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| 4 | 4 | | |
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| 5 | 5 | | 2025 -- H 6243 |
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| 6 | 6 | | ======== |
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| 7 | 7 | | LC002741 |
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| 8 | 8 | | ======== |
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| 9 | 9 | | S T A T E O F R H O D E I S L A N D |
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| 10 | 10 | | IN GENERAL ASSEMBLY |
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| 11 | 11 | | JANUARY SESSION, A.D. 2025 |
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| 12 | 12 | | ____________ |
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| 13 | 13 | | |
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| 14 | 14 | | A N A C T |
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| 15 | 15 | | RELATING TO STATE AFFAIRS AND GOVERNMENT -- RHODE ISLAND |
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| 16 | 16 | | BIOTECHNOLOGY REGULA TORY SANDBOX ACT |
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| 17 | 17 | | Introduced By: Representative David J. Place |
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| 18 | 18 | | Date Introduced: April 23, 2025 |
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| 19 | 19 | | Referred To: House Corporations |
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| 20 | 20 | | |
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| 21 | 21 | | |
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| 22 | 22 | | It is enacted by the General Assembly as follows: |
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| 23 | 23 | | SECTION 1. Title 42 of the General Laws entitled "STATE AFFAIRS AND 1 |
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| 24 | 24 | | GOVERNMENT" is hereby amended by adding thereto the following chapter: 2 |
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| 25 | 25 | | CHAPTER 167 3 |
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| 26 | 26 | | RHODE ISLAND BIOTECHNOLOGY REGULATORY SANDBOX ACT 4 |
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| 27 | 27 | | 42-167-1. Short title. 5 |
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| 28 | 28 | | This chapter shall be known and may be cited as the “Rhode Island Biotechnology 6 |
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| 29 | 29 | | Regulatory Sandbox Act.” 7 |
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| 30 | 30 | | 42-167-2. Definitions. 8 |
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| 31 | 31 | | As used in this chapter: 9 |
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| 32 | 32 | | (1) “Applicable agency” means a department or agency of the state that by law regulates 10 |
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| 33 | 33 | | biotechnology-related business activity, including licensing, compliance, and consumer protection 11 |
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| 34 | 34 | | requirements. 12 |
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| 35 | 35 | | (2) “Applicant” means a biotechnology company, research institution, or entity applying 13 |
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| 36 | 36 | | for participation in the regulatory sandbox. 14 |
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| 37 | 37 | | (3) “Consumer” means any person or entity that enters into a transaction to receive a 15 |
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| 38 | 38 | | biotechnology product or service tested within the regulatory sandbox. 16 |
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| 39 | 39 | | (4) “Department” means the department of business regulation (DBR), responsible for 17 |
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| 40 | 40 | | overseeing the biotechnology regulatory sandbox program. 18 |
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| 41 | 41 | | |
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| 42 | 42 | | |
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| 43 | 43 | | LC002741 - Page 2 of 8 |
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| 44 | 44 | | (5) “Innovation” means the use of emerging technology or novel applications of existing 1 |
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| 45 | 45 | | technology to solve industry challenges, improve efficiency, or enhance consumer access to 2 |
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| 46 | 46 | | biotechnology products or services. 3 |
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| 47 | 47 | | (6) “Innovative biotechnology product or service” means any biotechnology-related 4 |
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| 48 | 48 | | product or service that incorporates an innovation and requires state licensure, authorization, or 5 |
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| 49 | 49 | | oversight under Rhode Island law. 6 |
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| 50 | 50 | | (7) “Regulatory sandbox” means the biotechnology regulatory sandbox program, which 7 |
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| 51 | 51 | | allows approved participants to test biotechnology innovations under limited exemptions from 8 |
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| 52 | 52 | | certain state regulations. 9 |
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| 53 | 53 | | (8) “Sandbox participant” means an entity whose application has been approved to test an 10 |
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| 54 | 54 | | innovative biotechnology product or service within the sandbox. 11 |
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| 55 | 55 | | (9) “Test” means to provide an innovative biotechnology product or service under the 12 |
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| 56 | 56 | | conditions set forth in this chapter. 13 |
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| 57 | 57 | | 42-167-3. Establishment of the biotechnology regulatory sandbox. 14 |
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| 58 | 58 | | (a) The biotechnology regulatory sandbox program is hereby established within the 15 |
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| 59 | 59 | | department. 16 |
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| 60 | 60 | | (b) In administering the biotechnology regulatory sandbox, the department: 17 |
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| 61 | 61 | | (1) Shall consult with each applicable agency; 18 |
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| 62 | 62 | | (2) Establish a program to enable a person or entity to obtain limited access to the market 19 |
