CLA–2 OT:RR:CTF:TCM H207575 ERB
Mr. Herbert J. Lynch, Esp.
Sullivan & Lynch, P.C
56 Roland Street, Suite 303
Boston, MA 02129-1223
RE: Revocation of New York Ruling Letter J80522; classification of Amevive® (alefacept), Alefacept (CAS-222535-22-0), imported in bulk form and single-dose vials, from Germany
Dear Mr. Lynch,
This is in regard to New York Ruling Letter (NY) J80522, dated February 21, 2003, regarding the classification under the Harmonized Tariff Schedule of the United States (HTSUS) of Amevive® (alefacept). In NY J80522, Customs and Border Protection (CBP) classified the product in its bulk form under heading 3003, HTSUS, and in its single-dose vial form under heading 3004, HTSUS, as medicaments. We have reconsidered this ruling and have determined that these modified immunological products, in both forms, are provided for in heading 3002, HTSUS.
Pursuant to section 625(c), Tariff Act of 1930 (19 U.S.C. 1625(c)), 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), this notice advises interested parties that CBP is revoking a ruling concerning the classification of Amevive® (alefacept), under the HTSUS. Similarly, CBP is revoking any treatment previously accorded by CBP to substantially identical transactions. Notice of the proposed revocation was published on April 30, 2014, in Volume 48, Number 17, of the Customs Bulletin. No comments were received in opposition to the proposed notice.
FACTS:
NY J80522 described Amevive® as follows:
Amevive® (alefacept) is a formulated drug product containing Alefacept (CAS-222535-22-0), an antipsoriatic drug, as the active ingredient. It is a fusion protein (human) consisting of the portion of the LFA-3 molecule that binds to CD-2 antigen, linked to the Fc portion of human immunoglobulin G1. It is produced by recombinant DNA techniques, and is represented by the following empirical chemical formula: C3264H5002N840O988S20. Alefacept belongs to the class of drugs known as immunomodulators, and is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis.
NY J80522 classified Amevive® (alefacept), imported in bulk form under subheading 3003.90.000, HTSUS, which provides for “Medicaments…consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: Other.” NY J80522 also classified Amevive® (alefacept) imported as single-dose vials under subheading 3004.90.9145, HTSUS, which provides for “Medicaments…consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other: Dermatological agents and local anesthetics.”
ISSUE:
Are the subject modified immunological products, imported in bulk or single-dosage vial form, both properly classified under heading 3002, HTSUS, as “modified immunological products,” or separately under heading 3003, HTSUS, as “medicaments… not put up in measured does or in forms or packings for retail sale: Other” or heading 3004, HTSUS, as “medicaments … put up in measured dose or in forms or packings for retail sale: Other: Other: Dermatological agents and local anesthetics”?
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 GRI 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:
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3003 Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured does or in forms or packings for retail sale:
3003.90.00 Other
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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 2002, the EN to Heading 30.02 stated, in pertinent part:
This heading covers:
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(C) Antisera and other blood fractions and modified immunological products.
These products include:
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(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 J805229 classified Amevive® under heading 3003 and 3004, HTSUS, depending on whether it was imported in bulk form or in single-dose vials, respectively. However, the terms of these two headings specifically exclude 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 3003, HTSUS or 3004, HTSUS.
Amevive® is an antibody fragment conjugate, an antibody combined with a protein, a class of monoclonal antibodies (MABs) which is a type of immunomodulator. Antibody fragment conjugates and MABs are included within the definition of “modified immunological products”. See Note 2 to Chapter 30, HTSUS. They are produced by the body’s immune system for the function of recognizing, binding, and subsequently destroying infectious agents that display foreign antigens, in the instant case, severe chronic plaque psoriasis. The subject merchandise is imported in two forms, bulk and measured doses for retail sale, but the products remain classified in heading 3002, HTSUS, regardless. See 2002 EN 30.02 (C)(2)(a).
Clarifications have been 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:
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(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…
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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, include MABs and antibody fragment conjugates (an antibody combined with a protein), are included in heading 3002, HTSUS. The instant merchandise is just such a fusion protein as is noted in NY J80522. Additionally, the clause, “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 small packings,” was present in the 2002 version of the ENs, as it remains today.
Therefore, the subject merchandise is properly classified under heading 3002, HTSUS, and is excluded from classification under heading 3003 and 3004, HTSUS. The product 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 Amevive® 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 J80522, dated February 21, 2003, is REVOKED.
In accordance with 19 U.S.C. § 1625(c), this ruling will become effective 60 days after its publication in the Customs Bulletin.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division