JurisdictionCaliforniaCode HSCHealth and Safety Code - HSC
Div. 104.DIVISION 104. ENVIRONMENTAL HEALTH
Part 3.PART 3. PRODUCT SAFETY
Ch. 18.CHAPTER 18. Chemicals in Medical Devices
This text of California § 109050. (109050. (Added by Stats. 2024, Ch. 562, Sec. 1.)) is published on Counsel Stack Legal Research, covering California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
The Legislature finds and declares all of the following:
(a)Di(2-ethylhexyl) phthalate (DEHP) and other ortho-phthalates are toxic chemicals and can have negative impacts on human health as determined by the United States Food and Drug Administration, the United States Environmental Protection Agency, or the Office of Environmental Health Hazard Assessment within the California Environmental Protection Agency.
(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.
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The Legislature finds and declares all of the following:
(a)
Di(2-ethylhexyl) phthalate (DEHP) and other ortho-phthalates are toxic chemicals and can have negative impacts on human health as determined by the United States Food and Drug Administration, the United States Environmental Protection Agency, or the Office of Environmental Health Hazard Assessment within the California Environmental Protection Agency.
(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 alternatives to DEHP, approximately 70 percent of California hospitals are buying and using IV bags made with DEHP.
(k)
DEHP dosed at varying concentrations in cell culture studies has been linked to potential multidrug resistance in breast cancer cells that may inhibit the effectiveness of breast cancer drugs.
(l)
Triple-negative breast cancer cells dosed in culture with DEHP have been potentially linked to multidrug resistance, inhibiting the apoptosis mechanism induced by breast cancer drugs such as tamoxifen and increasing cell proliferation in vitro. One proposed mechanism is that DEHP may serve as a mitogenic factor for
estrogen receptor-positive breast cancer cells, potentially making them multidrug resistant.