Imported Hypodermic Needles Not Substantially Transformed by Plastic Components in US, CBP Says

Hypodermic needle assemblies made in the U.S. by Cardinal Health from imported stainless steel needles and U.S.-made plastic parts keep the country of origin of the imported needles, CBP said in a recent ruling.

Affirming a 2021 ruling from the agency’s New York office, CBP headquarters found that the molding of the plastic hub adapters, safety shields and needle sheaths and their assembly with the imported needles do not substantially transform the needles themselves. “Therefore, based on the facts provided, the country of origin of the hypodermic safety needles is China, Japan, France, or South Korea depending on where the pre-cut, stainless steel needles/cannulae are manufactured,” CBP said in HQ H322967.

Cardinal Health had requested reconsideration on the basis that extensive and complex manufacturing and assembly operations in the U.S. transformed the imported needles, and that the finished hypodermic safety needles should be considered of U.S. origin.

The needles themselves, pre-cut, thin and hollow stainless steel tubes with a sharp tip, were assembled with the U.S.-molded plastic components using an ultraviolet epoxy “in an automated sequential assembly process,” CBP said. The needle assemblies are then packaged and sterilized by means of irradiation.

The assembly and processing operations in the U.S. are “simple and minor processes which leave the identity of the pre-cut, stainless steel needle/cannulae intact,” CBP said. While “substantial processing operations” go into making the hypodermic safety needles in China, Japan and South Korea, the assembly in the U.S. is “relatively simple,” done via an automated process consisting only of adhering components together with epoxy and flashes of UV radiation, CBP said.

“This mechanized assembly of the various hypodermic needle components is a highly repetitive, low-skill function; merely requiring that the assembly line be switched on and that adhesive epoxy be utilized,” CBP said.

The processing does not change the name, character or use of the imported needles, which are still called needles after being assembled in the U.S., CBP said. The imported needle keeps its intended function, and the “character, properties, and uses of the pre-cut, stainless steel needles/cannulae are pre-determined by the products themselves and are not altered as a result of the aforementioned U.S. assembly and processing operations,” the agency said.

CBP also has made several similar rulings in the past. In a 2018 ruling, it found subdermal needle electrodes made from a needle electrode that’s assembled with a lead wire, solder, a heat shrink tube and a protective cover, still originate in the country of origin of the needle electrode. Likewise, the agency has found stimulating probes attached to lead wires and other minor components retain the country of origin of the probes.

Cardinal Health pointed to rulings on suture needles that found the attachment of the surgical needles to thread was a substantial transformation. But the suture needles are different from the hypodermic needles in that the thread plays a critical role in stitching and holding together surgical incisions, CBP said. “They are more akin to sewing needles as opposed to injection needles,” CBP said. “These ‘needles’ are homonyms -- both understood as ‘needles’ but with completely different lexical definitions and purposes,” the agency said.

“As the name, character, and use of the pre-cut, stainless steel needles/cannulae remain unchanged after the attachment of the plastic components to form the completed hypodermic safety needle, we find that the pre-cut, stainless steel needles/cannulae are not substantially transformed as a result of assembly and processing operations in the United States,” CBP said.