CLA-2-30:OT:RR:NC:2:238
Mr. Steve Synder
CHB
1720 NW 95th Avenue
Doral, FL 33172
RE: The tariff classification, country of origin marking, and status under the United States-Australia Free Trade Agreement (UAFTA), of Influenza Virus Vaccine from Australia.
Dear Mr. Synder:
In your letter dated May 12, 2011 you requested a ruling on the status of Influenza Virus Vaccine from Australia under the UAFTA.
The subject product, Influenza Virus Vaccine will be shipped in bulk from Australia to Germany in a stainless steel sterile tank. In Germany, the product will be transferred to an automatic filling machine where it is injected into either a syringe or glass vial resulting in a pre-filled syringe or pre-filled glass vial. You state in your letter, the filled syringes/vials are then packaged and boxed for shipment to a related party in the United States.
The applicable tariff provision for the Influenza Virus Vaccine will be 3002.20.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Human blood; … , cultures of micro-organisms (excluding yeasts) and similar products: Vaccines for human medicine.” The rate of duty will be free.
General Note 28(b), HTSUS, sets forth the criteria for determining whether a good is originating under the UAFTA. General Note 28(b), HTSUS, (19 U.S.C. § 1202) states, in pertinent part, that
For the purposes of this note, subject to the provisions of subdivisions (c), (d), (m) and (n) thereof, a good imported into the customs territory of the United States is eligible for treatment as an originating good of a UAFTA country under the terms of this note only if –
(i) the good is a good wholly obtained or produced entirely in the territory of Australia or of the United States, or both;
(ii) the good was produced entirely in the territory of Australia or of the United States, or both, and—
(A) each of the nonoriginating materials used in the production of the good undergoes an applicable change in tariff classification specified in subdivision (n) of this note;
(B) the good otherwise satisfies any applicable regional value content requirement referred to in subdivision (n) of this note; or
(C) the good meets any other requirements specified in subdivision (n) of this note;
and such good satisfies all other applicable requirements of this note;
(iii) the good was produced entirely in the territory of Australia or of the United States, or both, exclusively from materials described in subdivision (b)(i) or (b)(ii) of this note; or
(iv) the good otherwise qualifies as an originating good under this note,
and is imported directly into the customs territory of the United States from the territory of Australia.
Based on the facts provided, the product described above does not qualify for UAFTA preferential treatment, because none of the above requirements are met.
The marking statute, Section 304 of the Tariff Act of 1930, as amended (19 U.S.C 1304), provides that, unless excepted, every article of foreign origin imported into the United States shall be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article (or 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. Section 134.1(b) defines the country of origin as "the country of manufacture, production, or growth of any article of foreign origin entering the U.S. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the country of origin' within the meaning of this part." A substantial transformation occurs when articles lose their identity and become articles having a new name, character or use. United States v. Gibson-Thomsen Co., 27 CCPA 267 at 270 (1940), National Juice Products v. United States, 10 CIT 48, 628 F. Supp. 978 (CIT 1986).
In this case, we find that the imported influenza virus vaccine is not substantially transformed as a result of processing in Germany, and the country of origin is Australia for marking purposes.
Drugs and medical devices are also 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, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 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 Harvey Kuperstein at (646) 733-3033.
Should you wish to request an administrative review of this ruling, submit a copy of this ruling and all relevant facts and arguments within 30 days of the date of this letter, to the Director, Commercial Rulings Division, U.S. Customs and Border Protection, Regulations & Rulings, 799 9th Street N.W. - 7th floor, Washington, DC 20229-1177.
Sincerely,
Robert B. Swierupski
Director
National Commodity Specialist Division