section 134.46, Customs Regulations (19 CFR 134.46), deals with cases in which the words “United States,” or “American,” the letters “U.S.A.,” any variation of such words or letters, or the name of any city or locality in the United States, or the name of any foreign country or locality other than the country or locality in which the article was manufactured or produced, appears on an imported article or its container, and those words, letters or names may mislead or deceive the ultimate purchaser as to the actual country of origin. In such a case, there shall appear, legibly and permanently, in close proximity to such words, letters, or name, and in at least a comparable size, the name of the country of origin preceded by “Made in,” “Product of,” or other words of similar meaning.
The proposed marking of the imported specimen collection and return kit with the name and address of the manufacturer, Quidel Corporation of San Diego, CA. is not an acceptable country of origin marking. In order to satisfy the close proximity requirement, the country of origin marking must generally appear on the same side(s) or surface(s) in which the name or locality other than the actual country of origin appears and in at least a comparable size, the name of the country of origin preceded by “Made in,” “Product of,” or other words of similar meaning. In this case, the specimen collection kit must specify that it is “Made in Mexico” or other words of similar meaning and on the same side of the printed box in close proximity to the name of the manufacturer, Quidel Corporation of San Diego, CA.
However, the in vitro diagnostic immunoassay kit is an article of U.S. origin and 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,
Thomas J. Russo
Director
National Commodity Specialist Division