CLA-2-05:OT:RR:NC:2:231

Mr. John R. Haupt
Bako Pathology Services
2001 Westside Parkway (Ste 290)
Alpharetta, GA 30004

RE: The tariff classification of human skin and nail specimens from the Virgin Islands, Costa Rica or Canada.

Dear Mr. Haupt:

In your letter dated August 5, 2010, you requested a tariff classification ruling.

You have outlined a scenario in which your company will export “medical test and collection kits” of U.S. origin to the Virgin Islands, Costa Rica and Canada. In those countries, doctors will collect specimens from their patients, fill the kits with those specimens, and then return the filled kits to the United States, where the specimens will be analyzed. You explain that some of the medical kits will consist of plastic bags intended for the receipt of dry skin shavings or dry “keratin specimens” (i.e., unprocessed human nail clippings), for fungal growth analysis. Other kits will consist of vials of formalin (a water/formaldehyde mixture) to be used to preserve and kill human tissue specimens (primarily skin biopsies) for analysis.

The applicable subheading for the imported human nail-clipping specimens packaged in the above-described medical kits will be 0507.90.0090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for ivory, tortoise-shell, whalebone and whalebone hair, horns, antlers, hooves, nails, claws and beaks, unworked or simply prepared but not cut to shape; powder and waste of such products: other: other. The rate of duty will be free.

The applicable subheading for the imported human skin specimens packaged in the above-described medical kits will be 0511.99.2000, HTSUS, which provides for animal products not elsewhere specified or included;… other: other: parings and similar waste of raw hides or skins…. The 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 http://www.usitc.gov/tata/hts/.

Upon compliance with the documentation requirements of section 10.1 of the Customs & Border Protection Regulations (19 CFR 10.1), that portion of each importation represented by the U.S.-origin packaging materials (the medical test/collection kits) will be entitled to duty-free treatment under subheading 9801.00.1010, HTSUS, which provides for products of the U.S. which are exported and returned without having been advanced in value or improved in condition by any process of manufacture or other means while abroad: articles previously exported with intent to reimport after temporary use abroad.

These importations may be subject to the regulations of the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, Office of Health and Safety, Biosafety Branch. You may contact them at 1600 Clifton Road, Atlanta, GA 30333, telephone number 404-633-5313.

These importations may also be subject to regulations or restrictions administered by the U.S. Department of Agriculture, Animal and Plant Health Division (APHIS). You may contact this agency regarding possible applicable regulations at the following location: U.S. Department of Agriculture APHIS, VS, NCIE Products Program 4700 River Road, Unit 40 Riverdale, MD 20737-1231 Telephone number: 301-734-3277

These importations may also be subject to The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which is regulated by the United States Food and Drug Administration (FDA). Information on the Bioterrorism Act can be obtained by calling the FDA at telephone number (301) 575-0156, or at the Web site www.fda.gov/oc/bioterrorism/bioact.html. 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 Nathan Rosenstein at (646) 733-3030.

Sincerely,

Robert B. Swierupski
Director
National Commodity Specialist Division