AN ACT RELATING TO STATE AFFAIRS AND GOVERNMENT -- RHODE ISLAND BIOTECHNOLOGY REGULATORY SANDBOX ACT (Establishes the biotechnology regulatory sandbox program within the department of business regulation.)

H7337

2026 -- H 7337
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LC004327
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STATE OF RHODE ISLAND
IN GENERAL ASSEMBLY
JANUARY SESSION, A.D. 2026
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A N A C T
RELATING TO STATE AFFAIRS AND GOVERNMENT -- RHODE ISLAND
BIOTECHNOLOGY REGULATORY SANDBOX ACT

Introduced By:
Representatives Place, Fascia, Hopkins, and Santucci

Date Introduced:
January 28, 2026

Referred To:
House Corporations
It is enacted by the General Assembly as follows:
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SECTION 1. Title 42 of the General Laws entitled "STATE AFFAIRS AND
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GOVERNMENT" is hereby amended by adding thereto the following chapter:
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CHAPTER 169
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RHODE ISLAND BIOTECHNOLOGY REGULATORY SANDBOX ACT
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42-169-1. Short title.

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This chapter shall be known and may be cited as the “Rhode Island Biotechnology
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Regulatory Sandbox Act.”
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42-169-2. Definitions.

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As used in this chapter:
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(1) “Applicable agency” means a department or agency of the state that by law regulates
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biotechnology-related business activity, including licensing, compliance, and consumer protection
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requirements.
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(2) “Applicant” means a biotechnology company, research institution, or entity applying
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for participation in the regulatory sandbox.
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(3) “Consumer” means any person or entity that enters into a transaction to receive a
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biotechnology product or service tested within the regulatory sandbox.
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(4) “Department” means the department of business regulation (DBR), responsible for
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overseeing the biotechnology regulatory sandbox program.

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(5) “Innovation” means the use of emerging technology or novel applications of existing
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technology to solve industry challenges, improve efficiency, or enhance consumer access to
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biotechnology products or services.
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(6) “Innovative biotechnology product or service” means any biotechnology-related
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product or service that incorporates an innovation and requires state licensure, authorization, or
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oversight under Rhode Island law.
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(7) “Regulatory sandbox” means the biotechnology regulatory sandbox program, which
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allows approved participants to test biotechnology innovations under limited exemptions from
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certain state regulations.
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(8) “Sandbox participant” means an entity whose application has been approved to test an
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innovative biotechnology product or service within the sandbox.
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(9) “Test” means to provide an innovative biotechnology product or service under the
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conditions set forth in this chapter.
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42-169-3. Establishment of the biotechnology regulatory sandbox.

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(a) The biotechnology regulatory sandbox program is hereby established within the
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department.
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(b) In administering the biotechnology regulatory sandbox, the department:
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(1) Shall consult with each applicable agency;
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(2) Establish a program to enable a person or entity to obtain limited access to the market
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in the state to test an innovative biotechnology product or service without obtaining a license or
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other state authorization that might otherwise be required;
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(3) May enter into agreements with or follow the best practices of similar programs being
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administered in other states or federal agencies; and
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(4) Shall not approve participation in the biotechnology regulatory sandbox by an applicant
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or any other participant who has been convicted, entered a plea of nolo contendere or entered a plea
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of guilty or nolo contendere held in abeyance, for a serious crime:
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(i) Involving theft, fraud, or dishonesty; or
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(ii) That bears a substantial relationship to the applicant’s or participant’s ability to safely
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or competently participate in the regulatory sandbox program.
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(c) The department shall coordinate with federal and state agencies to ensure sandbox
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participation aligns with federal regulatory frameworks, including those of the FDA, USDA, and
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EPA.
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42-169-4. Application process.

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(a) An applicant shall submit to the department an application that:

