CLA-2-38:OT:RR:NC:N1:239
Ms. Deborah Stern
Sandler, Travis, and Rosenberg, P.A.
1000 NW 57th Court
Suite 600
Miami, FL 33126
RE: The tariff classification and country of origin for R1 (Salicylate-SL NADH Reagent) and R2 (Salicylate-SL Enzyme Reagent)
Dear Ms. Stern:
In your letter dated September 1, 2016, filed on behalf of Sekisui Diagnostics, LLC, you requested a ruling on the classification and country of origin of two reagents, R1 (Salicylate-SL NADH Reagent) and R2 (Salicylate-SL Enzyme Reagent) contained in your submission.
It is to be used in order to determine Salicylate in human serum or plasma utilizing a clinical chemical analyzer. These two reagents will be imported separately and in bulk.
The product, identified as R1, consists of Salicylate-SL NADH Reagent, a solution containing a buffer (pH 10.4 at 25°C), and 1.2 mmol/L NADH.
The applicable subheading for R1 imported in bulk will be in subheading 3824.90.9295, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Prepared binders for foundry molds or cores; chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included: Other: Other: Other: Other: Other: Other. The rate of duty will be 5 percent ad valorem.
The product, identified as R2, consists of a solution containing salicylate hydroxylase, a buffer, stabilizers and a preservative. It is used with R1 to test for the amount of salicylate in blood serum and plasma. The product has components of Dutch, Chinese, and American origin. These components are combined in Canada to yield R2.
The applicable subheading for R2 imported in bulk will be 3507.90.7000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Enzymes: prepared enzymes not specified or included: Other: Other.” The general rate of duty will be 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 World Wide Web at https://hts.usitc.gov/current.
COUNTRY OF ORIGIN
With regard to country of origin and marking of the R2 product, Section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article.
Part 134, Customs Regulations (19 CFR Part 134), implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Pursuant to 19 CFR Section 134.1(b), the country of origin is the country of manufacture, production or growth of any article of foreign origin entering the U.S. Further work or material added to a foreign article in the United States must effect a substantial transformation in order to render the final product a good of the U.S. However, for a good of a NAFTA country, the NAFTA Rules of Origin (set forth in 19 CFR Part 102) will determine the country of origin and marking. Because the R2 product is partly manufactured in a NAFTA country (United States), the NAFTA rules govern the current scenario.
19 CFR 102.11 states: The following rules shall apply for purposes of determining the country of origin of imported goods other than textile and apparel products covered by § 102.21:
(a) The country of origin of a good is the country in which:
(1) The good is wholly obtained or produced;
(2) The good is produced exclusively from domestic materials; or
(3) Each foreign material incorporated in that good undergoes an applicable change in tariff classification set out in §102.20 and satisfies any other applicable requirements of that section, and all other applicable requirements of these rules are satisfied.
(b) Except for a good that is specifically described in the Harmonized System as a set, or is classified as a set pursuant to General Rule of Interpretation 3, where the country of origin cannot be determined under paragraph (a) of this section:
(1) The country of origin of the good is the country or countries of origin of the single material that imparts the essential character to the good,
No country of origin determination can be made under 19CFR 102.11(a). The finished product is neither wholly obtained nor produced in a single country as provided under 19 CFR 102.11(a)(1), nor is the finished product produced exclusively from domestic materials as provided for in 19 CFR 102.11(a)(2). The product does not undergo the required tariff shift pursuant to 19 C.F.R. §102.11(a)(3) and 19 C.F.R. §102.20(d).
Since an analysis of section 102.11(a) does not yield a country of origin determination, the analysis turns to section 102.11(b) which focuses on an examination of the single material that imparts the essential character of the good to determine the country or countries of origin of the R2 product. Section 102.18(b)(1) of the regulations provides that only materials (domestic and foreign) that do not undergo a tariff shift are to be taken into consideration in determining the essential character of a good. We find that the salicylate hydroxylase imparts the essential character of the finished product. Therefore, the country of origin for marking purposes will be the United States. If a good is determined to be an article of U.S. origin, it is not subject to the country of origin marking requirements of 19 U.S.C. §1304.
In your September 1, 2016, ruling request, you state that the country of origin and marking of the R1 product, 3824.909295, is Canada.
The applicable rule for 3824.90 is: “A change to any other good of subheading 3824.71 through 3824.90 from any other subheading, including another subheading within that group, provided that no more than 60 percent by weight of the good classified in this subheading is attributable to one substance or compound.” You state: “Each of the three components of the reagent are separate chemically defined organic compounds, as each has its own CAS; each falls within Chapter 29 and each is of foreign origin. Thus, they come from different subheadings, and pursuant to the confidential component breakdown by percentages by weight provided in the FACTS section above, none comprise more than 60% by weight of the total water. Accordingly, we believe based on the application of this tariff shift rule that the country of origin for marking purposes is Canada.”
This office agrees and the country of origin for R1 is Canada.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Patrick Day at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division