OT:RR:CTF:CPMMA H338086 CMD
Ms. Ivette Hernandez
Nestor Reyes, Inc.
1055 Marginal Kennedy Avenue
ILA Building, Suite 801
San Juan, Puerto Rico 00920
RE: Tariff classification of a transport medium kit
Dear Ms. Hernandez:
This ruling is being issued in response to your electronic submission, dated August 18, 2023, on behalf of Copan Industries, Inc., requesting a binding ruling regarding tariff classification of a transport medium kit. Your electronic ruling request was forwarded to this office from the National Commodity Specialist Division for response. Our ruling is set forth below.
FACTS:
The Universal Transport Medium (UTM-RT) system consists of a single flexible "minitip" flocked swab and 3 milliliters (ml) of viral transport medium housed in a 12x80 millimeters (mm) round bottom tube with a red plastic cap, packaged together in a zip top plastic bag as a kit. The swab consists of a molded plastic applicator stick with a variable size and shape tip. The tip of the applicator is coated with short Nylon fibers that are arranged in perpendicular fashion. The transport medium includes proteins for virus stabilization, antibiotics to prevent overgrowth of bacteria and yeasts, and a buffer solution to maintain a neutral pH. The kit is intended for the collection, transport, and preservation of clinical specimens containing viruses, chlamydia, mycoplasma, and urea plasma. The transport medium consists of sucrose, "Hank's Balanced Salt Solution," bovine serum albumin, buffered solution, gelatin, amino acids, antibiotics, and phenol red. The kit requires no further preparation.
The request states that the components will be imported from Italy, to be admitted into a Foreign Trade Zone (FTZ) under nonprivileged foreign status. The components will be processed into the finished products, namely the swab and the solution. The finished products will be placed in a plastic bag and entered for consumption in the United States.
ISSUE:
Whether the set is classifiable in heading 3821, HTSUS which provides for "Prepared culture media for development or maintenance of micro-organisms (including viruses and the like) or of plant, human or animal cells." or in heading 9027, HTSUS, which provides for "Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments for apparatus for measuring or checking viscosity, porosity, expansion, or surface tension or the like; instruments and apparatus for measuring or checking quantities of hear, sound or light (including exposure meters); microtomes; parts and accessories thereof."
LAW AND ANALYSIS:
As an initial matter, we note that FTZs are legally outside the customs territory of the United States. 19 U.S.C. 81c(a). Consequently, imported merchandise may be admitted into an FTZ without being entered into customs territory for consumption. Merchandise may be admitted into an FTZ under one of four zone statuses: nonprivileged foreign, privileged foreign, domestic, and zone-restricted. See 19 C.F.R. 146.42, 146.41, 146.43, 146.44. Nonprivileged foreign and privileged foreign status is applicable to "imported merchandise which has not been properly released from Customs custody in Customs territory." See 19 C.F.R. 146.1. Merchandise admitted in nonprivileged foreign status may not be manipulated or manufactured within an FTZ "except under Customs permit." 19 C.F.R. 146.51. For tariff classification purposes, "[n]onprivileged foreign merchandise . . . will be subject to tariff classification in accordance with its character, condition and quantity as constructively transferred to Customs territory at the time the entry or entry summary is filed with Customs." 19 C.F.R. 146.65(a)(2). Consequently, the classification analysis that follows is applicable to the finished products that will be entered for consumption into the customs territory of the United States.
Classification under the Harmonized Tariff Schedule of the United States (HTSUS) is made in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. If the goods cannot be classified solely based on GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 may then be applied in order.
The 2024 HTSUS subheadings under consideration are the following:
3821.00.00 Prepared culture media for development or maintenance of micro-organisms (including viruses and the like) or of plant, human or animal cells
3821.00.0010 Viral transport media
9027 Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories thereof:
9027.50 Other instruments and apparatus using optical radiations (ultraviolet, visible, infrared):
9027.50.80 Other
9027.50.8015 Chemical analysis instruments and apparatus
GRI 3(b) states that:
Mixtures, composite goods consisting of different materials or made up of different components, and goods put up in sets for retail sale, which cannot be classified by reference to 3 (a), shall be classified as if they consisted of the material or component which gives them their essential character, insofar as this criterion is applicable.
In understanding the language of the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and coding System, which constitutes the official interpretation of the Harmonized System at the international level, may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading and are generally indicative of the proper interpretation of the HTSUS.
The ENs to GRI 3(b) state at Note X that the term "goods put up in sets for retail sale" means goods that: (a) consist of at least two different articles that are, prima facie, classifiable in different headings; (b) consist of products or articles put up together to meet a particular need or carry out a specific activity; and (c) are put up in a manner suitable for sale directly to end users without repackaging.
The ENs to the HTSUS, GRI 3(b) (VIII), state that "the factor which determines essential character will vary between different kinds of goods. It may, for example, be determined by the nature of the materials or components, its bulk, quantity, weight or value, or by the role of a constituent material in relation to the use of the goods." When the essential character of a composite good can be determined, the whole product is classified as if it consisted only of the material or component that imparts the essential character to the composite good.
