Bill Text: CA AB2300 | 2023-2024 | Regular Session | Amended

California Assembly Bill 2300

NOTE: There are more recent revisions of this legislation. Read Latest Draft

Bill Title: Medical devices: Di-(2-ethylhexyl) phthalate (DEHP).

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Introduced) 2024-05-20 - Read third time and amended. Ordered to third reading. (Ayes 55. Noes 11.) [AB2300 Detail]

Download: California-2023-AB2300-Amended.html

Amended IN Assembly April 01, 2024

Amended IN Assembly March 06, 2024

CALIFORNIA LEGISLATURE— 2023–2024 REGULAR SESSION

Assembly Bill

No. 2300

Introduced by Assembly Member Wilson

February 12, 2024

An act to add Chapter 18 (commencing with Section 109050) to Part 3 of Division 104 of the Health and Safety Code, relating to product safety.

LEGISLATIVE COUNSEL'S DIGEST

AB 2300, as amended, Wilson. Medical devices: Di-(2-ethylhexyl) phthalate (DEHP).

Existing law prohibits a person or entity from manufacturing, selling, or distributing in commerce any toy or childcare article that contains, among other things, Di-(2-ethylhexyl) phthalate (DEHP) in concentrations exceeding 0.1%.

This bill would, commencing January 1, 2026, prohibit a person or entity from manufacturing, selling, or distributing into commerce in the State of California certain intravenous solution containers made with intentionally added DEHP. The bill would, commencing January 1, 2031, prohibit a person or entity from manufacturing, selling, or distributing into commerce in the State of California certain intravenous tubing made with intentionally added DEHP for use in neonatal intensive care units, nutrition infusions, or oncology treatment infusions. The bill would prohibit a person or entity from replacing DEHP for revised or new products with other specified ortho-phthalates.

Vote: MAJORITY Appropriation: NO Fiscal Committee: NO Local Program: NO

The people of the State of California do enact as follows:

SECTION 1.

Chapter 18 (commencing with Section 109050) is added to Part 3 of Division 104 of the Health and Safety Code, to read:

CHAPTER 18. Chemicals in Medical Devices

109050.

The Legislature finds and declares all of the following:

(a) Di(2-ethylhexyl) phthalate (DEHP) and other ortho-phthalates are toxic chemicals.

(b) They are used primarily to produce flexibility in plastics, mainly polyvinyl chloride (PVC).

(c) This includes DEHP, the most common ‘plasticizer’ used in medical devices, including intravenous solution containers (IV bags) and IV tubing.

(d) Over the course of its shelf life, DEHP leaches out of the plastic into the solution being held in the container.

(e) DEHP is classified as an endocrine-disrupting compound, meaning it can interfere with the hormonal system in humans and animals. It can mimic or block the actions of hormones, leading to adverse effects on reproductive health, development, and metabolism.

(f) Studies have suggested a potential link between DEHP exposure and certain types of cancer, including breast, liver, lung, and testicular cancer. The United States Environmental Protection Agency (EPA) has determined that DEHP is a probable human carcinogen, and it is included on the Proposition 65 list of chemicals known to the State of California to cause cancer, birth defects, or other reproductive harm.

(g) DEHP exposure has been associated with adverse effects on reproductive organs and fertility. It can disrupt normal reproductive development, reduce sperm quality, and affect hormone levels in both males and females.

(h) DEHP is metabolized in the liver and can accumulate in the body over time. Prolonged exposure to high levels of DEHP has been shown to cause liver and kidney damage in animal studies.

(i) Inhalation or ingestion of DEHP can cause respiratory irritation and allergic reactions in some individuals, particularly those with preexisting respiratory conditions or sensitivities.

(j) While some major hospital systems use IV bags made with nontoxic alternatives to DEHP, approximately 70 percent of California hospitals are buying and using toxic IV bags exposing patients directly to DEHP.

(k) The leaching of DEHP from medical devices at varying concentrations has been linked to multidrug resistance in breast cancer cells, inhibiting the effectiveness of breast cancer drugs. This phenomenon has been observed at both high and low concentrations of DEHP, highlighting the potential impact of DEHP leaching on cancer treatment outcomes.

(l) Exposure to DEHP has been linked to multidrug resistance in triple-negative breast cancer cells, inhibiting the apoptosis mechanism induced by breast cancer drugs such as tamoxifen and increasing cell proliferation. Moreover, DEHP has been suggested to serve as a mitogenic factor for estrogen receptor-positive breast cancer cells, potentially making them multidrug resistant.

109051.

For purposes of this chapter, the following terms have the following definitions:

(a) “DEHP” means Di(2-ethylhexyl) phthalate.

(b) “Intentionally added DEHP” means DEHP that a manufacturer has intentionally added to a product and that has a functional or technical effect on the product.

(c) “Intravenous solution containers” means a container used to house medicine, fluid, or nutrition therapy that is intravenously administered to patients in a hospital, outpatient, or other health care facility.

(d) “Intravenous tubing” means any tubing used to administer fluids, medication, or nutrients directly to an adult, child, or infant.

(e) “Ortho-phthalates” means a class of chemicals that are esters of ortho-phthalic acid, including all of the following:

(1) Benzyl-butyl phthalate (BBP) 85-68-7.

(2) Dibutyl phthalate (DBP) 84-74-2.

(3) Dicyclohexyl phthalate (DCHP) 84-61-7.

(4) Di-(2-ethylhexyl) phthalate (DEHP) 117-81-7.

(5) Diethyl phthalate (DEP) 84-66-2.

(6) Di-isobutyl phthalate (DIBP) 84-69-5.

(7) Di-isodecyl phthalate (DIDP) 26761-40-0.

(8) Di-isononyl phthalate (DINP) 28553-12-0.

(9) Di-n-hexyl phthalate (DnHP) 84-75-3.

(10) Di-n-octyl phthalate (DNOP) 117-84-0.

(11) Di-n-pentyl (DnPP) phthalate 131-18-0.

(12) Diisoheptyl phthalate (DIHP) 71888-89-6.

109052.

(a) Commencing January 1, 2026, a person or entity shall not manufacture, sell, or distribute into commerce in the State of California intravenous solution containers made with intentionally added DEHP.

(b) Commencing January 1, 2031, a person or entity shall not manufacture, sell, or distribute into commerce in the State of California intravenous tubing made with intentionally added DEHP for use in neonatal intensive care units, nutrition infusions, or oncology treatment infusions.

(c) A person or entity shall not replace DEHP, pursuant to this chapter, for revised or new products with other ortho-phthalates.

(d) The following items, as described in Title 21 of the Code of Federal Regulations, are exempt from these provisions:
(1) Human blood collection and storage bags.
(2) Apheresis and cell therapy blood kits and bags, including integral tubing.