Rhode Island 2025 Regular Session

Rhode Island House Bill H6243 Compare Versions

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55 2025 -- H 6243
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99 S T A T E O F R H O D E I S L A N D
1010 IN GENERAL ASSEMBLY
1111 JANUARY SESSION, A.D. 2025
1212 ____________
1313
1414 A N A C T
1515 RELATING TO STATE AFFAIRS AND GOVERNMENT -- RHODE ISLAND
1616 BIOTECHNOLOGY REGULA TORY SANDBOX ACT
1717 Introduced By: Representative David J. Place
1818 Date Introduced: April 23, 2025
1919 Referred To: House Corporations
2020
2121
2222 It is enacted by the General Assembly as follows:
2323 SECTION 1. Title 42 of the General Laws entitled "STATE AFFAIRS AND 1
2424 GOVERNMENT" is hereby amended by adding thereto the following chapter: 2
2525 CHAPTER 167 3
2626 RHODE ISLAND BIOTECHNOLOGY REGULATORY SANDBOX ACT 4
2727 42-167-1. Short title. 5
2828 This chapter shall be known and may be cited as the “Rhode Island Biotechnology 6
2929 Regulatory Sandbox Act.” 7
3030 42-167-2. Definitions. 8
3131 As used in this chapter: 9
3232 (1) “Applicable agency” means a department or agency of the state that by law regulates 10
3333 biotechnology-related business activity, including licensing, compliance, and consumer protection 11
3434 requirements. 12
3535 (2) “Applicant” means a biotechnology company, research institution, or entity applying 13
3636 for participation in the regulatory sandbox. 14
3737 (3) “Consumer” means any person or entity that enters into a transaction to receive a 15
3838 biotechnology product or service tested within the regulatory sandbox. 16
3939 (4) “Department” means the department of business regulation (DBR), responsible for 17
4040 overseeing the biotechnology regulatory sandbox program. 18
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4444 (5) “Innovation” means the use of emerging technology or novel applications of existing 1
4545 technology to solve industry challenges, improve efficiency, or enhance consumer access to 2
4646 biotechnology products or services. 3
4747 (6) “Innovative biotechnology product or service” means any biotechnology-related 4
4848 product or service that incorporates an innovation and requires state licensure, authorization, or 5
4949 oversight under Rhode Island law. 6
5050 (7) “Regulatory sandbox” means the biotechnology regulatory sandbox program, which 7
5151 allows approved participants to test biotechnology innovations under limited exemptions from 8
5252 certain state regulations. 9
5353 (8) “Sandbox participant” means an entity whose application has been approved to test an 10
5454 innovative biotechnology product or service within the sandbox. 11
5555 (9) “Test” means to provide an innovative biotechnology product or service under the 12
5656 conditions set forth in this chapter. 13
5757 42-167-3. Establishment of the biotechnology regulatory sandbox. 14
5858 (a) The biotechnology regulatory sandbox program is hereby established within the 15
5959 department. 16
6060 (b) In administering the biotechnology regulatory sandbox, the department: 17
6161 (1) Shall consult with each applicable agency; 18
6262 (2) Establish a program to enable a person or entity to obtain limited access to the market 19
6363 in the state to test an innovative biotechnology product or service without obtaining a license or 20
6464 other state authorization that might otherwise be required; 21
6565 (3) May enter into agreements with or follow the best practices of similar programs being 22
6666 administered in other states or federal agencies; 23
6767 (4) May not approve participation in the biotechnology regulatory sandbox by an applicant 24
6868 or any other participant who has been convicted, entered a plea of nolo contendere or entered a plea 25
6969 of guilty or nolo contendere held in abeyance, for a serious crime: 26
7070 (i) Involving theft, fraud, or dishonesty; or 27
7171 (ii) That bears a substantial relationship to the applicant’s or participant’s ability to safely 28
7272 or competently participate in the regulatory sandbox program. 29
7373 (c) The department shall coordinate with federal and state agencies to ensure sandbox 30
7474 participation aligns with federal regulatory frameworks, including those of the FDA, USDA, and 31
7575 EPA. 32
7676 42-167-4. Application process. 33
7777 (a) An applicant shall submit to the department an application that: 34
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8181 (1) Includes a nonrefundable application fee sufficient to cover administration costs; 1
8282 (2) Demonstrates the applicant is subject to the jurisdiction of the state; 2
8383 (3) Demonstrates the applicant has established a physical or virtual location that is 3
8484 adequately accessible to the department, from which testing will be developed and performed and 4
8585 where all required records, documents, and data will be maintained; 5
8686 (4) Contains relevant personal and contact information, including legal names, addresses, 6
8787 telephone numbers, email addresses, website addresses, and other information required by the 7
8888 department; 8
8989 (5) Discloses criminal convictions of the applicant or other participating personnel, if any; 9
9090 (6) Demonstrates that the applicant has the necessary personnel, financial and technical 10
9191 expertise, access to capital, and a developed plan to test, monitor, and assess the innovative 11
9292 biotechnology product or service; 12
9393 (7) Contains a description of the innovative biotechnology product or service to be tested, 13
9494 including statements regarding the following: 14
9595 (i) How the innovative biotechnology product or service is subject to licensing or other 15
9696 authorization requirements outside of the biotechnology regulatory sandbox, including a specific 16
9797 list of all state laws, regulations, and licensing or other requirements that the applicant is seeking 17
9898 to have waived during the testing period; 18
