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SB 1301

An Act amending the act of December 5, 1936 (2nd Sp.Sess., 1937 P.L.2897, No.1), known as the Unemployment Compensation Law, in preliminary provisions, further providing for definitions.

2025-2026 Regular Session Introduced by Carolyn Comitta and 5 co-sponsors

Prohibits intentional DEHP in IV solution containers from 2026 and in IV tubing (staged to all tubing by 2031), forbids ortho-phthalate substitutions, with patient notice requireme

Referred to Labor & Industry
0
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Bill Summary · SB 1301

Summary of Pennsylvania SB 1301 (2025-2026)

Purpose and Intent

  • SB 1301 aims to reduce exposure to certain toxic chemicals in medical devices by restricting the use of di(2-ethylhexyl) phthalate (DEHP) and other ortho-phthalates in specific medical device components.
  • The bill creates a new Chapter 58A, Medical Devices, within Title 35 (Health and Safety) to prohibit the use of intentionally added DEHP in intravenous solutions containers and intravenous tubing, with staged phase-in dates and consumer-provider notification requirements.

Key Provisions

Scope and Definitions

  • Establishes definitions specific to the subchapter, including:
    • DEHP (the common plasticizer in PVC)
    • Ortho-phthalate (a broader class that includes DEHP and other phthalates)
    • Intravenous solution container (IV bags, etc.)
    • Intravenous tubing
    • Health care practitioner, patient, and related terms to clarify who is protected and who must comply

Prohibitions (Procurement and Use)

  • Intravenous solution containers:
    • Beginning January 1, 2026, manufacturers, sellers, and distributors may not manufacture, sell, or distribute intravenous solution containers made with an intentionally added DEHP.
  • Intravenous tubing:
    • Beginning January 1, 2026, IV tubing used in neonatal intensive care units (NICUs) or for nutrition or oncology infusions may not be manufactured, sold, or distributed if it contains intentionally added DEHP.
    • Beginning January 1, 2031, IV tubing may not be manufactured, sold, or distributed if it contains intentionally added DEHP (expansion beyond NICU/nutrition/oncology to all IV tubing).
  • Replacement prohibition:
    • A person may not replace DEHP with another ortho-phthalate in a new or revised medical device, effectively limiting substitution with other ortho-phthalates.

Notice Requirements

  • Health care practitioners must inform patients prior to using IV solution containers or IV tubing that contain DEHP or other ortho-phthalates.
  • Notice must include at least:
    • The risks associated with exposure to DEHP and ortho-phthalates.
    • The patient’s right to request an IV solution container or IV tubing free from DEHP and other ortho-phthalates.

Affected Parties

  • Medical device manufacturers, distributors, and retailers that produce or supply intravenous solution containers and intravenous tubing.
  • Health care providers and facilities that administer IV solutions or use IV tubing (e.g., hospitals, clinics, NICUs, outpatient facilities).
  • Patients receiving IV therapy where DEHP-containing devices might be used.

Effective Date and Implementation

  • The act takes effect 90 days after enactment.
  • Specific prohibition dates:
    • January 1, 2026: Prohibition on DEHP in IV solution containers and NICU/nutrition/oncology IV tubing.
    • January 1, 2031: Prohibition on DEHP in all IV tubing (beyond the NICU/nutrition/oncology scope).
  • Notice requirements apply to patient interactions when DEHP-containing devices are used.

Potential Impacts (High-Level)

  • Public health protection: Reduces potential DEHP exposure from IV solutions and tubing, addressing concerns about DEHP’s endocrine-disrupting properties and potential links to reproductive and developmental effects.
  • Industry adjustments: Manufacturers may need to reformulate or replace DEHP-containing components with DEHP-free or alternative materials; suppliers may need to certify compliance.
  • Healthcare decision-making: Patients and providers gain the option to request DEHP-free devices, supported by required disclosures.

Summary

SB 1301 creates a new regulatory framework to prohibit intentional DEHP use in intravenous solution containers starting 2026 and in IV tubing in stages (2026 for NICU/nutrition/oncology; 2031 for all IV tubing), while prohibiting substitutions with other ortho-phthalates in new or revised devices. It imposes patient notification requirements about DEHP/ortho-phthalate exposure and expands protections for patients through informed consent in IV care. The act becomes effective 90 days after enactment.

Compiled from official sources — confirm details with the bill’s official record.

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