S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   2133
 
                        2025-2026 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             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:
 
   Section 1. Article 37 of the environmental conservation law is amended
 by adding a new title 8 to read as follows:
                                TITLE VIII
                      INTRAVENOUS SOLUTION CONTAINERS
 SECTION 37-0801. LEGISLATIVE INTENT.
         37-0803. DEFINITIONS.
         37-0805. INTRAVENOUS SOLUTION CONTAINER.
 § 37-0801. LEGISLATIVE INTENT.
   THE LEGISLATURE FINDS AND DECLARES ALL OF THE FOLLOWING:
   1.  DI(2-ETHYLHEXYL)  PHTHALATE  (DEHP) AND OTHER ORTHO-PHTHALATES ARE
 TOXIC CHEMICALS.
   2. THEY ARE USED PRIMARILY TO PRODUCE FLEXIBILITY IN PLASTICS,  MAINLY
 POLYVINYL CHLORIDE (PVC).
   3.  THIS  INCLUDES DEHP, THE MOST COMMON 'PLASTICIZER' USED IN MEDICAL
 DEVICES, INCLUDING INTRAVENOUS SOLUTION  CONTAINERS  (IV  BAGS)  AND  IV
 TUBING.
   4.  OVER THE COURSE OF ITS SHELF LIFE, DEHP LEACHES OUT OF THE PLASTIC
 INTO THE SOLUTION BEING HELD IN THE CONTAINER.
   5. 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.
   6.  STUDIES  HAVE SUGGESTED A POTENTIAL LINK BETWEEN DEHP EXPOSURE AND
 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
 
 CANCER.  THE  UNITED  STATES  ENVIRONMENTAL  PROTECTION AGENCY (EPA) HAS
 DETERMINED THAT DEHP IS A PROBABLE HUMAN CARCINOGEN.
   7. DEHP EXPOSURE HAS BEEN ASSOCIATED WITH ADVERSE EFFECTS ON REPRODUC-
 TIVE  ORGANS  AND FERTILITY. IT CAN DISRUPT NORMAL REPRODUCTIVE DEVELOP-
 MENT, REDUCE SPERM QUALITY, AND AFFECT HORMONE LEVELS IN BOTH MALES  AND
 FEMALES.
   8.  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.
   9.  INHALATION  OR  INGESTION OF DEHP CAN CAUSE RESPIRATORY IRRITATION
 AND ALLERGIC REACTIONS IN  SOME  INDIVIDUALS,  PARTICULARLY  THOSE  WITH
 PREEXISTING RESPIRATORY CONDITIONS OR SENSITIVITIES.
   10.  THE  LEACHING  OF  DEHP  FROM  MEDICAL DEVICES AT VARYING CONCEN-
 TRATIONS 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.
   11.  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.
 § 37-0803. DEFINITIONS.
   FOR PURPOSES OF THIS TITLE, THE FOLLOWING TERMS SHALL HAVE THE FOLLOW-
 ING MEANINGS:
   1. "DEHP" MEANS DI(2-ETHYLHEXYL) PHTHALATE.
   2.  "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.
   3.  "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.
   4. "INTRAVENOUS TUBING" MEANS ANY TUBING USED  TO  ADMINISTER  FLUIDS,
 MEDICATION, OR NUTRIENTS DIRECTLY TO AN ADULT, CHILD, OR INFANT.
   5.  "ORTHO-PHTHALATES"  MEANS  A CLASS OF CHEMICALS THAT ARE ESTERS OF
 ORTHO-PHTHALIC ACID, INCLUDING ALL OF THE FOLLOWING:
   (A) BENZYL-BUTYL PHTHALATE (BBP) 85-68-7.
   (B) DIBUTYL PHTHALATE (DBP) 84-74-2.
   (C) DICYCLOHEXYL PHTHALATE (DCHP) 84-61-7.
   (D) DI-(2-ETHYLHEXYL) PHTHALATE (DEHP) 117-81-7.
   (E) DIETHYL PHTHALATE (DEP) 84-66-2.
   (F) DI-ISOBUTYL PHTHALATE (DIBP) 84-69-5.
   (G) DI-ISODECYL PHTHALATE (DIDP) 26761-40-0.
   (H) DI-ISONONYL PHTHALATE (DINP) 28553-12-0.
   (I) DI-N-HEXYL PHTHALATE (DNHP) 84-75-3.
   (J) DI-N-OCTYL PHTHALATE (DNOP) 117-84-0.
   (K) DI-N-PENTYL (DNPP) PHTHALATE 131-18-0.
   (L) DIISOHEPTYL PHTHALATE (DIHP) 71888-89-6.
 § 37-0805. INTRAVENOUS SOLUTION CONTAINERS.
   1. BEGINNING JANUARY FIRST, TWO  THOUSAND  TWENTY-SIX,  NO  PERSON  OR
 ENTITY  SHALL MANUFACTURE, SELL, OR DISTRIBUTE INTO COMMERCE IN NEW YORK
 INTRAVENOUS SOLUTION CONTAINERS MADE WITH INTENTIONALLY ADDED DEHP.
   2. BEGINNING JANUARY FIRST, TWO  THOUSAND  THIRTY-ONE,  NO  PERSON  OR
 ENTITY  SHALL MANUFACTURE, SELL, OR DISTRIBUTE INTO COMMERCE IN NEW YORK
 INTRAVENOUS TUBING MADE WITH INTENTIONALLY ADDED DEHP FOR USE IN  NEONA-
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 TAL  INTENSIVE  CARE  UNITS,  NUTRITION INFUSIONS, OR ONCOLOGY TREATMENT
 INFUSIONS.
   3. NO PERSON OR ENTITY SHALL REPLACE DEHP, PURSUANT TO THIS TITLE, FOR
 REVISED OR NEW PRODUCTS WITH OTHER ORTHO-PHTHALATES.
   4.  THE  FOLLOWING ITEMS, AS DESCRIBED IN TITLE TWENTY-ONE OF THE CODE
 OF FEDERAL REGULATIONS, ARE EXEMPT FROM THE PROVISIONS OF THIS SECTION:
   (A) HUMAN BLOOD COLLECTION AND STORAGE BAGS; AND
   (B) APHERESIS AND CELL THERAPY BLOOD KITS AND BAGS, INCLUDING INTEGRAL
 TUBING.
   § 2. This act shall take effect immediately.