OT:RR:CTF:CPMMA H317142 RRB

Mr. Justin McCreary
EMD Biosciences, Inc.
10394 Pacific Center Court
San Diego, CA 92121

RE: Revocation of NY R03338, NY N283432; NY C80101, NY B80750, and NY B82258; Modification of NY 870664 and NY R03056; tariff classification of human tissue samples and other human bodily specimens not prepared for therapeutic or prophylactic uses

Dear Mr. McCreary:

This letter is in reference to New York Ruling Letter ("NY") R03338, dated March 13, 2006, regarding the classification of human tissue samples under the Harmonized Tariff Schedule of the United States ("HTSUS"). In NY R03338, U.S. Customs and Border Protection ("CBP") classified human tissue samples, specifically breast invasive ductal carcinoma sections, in subheading 9705.00.0090, HTSUSA ("Annotated") (2006), as "Collections and collectors' pieces of zoological, botanical, mineralogical, anatomical, historical, archeological, paleontological, ethnographic or numismatic interest: Other." After reviewing the ruling in its entirety, we find it to be in error. For the reasons set forth below, we are revoking NY R03338.

In NY C80101, dated October 3, 1997; NY B80750, dated January 16, 1997; and NY B82258, dated March 3, 1997, CBP classified certain human tissue samples and other bodily specimens not prepared for therapeutic or prophylactic uses under subheading 3001.90.00, HTSUS, as "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." In NY N283432, dated March 15, 2017, CBP classified human urine samples not prepared for therapeutic or prophylactic uses in subheading 3825.90.00, HTSUS, as "Residual products of the chemical or allied industries, not elsewhere specified or included; municipal waste; sewage sludge; other wastes specified in note 6 to this chapter: Other." For the reasons set forth below, we are also revoking NY C80101, NY B80750, NY B82258, and NY N283432.

Similarly, in NY 870664, dated February 12, 1992, CBP classified human tissue and human urine specimens not prepared for therapeutic or prophylactic uses in subheading 3001.90.00, HTSUS, as "[g]lands 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." In NY R03056, dated February 1, 2006, CBP classified human urine samples in subheading 3825.90.00, HTSUS. After reviewing NY 870664 in its entirety, we find it to be partially in error with respect to the classification of the human tissue and human urine specimens. We also find NY R03056 to be partially in error with respect to the classification of human urine samples. For the reasons set forth below, we hereby modify NY 870664 with respect to the classification of the human tissue and human urine specimens. We also hereby modify NY R03056 with respect to the classification of the human urine samples. The remaining analyses of NY 870664 and NY R03056 remain unchanged.

Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C. 1625(c)(1)), as amended by section 623 of Title VI, notice proposing to revoke NY R03338, NY N283432, NY C80101, NY B80750, and NY B82258; and to modify NY 870664 and NY R03056 was published on December 13, 2023, in Volume 57, No. 46 of the Customs Bulletin. One comment was received in response to this notice and is addressed below.

FACTS:

In NY R03338, CBP described the subject merchandise as follows:

The articles under consideration are Breast Invasive Ductal Carcinoma Sections (paraffin tissue section slides) to be imported from Abcam PLC. Abcam's and EMD's equivalent product names and item codes for the specific quantity sizes are as follows:

Abcam: ab4697, Breast tumor (human): ductal carcinoma (invasive) tissue slides, 5 slides, 5 grams

EMD: 70332, Human Breast Invasive Ductal Carcinoma Sections, 5 slides, 5 grams.

Paraffin tissue sections are ideal for rapidly identifying cellular localization of RNA or protein. The tissues were excised, immediately fixed by formalin, and then pathologically identified. Each slide contains tissue from a single human tumor. A single tissue section with 5 microns thickness is mounted on a positively charged glass slide.

The paraffin tissue section slides will be sold in packages containing 5 slides each. The tissue slides are to be used for in vitro laboratory research only. Using these tissue slides scientists can further study the mechanisms by which cancer develops and proliferates.

