North Carolina 2025-2026 Regular Session

North Carolina House Bill H592 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1	1		GENERAL ASSEMBLY OF NORTH CAROLINA
2	2		SESSION 2025
3		-	H 2
	3	+	H 1
4	4		HOUSE BILL 592
5		-	~~Committee Substitute Favorable 4/15/25~~
	5	+
6	6
7	7		Short Title: Toxic-Free Medical Devices Act of 2025. (Public)
8		-	Sponsors:
9		-	Referred to:
	8	+	Sponsors: Representatives Reeder and Rhyne (Primary Sponsors).
	9	+	For a complete list of sponsors, refer to the North Carolina General Assembly web site.
	10	+	Referred to: Health, if favorable, Rules, Calendar, and Operations of the House
10	11		April 1, 2025
11		-	H592 -v-2
	12	+	H592 -v-1
12	13		A BILL TO BE ENTITLED 1
13	14		AN ACT TO PROHIBIT THE MANUFACTURING, SE LLING, AND DISTRIBUTING OF 2
14	15		INTRAVENOUS SOLUTION CONTAINERS AND INTR AVENOUS TUBING THAT 3
15	16		ARE INTENTIONALLY MA DE WITH DEHP. 4
16	17		The General Assembly of North Carolina enacts: 5
17	18		SECTION 1. Chapter 130A of the General Statutes is amended by adding a new 6
18	19		Article to read as follows: 7
19	20		"Article 19C. 8
20	21		"DEHP Hazard Management. 9
21	22		"§ 130A-453.33. Legislative finding. 10
22	23		The General Assembly finds all of the following: 11
23	24		(1) DEHP and other ortho-phthalates are toxic chemicals used primarily to 12
24	25		produce flexibility in plastics, mainly polyvinyl chloride (PVC). 13
25	26		(2) DEHP is the most common plasticizer used in medical devices, including 14
26	27		intravenous solution containers, which are also known as IV bags, and 15
27	28		intravenous tubing. 16
28	29		(3) Over the course of its shelf life, DEHP leaches from IV bags and tubing made 17
29	30		from DEHP into the solutions being held in the medical devices. 18
30	31		(4) DEHP is classified by the United States Environmental Protection Agency as 19
31	32		an endocrine-disrupting compound since it can: 20
32	33		a. Interfere with the hormonal system in humans and animals. 21
33	34		b. Mimic or block the actions of hormones, leading to adverse effects on 22
34	35		reproductive health, development, and metabolism. 23
35	36		(5) DEHP exposure has been associated with adverse effects on reproductive 24
36	37		organs and fertility. DEHP can also disrupt normal reproductive development, 25
37	38		reduce sperm quality, and affect hormone levels in both males and females. 26
38	39		(6) DEHP is metabolized in the liver and can accumulate in the body over time. 27
39	40		Prolonged exposure to high levels of DEHP has been shown to cause liver and 28
40	41		kidney damage in animal studies. 29
41	42		(7) Inhalation or ingestion of DEHP can cause respiratory irritation and allergic 30
42	43		reactions in some individuals, particularly those with preexisting respiratory 31
43	44		conditions or sensitivities. 32
44	45		(8) Studies have suggested a potential link between DEHP exposure and certain 33
45		-	types of cancer, including breast, liver, lung, and testicular cancer. 34
46		-	(9) The United States Environmental Protection Agency has determined that 35
47		-	DEHP is a probable human carcinogen. 36 General Assembly Of North Carolina Session 2025
48		-	Page 2 House Bill 592-Second Edition
49		-	(10) The leaching of DEHP from medical devices at varying concentrations has 1
50		-	been linked to multidrug resistance in breast cancer cells, inhibiting the 2
51		-	effectiveness of breast cancer drugs. This phenomenon has been observed at 3
52		-	both high and low concentrations of DEHP, highlighting the potential impact 4
53		-	of DEHP leaching on cancer treatment outcomes. 5
54		-	(11) Exposure to DEHP has been linked to multidrug resistance in triple-negative 6
55		-	breast cancer cells, inhibiting the apoptosis mechanism induced by breast 7
56		-	cancer drugs, such as tamoxifen, and increasing cell proliferation. 8
57		-	(12) DEHP has been suggested to serve as a mitogenic factor for estrogen 9
58		-	receptor-positive breast cancer cells, potentially making them multidrug 10
59		-	resistant. 11
60		-	"§ 130A-453.34. Definitions. 12
61		-	The following definitions apply in this Article: 13
62		-	(1) DEHP. – Di(2-ethylhexyl) phthalate. 14
63		-	(2) Health care practitioner. – An individual who is authorized to practice some 15
64		-	component of the healing arts by a license, permit, certificate, or registration 16
65		-	issued by a State licensing agency or board. 17
66		-	(3) Intentionally added DEHP. – DEHP that a manufacturer has intentionally 18
67		-	added to a product and that has a functional or technical effect on the product. 19