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| 63 | 63 | | in the state to test an innovative biotechnology product or service without obtaining a license or 20 |
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| 64 | 64 | | other state authorization that might otherwise be required; 21 |
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| 65 | 65 | | (3) May enter into agreements with or follow the best practices of similar programs being 22 |
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| 66 | 66 | | administered in other states or federal agencies; 23 |
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| 67 | 67 | | (4) May not approve participation in the biotechnology regulatory sandbox by an applicant 24 |
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| 68 | 68 | | or any other participant who has been convicted, entered a plea of nolo contendere or entered a plea 25 |
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| 69 | 69 | | of guilty or nolo contendere held in abeyance, for a serious crime: 26 |
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| 70 | 70 | | (i) Involving theft, fraud, or dishonesty; or 27 |
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| 71 | 71 | | (ii) That bears a substantial relationship to the applicant’s or participant’s ability to safely 28 |
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| 72 | 72 | | or competently participate in the regulatory sandbox program. 29 |
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| 73 | 73 | | (c) The department shall coordinate with federal and state agencies to ensure sandbox 30 |
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| 74 | 74 | | participation aligns with federal regulatory frameworks, including those of the FDA, USDA, and 31 |
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| 75 | 75 | | EPA. 32 |
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| 76 | 76 | | 42-167-4. Application process. 33 |
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| 77 | 77 | | (a) An applicant shall submit to the department an application that: 34 |
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| 78 | 78 | | |
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| 79 | 79 | | |
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| 80 | 80 | | LC002741 - Page 3 of 8 |
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| 81 | 81 | | (1) Includes a nonrefundable application fee sufficient to cover administration costs; 1 |
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| 82 | 82 | | (2) Demonstrates the applicant is subject to the jurisdiction of the state; 2 |
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| 83 | 83 | | (3) Demonstrates the applicant has established a physical or virtual location that is 3 |
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| 84 | 84 | | adequately accessible to the department, from which testing will be developed and performed and 4 |
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| 85 | 85 | | where all required records, documents, and data will be maintained; 5 |
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| 86 | 86 | | (4) Contains relevant personal and contact information, including legal names, addresses, 6 |
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| 87 | 87 | | telephone numbers, email addresses, website addresses, and other information required by the 7 |
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| 88 | 88 | | department; 8 |
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| 89 | 89 | | (5) Discloses criminal convictions of the applicant or other participating personnel, if any; 9 |
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| 90 | 90 | | (6) Demonstrates that the applicant has the necessary personnel, financial and technical 10 |
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| 91 | 91 | | expertise, access to capital, and a developed plan to test, monitor, and assess the innovative 11 |
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| 92 | 92 | | biotechnology product or service; 12 |
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| 93 | 93 | | (7) Contains a description of the innovative biotechnology product or service to be tested, 13 |
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| 94 | 94 | | including statements regarding the following: 14 |
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| 95 | 95 | | (i) How the innovative biotechnology product or service is subject to licensing or other 15 |
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| 96 | 96 | | authorization requirements outside of the biotechnology regulatory sandbox, including a specific 16 |
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| 97 | 97 | | list of all state laws, regulations, and licensing or other requirements that the applicant is seeking 17 |
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| 98 | 98 | | to have waived during the testing period; 18 |
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| 99 | 99 | | (ii) How the innovative biotechnology product or service would benefit consumers; 19 |
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| 100 | 100 | | (iii) How the innovative biotechnology product or service is different from other 20 |
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| 101 | 101 | | biotechnology products or services available in the state; 21 |
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| 102 | 102 | | (iv) What risks may confront consumers who use or purchase the innovative biotechnology 22 |
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| 103 | 103 | | product or service; 23 |
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| 104 | 104 | | (v) How participating in the regulatory sandbox would enable a successful test of the 24 |
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| 105 | 105 | | innovative biotechnology product or service; 25 |
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| 106 | 106 | | (vi) A description of how the applicant will perform ongoing duties after the test; 26 |
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| 107 | 107 | | (vii) How the applicant will end the test and protect consumers if the test fails, including 27 |
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| 108 | 108 | | providing evidence of sufficient liability coverage and financial reserves to protect consumers and 28 |
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| 109 | 109 | | to protect against insolvency by the applicant; and 29 |
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| 110 | 110 | | (viii) Provides any other required information as determined by the department. 30 |
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| 111 | 111 | | (b) An applicant shall file a separate application for each innovative biotechnology product 31 |