In NY N283432, an entity known as the "US Anti-Doping Agency" asked for a ruling on the classification of human urine samples collected from athletes from Brazil for testing purposes.

In NY C80101, CBP described the subject merchandise as follows:

The subject product consists of human cancerous tumor tissue, which, you indicate, will be imported by your client for use in the development of a new, in-vitro, testing procedure in order to determine the most effective treatment for a particular patient.

In NY B80750, CBP described the subject merchandise as follows:

The subject product you wish to import consists of frozen, human fecal specimens containing or suspected of containing parasites, including: Entamoeba histolytica, Giardia lambia, Cryptosporidium parvum, and various helminths. According to your letter, these specimens will be used in the development of diagnostic tests to detect the presence of the aforementioned organisms.

In NY B82258, CBP described the subject merchandise as follows:

According to your letter, the subject product consists of extracted human teeth, preserved in formaldehyde, to be used for dental research purposes.

In NY 870664, CBP described the subject merchandise as follows:

The specific items in question which you wish to import are as follows: specimens of human blood and urine, and tissue specimens of human skin biopsies, intestine and lung. You state that these items are for analysis only, and that a report on the chemical, biochemical or microscopic examination will be generated and reported to the requesting party in the country of origin.

In NY R03056, CBP described the subject merchandise as follows:

The specific items in question consist of human. . . urine samples from real patients that will be imported for diagnostic analysis only.

ISSUE:

Whether various human tissue samples, human fecal specimens, extracted human teeth, human urine specimens and other human bodily specimens not prepared for therapeutic or prophylactic uses are classified in heading 0507, HTSUS, as "ivory.... unworked or simply prepared but not cut to shape," in heading 0511, HTSUS, as "animal products not elsewhere specified or included," in heading 3001, HTSUS, as "other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included," in heading 3825, HTSUS, as "residual products of the chemical or allied industries, not elsewhere specified or included; municipal waste; sewage sludge; other wastes specified in note 6 to this chapter," or in heading 9705, HTSUS, as "collections and collectors' pieces of zoological, botanical, mineralogical, anatomical, historical, archeological, paleontological, ethnographic or numismatic interest."

LAW AND ANALYSIS:

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.

The 2024 HTSUS headings under consideration are as follows:

0507 Ivory, tortoise-shell, whalebone and whalebone hair, horns, antlers, hooves, nails, claws and beaks, unworked or simply prepared but not cut to shape; powder and waste of these products:

0511 Animal products not elsewhere specified or included; dead animals of chapter 1 or 3, unfit for human consumption:

3001 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:

3825 Residual products of the chemical or allied industries, not elsewhere specified or included; municipal waste; sewage sludge; other wastes specified in note 6 to this chapter:

9705 Collections and collectors' pieces of zoological, botanical, mineralogical, anatomical, historical, archeological, paleontological, ethnographic or numismatic interest:

* * * *

Note 4 to chapter 38, HTSUS, defines "municipal waste" throughout the tariff schedule as follows:

[W]aste of a kind collected from households, hotels, restaurants, hospitals, shops offices, etc., road and pavement sweepings, as well as construction and demolition waste. Municipal waste generally contains a large variety of materials. Municipal waste generally contains a large variety of materials such as plastics, rubber, wood, paper, textiles, glass, metals, food materials, broken furniture and other damaged or discarded articles. The term "municipal waste," does not cover: ... (d) Clinical waste as defined in note 6(a), below.

Note 5 to chapter 38, HTSUS, defines "sewage sludge," for purposes of heading 3825, HTSUS, as follows:

[S]ludge arising from urban effluent treatment plants and includes pre-treatment waste, scourings and unstabilized sludge.

Under note 6 to chapter 38, HTSUS, the expression "other wastes" for purposes of headings 3825, HTSUS, applies to:

a) Clinical waste, that is, contaminated waste arising from medical research, diagnosis, treatment or other medical, surgical, dental or veterinary procedures, which often contain pathogens and pharmaceutical substances and require special disposal procedures (for example, soiled dressings, used gloves and used syringes);

...

