WeVote
Log In

Bill

Bill

HB 6243

AN ACT RELATING TO STATE AFFAIRS AND GOVERNMENT -- RHODE ISLAND BIOTECHNOLOGY REGULATORY SANDBOX ACT

2025 Regular Session Introduced by David Place

Establishes RI's Biotechnology Regulatory Sandbox to test innovative biotech products under limited waivers, overseen by DBR with agency coordination and consumer protections.

04/23/2025 Introduced, referred to House Corporations
0
WeVote Research Nonpartisan
Bill Summary · HB 6243

Summary — HB 6243: Rhode Island Biotechnology Regulatory Sandbox Act

Status: Introduced April 23, 2025 (referred to House Corporations)
Introduced by: Representative David J. Place (bill text LC002741)

Note: The materials provided included an unrelated Michigan statutory excerpt; this summary addresses the Rhode Island “Rhode Island Biotechnology Regulatory Sandbox Act” (LC002741 / HB 6243).

Purpose

Establish a state-run “biotechnology regulatory sandbox” to allow qualified biotechnology companies, research institutions, or other entities to test innovative biotechnology products or services in Rhode Island under limited, time‑bound exemptions from certain state licensing, authorization, or regulatory requirements. The goal is to encourage innovation and market testing while maintaining consumer protections and coordination with applicable state and federal regulators.

Key provisions

  • Creates Chapter 167 in Title 42: “Rhode Island Biotechnology Regulatory Sandbox Act.”
  • Designates the Department of Business Regulation (DBR) to administer the sandbox program and to consult with state agencies that regulate biotechnology-related activity.
  • Requires coordination with federal agencies (FDA, USDA, EPA) to align sandbox testing with federal regulatory frameworks.
  • Authorizes DBR to adopt best practices/agreements consistent with other jurisdictional sandboxes.

Application and admission process

  • Applicants must submit a separate application for each product/service, including:
    • Nonrefundable application fee (to cover admin costs).
    • Evidence of state jurisdiction and a physical/virtual site for testing and recordkeeping.
    • Contact and personnel information; disclosure of criminal convictions.
    • Technical, financial, and operational plans for testing, monitoring, risk management, consumer protections, and post‑test transition or wind‑down.
    • A specific list of state laws, regulations, or licensing requirements for which waivers are requested.
    • Proof of liability coverage and financial reserves to protect consumers.
  • DBR must notify applicants whether accepted within 90 days of receiving a complete application (timeline may be mutually extended).
  • DBR must consult and obtain approval from each applicable state agency before admitting an applicant; agencies may flag requirements that should not be waived.
  • Applicants with convictions for serious crimes involving theft, fraud, dishonesty, or crimes bearing on safety/competence are ineligible.

Eligibility & restrictions

  • Sandbox open to biotechnology companies, research institutions, and similar entities subject to Rhode Island jurisdiction.
  • Consumer protections required (risk disclosures, liability coverage, plans for failure/exit).
  • DBR will consider whether competitors have participated previously when reviewing applications.

Who is affected

  • Directly: biotech firms and research entities seeking to pilot novel biotech products/services in Rhode Island.
  • Indirectly: consumers receiving sandbox-tested products, DBR and other state regulatory agencies, and potentially federal regulators.
  • Economic actors: may encourage investment, local testing, and commercialization activity.

Potential impacts and considerations

  • Pros: lowers regulatory barriers to pilot novel biotech, may speed innovation and local economic development, creates structured oversight for experiments in the market.
  • Cons/risks: consumer safety and public‑health concerns if waivers are broad; potential conflicts with federal law; need for robust monitoring, liability protections, and interagency coordination.
  • The bill mandates safeguards (disclosures, liability coverage, agency consultation) but leaves implementation details (scope of waivers, monitoring mechanisms, duration/limits of tests) to DBR rulemaking or later sections of the statute.

Timeline / Next steps

  • DBR must act on complete applications within 90 days (unless extended by mutual agreement).
  • Procedural status: introduced and referred to House Corporations (4/23/2025). Further committee review, hearings, and potential amendments expected before any advancement.

If you want, I can extract and summarize specific application form requirements or draft a one‑page checklist for prospective sandbox applicants.

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

Sign in to ask a question.