OT:RR:CTF:CPMM H304055 RRB
Melissa Proctor
Miller Proctor Law PLLC
16427 Scottsdale Rd., Suite 410
Scottsdale, AZ 85254
RE: Request for Reconsideration of NY N287866; tariff classification of human tissue samples
Dear Ms. Proctor:
This is in reply to your letter, dated May 24, 2019, in which you requested reconsideration of New York Ruling Letter (“NY”) N287866, dated July 6, 2017, issued to your client, Roche Diagnostics Operations, Inc. (“Roche”), by U.S. Customs and Border Protection (“CBP”), concerning the classification of certain human tissue samples under the Harmonized Tariff Schedule of the United States (“HTSUS”).
In NY N287866, we described Roche’s merchandise as follows:
The subject merchandise is three different forms of human tissue samples as follows: The first item is Formalin-fixed Paraffin Embedded (FFPE) Tissue Block. You state that once the tissue sample is collected, it is immediately fixed in 10 percent neutral buffered formalin to preserve the morphology and cellular details of the sample. The fixed tissue is then embedded into paraffin blocks. The second item is Formalin-fixed Paraffin Embedded Tissue (unstained slides). You state that once the tissue sample is collected, it is fixed in neutral buffered formalin and embedded into paraffin blocks then four micrometer-thick slices of the sample are mounted onto Superfrost® Plus Micro Slides. The product is subsequently air dried for at least an hour. The third item is Fresh (Wet) Tissue Biopsy. You state that once collected the tissue sample is immediately placed in a 60 milliliter pre-filled polypropylene container that contains 30 milliliters of 10 percent neutral buffered formalin. All three items will be imported for diagnostic analysis.
We classified these human tissue samples in subheading 0511.99.4070, HTSUSA (“Annotated”), which provides for “Animal products not elsewhere specified or included; dead animals of chapter 1 or 3, unfit for human consumption: Other: Other: Other … Other.”
You assert that the human tissue samples are properly classified in subheading 3001.90.0190, HTSUSA, which provides for “Glands and other organs for organotherapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organotherapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included: Other: Other.” In the alternative, you claim that the human tissue samples may also be classifiable in subheading 9705.00.0085, HTSUSA, which provides for “Collections and collectors' pieces of zoological, botanical, mineralogical, anatomical, historical, archeological, paleon-tological, ethnographic or numismatic interest: Other.”
Classification under the 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. In the event that the goods cannot be classified solely on the basis of 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. Pursuant to GRI 6, classification at the subheading level uses the same rules, mutatis mutandis, as classification at the heading level.
Subheading 0511.99.40, HTSUS, which covers “[a]nimal products not elsewhere specified or included; … Other: Other: Other…” is a “basket provision,” as indicated by the terms “not elsewhere specified or included.” Similarly, subheading 3001.90.01, HTSUS, which covers “… other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included: Other” is also a “basket provision.” Classification in a basket provision is only appropriate if there is no tariff category that covers the merchandise more specifically. See E.M. Industries v. U.S., 999 F. Supp. 1473, 1480 (CIT 1998) ("'Basket' or residual provisions of HTSUS headings … are intended as a broad catch-all to encompass the classification of articles for which there is no more specifically applicable subheading.” On the other hand, subheading 9705.00.00, HTSUS, specifically provides for “collections and collectors' pieces of . . . anatomical interest: other.” Therefore, we will first address whether the subject human tissue samples are more specifically classifiable under subheading 9705.00.00, HTSUS, as “… [c]ollections and collectors’ pieces of … anatomical interest …”
The EN 97.05 states that articles in this heading “are very often of little intrinsic value but derive their interest from their rarity, their grouping or their presentation.” The EN also provides for “collections and collectors’ pieces of zoological, botanical, mineralogical or anatomical interest, such as. . . [a]natomical or pathological specimens.” Within the context of an article’s rarity, grouping and presentation, the EN 97.05(A)(1)-(6), HTSUS, describes various preservation techniques for preparing specimens as parts of collections or collectors’ pieces. Along these lines, we have classified items such as natural fossils, stuffed animals and animal heads, and mounted animal heads in subheading 9705.00.00, HTSUS, based on their rarity and presentation as collectors’ items. Unlike items such as natural fossils and stuffed animals or animal heads, which are noted for and displayed as collectors’ pieces based on their rarity, Roche’s human tissue samples in NY N287866 a will not be preserved for longevity in a manner within the context of chapter 97, HTSUS, for collections and collectors’ pieces. Moreover, unlike the fossils and stuffed animal heads, the human tissue samples in NY N287866 will be further examined, analyzed, dissected, or otherwise adulterated for laboratory research and diagnostic purposes rather than for preservation or display. Therefore, we find that the human tissue samples in NY N287866 cannot be classified in heading 9705, HTSUS.
Roche’s primary assertion in its reconsideration request is that the human tissue samples in NY N287866 were wrongly classified in heading 0511, HTSUS, as “animal products not elsewhere specified or included” and should have been classified in heading 3001, HTSUS, as “. . .other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specific or included.”