(d) Other wastes from chemical or allied industries.

The Explanatory Notes ("ENs") to the Harmonized Commodity Description and Coding System represent the official interpretation of the tariff at the international level. While neither legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of these headings at the international level. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (Aug. 23, 1989).

The EN 38.25 states, in pertinent part, the following:

(D) OTHER WASTES SPECIFIED IN NOTE 6 TO THIS CHAPTER

The heading also covers a wide variety of other wastes specified in Note (6) to this Chapter. They include :

1) Clinical waste which is contaminated waste arising from medical research, diagnosis, treatment or other medical, surgical, dental or veterinary procedures. Such waste often contains pathogens, pharmaceutical substances and body fluids and request special disposal procedures (e.g., soiled dressings, used gloves and used syringes). ...

4) Other wastes from the chemical or allied industries. This group includes, inter alia, wastes from the production, formulation and use of inks, dyes, pigments, paints, lacquers and varnishes, other than municipal waste and waste organic solvents.

The EN 97.05 states, in pertinent part, the following:

These articles are very often of little intrinsic value but derive their interest from their rarity, their grouping or their presentation....

A) Collections and collectors' pieces of zoological, botanical, mineralogical or anatomical interest, such as;

1) Dead animals of any species preserved dry or in liquid; stuffed animal for collections.

2) Blown or sucked eggs; insects in boxes, frames, etc. (other than mounted articles constituting imitation jewellery or trinkets); empty shells, other than those of a kind suitable for industrial use.

3) Seeds or plants, dried or preserved in liquid; herbariums.

4) Specimens of mineral (not being precious or semi-precious stones falling in Chapter 71); specimens of petrification.

5) Osteological specimens (skeletons, skulls, bones).

6) Anatomical and pathological specimens.

* * * *

The articles in NY R03338, NY C80101, NY B80750, and NY B82258, and some of the articles in NY 870664 and NY R03056 consist of various types of human tissue samples, such as breast invasive ductal carcinoma sections, human cancerous tumor tissue, and tissue specimens of human skin biopsies, intestines and lung; human fecal specimens; and extracted human teeth. The articles in NY N238432, and some of the merchandise in NY 870664 and NY R03056 consist of human urine samples. The human tissue specimens in NY C80101, NY B80750, NY B82258, and NY 870664, and the human urine specimens in NY 870664 were classified in heading 3001, HTSUS, as "[o]ther human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included." The human tissue specimens in NY R03338 were classified in heading 9705, HTSUS, as "[c]ollections and collectors' pieces of zoological, botanical, mineralogical, anatomical, historical, archeological, paleontological, ethnographic or numismatic interest."

Subheading 0511.99.40, HTSUS, which covers "[a]nimal products not elsewhere specified or included; ... [o]ther: [o]ther: [o]ther..." is a "basket provision," as indicated by the terms "not elsewhere specified or included." Similarly, subheading 3001.90.01, HTSUS, which covers "[o]ther human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included: [o]ther" is also "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, heading 9705, HTSUS, specifically provides for "[c]ollections and collectors' pieces of ... anatomical interest." Therefore, we will first address whether the subject human tissue samples are more specifically classifiable under heading 9705, HTSUS."

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, CBP have classified items such as natural fossils,[1] stuffed animals and animal heads,[2] and mounted animal heads[3] 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 their rarity and are displayed as collectors' pieces, the human tissue samples, and other bodily specimens in NY R03338, NY C80101, NY B80750, NY B82258, and NY 870664 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 and other bodily specimens in NY R03338, NY C80101, NY B80750, NY B82258, and NY 870664 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 R03338 were improperly classified in heading 9705, HTSUS. Similarly, none of the human tissue samples and other bodily specimens in NY C80101, NY B80750, NY B82258, and NY 870664 are classifiable in heading 9705, HTSUS.

Turning to heading 3001, HTSUS, we note that 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".[4] See also Headquarters Ruling Letter ("HQ") H095405, dated June 15, 2010.

