HQ H250457
CLA–2 OT:RR:CTF:TCM H250457 LOR
Mr. Richard D’Innocenzo
International Trade Compliance Manger
Genzyme Corporation
500 Kendall Street
Cambridge, MA 02142
RE: Revocation of New York Ruling Letter L80355; classification of Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] Sterile Lyophilized Preparation, imported from France
Dear Mr. D’Innocenzo,
This is in regard to New York Ruling Letter (NY) L80355, dated October 28, 2004, regarding the classification under the Harmonized Tariff Schedule of the United States (HTSUS) of Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] Sterile Lyophilized Preparation (“Thymoglobulin”). In NY L80355, U.S. Customs and Border Protection (CBP) classified the product, under heading 3004, HTSUS, as medicaments. We have determined that NY L80355 is in error because the merchandise at issue is specifically provided for in heading 3002, HTSUS, and is therefore, excluded from classification in heading 3004, HTSUS. Therefore, this ruling revokes NY L80355.
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 (Customs Modernization) of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057), ), a notice was published in the CUSTOMS BULLETIN, Vol. 49, No. 17, on April 29, 2015, proposing to revoke New York Ruling Letter (NY) L80355, dated October 28, 2004, and any treatment accorded to substantially identical transactions. No comments were received in response to this notice
FACTS:
NY L80355 described Thymoglogulin® as follows:
[T]hymoglobulin® [Anti-thymocyte Globulin (Rabbit)] Sterile Lyophilized Preparation, is a medicament, for intravenous administration, put up in a package containing two 7 mL vials. Vial 1 contains a sterile, freeze-dried powder consisting of Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] (the active ingredient) mixed with several excipients. Vial 2 contains sterile water for injection (the diluent), which is used to reconstitute the freeze-dried powder in Vial 1. Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)], is a purified, pasteurized, gamma immune globulin, obtained by immunization of rabbits with human thymocytes, containing cytotoxic antibodies directed against antigens expressed on human T-lymphocytes. Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] is indicated for the treatment of renal transplant acute rejection, in conjunction with concomitant immunosuppression.
The CBP Laboratory and Scientific Services Department (LSSD) report #NY20132148, dated November 15, 2013, states in pertinent part, the following:
The product is a mixture of immunoglobulins derived from a rabbit antiserum. It is consistent with the definitions provided in the EN for serum globulins, blood fractions, and immunological products.
NY L80355 classified Thymoglobulin® under subheading 3004.90.9115, HTSUS (Annotated), which provides for “Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings: Other: Antineoplastic and immunosuppressive medicaments.”
ISSUE:
Are the subject modified immunological products, imported in single-dosage vial form, properly classified under heading 3002, HTSUS, as “modified immunological products,” or heading 3004, HTSUS, as “medicaments … put up in measured dose or in forms or packings for retail sale: Other: Other?
LAW AND ANALYSIS:
Classification of goods under the HTSUS is governed by the General Rules of Interpretation (GRI). GRI 1 provides that classification 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 may then be applied.
The HTSUS provisions at issue are as follows:
3002 Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products:
3002.10.02 Antisera, other blood fractions and immunological products, whether or not obtained by means of biotechnological processes:
***
3004 Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale:
3004.90 Other:
3004.90.91 Other
Note 2 to Chapter 30, HTSUS (2002), states: “For the purposes of heading 3002, the expression ‘modified immunological products’ applies only to monoclonal antibodies (MABs), antibody fragments, antibody conjugates and antibody fragment conjugates.”
The Harmonized Commodity Description and Coding System Explanatory Notes (EN) constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the EN provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of the headings. It is CBP’s practice to consult, whenever possible, the terms of the ENs when interpreting the HTSUS. See T.D. 89–80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
In 2004, the EN to Heading 30.02 stated, in pertinent part:
This heading covers:
***
(C) Antisera and other blood fractions and modified immunological products.
These products include:
***
(2) Modified immunological products, whether or not obtained by means of biotechnological processes. [Emphasis in original]
Products whose antigen-antibody reaction corresponds to natural antisera and which are used for diagnostic or therapeutic purposes and for immunological tests are to be regarded as falling within this product group. They can be defined as follows:
Monoclonal antibodies (MABs) - specific immunoglobulins from selected and cloned hybridoma cells cultured in a culture medium or ascites.
Antibody fragments – parts of an antibody protein obtained by means of specific enzymatic splitting.