68		-	(4) Intravenous solution container. – A container used to house medicine, fluid, 20
69		-	or nutrition therapy that is intravenously delivered to a patient in a hospital, 21
70		-	outpatient facility, or other health care facility. 22
71		-	(5) Intravenous tubing. – Tubing used to intravenously administer fluids, 23
72		-	medication, or nutrients directly to an adult, child, or infant. 24
73		-	(6) Ortho-phthalate. – A class of chemicals that are esters of ortho-phthalic acid, 25
74		-	including DEHP or any of the following: 26
75		-	a. Benzyl butyl phthalate (BBP). 27
76		-	b. Dibutyl phthalate (DBP). 28
77		-	c. Dicyclohexyl phthalate (DCHP). 29
78		-	d. Diethyl phthalate (DEP). 30
79		-	e. Diisobutyl phthalate (DIBP). 31
80		-	f. Diisodecyl phthalate (DIDP). 32
81		-	g. Diisononyl phthalate (DINP). 33
82		-	h. Di-n-hexyl phthalate (DnHP). 34
83		-	i. Di-n-octyl phthalate (DNOP). 35
84		-	j. Di-n-pentyl phthalate (DnPP). 36
85		-	k. Diisoheptyl phthalate (DIHP). 37
86		-	(7) Unintentionally added DEHP. – DEHP in an intravenous solution container 38
87		-	or intravenous tubing product that is not used for functional or technical effect 39
88		-	on the product. 40
89		-	"§ 130A-453.35. Prohibitions. 41
90		-	(a) Intravenous Solution Containers. – Beginning January 1, 2030, a person or entity shall 42
91		-	not manufacture, sell, or distribute into commerce in the State of North Carolina intravenous 43
92		-	solution containers made with intentionally added DEHP. 44
93		-	(b) Intravenous Tubing. – Beginning January 1, 2035, a person or entity shall not 45
94		-	manufacture, sell, or distribute into commerce in the State of North Carolina intravenous tubing 46
95		-	made with intentionally added DEHP. 47
96		-	(c) Replacement. – A person may not replace DEHP, pursuant to this Article, with 48
97		-	another ortho-phthalate in a new or revised medical device. 49 General Assembly Of North Carolina Session 2025
98		-	House Bill 592-Second Edition Page 3
	46	+	types of cancer, including breast, liver, lung, and testicular cancer. 34 General Assembly Of North Carolina Session 2025
	47	+	Page 2 House Bill 592-First Edition
	48	+	(9) The United States Environmental Protection Agency has determined that 1
	49	+	DEHP is a probable human carcinogen. 2
	50	+	(10) The leaching of DEHP from medical devices at varying concentrations has 3
	51	+	been linked to multidrug resistance in breast cancer cells, inhibiting the 4
	52	+	effectiveness of breast cancer drugs. This phenomenon has been observed at 5
	53	+	both high and low concentrations of DEHP, highlighting the potential impact 6
	54	+	of DEHP leaching on cancer treatment outcomes. 7
	55	+	(11) Exposure to DEHP has been linked to multidrug resistance in triple-negative 8
	56	+	breast cancer cells, inhibiting the apoptosis mechanism induced by breast 9
	57	+	cancer drugs, such as tamoxifen, and increasing cell proliferation. 10
	58	+	(12) DEHP has been suggested to serve as a mitogenic factor for estrogen 11
	59	+	receptor-positive breast cancer cells, potentially making them multidrug 12
	60	+	resistant. 13
	61	+	"§ 130A-453.34. Definitions. 14
	62	+	The following definitions apply in this Article: 15
	63	+	(1) DEHP. – Di(2-ethylhexyl) phthalate. 16
	64	+	(2) Health care practitioner. – An individual who is authorized to practice some 17
	65	+	component of the healing arts by a license, permit, certificate, or registration 18
	66	+	issued by a State licensing agency or board. 19
	67	+	(3) Intentionally added DEHP. – Any of the following: 20
	68	+	a. DEHP that a manufacturer has intentionally added to a product and 21
	69	+	that has a functional or technical effect on the product. 22
	70	+	b. DEHP that is an intentional breakdown product of an added chemical. 23
	71	+	(4) Intravenous solution container. – A container used to house medicine, fluid, 24
	72	+	or nutrition therapy that is intravenously delivered to a patient in a hospital, 25
	73	+	outpatient facility, or other health care facility. 26
	74	+	(5) Intravenous tubing. – Tubing used to intravenously administer fluids, 27
	75	+	medication, or nutrients directly to an adult, child, or infant. 28
	76	+	(6) Ortho-phthalate. – A class of chemicals that are esters of ortho-phthalic acid, 29
	77	+	including DEHP or any of the following: 30
	78	+	a. Benzyl butyl phthalate (BBP). 31
	79	+	b. Dibutyl phthalate (DBP). 32
	80	+	c. Dicyclohexyl phthalate (DCHP). 33
	81	+	d. Diethyl phthalate (DEP). 34
	82	+	e. Diisobutyl phthalate (DIBP). 35
	83	+	f. Diisodecyl phthalate (DIDP). 36
	84	+	g. Diisononyl phthalate (DINP). 37
	85	+	h. Di-n-hexyl phthalate (DnHP). 38