The wadding is made of a man-made textile, viz. nylon. The flocked swab element is classifiable, under the principle of GRI 1, in heading 5601, HTSUS, as wadding of textile. The universal transport medium is prima facie classifiable in heading 3821, HTSUS. The universal transport medium is essentially a prepared culture media for the maintenance of human viral specimens. The transport medium contains proteins, antibiotics, and a buffer solution all intended to maintain the viability for human cells to facilitate clinical testing. The solution is specifically designed to transport viral cells, leading to classification in heading 3821, HTSUS, which provides for prepared culture media for development or maintenance of micro-organisms (including viruses and the like) or of plant, human or animal cells.
The universal transport medium packaged with the flocked swab meets the definition of a set as laid out in GRI 3(b). The UTM-RT is made up of different goods put up in sets for retail sale. The UTM-RT meets the criteria for "goods put up in sets for retail sale" set out in the ENs to GRI 3(b) because it (a) consists of the transport medium contained in a plastic tube with cap as well as the flocked swab, both classified in different headings; (b) meets the particular need of collecting and storing human viral cells to facilitate clinical testing; and (c) its components are packaged together in a zip top plastic bag in a manner suitable for sale to end users as a single unit. The flocked swab is a part of, and acts to support, the purpose of the set by collecting the specimen which the transport medium holds and maintains. The UTM-RT, the combination of a 3ml vial containing a transport medium with a flocked swab together in packaging qualifies the UTM-RT as a set. Sets must be classified as a single good, which means that determining the essential character of the set is necessary.
Essential character may be imparted by a number of characteristics of a good, and this will change depending on the type of good. It may be determined by weight, value, quantity, the nature of the material, or by the role of a constituent material in relation to the use of goods. In the ruling request, you suggest that the set is classifiable in subheading 9027.50.8015, HTSUSA (Annotated), which provides for "Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories thereof: Other instruments and apparatus using optical radiations (ultraviolet, visible, infrared): Other: Chemical analysis instruments and apparatus." This analysis misinterprets the general rules of interpretation. Neither of the individual components are classifiable in heading 9027, HTSUS, so the set may not be classified in that heading. Heading 9027, HTSUS, covers instruments and apparatus for measuring, checking, or analyzing physical or chemical substances. This includes articles such as "quantitative polymerase chain reaction devices" which are instruments for performing DNA analysis (see New York Ruling Letter (NY) N337036, dated January 9, 2024) and devices like an "automated system designed to perform multiplex fluorescent immunohistology assays" which work by "detect[ing] the emission of light of a specific wavelength from a fluorophore bound to the sample by exciting it with light of a specific wavelength" (see NY N331109, dated March 8, 2023). These articles themselves perform the analysis, which is what warrants their classification in heading 9027, HTSUS.
An essential character analysis requires determining which component or part of a set gives the overall item or set its essential character. You cite NY N325218, dated April 29, 2022, which classified a COVID-19 test kit in heading 9027, HTSUS. However, the test kits therein at issue included an electronic test unit, which analyzed the cells contained in the transport medium. This component of the set gave the set its essential character, allowing a user to test the sample with a component of the set itself. That essential and determinative feature is not present in the UTM-RT, which contains no instrument or apparatus capable of performing a chemical or physical measurement or analysis.
Under any of the frames of determining the essential character of the UTM-RT, the essential character is imparted by the 3 ml vial and the viral transport medium which it contains. The role of the vial and the transport medium is inseparable from the purpose of the UTM-RT. The purpose of the good is to provide stable maintenance and transport of viral specimens. The flocked swab is not necessary for this maintenance, whereas the transport medium solution and its container are. The essential character of the transport medium kit is provided by the transport medium.
In NY N038902, dated September 26, 2008, CBP ruled that a product called EmbryoGlue, which consisted of a "buffered liquid medium designed for embryo transfer and implantation" which was "packed in 10 mL plastic bottles" was an article of heading 3821, HTSUS. The purpose of the article was to "provide safe transfer of the embryo and then to support it through the various stages of implantation." The medium contained additives meant to maintain the sample and support development.
Like the EmbryoGlue at issue in NY N038902, the UTM-RT maintains human cells in a transport medium, supported by a liquid formulated to do so. As such the correct classification of the UTM-RT is under heading 3821, HTSUS. Per GRI 6, the transport medium kit is classified in subheading 3821.00.0010, HTSUSA, which provides for "Prepared culture media for development or maintenance of micro-organisms (including viruses and the like) or of plant, human or animal cells: Viral transport media."
HOLDING:
Pursuant to GRIs 1 and 3, the transport medium kit, as described above, is classified in heading 3821, HTSUS, and specifically, subheading 3921.00.0010, HTSUSA, which provides for "Prepared culture media for development or maintenance of micro-organisms (including viruses and the like) or of plant, human or animal cells: Viral transport media." The column 1 general duty rate is 5% ad valorem.
Duty rates are provided for your convenience and subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided for at https://hts.usitc.gov/.
Sincerely,
Andrew M. Langreich, Chief
Chemicals, Petroleum, Metals
and Miscellaneous Articles Branch