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(1) Includes a nonrefundable application fee sufficient to cover administration costs;
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(2) Demonstrates the applicant is subject to the jurisdiction of the state;
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(3) Demonstrates the applicant has established a physical or virtual location that is
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adequately accessible to the department, from which testing will be developed and performed and
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where all required records, documents, and data will be maintained;
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(4) Contains relevant personal and contact information, including legal names, addresses,
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telephone numbers, email addresses, website addresses, and other information required by the
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department;
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(5) Discloses criminal convictions of the applicant or other participating personnel, if any;
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(6) Demonstrates that the applicant has the necessary personnel, financial and technical
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expertise, access to capital, and a developed plan to test, monitor, and assess the innovative
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biotechnology product or service; and
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(7) Contains a description of the innovative biotechnology product or service to be tested,
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including statements regarding the following:
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(i) How the innovative biotechnology product or service is subject to licensing or other
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authorization requirements outside of the biotechnology regulatory sandbox, including a specific
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list of all state laws, regulations, and licensing or other requirements that the applicant is seeking
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to have waived during the testing period;
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(ii) How the innovative biotechnology product or service would benefit consumers;
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(iii) How the innovative biotechnology product or service is different from other
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biotechnology products or services available in the state;
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(iv) What risks may confront consumers who use or purchase the innovative biotechnology
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product or service;
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(v) How participating in the regulatory sandbox would enable a successful test of the
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innovative biotechnology product or service;
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(vi) A description of how the applicant will perform ongoing duties after the test;
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(vii) How the applicant will end the test and protect consumers if the test fails, including
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providing evidence of sufficient liability coverage and financial reserves to protect consumers and
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to protect against insolvency by the applicant; and
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(viii) Provides any other required information as determined by the department.
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(b) An applicant shall file a separate application for each innovative biotechnology product
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or service the applicant wants to test.
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(c) After the application is filed and before approving the application, the department may
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seek any additional information from the applicant that the department determines is necessary.

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(d) Subject to subsection (e) of this section, and not later than ninety (90) days after the
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day on which a complete application is received by the department, it shall inform the applicant as
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to whether the application is approved for entry into the regulatory sandbox.
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(e) The department and an applicant may mutually agree to extend the ninety (90) day
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timeline for the department to determine whether an application is approved for entry into the
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regulatory sandbox.
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(f) The department shall consult with, and get approval from, each applicable agency before
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admitting an applicant into the regulatory sandbox. The consultation with an applicable agency
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may include seeking information about whether:
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(1) The applicable agency has previously issued a license or other authorization to the
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applicant;
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(2) The applicable agency has previously investigated, sanctioned, or pursued legal action
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against the applicant;
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(3) Whether the applicant could obtain a license or other authorization from the applicable
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agency after exiting the regulatory sandbox; and
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(4) Whether certain licensure or other regulations should not be waived even if the
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applicant is accepted into the regulatory sandbox.
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(g) In reviewing an application under this section, the department shall consider whether a
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competitor to the applicant is or has been a biotechnology sandbox participant and weigh that as a
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factor in allowing the applicant to also become a biotechnology sandbox participant. If the
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department and each applicable agency approve admitting an applicant into the biotechnology
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regulatory sandbox, an applicant shall become a sandbox participant.
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(h) The department may deny any application submitted under this section, for any reason,
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in the department’s discretion.
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(i) If the department denies an application submitted under this section, it shall provide to
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the applicant a written description of the reasons for the denial as a sandbox participant.
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42-169-5. Regulatory relief and conditions.

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(a) Approved participants may receive temporary exemptions from state laws or
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regulations that were identified by the participant’s application and have been waived in writing by
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the department, except for:
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(1) Human genetic modification prohibitions (e.g., germline editing).
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(2) State or federal environmental protection laws deemed necessary.
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(3) Ethical standards for human or animal research.
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(b) The sandbox period shall not exceed twenty-four (24) months, with an option for

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renewal based on further review.
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(c) Participants shall submit quarterly progress reports detailing compliance, risks, and
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findings.
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(d) By written notice, the department may terminate a participant’s involvement in the
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regulatory sandbox for non-compliance, unethical conduct, or public safety concerns.
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(e) A sandbox participant does not have immunity related to any criminal offense
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committed during the sandbox participant’s time in the regulatory sandbox.
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42-169-6. Consumer protections.

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(a) Before providing an innovative biotechnology product or service to a consumer, a
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sandbox participant shall disclose the following to the consumer:
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(1) The name and contact information of the sandbox participant;
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(2) That the innovative biotechnology product or service is authorized pursuant to the
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regulatory sandbox and, if applicable, that the sandbox participant does not have a license or other
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authorization to provide a biotechnology product or service under state laws that regulate
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biotechnology products outside the regulatory sandbox;
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(3) That the innovative biotechnology product or service is undergoing testing and may not
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function as intended and may expose the customer to financial risk;
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(4) That the provider of the innovative biotechnology product is not immune from civil
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liability for any losses or damages caused by the innovative biotechnology product or service;
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(5) That the state does not endorse or recommend the innovative biotechnology product or
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service;
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(6) That the innovative biotechnology product or service is a temporary test that may be
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discontinued at the end of the testing period;
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(7) The expected end date of the testing period; and
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(8) That a consumer may contact the department to file a complaint regarding the
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innovative biotechnology product or service being tested and provide the department’s telephone
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number and website address where a complaint may be filed.
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(b) The disclosures required in this section shall be provided to a consumer in a clear and
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conspicuous form and, for an Internet or application-based innovative biotechnology product or
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service, a consumer shall acknowledge receipt of the disclosure before a transaction shall be
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completed.
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(c) The department may require that a sandbox participant make additional disclosures to
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a consumer.
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42-169-7. Data reporting.