	86	+	i. Di-n-octyl phthalate (DNOP). 39
	87	+	j. Di-n-pentyl phthalate (DnPP). 40
	88	+	k. Diisoheptyl phthalate (DIHP). 41
	89	+	"§ 130A-453.35. Prohibitions. 42
	90	+	(a) Intravenous Solution Containers. – Beginning January 1, 2030, a person or entity shall 43
	91	+	not manufacture, sell, or distribute into commerce in the State of North Carolina intravenous 44
	92	+	solution containers made with intentionally added DEHP. 45
	93	+	(b) Intravenous Tubing. – Beginning January 1, 2035, a person or entity shall not 46
	94	+	manufacture, sell, or distribute into commerce in the State of North Carolina intravenous tubing 47
	95	+	made with intentionally added DEHP. 48
	96	+	(c) Replacement. – A person may not replace DEHP, pursuant to this Article, with 49
	97	+	another ortho-phthalate in a new or revised medical device. 50 General Assembly Of North Carolina Session 2025
	98	+	House Bill 592-First Edition Page 3
99	99		(d) Maximum Quantity. – An intravenous solution container or intravenous tubing 1
100	100		product shall not have unintentionally added DEHP present at a quantity at or above 0.1 percent 2
101	101		weight per weight (w/w). 3
102	102		(e) Exemptions. – The following items, as described in Title 21 of the Code of Federal 4
103	103		Regulations, are exempt from these provisions: 5
104	104		(1) Human blood collection and storage bags. 6
105		-	(2) Apheresis and cell therapy blood kits and bags, including integral tubing. 7
106		-	(f) Delayed Compliance. – A person or entity, due to pending United States Food and 8
107		-	Drug Administration approval for the DEHP-free intravenous solution container or due to the 9
108		-	manufacturer not having adequate equipment to manufacture the DEHP-free intravenous solution 10
109		-	container, shall meet the requirement in subsection (a) of this section by January 1, 2032, if all 11
110		-	of the following conditions are met: 12
111		-	(1) The person or entity notified its North Carolina customers, no later than 13
112		-	October 1, 2025, that it has commenced development of the DEHP-free 14
113		-	intravenous solution container to meet the requirements of this section. 15
114		-	(2) The person or entity provides notice to its customers and posts to its official 16
115		-	internet website, no later than January 1, 2028, that it will not meet the 17
116		-	deadline imposed pursuant to subsection (a) of this section." 18
117		-	SECTION 2. G.S. 130A-22(b3) reads as rewritten: 19
118		-	"(b3) The Secretary may impose an administrative penalty on a person who violates Article 20
119		-	19A or 19B Article 19A, 19B, or 19C of this Chapter or any rules adopted pursuant to Article 21
120		-	19A or 19B Article 19A, 19B, or 19C of this Chapter. Each day of a continuing violation is a 22
121		-	separate violation. The penalty shall not exceed five thousand dollars ($5,000) for each day the 23
122		-	violation continues for Article 19A of this Chapter. The penalty shall not exceed five thousand 24
123		-	dollars ($5,000) for each day the violation continues for Article 19B of this Chapter. The penalty 25
124		-	shall not exceed five thousand dollars ($5,000) for each day the violation continues for Article 26
125		-	19C of this Chapter. The penalty authorized by this section does not apply to a person who is not 27
126		-	required to be certified under Article 19A or 19B." 28
127		-	SECTION 3. Except as otherwise provided, this act is effective when it becomes 29
128		-	law. 30
	105	+	(2) Apheresis and cell therapy blood kits and bags, including integral tubing." 7
	106	+	SECTION 2. G.S. 130A-22(b3) reads as rewritten: 8
	107	+	"(b3) The Secretary may impose an administrative penalty on a person who violates Article 9
	108	+	19A or 19B Article 19A, 19B, or 19C of this Chapter or any rules adopted pursuant to Article 10
	109	+	19A or 19B Article 19A, 19B, or 19C of this Chapter. Each day of a continuing violation is a 11
	110	+	separate violation. The penalty shall not exceed five thousand dollars ($5,000) for each day the 12
	111	+	violation continues for Article 19A of this Chapter. The penalty shall not exceed five thousand 13
	112	+	dollars ($5,000) for each day the violation continues for Article 19B of this Chapter. The penalty 14
	113	+	shall not exceed five thousand dollars ($5,000) for each day the violation continues for Article 15
	114	+	19C of this Chapter. The penalty authorized by this section does not apply to a person who is not 16
	115	+	required to be certified under Article 19A or 19B." 17
	116	+	SECTION 3. Except as otherwise provided, this act is effective when it becomes 18
	117	+	law. 19