OT:RR:CTF:CPMMA H325402 ACA
Ms. Amy H. Smith
Seqirus
475 Green Oaks Parkway
Holly Springs, NC 27540
Re: Affirmation of NY N325292; Classification of MF-59 vaccine adjuvant
Dear Ms. Smith:
This is in response to your letter, dated May 19, 2022, in which you request reconsideration of New York Ruling Letter (NY) N325292, dated May 2, 2022, issued to Seqirus by U.S. Customs and Border Protection (CBP). NY N325292 involves the classification of a vaccine adjuvant commonly known as MF-59, under the Harmonized Tariff Schedule of the United States (HTSUS). CBP classified the merchandise in subheading 3824.99.9397, HTSUSA (Annotated). Having reviewed NY N325292 and determined that it is correct, we hereby affirm that ruling for the reasons set forth below.
The MF-59 vaccine adjuvant at issue was described in NY N325292 as follows:
The product in question is a vaccine adjuvant commonly known as MF-59, a key ingredient in the manufacture of influenza vaccines (seasonal and pandemic), having commercial and clinical applications. The MF59 [sic] adjuvant is a solution of mainly water, squalene, and sodium citrate-citric acid buffer, in which the ultimate product is a combination of influenza antigen, MF-59 adjuvant, and buffer solutions.
The descriptions of the MF-59 vaccine adjuvant included in your reconsideration request are consistent with those set forth above. Your reconsideration request further states that you import MF-59 as a pharmaceutical necessity, and classify the subject merchandise in the United Kingdom (UK) and the European Union (EU) under tariff number 3824.99.6400 (UK HTS, EU HTS), which provides for “Prepared binders for foundry moulds or cores; chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included: Other: Other: Other: Products and preparations for pharmaceutical or surgical uses: Other.” You argue that the subject merchandise should be classified under this subheading, or classified under a subheading that provides for pharmaceutical blend rather than a chemical.
In NY N325292, CBP classified the subject merchandise in subheading 3824.99.9397, HTSUSA, which provides for “Prepared binders for foundry molds or cores; chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included: Other: Other: Other: Other: Other: Other: Other.”
The Harmonized System (HS) of tariff nomenclature is an internationally standardized system used by members of the World Customs Organization (WCO) to classify goods. The HS consists of four-digit headings and subordinate six-digit subheadings used to classify merchandise. Classification beyond the six-digit level is country-specific. Article 3.3 of the International Convention on the Harmonized Commodity Description and Coding System states:
Nothing in this Article shall prevent a Contracting Party from establishing, in its Customs tariff or statistical nomenclatures, subdivisions classifying goods beyond the level of the Harmonized System, provided that any such subdivision is added and coded at a level beyond that of the six-digit numerical code set out in the Annex to this Convention.
Although classification is largely uniform among countries using the HS, national differences may exist in regard to classification at the eight-digit or ten-digit level due to judicial or customs rulings, national legislation, or with regard to newly developed types of goods. For CBP purposes, while other countries’ classification determinations can be informative, they are neither legally binding, nor considered dispositive for classification under the HTSUS. Goods imported into the United States are subject to the classification subheadings in the HTSUS, regardless of the classification for that good when imported into another country. The US, UK, and EU have set forth different eight-digit subheading designations under the six-digit level of the HS at subheading 3824.99. Significantly, the HTSUS does not include HTS code 3824.99.6400 as a potential classification.
Because HTS code 3824.99.6400 is not found in the HTSUSA, the next question is whether there is a comparable listing for preparation mixtures to be used for pharmaceutical or surgical uses within the HTSUS. The HTSUS subordinate subheadings under subheading 3824.99, HTSUS, do not provide for a comparable eight-digit subheading for “products and preparation for pharmaceutical or surgical uses” that would be applicable in this instance. Further, the subordinate subheadings under subheading 3824.99, HTSUS, do not otherwise distinguish the use of the subject merchandise for pharmaceutical uses. Therefore, there is no comparable listing applicable to the subject merchandise.
Because HTS code 3824.99.6400 is not found in the HTSUSA, there is no specific carve out for “products and preparations for pharmaceutical or surgical uses” under subheading 3824.99, HTSUS, and there is not otherwise a comparable listing for preparation mixtures to be used for pharmaceutical or surgical uses within the HTSUS, the proper classification for the MF-59 adjuvant is in subheading 3824.99.9397, HTSUSA.
Therefore, NY N325292 is hereby affirmed.
Sincerely,
Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division