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| 112 | 112 | | or service the applicant wants to test. 32 |
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| 113 | 113 | | (c) After the application is filed and before approving the application, the department may 33 |
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| 114 | 114 | | seek any additional information from the applicant that the department determines is necessary. 34 |
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| 115 | 115 | | |
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| 116 | 116 | | |
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| 117 | 117 | | LC002741 - Page 4 of 8 |
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| 118 | 118 | | (d) Subject to subsection (e) of this section, and not later than ninety (90) days after the 1 |
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| 119 | 119 | | day on which a complete application is received by the department, it shall inform the applicant as 2 |
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| 120 | 120 | | to whether the application is approved for entry into the regulatory sandbox. 3 |
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| 121 | 121 | | (e) The department and an applicant may mutually agree to extend the ninety (90) day 4 |
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| 122 | 122 | | timeline for the department to determine whether an application is approved for entry into the 5 |
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| 123 | 123 | | regulatory sandbox. 6 |
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| 124 | 124 | | (f) The department shall consult with, and get approval from, each applicable agency before 7 |
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| 125 | 125 | | admitting an applicant into the regulatory sandbox. The consultation with an applicable agency 8 |
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| 126 | 126 | | may include seeking information about whether: 9 |
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| 127 | 127 | | (1) The applicable agency has previously issued a license or other authorization to the 10 |
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| 128 | 128 | | applicant. 11 |
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| 129 | 129 | | (2) The applicable agency has previously investigated, sanctioned, or pursued legal action 12 |
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| 130 | 130 | | against the applicant, 13 |
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| 131 | 131 | | (3) Whether the applicant could obtain a license or other authorization from the applicable 14 |
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| 132 | 132 | | agency after exiting the regulatory sandbox; and 15 |
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| 133 | 133 | | (4) Whether certain licensure or other regulations should not be waived even if the 16 |
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| 134 | 134 | | applicant is accepted into the regulatory sandbox. 17 |
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| 135 | 135 | | (g) In reviewing an application under this section, the department shall consider whether a 18 |
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| 136 | 136 | | competitor to the applicant is or has been a biotechnology sandbox participant and weigh that as a 19 |
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| 137 | 137 | | factor in allowing the applicant to also become a biotechnology sandbox participant. If the 20 |
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| 138 | 138 | | department and each applicable agency approve admitting an applicant into the biotechnology 21 |
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| 139 | 139 | | regulatory sandbox, an applicant may become a sandbox participant. 22 |
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| 140 | 140 | | (h) The department may deny any application submitted under this section, for any reason, 23 |
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| 141 | 141 | | in the department’s discretion. 24 |
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| 142 | 142 | | (i) If the department denies an application submitted under this section, it shall provide to 25 |
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| 143 | 143 | | the applicant a written description of the reasons for the denial as a sandbox participant. 26 |
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| 144 | 144 | | 42-167-5. Regulatory relief and conditions. 27 |
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| 145 | 145 | | (a) Approved participants may receive temporary exemptions from state laws or 28 |
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| 146 | 146 | | regulations that were identified by the participant’s application and have been waived in writing by 29 |
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| 147 | 147 | | the department, except for: 30 |
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| 148 | 148 | | (1) Human genetic modification prohibitions (e.g., germline editing). 31 |
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| 149 | 149 | | (2) State or federal environmental protection laws deemed necessary. 32 |
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| 150 | 150 | | (3) Ethical standards for human or animal research. 33 |
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| 151 | 151 | | (b) The sandbox period shall not exceed twenty-four (24) months, with an option for 34 |
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| 152 | 152 | | |
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| 153 | 153 | | |
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| 154 | 154 | | LC002741 - Page 5 of 8 |
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| 155 | 155 | | renewal based on further review. 1 |
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| 156 | 156 | | (c) Participants shall submit quarterly progress reports detailing compliance, risks, and 2 |
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| 157 | 157 | | findings. 3 |
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| 158 | 158 | | (d) By written notice, the department may terminate a participant’s involvement in the 4 |
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| 159 | 159 | | regulatory sandbox for non-compliance, unethical conduct, or public safety concerns. 5 |
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| 160 | 160 | | (e) A sandbox participant does not have immunity related to any criminal offense 6 |
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| 161 | 161 | | committed during the sandbox participant’s time in the regulatory sandbox. 7 |
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| 162 | 162 | | 42-167-6. Consumer protections. 8 |