The terms “therapeutic” and “prophylactic” are not defined in chapter 30 of the HTSUS, nor are they defined elsewhere in the Nomenclature or the ENs. In the absence of a definition of a term in the HTSUS or ENs, the term’s correct meaning is its common and commercial meaning. Nippon Kogasku (USA), Inc. v. United States, 69 CCPA 89, 673 F.2d 380 (1982). Common and commercial meaning may be determined by consulting dictionaries, lexicons, scientific authorities and other reliable sources. C.J. Tower & Sons v. United States, 69 CCPA 128, 673, F.2d 1268 (1982). The Court of Appeals for the Federal Circuit (“CAFC”) has defined “therapeutic” as “having healing or curative powers.” See Lonza, Inc. v. U.S. 46 F.3d 1098 (Fed. Cir. 1995). Additionally, according to Merriam-Webster’s Online Dictionary, “prophylactic” means (1) “guarding from or preventing the spread of occurrence of disease or infection”; (2) “tending to prevent or ward off”. See also HQ H095405, dated June 15, 2010.
Based on the above definitions, we find that the human tissue samples in NY N287866 are precluded from classification in heading 3001, HTSUS, which is limited to human substances that are prepared for therapeutic or prophylactic uses. The human tissue samples in NY N287866 are utilized for the development of in vitro diagnostic tests, which are then used as an aid in the benefit-risk decision making on the use of another therapeutic product. Nowhere in the definition of therapeutic is use in developing diagnostic tests to help determine the proper therapeutic treatment at a future, indefinite time included. Therefore, the human tissue samples in NY N287866 are not prepared for therapeutic or prophylactic uses and thus not described by the terms of heading 3001, HTSUS.
You also assert that under the principle of “relative specificity,” the human tissue samples in NY N287866 should be classified in heading 3001, HTSUS, because the terms of that heading are more specific and contain more rigorous requirements than heading 0511, HTSUS. However, this argument is irrelevant since the human tissue samples do not meet the terms of heading 3001, HTSUS.
Turning to heading 0511, we note that the term “human” is not defined in chapter 5 of the HTSUS, nor is it defined elsewhere in the Nomenclature or the ENs. However, the Encyclopedia Britannica defines human being as a “culture-bearing primate classified in the genus Homo, especially the species H. sapiens. Human beings are anatomically similar and related to the great apes but are distinguished by a more highly developed brain and a resultant capacity for articulate speech and abstract reasoning.” Additionally, “a primate is any mammal of the group that includes lemurs, lorises, tarsiers, monkeys, apes, and humans.”
The crux of Roche’s argument is that heading 0511, HTSUS, is not applicable to its human tissue samples where the heading language and the EN 05.11 do not include the word “human,” nor do they indicate any intention to include human products. You assert that if heading 0511, HTSUS, were intended to cover human products, a specific reference to “human” would have been utilized. However, we note that although the word “human” is not prevalent in much of chapter 5, heading 0501, HTSUS, does include some products of human origin, such as human hair, implying that the boundaries of chapter 5 are not strict.
In considering heading 0511, HTSUS, we are presented with the ethical dilemma of deciding the distinction between an “animal” and a “human being,” a question we of course will not attempt to answer. Nevertheless, we note that during a session of the Harmonized System Review Sub-Committee (“RSC”) discussing possible amendments to the Nomenclature with regard to human body parts such as organs and tissues, the Secretariat rightly noted that “given that there is no specific heading which covers [human body parts such as organs and tissues], heading 05.11, the first part of which reads ‘animal products not elsewhere specified or included’, merits consideration.” In exploring the issue, the Secretariat noted that under the EN 30.01 human body parts such as bone, organs, and other human or animal tissues that are suitable for permanent grafting or implantation are classifiable in heading 30.01, because such uses are rightly considered “therapeutic or prophylactic.” However, “cadavers and other human body parts, including those intended for medical studies . . . , would appear to be classifiable in heading 05.11.” The implication from the Secretariat’s reasoning is that human tissue samples and similar human by-products that are not prepared for veritably therapeutic or prophylactic uses such as implantation or grafting are classifiable in heading 0511, HTSUS, rather than heading 3001, HTSUS.
Further to the point, there is clear precedence in our past rulings for classifying human tissue samples and other human by-products within chapter 5, heading 0511, HTSUS. For example, in NY 887293, dated June 29, 1993, and in NY H82224, dated June 28, 2001, we classified human embryos that were frozen and shipped to the United States in heading 0511, HTSUS. In NY R03056, dated February 1, 2006, we classified human prostrate, bladder, and gastrointestinal tract tissue specimens, imported in formalin or in an alcohol-based fixative, which were intended for diagnostic analysis only—and not for therapeutic or prophylactic uses such as the development of new drugs—in heading 0511, HTSUS. Similarly, in NY N003566, dated December 14, 2006, we classified human dental pulp cells in vials and human colon carcinoma tissue arrays in paraffin-embedded blocks, which were used solely for non-clinical research, in heading 0511, HTSUS. Moreover, in NY N133477, dated December 13, 2010, we classified samples of human fecal matter imported for laboratory testing in heading 0511, HTSUS, while in NY N284008, dated March 28, 2017, we also classified human placenta tissue specimens used in non-clinical research in heading 0511, HTSUS.
In support of your positions, you cite to NY R03338, dated March 13, 2006, NY C80101, dated October 3, 1997, and NY 870664, dated February 12, 1992. We intend to propose to revoke NY R03338, NY C80101 and NY 870664 in an upcoming edition of the Customs Bulletin under our file number Headquarters Ruling Letter (“HQ”) H317142. We invite you to comment on that proposed revocation upon publication.
Based on the foregoing, we affirm classification of the human tissue samples in NY N287866 were properly classified in subheading 0511.99.4070, HTSUSA, as “Animal products not elsewhere specified or included; dead animals of chapter 1 or 3, unfit for human consumption: Other: Other: Other…Other.”
Sincerely,
for
Craig T. Clark, Director
Commercial and Trade Facilitation Division