CLA-2-35:OT:RR:NC:2:236
Mr. Charles Goodwin
Biolamina Inc.
432 Route 34, Unit 1A
Matawan, NJ 07747
RE: The tariff classification of laminin protein from Sweden
Dear Mr. Goodwin:
In your ruling request received January 27, 2014, you requested a tariff classification ruling on laminin protein.
You describe laminins as large trimeric proteins that contain an alpha-chain, beta-chain, and gamma-chain that can be found in five, three, and two genetic variants, respectively. You state that laminins support the survival and growth of different cells and cell lines. This product is delivered in a mixture of glycerol, and sodium azide. You state that based on OSHA standards, this product should not be considered hazardous. You state that the main application is for culturing pluripotent stem cells where the laminins are used as a matrix that mimics the natural environment for these cells in the petri dish. Your letter also indicates that this product is for research use only and should not be used for therapeutic applications and not for human or animal consumption. This product is imported in 12 mcg, 20 mcg, 60 mcg, or 100 mcg plastic vials and stored at or below -20 degrees Celsius.
The U.S. Customs and Border Protection Laboratory has reported that the product at issue undergoes no measureable or observable change in response to a physical, biophysical, or biochemical process or state in animals or humans.
In your letter you suggest classification under subheading 3822.00.5090 which provides for "Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents, whether or not on a backing, other than those of heading 30.02 or 30.06: Other: Other." We respectfully disagree. Pursuant to classification guidance provided by the Explanatory Notes to heading 38.22 "Diagnostic reagents are used in the evaluation of physical, biophysical or biochemical processes and states in animals and humans; their function is based upon a measurable or observable change in the biological or chemical substances constituting the reagent.” This office has determined that the product at issue does not meet the terms of heading 3822 and will be classified elsewhere.
The applicable subheading for laminin protein will be 3504.00.5000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed: Other. The general rate of duty will be 4 percent ad valorem.
This merchandise may be subject to The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which is administered by the Food and Drug Administration (FDA). Information concerning FDA import requirements and regulations can be obtained by contacting the FDA at: Food and Drug Administration, Division of Import Operations and Policy, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone: (888) 463-6332. Information on the Bioterrorism Act can be obtained by calling FDA at (301) 575-0156, or at the Web site www.fda.gov/oc/bioterrorism/bioact.html.
This merchandise may be subject to the requirements of the Toxic Substances Control Act (TSCA), which are administered by the U.S. Environmental Protection Agency. Information on the TSCA can be obtained by contacting the EPA at 1200 Pennsylvania Avenue, N.W., Mail Code 70480, Washington, D.C., by telephone at (202) 554-1404, or by visiting their website at www.epa.gov.
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 http://www.usitc.gov/tata/hts/.
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 Nuccio Fera at (646) 733-3034.
Sincerely,
Gwenn Klein Kirschner
Acting Director
National Commodity Specialist Division