Bill > H7337

This bill establishes the Rhode Island Biotechnology Regulatory Sandbox Act, creating a program within the Department of Business Regulation (DBR) to allow companies to test innovative biotechnology products or services in the state for a limited time without needing all the usual licenses or state authorizations. This "regulatory sandbox" is designed to foster innovation by letting entities, referred to as "sandbox participants," test new technologies or applications under specific conditions, with the DBR consulting with other relevant state agencies, like those overseeing food, drugs, or environmental protection, to ensure safety and compliance. Applicants must go through a detailed application process, including disclosing criminal history and outlining how their product benefits consumers and manages risks, and while certain regulations can be waived, prohibitions on human genetic modification, environmental protection laws, and ethical research standards remain in place. Sandbox participants must provide clear disclosures to consumers about the testing nature of the product, potential risks, and their limited authorization, and they are not immune from civil or criminal liability. The testing period can last up to 24 months, with potential for extensions, and the DBR will report annually to the General Assembly on the program's effectiveness and any recommended regulatory reforms.

Business and Industry

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