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(a) A sandbox participant shall retain records, documents, and data produced in the
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ordinary course of business regarding an innovative biotechnology product or service tested in the
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regulatory sandbox.
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(b) If an innovative biotechnology product or service fails before the end of a testing period,
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the sandbox participant shall notify the department and report on actions taken by the sandbox
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participant to ensure consumers have not been harmed as a result of the failure.
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(c) The department shall establish quarterly reporting requirements for a sandbox
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participant, including information about any customer complaints.
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(d) The department may request records, documents, and data from a sandbox participant
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and, upon the department’s request, a sandbox participant shall make such records, documents, and
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data available for inspection by the department.
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(e) If the department determines that a sandbox participant has engaged in, is engaging in,
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or is about to engage in any practice or transaction that is in violation of this chapter or that
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constitutes a violation of state or federal criminal law, the department may remove a sandbox
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participant from the biotechnology regulatory sandbox.
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(f) By January 1, 2028, the department shall provide an annual written report to the general
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assembly that provides:
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(1) Information regarding each biotechnology sandbox participant.
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(2) Recommendations regarding the effectiveness of the biotechnology regulatory sandbox
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program.
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(3) Potential regulatory reforms.
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42-169-8. Exit strategy and post-sandbox regulatory pathways.

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(a) At least thirty (30) days before the twenty-four (24) month sandbox period ends, a
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participant shall:
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(1) Notify the department that the sandbox participant will exit the biotechnology
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regulatory sandbox, discontinue the sandbox participant’s test, and will stop offering any
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innovative biotechnology product or service in the regulatory sandbox within sixty (60) days after
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the day on which the trial period ends; or
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(2) Seek an extension in accordance with § 42-169-9.
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(b) Subject to subsection (c) of this section, if the department does not receive notification
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as required by subsection (a) of this section, the regulatory sandbox testing period ends at the end
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of the twenty-four (24) month testing period and the sandbox participant shall immediately stop
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offering each innovative biotechnology product or service being tested.
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(c) If a test includes offering an innovative biotechnology product or service that requires

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ongoing duties, the sandbox participant shall continue to fulfill those duties or arrange for another
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person to fulfill those duties after the date on which the sandbox participant exits the regulatory
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sandbox.
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42-169-9. Extensions.

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(a) Not later than thirty (30) days before the end of the regulatory sandbox testing period,
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a sandbox participant may request from the department an extension of the regulatory sandbox
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testing period for the purpose of obtaining a license or other authorization.
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(b) The department shall make a decision as to whether it will grant or deny the request for
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an extension by the end of the regulatory sandbox testing period.
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(c) The department may grant an extension in accordance with this section for not more
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than twelve (12) months after the end of the regulatory sandbox testing period.
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(d) A sandbox participant that obtains an extension in accordance with this section shall
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provide the department with a written report every three (3) months that provides an update on
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efforts to obtain a license or other authorization required by law, including any submissions for
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licensure or other authorization, rejected applications, or issued licenses or other authorizations.
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42-169-10. Rules and regulations.

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The department shall promulgate rules and regulations necessary for the administration and
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implementation of the biotechnology regulatory sandbox program.
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SECTION 2. This act shall take effect upon passage.
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EXPLANATION
BY THE LEGISLATIVE COUNCIL
OF
A N A C T
RELATING TO STATE AFFAIRS AND GOVERNMENT -- RHODE ISLAND
BIOTECHNOLOGY REGULATORY SANDBOX ACT
***
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This act would establish the biotechnology regulatory sandbox program within the
2
department of business regulation (DBR) to enable a person or entity to obtain limited access to the
3
market in the state to test an innovative biotechnology product or service without obtaining a license
4
or other state authorization that might otherwise be required.
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This act would take effect upon passage.
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