CLA-2-29:OT:RR:NC:N3 140
Elizabeth Bishop
Charles River Labs
251 Ballardvale St Wilmington, MA 01887
RE: The tariff classification of pHelper-Kan-OTS DNA Plasmid from the United Kingdom
Dear Ms. Bishop:
In your letter dated April 11, 2023, you requested a tariff classification ruling.
The subject merchandise is pHelper-Kan-OTS DNA Plasmid, used in combination with separate Rep/Cap and gene of Interest (GOI) plasmids, as a biological reagent for triple transfection of mammalian host cell lines to generate Adeno-Associated Virus (AAV) viral vectors for gene therapy applications. The country of origin and export is the United Kingdom.
You opine that classification of both the extracted pure plasmids and the plasmids introduced into bacterial cells should be classified in subheading 3002.49.0000, Harmonized Tariff Schedule of the United States, which provides for “Human blood; …; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Other:” You claim that plasmids are similar products to the vaccines, toxins, cultures of micro-organisms of that subheading. We respectfully disagree.
The World Customs Organization and World Trade Organization have both placed Plasmids in subheading 2934.99. For more information, please see NY N049257, dated December 3, 2009 .
The applicable subheading for the pHelper-Kan-OTS DNA Plasmid will be 2934.99.9001, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Other: Other: Other.” The rate of duty will be 6.5 percent ad valorem.
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 at https://hts.usitc.gov/current.
This 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 U.S. Food and Drug Administration (FDA). Information on 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.
This merchandise may also be subject to the rules and regulations of the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. You may contact them at 1600 Clifton Road, Atlanta, GA 30333, telephone number (404) 633-5313 or (800) CDC-INFO, or at the Web address [email protected].
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection 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 Evan Thomas at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division