Amends Chapter 130A adding Article 19C regarding Di(2-ethylhexyl) phthalate (DEHP) Hazard Management.
Sets out 12 NCGA findings about DEHP and other ortho-phthalates that are toxic chemicals, DEHP’s common use in medical devices, and the potential harms of DEHP leaching and exposure to humans.
Contains six definitions including DEHP, health care practitioner, intentionally added DEHP, intravenous solution container, intravenous tubing, and ortho-phthalate. Defines intentionally added DEHP as DEHP that a manufacturer intentionally added to a product that has a functional or technical effect on the product or DEHP that is an intentional breakdown product of an added chemical. Defines intravenous solution container as a container used to house medicine, fluid, or nutrition therapy that is intravenously delivered to a patient in a hospital, outpatient facility, or other healthcare facility. Defines intravenous tubing as tubing used to intravenously administer fluids, medication, or nutrients directly to an adult, child, or infant. Defines ortho-phthalate using a list of chemical classes.
Prohibits any person or entity from manufacturing, selling, or distributing into commerce in the state: (1) intravenous solution containers made with intentionally added DEHP, beginning January 1, 2030; and (2) intravenous tubing made with intentionally added DEHP, beginning January 1, 2035. Prohibits a person from replacing DEHP with another ortho-phthalate in a new or revised medical device. Mandates that an intravenous solution container or intravenous tubing product cannot have unintentionally added DEHP present in a quantity at or above 0.1 percent weight per weight.
Provides exemptions from these provisions for human blood collection and storage bags and apheresis and cell therapy blood kits and bags, including integral tubing.
Makes conforming changes to GS 130A-22(b3) and adds a penalty cap of $5,000 per day a violation of Article 19C continues.

Statutes affected:
Filed: 130A-22
Edition 1: 130A-22