Based on the above definitions, we find that the human tissue samples and other human bodily specimens, including human fecal specimens, extracted human teeth, and human urine samples, in NY C80101, NY B80750, NY 870664, and NY B82258 were wrongly classified in heading 3001, HTSUS, which is limited to human substances that are prepared for therapeutic or prophylactic uses. The human cancerous tumor tissue samples in NY C80101 are utilized for the development of in vitro diagnostic testing procedures for determining the most effective treatment for a particular patient. The human fecal specimens containing or suspected of containing parasites in NY B80750 will be used in the development of diagnostic tests to detect the presence of such parasites. The extracted human teeth, preserved in formaldehyde, in NY B82258, will be used for dental research purposes. The human urine samples in NY 870664 are used for laboratory analysis purposes only. Nowhere in the definition of therapeutic or prophylactic is use for dental research or in vitro laboratory research for purposes such as developing diagnostic tests to help determine effective treatment at a future, indefinite time included. Therefore, the human tissue samples and other human bodily specimens in NY C80101, NY B80750, NY 870664, and NY B82258 are not prepared for therapeutic or prophylactic uses and are thus, precluded from classification in heading 3001, HTSUS. Likewise, none of the other human tissue samples and other human bodily specimens in the rulings at issue here, including those in NY R03338, NY R03056 and NY N283432, are prepared for therapeutic or prophylactic uses, and are also precluded from classification in heading 3001, HTSUS. Moreover, CBP recently affirmed in HQ H304055, dated March 31, 2021, that human tissue samples utilized for the development of in vitro diagnostic tests are precluded from classification in heading 3001, HTSUS, and are more appropriately classified in heading 0511, HTSUS. Much of our analysis in that ruling applies here.

Heading 3825, HTSUS, covers "[r]esidual products of the chemical or allied industries, not elsewhere specified or included; municipal waste; sewage sludge; other wastes specified in note 6 to this chapter." In NY N283432 and NY R03056, the human urine samples were specifically classified in subheading 3825.90, HTSUS, as "[r]esidual products of the chemical or allied industries" other than "municipal waste" (subheading 3825.10), "sewage sludge" (subheading 3825.20), "clinical waste" (3825.30), "waste organic solvents" (subheadings 3825.41 and 3825.49), "wastes of metal-pickling liquors, hydraulic fluids, brake fluids and anti-free fluids" (subheading 3825.50), "other wastes from the chemical or allied industries" (subheadings 3825.61 and 3825.69).

Notes 4, 5, and 6 to chapter 38 define the terms "municipal waste," "sewage sludge," and "other wastes" in heading 3825, HTSUS, but do not provide guidance as to what is meant by "residual products." Note 4 to chapter 38 describes municipal waste as the type of waste that is "collected from households, hotels, restaurants, hospitals, shops offices, etc., road and pavement sweepings, as well as construction and demolition waste. . .[and] generally contains a large variety of materials such as plastics, rubber, wood, paper, textiles, glass, metals, food materials, broken furniture and other damaged or discarded articles." Note 5 defines "sewage sludge" as "[s]ludge arising from urban effluent treatment plants." Note 6 states that "other wastes" applies to "[c]linical waste, that is, contaminated waste arising from medical research, diagnosis, treatment or other medical, surgical, dental or veterinary procedures, which often contain pathogens and pharmaceutical substances and require special disposal procedures (for example, soiled dressings, used gloves and used syringes)." Pursuant to EN 38.25, the phrase "other wastes from the chemical or allied industries. . . includes, inter alia, wastes from the production, formulation and use of inks, dyes, pigments, paints, lacquers and varnishes, other than municipal or waste organic solvents."

