Bill
H 5382
Massachusetts would ban intentionally added DEHP in IV solution containers by 2030 and in IV tubing by 2035, and restrict unintentional DEHP above 0.1% in such devices.
Title: An Act relative to toxic-free medical additives reforming your health
Purpose and intent
- Establishes a regulatory framework to prohibit the use of intentional and certain levels of unintentional DEHP (a phthalate) in intravenous solutions and related medical device components in Massachusetts.
- Aims to reduce exposure to potentially harmful ortho-phthalates (including DEHP and a broader class of phthalates) in healthcare settings.
Key provisions and changes
- Definitions (Section 245):
- DEHP: Di(2-ethylhexyl) phthalate.
- Ortho-phthalate: Broad class of phthalates listed (BBP, DBP, DCHP, DEP, DIBP, DIDP, DINP, DnHP, DNOP, DnPP, DIHP, etc.).
- Intravenous solution container: Containers that hold intravenously delivered medicines, fluids, or nutrition.
- Intravenous tubing: Tubing used to deliver intravenously.
- Intentionally added DEHP: DEHP added on purpose to have a functional/technical effect.
- Unintentionally added DEHP: DEHP present without a functional/technical purpose.
- Health care practitioner: Licensed or registered healthcare professional.
- Prohibitions and timelines:
- January 1, 2030: Prohibition on manufacturing, selling, or introducing into commerce intravenous solution containers with intentionally added DEHP.
- January 1, 2035: Prohibition on manufacturing, selling, or distributing intravenous tubing made with intentionally added DEHP.
- General prohibition on replacing DEHP with any other ortho-phthalate in new or revised medical devices (no “DEHP replacement” loopholes within this context).
- Intravenous solution containers or tubing with unintentional DEHP at or above 0.1% weight/weight (0.1% w/w) are prohibited.
- Exemptions:
- Certain items under federal regulations are exempt (e.g., human blood collection/storage bags; certain apheresis and cell therapy kits and bags with integral tubing).
- Compliance flexibility and delays:
- If a manufacturer is awaiting FDA approval for a DEHP-free container or lacks necessary equipment, it may delay compliance to January 1, 2032, under specific conditions:
- Notification to Massachusetts customers by Oct 1, 2026 about development of DEHP-free containers.
- Notice and public posting by Jan 1, 2028 if the entity cannot meet the deadline, explaining the inability to comply.
Affected parties and impact
- Manufacturers and distributors of intravenous solution containers and intravenous tubing used in health care settings in Massachusetts.
- Health care facilities and practitioners that use or purchase intravenous solutions and related devices.
- Patients could experience reduced exposure to DEHP and other ortho-phthalates in medical treatments, particularly during IV therapy.
- Exempted categories (per CFR-related items) remain in scope for exemptions, maintaining continuity for certain blood collection and apheresis products.
Procedural and timeline notes
- Enactment date references: Bill introduced in the 194th General Court (2025-2026 session) with actions in 2026.
- Key dates:
- 2030: Prohibition on intentionally added DEHP in IV solution containers.
- 2032: Possible compliance extension for DEHP-free containers if conditions are met.
- 2035: Prohibition on intentionally added DEHP in IV tubing.
- Administrative definitions are codified in Chapter 111, Section 245 (new section).
Overall effect
- The bill moves Massachusetts toward eliminating intentionally added DEHP in critical IV-use devices and reducing unintentional DEHP presence above a threshold, aligning with public health goals to minimize phthalate exposure in medical care.
Compiled from official sources — confirm details with the bill’s official record.
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