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| 163 | 163 | | (a) Before providing an innovative biotechnology product or service to a consumer, a 9 |
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| 164 | 164 | | sandbox participant shall disclose the following to the consumer: 10 |
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| 165 | 165 | | (1) The name and contact information of the sandbox participant; 11 |
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| 166 | 166 | | (2) That the innovative biotechnology product or service is authorized pursuant to the 12 |
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| 167 | 167 | | regulatory sandbox and, if applicable, that the sandbox participant does not have a license or other 13 |
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| 168 | 168 | | authorization to provide a biotechnology product or service under state laws that regulate 14 |
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| 169 | 169 | | biotechnology products outside the regulatory sandbox; 15 |
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| 170 | 170 | | (3) That the innovative biotechnology product or service is undergoing testing and may not 16 |
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| 171 | 171 | | function as intended and may expose the customer to financial risk; 17 |
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| 172 | 172 | | (4) That the provider of the innovative biotechnology product is not immune from civil 18 |
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| 173 | 173 | | liability for any losses or damages caused by the innovative biotechnology product or service; 19 |
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| 174 | 174 | | (5) That the state does not endorse or recommend the innovative biotechnology product or 20 |
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| 175 | 175 | | service; 21 |
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| 176 | 176 | | (6) That the innovative biotechnology product or service is a temporary test that may be 22 |
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| 177 | 177 | | discontinued at the end of the testing period; 23 |
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| 178 | 178 | | (7) The expected end date of the testing period; 24 |
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| 179 | 179 | | (8) That a consumer may contact the department to file a complaint regarding the 25 |
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| 180 | 180 | | innovative biotechnology product or service being tested and provide the department’s telephone 26 |
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| 181 | 181 | | number and website address where a complaint may be filed. 27 |
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| 182 | 182 | | (b) The disclosures required in this section shall be provided to a consumer in a clear and 28 |
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| 183 | 183 | | conspicuous form and, for an Internet or application-based innovative biotechnology product or 29 |
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| 184 | 184 | | service, a consumer shall acknowledge receipt of the disclosure before a transaction may be 30 |
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| 185 | 185 | | completed. 31 |
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| 186 | 186 | | (c) The department may require that a sandbox participant make additional disclosures to 32 |
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| 187 | 187 | | a consumer. 33 |
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| 188 | 188 | | 42-167-7. Data reporting. 34 |
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| 189 | 189 | | |
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| 190 | 190 | | |
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| 191 | 191 | | LC002741 - Page 6 of 8 |
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| 192 | 192 | | (a) A sandbox participant shall retain records, documents, and data produced in the 1 |
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| 193 | 193 | | ordinary course of business regarding an innovative biotechnology product or service tested in the 2 |
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| 194 | 194 | | regulatory sandbox. 3 |
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| 195 | 195 | | (b) If an innovative biotechnology product or service fails before the end of a testing period, 4 |
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| 196 | 196 | | the sandbox participant shall notify the department and report on actions taken by the sandbox 5 |
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| 197 | 197 | | participant to ensure consumers have not been harmed as a result of the failure. 6 |
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| 198 | 198 | | (c) The department shall establish quarterly reporting requirements for a sandbox 7 |
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| 199 | 199 | | participant, including information about any customer complaints. 8 |
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| 200 | 200 | | (d) The department may request records, documents, and data from a sandbox participant 9 |
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| 201 | 201 | | and, upon the department’s request, a sandbox participant shall make such records, documents, and 10 |
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| 202 | 202 | | data available for inspection by the department. 11 |
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| 203 | 203 | | (e) If the department determines that a sandbox participant has engaged in, is engaging in, 12 |
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| 204 | 204 | | or is about to engage in any practice or transaction that is in violation of this chapter or that 13 |
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| 205 | 205 | | constitutes a violation of state or federal criminal law, the department may remove a sandbox 14 |
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| 206 | 206 | | participant from the biotechnology regulatory sandbox. 15 |
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| 207 | 207 | | (f) By January 1, 2027, the department shall provide an annual written report to the general 16 |
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| 208 | 208 | | assembly that provides: 17 |
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| 209 | 209 | | (1) Information regarding each biotechnology sandbox participant. 18 |
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| 210 | 210 | | (2) Recommendations regarding the effectiveness of the biotechnology regulatory sandbox 19 |
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| 211 | 211 | | program. 20 |
