Toxic-Free Medical Devices: California AB 2300

At a Glance

The California Toxic-Free Medical Devices Act (AB 2300 – Wilson), signed into law by Governor Newsom in 2024, is a BCPP-sponsored bill that bans the manufacture, sale and use of Di(2-ethylhexyl)phthalate (DEHP) in IV bags and tubing in California.

Cosponsors: BCPP and the California Black Health Network

Bill Updates: Introduced in February 2024 by California Assemblymember Lori Wilson (D-Fairfield). Passed the Assembly Health Committee on April 2 (10-1). Passed the Environmental Safety & Toxic Materials Committee on April 23 (5-1). Passed the CA State Assembly (58 Yes, 21 No, 1 Abstain). See how your CA Assembly member voted. Signed into law by CA Governor Newsom Sept. 26, 2024. 

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Overview

DEHP is a chemical which belongs to a family of hormonally active industrial chemicals called phthalates used to make plastic soft and pliable. It’s found in a variety of products that add elasticity to a myriad of products ranging from raincoats to garden hoses to shower curtains to vinyl flooring, and building materials, particularly those made of polyvinyl chloride (PVC) plastic.

DEHP has been linked to breast, liver, lung, and testicular cancer. It is an endocrine disrupting compound, meaning it can interfere with the hormonal system in humans, leading to adverse effects on reproductive health, development, and metabolism and has been linked to early puberty and infertility and decreased testosterone and sperm mobility in men. Exposure to DEHP during pregnancy may lead to preterm birth, delayed mental development, and altered timing of puberty in the child.[1]

DEHP is also listed on California’s Proposition 65 as a reproductive and developmental toxicant [2] and as a U.S. National Toxicology Program and Prop. 65 Carcinogen.[2,3] Research indicates that DEHP interferes with the ability of chemotherapies to fight breast cancer, and that patients with higher levels of DEHP in their system had higher rates of relapse and breast cancer mortality.[4]

DEHP can contribute up to 40% by weight to IV bags and up to 80% by weight in IV tubing, where it can leach out of the IV bags and tubing and into the medication and other fluids being infused into the bloodstream of patients. DEHP-free IV bags and tubing exist and are being used by major health care systems like Kaiser Permanente. We don’t think Californians should have to wonder and worry if the medical device being used to treat their illness is instead making them sicker or contributing to an even worse health concern.

Breast Cancer Prevention Partners championed the passage of CA laws that banned the sale of children’s toys made with DEHP in 2007 (Ma) and the sale of cosmetics with DEHP in 2020 (Muratsuchi) because of its well-established threats to human health. We then took the California Toxic Toys ban to congress and President Bush signed it into law, banning DEHP and other toxic phthalates from kids toys throughout the country in 2008.

Impact: What AB2300 Would Do

The Toxic-Free Medical Act would ban DEHP—and its replacement with other chemicals in the same class of ortho-phthalates—from IV bags and tubing manufactured, sold or used in California for use in neonatal intensive care units, nutrition infusions, or oncology treatment infusions.

Resources

Bill language and voting record AB 2300

Supporting organizations

Related News:

Footnotes

[1] https://wwwn.cdc.gov/TSP/ToxFAQs/ToxFAQsDetails.aspx?faqid=377&toxid=65#:~:text=The%20U.S.%20Department%20of%20Health,is%20a%20probable%20human%20carcinogen

[2] NTP Report on Carcinogens, first listed in 1983, DEHP is reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity from studies in experimental animals

[3] DEHP was listed under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) by the Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency, in 1988 for cancer, and in 2003 for reproductive toxicity. https://oehha.ca.gov/proposition-65/chemicals/di2-ethylhexylphthalate-dehp

[4] See Plastic additive increases breast cancer relapse, mortality: New science and https://www.sciencedirect.com/science/article/pii/S0753332221011860

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