Phthalates/medical equipment

AN ACT Relating to phthalates in medical equipment used for 1
intravenous purposes; and adding a new chapter to Title 70A RCW.2
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:3
NEW SECTION. Sec. 1. The legislature finds and declares all of 4
the following:5
(1) Di(2-ethylhexyl) phthalate (DEHP) and other ortho-phthalates 6
are toxic chemicals and can have negative impacts on human health as 7
determined by the United States food and drug administration and the 8
United States environmental protection agency; 9
(2) DEHP and other ortho-phthalates are used primarily to produce 10
flexibility in plastics, mainly polyvinyl chloride (PVC);11
(3) DEHP is the most common plasticizer used in medical devices, 12
including intravenous solution containers (IV bags) and intravenous 13
tubing; 14
(4) Over the course of its shelf life, DEHP leaches out of the 15
plastic into the solution being held in the container;16
(5) DEHP is classified as an endocrine-disrupting compound, 17
meaning it can interfere with the hormonal system in humans and 18
animals. It can mimic or block the actions of hormones, leading to 19
adverse effects on reproductive health, development, and metabolism;20
H-2542.3
HOUSE BILL 2402
State of Washington 69th Legislature 2026 Regular Session
By Representatives Stonier, Parshley, Ramel, and Reed
Read first time 01/13/26. Referred to Committee on Environment &
Energy.
p. 1 HB 2402
(6) Studies have suggested a potential link between DEHP exposure 1
and certain types of cancer, including breast, liver, lung, and 2
testicular cancer. The United States environmental protection agency 3
has determined that DEHP is a probable human carcinogen;4
(7) DEHP exposure has been associated with adverse effects on 5
reproductive organs and fertility. It can disrupt normal reproductive 6
development, reduce sperm quality, and affect hormone levels in both 7
males and females; 8
(8) DEHP is metabolized in the liver and can accumulate in the 9
body over time. Prolonged exposure to high levels of DEHP has been 10
shown to cause liver and kidney damage in animal studies;11
(9) Inhalation or ingestion of DEHP can cause respiratory 12
irritation and allergic reactions in some individuals, particularly 13
those with preexisting respiratory conditions or sensitivities;14
(10) DEHP dosed at varying concentrations in cell culture studies 15
has been linked to potential multidrug resistance in breast cancer 16
cells that may inhibit the effectiveness of breast cancer drugs; and17
(11) Triple-negative breast cancer cells dosed in culture with 18
DEHP have been potentially linked to multidrug resistance, inhibiting 19
the apoptosis mechanism induced by breast cancer drugs such as 20
tamoxifen and increasing cell proliferation in vitro. One proposed 21
mechanism is that DEHP may serve as a mitogenic factor for estrogen 22
receptor-positive breast cancer cells, potentially making them 23
multidrug resistant. 24
NEW SECTION. Sec. 2. The definitions in this section apply 25
throughout this chapter unless the context clearly requires 26
otherwise.27
(1) "DEHP" means Di(2-ethylhexyl) phthalate. 28
(2) "Intentionally added DEHP" means DEHP that a manufacturer has 29
intentionally added to an intravenous solution container or 30
intravenous tubing product that has a functional or technical effect 31
on the product. 32
(3) "Intravenous solution containers" means a container used to 33
house medicine, fluid, or nutrition therapy that is intravenously 34
administered to patients in a hospital, outpatient, or other health 35
care facility. 36
(4) "Intravenous tubing" means any tubing used to intravenously 37
administer fluids, medication, or nutrients directly to an adult, 38
child, or infant. 39
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(5) "Ortho-phthalates" means a class of chemicals that are esters 1
of ortho-phthalic acid, including all of the following:2
(a) Benzyl-butyl phthalate (BBP) 85-68-7; 3
(b) Dibutyl phthalate (DBP) 84-74-2; 4
(c) Dicyclohexyl phthalate (DCHP) 84-61-7; 5
(d) Di-(2-ethylhexyl) phthalate (DEHP) 117-81-7;6
(e) Diethyl phthalate (DEP) 84-66-2; 7
(f) Di-isobutyl phthalate (DIBP) 84-69-5; 8
(g) Di-isodecyl phthalate (DIDP) 26761-40-0; 9
(h) Di-isononyl phthalate (DINP) 28553-12-0; 10
(i) Di-n-hexyl phthalate (DnHP) 84-75-3; 11
(j) Di-n-octyl phthalate (DNOP) 117-84-0; 12
(k) Di-n-pentyl phthalate (DnPP) 131-18-0; 13
(l) Diisoheptyl phthalate (DIHP) 71888-89-6. 14
(6) "Unintentionally added DEHP" means DEHP in an intravenous 15
solution container or intravenous tubing product that is not used for 16
functional or technical effect on the product. 17
NEW SECTION. Sec. 3. (1) Except as provided in subsections (4) 18
and (5) of this section, beginning January 1, 2028, it is prohibited 19
for a person to manufacture, sell, or distribute into commerce in 20
Washington intravenous solution containers made with intentionally 21
added DEHP or that contain unintentionally added DEHP in a quantity 22
that equals or exceeds 0.1 percent weight per weight.23
(2) Beginning January 1, 2035, it is prohibited for a person to 24
manufacture, sell, or distribute into commerce in Washington 25
intravenous tubing made with intentionally added DEHP or that 26
contains unintentionally added DEHP in a quantity that equals or 27
exceeds 0.1 percent weight per weight. 28
(3) A person or entity shall not replace DEHP under this chapter 29
for revised or new products with other ortho-phthalates.30
(4) The following items, as described in 21 C.F.R. as it existed 31
as of January 1, 2026, are exempt from the requirements of this 32
section: 33
(a) Human blood collection and storage bags; and34
(b) Apheresis and cell therapy blood kits and bags, including 35
integral tubing. 36
(5) Nothing in this section limits the authority of the 37
department of ecology with respect to DEHP, other ortho-phthalates, 38
p. 3 HB 2402
intravenous solution containers, or intravenous tubing under chapter 1
70A.350 RCW. 2
NEW SECTION. Sec. 4. Sections 1 through 3 of this act 3
constitute a new chapter in Title 70A RCW.4
NEW SECTION. Sec. 5. If any provision of this act or its 5
application to any person or circumstance is held invalid, the 6
remainder of the act or the application of the provision to other 7
persons or circumstances is not affected.8
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