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| 212 | 212 | | (3) Potential regulatory reforms. 21 |
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| 213 | 213 | | 42-167-8. Exit strategy and post-sandbox regulatory pathways. 22 |
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| 214 | 214 | | (a) At least thirty (30) days before the twenty-four (24) month sandbox period ends, a 23 |
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| 215 | 215 | | participant shall: 24 |
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| 216 | 216 | | (1) Notify the department that the sandbox participant will exit the biotechnology 25 |
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| 217 | 217 | | regulatory sandbox, discontinue the sandbox participant’s test, and will stop offering any 26 |
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| 218 | 218 | | innovative biotechnology product or service in the regulatory sandbox within sixty (60) days after 27 |
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| 219 | 219 | | the day on which the trial period ends; or 28 |
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| 220 | 220 | | (2) Seek an extension in accordance with § 42-167-9. 29 |
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| 221 | 221 | | (b) Subject to subsection (c) of this section, if the department does not receive notification 30 |
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| 222 | 222 | | as required by subsection (a) of this section, the regulatory sandbox testing period ends at the end 31 |
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| 223 | 223 | | of the twenty-four (24) month testing period and the sandbox participant shall immediately stop 32 |
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| 224 | 224 | | offering each innovative biotechnology product or service being tested. 33 |
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| 225 | 225 | | (c) If a test includes offering an innovative biotechnology product or service that requires 34 |
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| 226 | 226 | | |
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| 227 | 227 | | |
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| 228 | 228 | | LC002741 - Page 7 of 8 |
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| 229 | 229 | | ongoing duties, the sandbox participant shall continue to fulfill those duties or arrange for another 1 |
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| 230 | 230 | | person to fulfill those duties after the date on which the sandbox participant exits the regulatory 2 |
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| 231 | 231 | | sandbox. 3 |
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| 232 | 232 | | 42-167-9. Extensions. 4 |
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| 233 | 233 | | (a) Not later than thirty (30) days before the end of the regulatory sandbox testing period, 5 |
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| 234 | 234 | | a sandbox participant may request from the department an extension of the regulatory sandbox 6 |
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| 235 | 235 | | testing period for the purpose of obtaining a license or other authorization. 7 |
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| 236 | 236 | | (b) The department shall make a decision as to whether it will grant or deny the request for 8 |
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| 237 | 237 | | an extension by the end of the regulatory sandbox testing period. 9 |
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| 238 | 238 | | (c) The department may grant an extension in accordance with this section for not more 10 |
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| 239 | 239 | | than twelve (12) months after the end of the regulatory sandbox testing period. 11 |
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| 240 | 240 | | (d) A sandbox participant that obtains an extension in accordance with this section shall 12 |
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| 241 | 241 | | provide the department with a written report every three (3) months that provides an update on 13 |
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| 242 | 242 | | efforts to obtain a license or other authorization required by law, including any submissions for 14 |
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| 243 | 243 | | licensure or other authorization, rejected applications, or issued licenses or other authorizations. 15 |
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| 244 | 244 | | SECTION 2. This act shall take effect upon passage. 16 |
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| 245 | 245 | | ======== |
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| 246 | 246 | | LC002741 |
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| 247 | 247 | | ======== |
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| 248 | 248 | | |
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| 249 | 249 | | |
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| 250 | 250 | | LC002741 - Page 8 of 8 |
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| 251 | 251 | | EXPLANATION |
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| 252 | 252 | | BY THE LEGISLATIVE COUNCIL |
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| 253 | 253 | | OF |
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| 254 | 254 | | A N A C T |
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| 255 | 255 | | RELATING TO STATE AFFAIRS AND GOVERNMENT -- RHODE ISLAND |
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| 256 | 256 | | BIOTECHNOLOGY REGULA TORY SANDBOX ACT |
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| 257 | 257 | | *** |
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| 258 | 258 | | This act would establish the biotechnology regulatory sandbox program within the 1 |
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| 259 | 259 | | department of business regulation to enable a person or entity to obtain limited access to the market 2 |
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| 260 | 260 | | in the state to test an innovative biotechnology product or service without obtaining a license or 3 |
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| 261 | 261 | | other state authorization that might otherwise be required. 4 |
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| 262 | 262 | | This act would take effect upon passage. 5 |
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| 263 | 263 | | ======== |
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| 264 | 264 | | LC002741 |
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| 265 | 265 | | ======== |
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