CLA–2 OT:RR:CTF:TCM H110420 AMM
Mr. Ron Reuben
Danzas AEI Customs Brokerage Services
5510 West 102nd Street
Los Angeles, CA 90045
RE: Modification of New York Ruling Letter K83509; classification of monoclonal antibody medicaments
Dear Mr. Reuben,
This is in regard to New York Ruling Letter (NY) K83509, dated March 12, 2004, regarding the classification under the Harmonized Tariff Schedule of the United States (HTSUS) of certain monoclonal antibody drug products. In NY K83509, Customs and Border Protection (CBP) classified the drug products Avastin™ (bevacizumab), and Herceptin® (trastuzumab) under heading 3004, HTSUS. We have reconsidered this ruling and have determined that these monoclonal antibody drug products are provided for in heading 3002, HTSUS.
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 modify NY K83509 was published on May 11, 2011, in Volume 45, Number 20, of the Customs Bulletin. CBP received no comments in response to this notice.
FACTS:
Avastin™ (bevacizumab) is a medicament containing Bevacizumab, a recombinant humanized monoclonal antibody to vascular endothelial growth factor (VEGF), as the active ingredient. It is indicated for the treatment of metastatic carcinoma of the colon or rectum. Avastin™ (bevacizumab) is supplied as a sterile solution in single-use glass vials.
Herceptin® (trastuzumab) is a medicament containing Trastuzumab, a recombinant DNA-derived humanized monoclonal antibody, as the active ingredient. It is indicated for the treatment of metastatic breast cancer. Herceptin® (trastuzumab) is supplied as a lyophilized, sterile powder in multi-dose vials. Each vial, in turn, is packaged with a vial of diluent in a paperboard box.
NY K83509 classified Avastin™ and Herceptin® under subheading 3004.90.91, HTSUS, which provides for: “Medicaments … 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: Other: Other”.
ISSUE:
Are the the subject monoclonal antibody medicaments properly classified under heading 3002, HTSUS, as “modified immunological products,” or under heading 3004, HTSUS, as “medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses?”
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 obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products:
3002.10.01 Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes:
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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 of Chapter 30, HTSUS, 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).
The EN to Heading 30.02 states, in pertinent part:
This heading covers:
* * *
(C) Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes. These products include:
* * *
(2) Modified immunological products, whether or not 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:
(a) Monoclonal antibodies (MABs) - specific immunoglobulins from selected and cloned hybridoma cells cultured in a culture medium or ascites.
* * *
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 K83509 classified the above-identified products under heading 3004, HTSUS. However, the heading specifically excludes goods which can be classified under heading 3002, HTSUS. Therefore, if the above-identified products can be properly classified under heading 3002 HTSUS, they are precluded from classification under heading 3004, HTSUS.
Both products, Avastin™ and Herceptin®, contain monoclonal antibodies as their active ingredient. Monoclonal antibodies (MAbs) are included within the definition of “modified immunological products”. See Note 2 to Chapter 30, HTSUS; EN 30.02(C)(2)(a). MAbs are used therapeutically to stimulate the immune system. Here, the MAbs are put up in measured doses for retail sale, but remain classified in heading 3002, HTSUS. See EN 30.02. Therefore, the above identified drug products are properly classified under heading 3002, HTSUS, and are excluded from classification under heading 3004, HTSUS. The products are specifically provided for under subheading 3002.10.01, 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 and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes”
HOLDING:
By application of GRI 1, the drug products Avastin™ and Herceptin® are properly classified under subheading 3002.10.01, 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 rate of duty is free. Duty rates are provided for your convenience and are subject to change.
EFFECT ON OTHER RULINGS:
New York Ruling Letter K83509, dated March 12, 2004, is hereby MODIFIED.
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