9999 (ii) How the innovative biotechnology product or service would benefit consumers; 19
100100 (iii) How the innovative biotechnology product or service is different from other 20
101101 biotechnology products or services available in the state; 21
102102 (iv) What risks may confront consumers who use or purchase the innovative biotechnology 22
103103 product or service; 23
104104 (v) How participating in the regulatory sandbox would enable a successful test of the 24
105105 innovative biotechnology product or service; 25
106106 (vi) A description of how the applicant will perform ongoing duties after the test; 26
107107 (vii) How the applicant will end the test and protect consumers if the test fails, including 27
108108 providing evidence of sufficient liability coverage and financial reserves to protect consumers and 28
109109 to protect against insolvency by the applicant; and 29
110110 (viii) Provides any other required information as determined by the department. 30
111111 (b) An applicant shall file a separate application for each innovative biotechnology product 31
112112 or service the applicant wants to test. 32
113113 (c) After the application is filed and before approving the application, the department may 33
114114 seek any additional information from the applicant that the department determines is necessary. 34
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118118 (d) Subject to subsection (e) of this section, and not later than ninety (90) days after the 1
119119 day on which a complete application is received by the department, it shall inform the applicant as 2
120120 to whether the application is approved for entry into the regulatory sandbox. 3
121121 (e) The department and an applicant may mutually agree to extend the ninety (90) day 4
122122 timeline for the department to determine whether an application is approved for entry into the 5
123123 regulatory sandbox. 6
124124 (f) The department shall consult with, and get approval from, each applicable agency before 7
125125 admitting an applicant into the regulatory sandbox. The consultation with an applicable agency 8
126126 may include seeking information about whether: 9
127127 (1) The applicable agency has previously issued a license or other authorization to the 10
128128 applicant. 11
129129 (2) The applicable agency has previously investigated, sanctioned, or pursued legal action 12
130130 against the applicant, 13
131131 (3) Whether the applicant could obtain a license or other authorization from the applicable 14
132132 agency after exiting the regulatory sandbox; and 15
133133 (4) Whether certain licensure or other regulations should not be waived even if the 16
134134 applicant is accepted into the regulatory sandbox. 17
135135 (g) In reviewing an application under this section, the department shall consider whether a 18
136136 competitor to the applicant is or has been a biotechnology sandbox participant and weigh that as a 19
137137 factor in allowing the applicant to also become a biotechnology sandbox participant. If the 20
138138 department and each applicable agency approve admitting an applicant into the biotechnology 21
139139 regulatory sandbox, an applicant may become a sandbox participant. 22
140140 (h) The department may deny any application submitted under this section, for any reason, 23
141141 in the department’s discretion. 24
142142 (i) If the department denies an application submitted under this section, it shall provide to 25
143143 the applicant a written description of the reasons for the denial as a sandbox participant. 26
144144 42-167-5. Regulatory relief and conditions. 27
145145 (a) Approved participants may receive temporary exemptions from state laws or 28
146146 regulations that were identified by the participant’s application and have been waived in writing by 29
147147 the department, except for: 30
148148 (1) Human genetic modification prohibitions (e.g., germline editing). 31
149149 (2) State or federal environmental protection laws deemed necessary. 32
150150 (3) Ethical standards for human or animal research. 33
151151 (b) The sandbox period shall not exceed twenty-four (24) months, with an option for 34
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155155 renewal based on further review. 1
156156 (c) Participants shall submit quarterly progress reports detailing compliance, risks, and 2
157157 findings. 3
158158 (d) By written notice, the department may terminate a participant’s involvement in the 4
159159 regulatory sandbox for non-compliance, unethical conduct, or public safety concerns. 5
160160 (e) A sandbox participant does not have immunity related to any criminal offense 6
161161 committed during the sandbox participant’s time in the regulatory sandbox. 7
162162 42-167-6. Consumer protections. 8
163163 (a) Before providing an innovative biotechnology product or service to a consumer, a 9
164164 sandbox participant shall disclose the following to the consumer: 10
165165 (1) The name and contact information of the sandbox participant; 11
166166 (2) That the innovative biotechnology product or service is authorized pursuant to the 12
167167 regulatory sandbox and, if applicable, that the sandbox participant does not have a license or other 13
168168 authorization to provide a biotechnology product or service under state laws that regulate 14
169169 biotechnology products outside the regulatory sandbox; 15
170170 (3) That the innovative biotechnology product or service is undergoing testing and may not 16
171171 function as intended and may expose the customer to financial risk; 17
172172 (4) That the provider of the innovative biotechnology product is not immune from civil 18
173173 liability for any losses or damages caused by the innovative biotechnology product or service; 19
174174 (5) That the state does not endorse or recommend the innovative biotechnology product or 20
175175 service; 21
176176 (6) That the innovative biotechnology product or service is a temporary test that may be 22
