CLA-2 OT:RR:CTF:TCM H143115 CkG
TARIFF NO: 3002.90.51
Attn: Lawrence Mruk
U.S. Customs and Border Protection
Port of Buffalo
726 Exchange Street, Suite 400 Buffalo, NY 14210
RE: Internal Advice #11/005; classification of pneumococcal proteins
Dear Port Director:
This letter is in reply to your memorandum forwarding Request for Internal
Advice #11/005, dated January 3, 2011, initiated on behalf of Sanofi Pasteur, Inc. (SPI).
At issue is the classification by U.S. Customs and Border Protection (CBP) of three
pneumococcal proteins under the Harmonized Tariff Schedule of the United States
(HTSUS).
FACTS:
The products at issue are three intact protein molecules ranging from 40,000 to 95,000 daltons molecular weight. They are imported for use by SPI for analytical testing only. Two of the three proteins were copied from the natural proteins that occur on the surface of the Streptococcus Pneumonia bacterium, and were expressed separately by recombinant DNA in non-pathogenic E. Coli. The third protein was copied from a natural protein that exists inside the Streptococcus Pneumonia bacterium, genetically modified to reduce its toxicity, and was also expressed separately by recombinant DNA methods. All proteins were purified to over 95% by column chromatography. Prior to importation, the purified proteins are stabilized and buffered with the addition of water, sodium chloride, Tris buffer, Tween detergent, and sometimes alum adjuvant.
ISSUE:
Whether the subject preparations are classified in heading 3002, HTSUS, as “similar products” to vaccines, toxins, or cultures of microorganisms.
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 2 through 6 may then be applied in order.
The HTSUS provisions under consideration 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:
3002.90: Other:
3002.90.51: Other…
* * * * * *
3504: Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed:
3504.00.10: Protein isolates . . .
* * * * * *
Note 1 to Chapter 35 provides, in pertinent part, as follows:
This chapter does not cover:
(b) Blood fractions (other than blood albumin not prepared for therapeutic or prophylactic uses), medicaments or other products of chapter 30;
* * * * * *
The Harmonized Commodity Description and Coding System Explanatory
Notes (ENs), constitute the official interpretation of the Harmonized System 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 the headings. It is CBP’s practice to follow, whenever possible, the terms of the ENs when interpreting the HTSUS. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
EN 30.02 provides, in pertinent part, as follows:
This heading covers :
…
(D) Vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products.
These products include :
(1) Vaccines.
The most typical vaccines are prophylactic preparations of microbial origin containing either viruses or bacteria suspended in saline solutions, oil (lipovaccines) or other media. These preparations have usually been treated to reduce their toxicity without destroying their immunizing properties.
Other vaccines include recombinant vaccines, peptide vaccines and carbohydrate vaccines. These vaccines generally contain an antigen, a recognised part of an antigen or a gene coding for a recognised part of an antigen (peptides, recombinants or conjugates of protein and others). The “recognised part of an antigen” is the part of an antigen which triggers the immunological response in the organism. Many of these vaccines target a specific virus or bacterium. These vaccines are used for prophylactic or therapeutic purposes.
The heading also covers mixtures consisting of vaccines or toxoids (such as Diphtheria, Tetanus and Pertussis (DPT) vaccine).
EN 35.04 provides, in pertinent part:
This heading covers :
(B) Other protein substances and their derivatives, not covered by a more specific heading in the Nomenclature, including in particular :
(1) Glutelins and prolamins (e.g., gliadins extracted from wheat or rye, and zein extracted from maize), being cereal proteins.
(2) Globulins, e.g., lactoglobulins and ovoglobulins (but see exclusion (d) at the end of the Explanatory Note).
(3) Glycinin, the main soya protein.
(4) Keratins obtained from hair, nails, horns, hoofs, feathers, etc.
(5) Nucleoproteids, being proteins combined with nucleic acids, and their derivatives. Nucleoproteids are isolated, for example, from brewer’s yeast, and their salts (of iron, copper, mercury, etc.) are used mainly in pharmacy.
However, nucleoproteids of mercury answering to a description in heading 28.52 are excluded.
(6) Protein isolates obtained by extraction from a vegetable substance (e.g., defatted soya bean flour) and consisting of a mixture of proteins contained therein. The protein content of these isolates is generally not less than 90%.
…
* * * * * *
SPI claims classification in heading 3002, HTSUS, specifically subheading 3002.90.51, HTSUS, which provides for, inter alia, vaccines, toxins and cultures of microorganisms.
The instant products are not vaccines, toxins, or other products enumerated in the text of heading 3002, HTSUS. However, heading 3002, HTSUS, also provides for “similar products.” The term “similar products” in heading 3002 is present after the last semicolon separating the phrases of the heading; thus, it refers only to products similar to the items listed in that phrase: vaccines, toxins, and cultures of microorganisms.
A typical vaccine is a prophylactic preparation containing (or derived from) a virus of bacteria which has been treated to reduce its toxicity. Recombinant vaccines contain an antigen, or the recognized part of an antigen which triggers the body’s immunological response to the microorganism. The antigen or antigen fragment stimulates the body's immune system to recognize the targeted virus or bacteria as foreign, destroy it, and "remember" it, so that the immune system can more easily recognize and destroy any of these microorganisms that it later encounters. A recombinant subunit vaccine is created by isolating and copying (via recombinant expression) the antigen or antigen fragment of a micro-organism thought to create the immune response, without introducing any other viral particles. The subunit vaccine against the hepatitis B virus, for example, is composed of only the surface proteins of the virus, produced by recombination of the viral genes into yeast. Vaccines for influenza are also of this type. See http://en.wikipedia.org/wiki/Vaccine. Recombinant vaccines are classified in heading 3002, HTSUS. See NY D80776, dated August 18, 1998. See also EN 30.02.
The three protein molecules at issue are created in the same manner as a recombinant subunit vaccine; the proteins are copied from the targeted microorganism and expressed via recombinant DNA methodology. Additionally, the third protein at issue has been modified to reduce its toxicity. Counsel notes that the instant protein molecules are not in and of themselves antigens (i.e., they do not necessarily provoke an immune response). However, as potential antigenic building blocks, they are components of a new vaccine being developed against infant pneumonia. Finally, the importer is a company dedicated to the testing and production of human vaccines. Although the instant products are used for research/testing only, they are produced in a similar manner and composed of similar materials as vaccines, and are dedicated for use in experimental vaccines. Hence, we find that the proteins are similar products to recombinant vaccines of heading 3002, HTSUS, and are classified therein.
We have also considered the applicability of heading 3504, HTSUS, which provides for other protein substances, not covered by a more specific heading. However, while the instant products appear to meet the general description of “other protein substances”, we find that they are more specifically described in heading 3002, HTSUS, as similar products to vaccines, etc., at GRI 1. As they are covered by a more specific heading, classification in heading 3504, HTSUS, is precluded. Furthermore, Note 1(b) to Chapter 35 excludes products of Chapter 30 from classification in Chapter 35, HTSUS.
HOLDING:
The pneumococcal proteins imported by SPI are classified in heading 3002,
HTSUS, specifically subheading 3002.90.51, 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: Other: Other.” The 2011 column one, general
rate of duty is Free.
You are to mail this decision to the internal advice requester no later than 60
days from the date of the decision. At that time, the Office of International Trade,
Regulations and Rulings, will make the decision available to CBP personnel and to the
public on the CBP Home Page on the World Wide Web at www.cbp.gov, by means of
the Freedom of Information Act, and other methods of public distribution.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division