First, we note that the human urine specimens in N283432 and NY R03056, which were classified in heading 3825, HTSUS, bear no resemblance to the exemplars of municipal and sewage waste in notes 4 and 5 to chapter 38, HTSUS. The exemplars of "other wastes from the chemical or allied industries" in EN 38.25 refer to by-products of industrial production processes rather than bodily specimens such as human urine samples. Clinical waste as defined in note 6 to chapter 38 and EN 38.25 is also inapplicable to the human urine samples at issue. These urine samples are not discarded waste as a result of medical research, diagnosis, treatment, or other medical procedures. Rather, the specimens in N283432 and NY R03056, as well as those in NY 870664, are being imported for diagnostic and testing purposes to be performed after importation. They do not potentially become waste until after importation once testing has been completed. Heading 3825, HTSUS, on the other hand, describes materials that are imported as waste, following the performance of any testing procedures prior to importation.

The term "residual product" is not statutorily defined in the HTSUS. In 2001, Presidential Proclamation 7515, issued pursuant to the Omnibus Trade and Competitive Act of 1988, created heading 3825, HTSUS, to cover environmentally sensitive and hazardous waste products. See HQ H018547, dated December 12, 2007. In HQ 967288, dated March 10, 2005, we noted that chapter 38 was suggested by the United States to track certain environmentally sensitive substances important to international trade. The importation of human urine specimens for testing and diagnostic analysis to be completed post-importation does not involve environmentally sensitive substances important to international trade for purposes of heading 3825, HTSUS.

In sum, based on the legal notes to chapter 38, EN 38.25, and the legislative history of heading 3825, HTSUS, we find that human urine samples imported for testing and diagnostic analysis post-importation are precluded from classification in heading 3825, HTSUS.

Having excluded the subject human tissue samples, human urine samples and other human bodily specimens from classification in headings 9705, 3001, and 3825, HTSUS, we turn to heading 0511, HTSUS. As we noted in HQ H304055, the term "human" is not defined in chapter 5 of the HTSUS, nor is it defined elsewhere in the Nomenclature or the ENs. The EN 05.11(1)-(14) identifies examples of products covered under this heading, which are derived from animals. Nowhere in the EN is there reference to products derived from human tissue. In HQ H304055, dated March 31, 2021, CBP noted that 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."

Furthermore, there is clear precedence in CBP's past rulings for classifying human tissue samples and other human bodily specimens within chapter 5, heading 0511, HTSUS. For example, in NY 887293, dated June 29, 1993, and in NY H82224, dated June 28, 2001, CBP classified human embryos that were frozen and shipped to the United States in heading 0511, HTSUS. In NY R03056, dated February 1, 2006, CBP 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, CBP 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, CBP classified samples of human fecal matter imported for laboratory testing in heading 0511, HTSUS, while in NY N284008, dated March 28, 2017, CBP also classified human placenta tissue specimens used in non-clinical research in heading 0511, HTSUS.

Based on the foregoing, we find that the human tissue samples and other human bodily specimens, including human fecal specimens, and human urine samples not prepared for therapeutic or prophylactic uses are properly classified in subheading 0511.99.4070, HTSUSA, as "[a]nimal products not elsewhere specified or included; dead animals of chapter 1 or 3, unfit for human consumption: [o]ther: [o]ther: [o]ther...[o]ther.

As noted above, we received one comment in response to the notice of the proposed revocation of NY B82258 concerning the classification of extracted human teeth, preserved in formaldehyde, to be used for dental research purposes. While the commenter agrees that the human tissue samples and other human bodily specimens covered by the proposed ruling are properly classified in subheading 0511.99.0470, HTSUSA, they disagree with respect to the classification of the human teeth in NY B82258. The commenter cites to note 3 to chapter 5 of the HTSUS, which states that '[t]hroughout the tariff schedule, elephant, hippopotamus, walrus, narwhal and wild boar tusks, rhinoceros horns and the teeth of all animals are regarded as "ivory." As such, the human teeth described in NY B82258 fall within this scope as "teeth of all animals." Accordingly, the commenter asserts that the human teeth in NY B82258 are properly classified as ivory in subheading 0507.10.0000, HTSUSA.

