North Carolina HB 592: Toxic-Free Medical Devices Act of 2025.

Bill Text

GENERAL ASSEMBLY OF NORTH CAROLINA
SESSION 2025
H 2
HOUSE BILL 592
Committee Substitute Favorable 4/15/25

Short Title: Toxic-Free Medical Devices Act of 2025. (Public)
Sponsors:
Referred to:
April 1, 2025
*H592-v-2*
A BILL TO BE ENTITLED 1
AN ACT TO PROHIBIT THE MANUFACTURING, SELLING, AND DISTRIBUTING OF 2
INTRAVENOUS SOLUTION CONTAINERS AND INTRAVENOUS TUBING THAT 3
ARE INTENTIONALLY MADE WITH DEHP. 4
The General Assembly of North Carolina enacts: 5
SECTION 1. Chapter 130A of the General Statutes is amended by adding a new 6
Article to read as follows: 7
"Article 19C. 8
"DEHP Hazard Management. 9
"§ 130A-453.33. Legislative finding. 10
The General Assembly finds all of the following: 11
(1) DEHP and other ortho-phthalates are toxic chemicals used primarily to 12
produce flexibility in plastics, mainly polyvinyl chloride (PVC). 13
(2) DEHP is the most common plasticizer used in medical devices, including 14
intravenous solution containers, which are also known as IV bags, and 15
intravenous tubing. 16
(3) Over the course of its shelf life, DEHP leaches from IV bags and tubing made 17
from DEHP into the solutions being held in the medical devices. 18
(4) DEHP is classified by the United States Environmental Protection Agency as 19
an endocrine-disrupting compound since it can: 20
a. Interfere with the hormonal system in humans and animals. 21
b. Mimic or block the actions of hormones, leading to adverse effects on 22
reproductive health, development, and metabolism. 23
(5) DEHP exposure has been associated with adverse effects on reproductive 24
organs and fertility. DEHP can also disrupt normal reproductive development, 25
reduce sperm quality, and affect hormone levels in both males and females. 26
(6) DEHP is metabolized in the liver and can accumulate in the body over time. 27
Prolonged exposure to high levels of DEHP has been shown to cause liver and 28
kidney damage in animal studies. 29
(7) Inhalation or ingestion of DEHP can cause respiratory irritation and allergic 30
reactions in some individuals, particularly those with preexisting respiratory 31
conditions or sensitivities. 32
(8) Studies have suggested a potential link between DEHP exposure and certain 33
types of cancer, including breast, liver, lung, and testicular cancer. 34
(9) The United States Environmental Protection Agency has determined that 35
DEHP is a probable human carcinogen. 36

General Assembly Of North Carolina Session 2025
Page 2 House Bill 592-Second Edition
(10) The leaching of DEHP from medical devices at varying concentrations has 1
been linked to multidrug resistance in breast cancer cells, inhibiting the 2
effectiveness of breast cancer drugs. This phenomenon has been observed at 3
both high and low concentrations of DEHP, highlighting the potential impact 4
of DEHP leaching on cancer treatment outcomes. 5
(11) Exposure to DEHP has been linked to multidrug resistance in triple-negative 6
breast cancer cells, inhibiting the apoptosis mechanism induced by breast 7
cancer drugs, such as tamoxifen, and increasing cell proliferation. 8
(12) DEHP has been suggested to serve as a mitogenic factor for estrogen 9
receptor-positive breast cancer cells, potentially making them multidrug 10
resistant. 11
"§ 130A-453.34. Definitions. 12
The following definitions apply in this Article: 13
(1) DEHP. – Di(2-ethylhexyl) phthalate. 14
(2) Health care practitioner. – An individual who is authorized to practice some 15
component of the healing arts by a license, permit, certificate, or registration 16
issued by a State licensing agency or board. 17
(3) Intentionally added DEHP. – DEHP that a manufacturer has intentionally 18
added to a product and that has a functional or technical effect on the product. 19
(4) Intravenous solution container. – A container used to house medicine, fluid, 20
or nutrition therapy that is intravenously delivered to a patient in a hospital, 21
outpatient facility, or other health care facility. 22
(5) Intravenous tubing. – Tubing used to intravenously administer fluids, 23
medication, or nutrients directly to an adult, child, or infant. 24
(6) Ortho-phthalate. – A class of chemicals that are esters of ortho-phthalic acid, 25
including DEHP or any of the following: 26
a. Benzyl butyl phthalate (BBP). 27
b. Dibutyl phthalate (DBP). 28
c. Dicyclohexyl phthalate (DCHP). 29
d. Diethyl phthalate (DEP). 30
e. Diisobutyl phthalate (DIBP). 31
f. Diisodecyl phthalate (DIDP). 32
g. Diisononyl phthalate (DINP). 33
h. Di-n-hexyl phthalate (DnHP). 34
i. Di-n-octyl phthalate (DNOP). 35
j. Di-n-pentyl phthalate (DnPP). 36
k. Diisoheptyl phthalate (DIHP). 37
(7) Unintentionally added DEHP. – DEHP in an intravenous solution container 38
or intravenous tubing product that is not used for functional or technical effect 39
on the product. 40
"§ 130A-453.35. Prohibitions. 41
(a) Intravenous Solution Containers. – Beginning January 1, 2030, a person or entity shall 42
not manufacture, sell, or distribute into commerce in the State of