A 2133: Prohibits the sale of certain medical solution containers containing PVC, DEHP or unintentionally added DEHP.

  
  STATE OF NEW YORK ________________________________________________________________________ 2133 2025-2026 Regular Sessions  IN ASSEMBLY January 15, 2025 ___________ Introduced by M. of A. ROSENTHAL -- read once and referred to the Committee on Environmental Conservation AN ACT to amend the environmental conservation law, in relation to prohibiting the sale of intravenous solution containers made with intentionally added DEHP The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Article 37 of the environmental conservation law is amended 2 by adding a new title 8 to read as follows: 3 TITLE VIII 4 INTRAVENOUS SOLUTION CONTAINERS 5 Section 37-0801. Legislative intent. 6 37-0803. Definitions. 7 37-0805. Intravenous solution container. 8 § 37-0801. Legislative intent. 9 The legislature finds and declares all of the following: 10 1. Di(2-ethylhexyl) phthalate (DEHP) and other ortho-phthalates are 11 toxic chemicals. 12 2. They are used primarily to produce flexibility in plastics, mainly 13 polyvinyl chloride (PVC). 14 3. This includes DEHP, the most common 'plasticizer' used in medical 15 devices, including intravenous solution containers (IV bags) and IV 16 tubing. 17 4. Over the course of its shelf life, DEHP leaches out of the plastic 18 into the solution being held in the container. 19 5. DEHP is classified as an endocrine-disrupting compound, meaning it 20 can interfere with the hormonal system in humans and animals. It can 21 mimic or block the actions of hormones, leading to adverse effects on 22 reproductive health, development, and metabolism. 23 6. Studies have suggested a potential link between DEHP exposure and 24 certain types of cancer, including breast, liver, lung, and testicular EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD02500-01-5 
 A. 2133 2 1 cancer. The United States Environmental Protection Agency (EPA) has 2 determined that DEHP is a probable human carcinogen. 3 7. DEHP exposure has been associated with adverse effects on reproduc- 4 tive organs and fertility. It can disrupt normal reproductive develop- 5 ment, reduce sperm quality, and affect hormone levels in both males and 6 females. 7 8. DEHP is metabolized in the liver and can accumulate in the body 8 over time. Prolonged exposure to high levels of DEHP has been shown to 9 cause liver and kidney damage in animal studies. 10 9. Inhalation or ingestion of DEHP can cause respiratory irritation 11 and allergic reactions in some individuals, particularly those with 12 preexisting respiratory conditions or sensitivities. 13 10. The leaching of DEHP from medical devices at varying concen- 14 trations has been linked to multidrug resistance in breast cancer cells, 15 inhibiting the effectiveness of breast cancer drugs. This phenomenon has 16 been observed at both high and low concentrations of DEHP, highlighting 17 the potential impact of DEHP leaching on cancer treatment outcomes. 18 11. Exposure to DEHP has been linked to multidrug resistance in 19 triple-negative breast cancer cells, inhibiting the apoptosis mechanism 20 induced by breast cancer drugs such as tamoxifen and increasing cell 21 proliferation. Moreover, DEHP has been suggested to serve as a mitogenic 22 factor for estrogen receptor-positive breast cancer cells, potentially 23 making them multidrug resistant. 24 § 37-0803. Definitions. 25 For purposes of this title, the following terms shall have the follow- 26 ing meanings: 27 1. "DEHP" means Di(2-ethylhexyl) phthalate. 28 2. "Intentionally added DEHP" means DEHP that a manufacturer has 29 intentionally added to a product and that has a functional or technical 30 effect on the product. 31 3. "Intravenous solution containers" means a container used to house 32 medicine, fluid, or nutrition therapy that is intravenously administered 33 to patients in a hospital, outpatient, or other health care facility. 34 4. "Intravenous tubing" means any tubing used to administer fluids, 35 medication, or nutrients directly to an adult, child, or infant. 36 5. "Ortho-phthalates" means a class of chemicals that are esters of 37 ortho-phthalic acid, including all of the following: 38 (a) Benzyl-butyl phthalate (BBP) 85-68-7. 39 (b) Dibutyl phthalate (DBP) 84-74-2. 40 (c) Dicyclohexyl phthalate (DCHP) 84-61-7. 41 (d) Di-(2-ethylhexyl) phthalate (DEHP) 117-81-7. 42 (e) Diethyl phthalate (DEP) 84-66-2. 43 (f) Di-isobutyl phthalate (DIBP) 84-69-5. 44 (g) Di-isodecyl phthalate (DIDP) 26761-40-0. 45 (h) Di-isononyl phthalate (DINP) 28553-12-0. 46 (i) Di-n-hexyl phthalate (DnHP) 84-75-3. 47 (j) Di-n-octyl phthalate (DNOP) 117-84-0. 48 (k) Di-n-pentyl (DnPP) phthalate 131-18-0. 49 (l) Diisoheptyl phthalate (DIHP) 71888-89-6. 50 § 37-0805. Intravenous solution containers. 51 1. Beginning January first, two thousand twenty-six, no person or 52 entity shall manufacture, sell, or distribute into commerce in New York 53 intravenous solution containers made with intentionally added DEHP. 54 2. Beginning January first, two thousand thirty-one, no person or 55 entity shall manufacture, sell, or distribute into commerce in New York 56 intravenous tubing made with intentionally added DEHP for use in neona- 
 A. 2133 3 1 tal intensive care units, nutrition infusions, or oncology treatment 2 infusions. 3 3. No person or entity shall replace DEHP, pursuant to this title, for 4 revised or new products with other ortho-phthalates. 5 4. The following items, as described in title twenty-one of the code 6 of federal regulations, are exempt from the provisions of this section: 7 (a) Human blood collection and storage bags; and 8 (b) Apheresis and cell therapy blood kits and bags, including integral 9 tubing. 10 § 2. This act shall take effect immediately.