While there is clear precedence for classification of human tissue samples and other human bodily specimens in chapter 5 of the tariff of the schedule, classification of extracted human teeth is a matter of first impression. The ENs to 05.07 state that "[t]his heading covers the products described below, unworked or simply prepared but not cut to shape, i.e., not having undergone processes extending beyond rasping, scraping, cleaning, removal of superfluous parts, trimming, splitting, cutting other than to shape, rough planing, straightening or flattening." While the human teeth in NY B82258 were prepared in formaldehyde, such preservation does not rise above the level of "simply prepared" as stated in the EN, and therefore, would not preclude classification of the human teeth in heading 0507, HTSUS. Moreover, heading 0511, HTSUS, which describes "animal products not elsewhere specific or included," is a basket provision in which classification is only appropriate if there is no tariff category that covers the human teeth more specifically. Not only is heading 0507 anterior to heading 0511 in the tariff schedule, but pursuant to note 3 to chapter 5, it also describes the human teeth more specifically as ivory. Accordingly, we find that the human teeth described in NY B82258 are properly classified in subheading 0507.10.0000, HTSUSA, as "ivory."

HOLDING:

By application of GRIs 1 and 6, the human tissue samples, human fecal specimens, , human urine specimens and other human bodily specimens, except for extracted human teeth, not prepared for therapeutic or prophylactic uses are classified in heading 0511, HTSUS, specifically under subheading 0511.99.4070, HTSUSA, which provides for "[a]nimal products not elsewhere specified or included; dead animals of chapter 1 or 3, unfit for human consumption: [o]ther: [o]ther: [o]ther...[o]ther." The 2024 column one, general rate of duty is 1.1% ad valorem.

By application of GRIs 1 and 6, the extracted human teeth, not prepared for therapeutic or prophylactic uses are classified in heading 0507, HTSUS, specifically under subheading 0507.10.0000, HTSUSA, which provides for "[i]vory, tortoise-shell, whalebone and whalebone hair, horns, antlers, hooves, nails, claws and beaks, unworked or simply prepared but not cut to shape; powder and waste of these products: [i]vory; ivory powder and waste." The 2024 column one, general rate of duty is Free.

EFFECT ON OTHER RULINGS:

NY R03338, dated March 13, 2006; NY C80101, dated October 3, 1997; NY B80750, dated January 16, 1997; and NY B82258, dated March 3, 1997; and NY N283432, dated March 15, 2017, are hereby revoked.

NY 870664, dated February 12, 1992, is hereby modified with respect to the classification of the human urine specimens and human tissue specimens only. NY R03056, dated February 1, 2006, is hereby modified with respect to the classification of the human urine samples only.

This ruling will become effective 60 days from the date of publication in the Customs Bulletin.
Sincerely,

Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division


Cc: Bruce H. Chiu, Esq. Mr. Pablo Fel
Cohen & Grigsby, P.C. Prost - Data Inc.
2900 CNG Tower 1854 Airline Drive (Suite 17A)
625 Liberty Avenue Nashville, TN 37210
Pittsburgh, PA 15222-3115

John F. Bruni, Ph.D.
Biosite Diagnostics
11030 Roselle Street
San Diego, CA 92121

Donna R. Harvey, Esq.
2633 Lincoln Boulevard, No. 131
Santa Monica, CA 90405

Mr. Logan Jett
U.S. Anti-Doping Agency
555 Tch Center Drive, Suite 200
Colorado Springs, CO 80919

Mr. Michael T. Grady
Tampa Pathology Laboratory
6515 North Armenia Avenue
Tampa, FL 33604

-----------------------
[1] In NY N004185, dated December 26, 2006, CBP classified natural fossils from Morocco in subheading 9705.00.0090, HTSUSA.
[2] In NY G81800, dated September 8, 2000, CBP classified stuffed animals and animal heads from Namibia, Zambia and South Africa in subheading 9705.00.0090, HTSUSA.
[3] In NY D88270, dated February 26, 1999, CBP classified mounted animal heads from South Africa in subheading 9705.00.0090, HTSUSA.
[4] MERRIAM-WEBSTER.COM, https://www.merriam-webster.com/dictionary/prophylactic?src=search-dict-box (last visited Feb. 1, 2021).