Antibody and antibody fragment conjugates - enzymes (e.g. alkaline phosphatase, peroxidase or betagalactosidase) or dyes (fluorescin) covalently bound to the protein structure are used for straightforward detection reactions.
* * *
The products of this heading remain classified here whether or not in measured doses or put up for retail sale and whether in bulk or in small packings.
Ruling NY L80355 classified Thymoglobulin® under heading 3004, HTSUS. However, the terms of this heading specifically excludes goods which can be classified under heading 3002, HTSUS. Therefore, if the subject merchandise can be properly classified under heading 3002, HTSUS, imported either in bulk or single-dose vials, it is precluded from classification under heading 3004, HTSUS.
Thymoglobulin® is a purified, pasteurized, gamma immune globulin. Based upon the literature provided during the U.S. Food and Drug Administration screening process, the product, which is obtained by the immunization of rabbits with human thymocytes, contains cytotoxic antibodies directed against antigens expressed on human T-lymphocytes. Human red blood cells are used in the manufacturing process to deplete cross-reactive antibodies to non-T-cell antigens. The product induces immune-suppression as a result of T-cell depletion and immune modulation in renal transplant patients. The imported good consists of one package containing two 7mL vials; with Vial 1 consisting of Freeze-dried Thymoglobulin Formulation and Vial 2 consisting of Diluent (sterile water for Injection), which are combined prior to injection. The reconstituted preparation contains 5 mg/mL of Thymoglobulin, of which 90% is rabbit gamma immune globulin.
Thymoglobulin® is an immunological product obtained from a biotechnical process (the immunization of rabbits with human thymocytes). It contains monoclonal antibodies (MABs), which are produced by the body’s immune system for the function of recognizing, binding, and subsequently destroying infectious agents that display foreign antigens. MABs are used therapeutically to stimulate the immune system. Whereas MABs are specifically provided for in Note 2 to Chapter 3002, HTSUS, and Thymoglobulin® provides for the treatment of renal transplant acute rejection in conjunction with concomitant immune-suppression, Thymoglobulin® is classified in heading 3002, HTSUS. It is excluded from classification in heading 3004, HTSUS.
Clarifications were made to the ENs of Heading 30.02 in 2007 and 2012, as well as to Note 2 to Chapter 30 in 2012.
EN 30.02(C)(2)(a) now reads, in pertinent part:
This heading covers:
***
(C) Antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes.
These products include:
(2) Immunological products, whether or not modified or obtained by means of biotechnological processes.
Products used for diagnostic or therapeutic purposes and for immunological tests are to be regarded as falling within this product group. They can be defined as follows:
Monoclonal antibodies (MAB) – specific immunoglobulins from selected and cloned hybridoma cells cultured in a culture medium or ascites.
Antibody fragments –active parts of an antibody protein obtained by means of e.g., specific enzymatic splitting. This group includes inter alia single-chain (scFv) antibodies.
Antibody conjugates and antibody fragment conjugates – conjugates which contain at least one antibody or an antibody fragment…
***
Note 2 to Chapter 30 now reads:
For the purposes of heading 3002, the expression “immunological products” applies to peptides and proteins (other than goods of heading 2937) which are directly involved in the regulation of immunological processes, such as monoclonal antibodies (MAB), antibody fragments, antibody conjugates and antibody fragment conjugates, interleukens, interferons (IFN), chemokines and certain tumor necrosis factors (TNF), growth factors (GF), hematopoietins and colony stimulating factors (CSF).
In 2002, as today, “modified immunological products” with regard specifically to immunological products, including MABs and antibody fragment conjugates (an antibody combined with a protein), are included in heading 3002, HTSUS.
Based on the foregoing, Thymoglobulin® is properly classified under heading 3002, HTSUS. It is excluded from classification under heading 3004, HTSUS.
Thymoglobulin® is specifically provided for under subheading 3002.10.02, HTSUS, which provides for: “Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Antisera, other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes”.
HOLDING:
By application of GRI 1, the subject merchandise is classified in subheading 3002.10.02, HTSUS, which provides for “… modified immunological products, whether or not obtained by means of biotechnological processes …: Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes”. The column one, general rate of duty is free.
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 on the World Wide Web at www.usitc.gov
EFFECT ON OTHER RULINGS:
New York Ruling Letter L80355, dated October 28, 2004, is REVOKED.
In accordance with 19 U.S.C. 1625(c), this ruling will become effective 60 days after publication in the CUSTOMS BULLETIN.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division