177177 discontinued at the end of the testing period; 23
178178 (7) The expected end date of the testing period; 24
179179 (8) That a consumer may contact the department to file a complaint regarding the 25
180180 innovative biotechnology product or service being tested and provide the department’s telephone 26
181181 number and website address where a complaint may be filed. 27
182182 (b) The disclosures required in this section shall be provided to a consumer in a clear and 28
183183 conspicuous form and, for an Internet or application-based innovative biotechnology product or 29
184184 service, a consumer shall acknowledge receipt of the disclosure before a transaction may be 30
185185 completed. 31
186186 (c) The department may require that a sandbox participant make additional disclosures to 32
187187 a consumer. 33
188188 42-167-7. Data reporting. 34
189189
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192192 (a) A sandbox participant shall retain records, documents, and data produced in the 1
193193 ordinary course of business regarding an innovative biotechnology product or service tested in the 2
194194 regulatory sandbox. 3
195195 (b) If an innovative biotechnology product or service fails before the end of a testing period, 4
196196 the sandbox participant shall notify the department and report on actions taken by the sandbox 5
197197 participant to ensure consumers have not been harmed as a result of the failure. 6
198198 (c) The department shall establish quarterly reporting requirements for a sandbox 7
199199 participant, including information about any customer complaints. 8
200200 (d) The department may request records, documents, and data from a sandbox participant 9
201201 and, upon the department’s request, a sandbox participant shall make such records, documents, and 10
202202 data available for inspection by the department. 11
203203 (e) If the department determines that a sandbox participant has engaged in, is engaging in, 12
204204 or is about to engage in any practice or transaction that is in violation of this chapter or that 13
205205 constitutes a violation of state or federal criminal law, the department may remove a sandbox 14
206206 participant from the biotechnology regulatory sandbox. 15
207207 (f) By January 1, 2027, the department shall provide an annual written report to the general 16
208208 assembly that provides: 17
209209 (1) Information regarding each biotechnology sandbox participant. 18
210210 (2) Recommendations regarding the effectiveness of the biotechnology regulatory sandbox 19
211211 program. 20
212212 (3) Potential regulatory reforms. 21
213213 42-167-8. Exit strategy and post-sandbox regulatory pathways. 22
214214 (a) At least thirty (30) days before the twenty-four (24) month sandbox period ends, a 23
215215 participant shall: 24
216216 (1) Notify the department that the sandbox participant will exit the biotechnology 25
217217 regulatory sandbox, discontinue the sandbox participant’s test, and will stop offering any 26
218218 innovative biotechnology product or service in the regulatory sandbox within sixty (60) days after 27
219219 the day on which the trial period ends; or 28
220220 (2) Seek an extension in accordance with § 42-167-9. 29
221221 (b) Subject to subsection (c) of this section, if the department does not receive notification 30
222222 as required by subsection (a) of this section, the regulatory sandbox testing period ends at the end 31
223223 of the twenty-four (24) month testing period and the sandbox participant shall immediately stop 32
224224 offering each innovative biotechnology product or service being tested. 33
225225 (c) If a test includes offering an innovative biotechnology product or service that requires 34
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229229 ongoing duties, the sandbox participant shall continue to fulfill those duties or arrange for another 1
230230 person to fulfill those duties after the date on which the sandbox participant exits the regulatory 2
231231 sandbox. 3
232232 42-167-9. Extensions. 4
233233 (a) Not later than thirty (30) days before the end of the regulatory sandbox testing period, 5
234234 a sandbox participant may request from the department an extension of the regulatory sandbox 6
235235 testing period for the purpose of obtaining a license or other authorization. 7
236236 (b) The department shall make a decision as to whether it will grant or deny the request for 8
237237 an extension by the end of the regulatory sandbox testing period. 9
238238 (c) The department may grant an extension in accordance with this section for not more 10
239239 than twelve (12) months after the end of the regulatory sandbox testing period. 11
240240 (d) A sandbox participant that obtains an extension in accordance with this section shall 12
241241 provide the department with a written report every three (3) months that provides an update on 13
242242 efforts to obtain a license or other authorization required by law, including any submissions for 14
243243 licensure or other authorization, rejected applications, or issued licenses or other authorizations. 15
244244 SECTION 2. This act shall take effect upon passage. 16
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251251 EXPLANATION
252252 BY THE LEGISLATIVE COUNCIL
253253 OF
254254 A N A C T
255255 RELATING TO STATE AFFAIRS AND GOVERNMENT -- RHODE ISLAND
256256 BIOTECHNOLOGY REGULA TORY SANDBOX ACT
257257 ***
258258 This act would establish the biotechnology regulatory sandbox program within the 1
259259 department of business regulation to enable a person or entity to obtain limited access to the market 2
260260 in the state to test an innovative biotechnology product or service without obtaining a license or 3
261261 other state authorization that might otherwise be required. 4
262262 This act would take effect upon passage. 5
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