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, SE LLING, AND DISTRIBUTING OF 2
INTRAVENOUS SOLUTION CONTAINERS AND INTR AVENOUS TUBING THAT 3
ARE INTENTIONALLY MA DE 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 North Carolina intravenous 43
solution containers made with intentionally added DEHP. 44
(b) Intravenous Tubing. – Beginning January 1, 2035, a person or entity shall not 45
manufacture, sell, or distribute into commerce in the State of North Carolina intravenous tubing 46
made with intentionally added DEHP. 47
(c) Replacement. – A person may not replace DEHP, pursuant to this Article, with 48
another ortho-phthalate in a new or revised medical device. 49 General Assembly Of North Carolina Session 2025
House Bill 592-Second Edition Page 3
(d) Maximum Quantity. – An intravenous solution container or intravenous tubing 1
product shall not have unintentionally added DEHP present at a quantity at or above 0.1 percent 2
weight per weight (w/w). 3
(e) Exemptions. – The following items, as described in Title 21 of the Code of Federal 4
Regulations, are exempt from these provisions: 5
(1) Human blood collection and storage bags. 6
(2) Apheresis and cell therapy blood kits and bags, including integral tubing. 7
(f) Delayed Compliance. – A person or entity, due to pending United States Food and 8
Drug Administration approval for the DEHP-free intravenous solution container or due to the 9
manufacturer not having adequate equipment to manufacture the DEHP-free intravenous solution 10
container, shall meet the requirement in subsection (a) of this section by January 1, 2032, if all 11
of the following conditions are met: 12
(1) The person or entity notified its North Carolina customers, no later than 13
October 1, 2025, that it has commenced development of the DEHP-free 14
intravenous solution container to meet the requirements of this section. 15
(2) The person or entity provides notice to its customers and posts to its official 16
internet website, no later than January 1, 2028, that it will not meet the 17
deadline imposed pursuant to subsection (a) of this section." 18
SECTION 2. G.S. 130A-22(b3) reads as rewritten: 19
"(b3) The Secretary may impose an administrative penalty on a person who violates Article 20
19A or 19B Article 19A, 19B, or 19C of this Chapter or any rules adopted pursuant to Article 21
19A or 19B Article 19A, 19B, or 19C of this Chapter. Each day of a continuing violation is a 22
separate violation. The penalty shall not exceed five thousand dollars ($5,000) for each day the 23
violation continues for Article 19A of this Chapter. The penalty shall not exceed five thousand 24
dollars ($5,000) for each day the violation continues for Article 19B of this Chapter. The penalty 25
shall not exceed five thousand dollars ($5,000) for each day the violation continues for Article 26
19C of this Chapter. The penalty authorized by this section does not apply to a person who is not 27
required to be certified under Article 19A or 19B." 28
SECTION 3. Except as otherwise provided, this act is effective when it becomes 29
law. 30