Senate File 2154 - Introduced SENATE FILE 2154 BY CAMPBELL A BILL FOR An Act relating to the distribution of gene-based vaccines and 1 providing penalties. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 5323XS (6) 91 ak/ko
S.F. 2154 Section 1. NEW SECTION . 139A.27 Distribution of gene-based 1 vaccines —— restrictions and penalties. 2 1. For purposes of this section, unless the context 3 otherwise requires: 4 a. “Deoxyribonucleic acid contamination” means an unintended 5 residual deoxyribonucleic acid fragment remains in a 6 manufactured gene-based vaccine. 7 b. “Distribute” means the delivery of a vaccine to an 8 individual patient. 9 c. “Gene-based vaccine” means a vaccine developed using 10 messenger ribonucleic acid technology, modified messenger 11 riboucleic acid technology, self-amplifying messenger 12 ribonucleic acid technology, or deoxyribonucleic acid 13 technology. 14 d. “Shedding” means the process by which weakened components 15 of a vaccine are released from a vaccinated individual into the 16 environment. 17 e. “Transmission” means the process by which components of 18 a vaccine are spread from an individual who has been vaccinated 19 to an unvaccinated individual. 20 2. A manufacturer shall conduct integrative 21 transmissibility, deoxyribonucleic acid contamination, 22 and shedding studies prior to the distribution of a gene-based 23 vaccine within the state. 24 3. A person that distributes within the state a gene-based 25 vaccine that poses an unreasonable risk of harm to public 26 health through transmission or shedding as determined by the 27 United States food and drug administration may be subject to 28 a fine of one thousand dollars per occurrence, and licensee 29 discipline pursuant to section 148.6, if applicable. 30 4. A manufacturer that distributes, sells, or uses a 31 gene-based vaccine within the state shall not be immune from 32 liability arising from injury or death caused by a design 33 defect in the gene-based vaccine. 34 5. The department of inspections, appeals, and licensing 35 -1- LSB 5323XS (6) 91 ak/ko 1/ 2
S.F. 2154 shall promulgate rules pursuant to chapter 17A to enforce and 1 administer this section. 2 EXPLANATION 3 The inclusion of this explanation does not constitute agreement with 4 the explanation’s substance by the members of the general assembly. 5 This bill relates to the distribution of gene-based 6 vaccines. The bill defines “deoxyribonucleic acid 7 contamination”, “distribute”, “gene-based vaccine”, “shedding”, 8 and “transmission”. 9 The bill requires a manufacturer of gene-based vaccines to 10 conduct integrative transmissibility, deoxyribonucleic acid 11 contamination, and shedding studies prior to the distribution 12 of a gene-based vaccine within the state. 13 The bill provides that any person that distributes a 14 gene-based vaccine within the state posing an unreasonable 15 risk of harm to public health, as determined by the United 16 States food and drug administration, due to transmission 17 or shedding is subject to a $1,000 fine per occurrence and 18 licensing discipline by the appropriate licensing authority, 19 if applicable. 20 The bill provides that a manufacturer that distributes, 21 sells, or uses a gene-based vaccine within the state is not 22 immune from liability for injury or death caused by a design 23 defect in the gene-based vaccine. 24 The bill directs to the department of inspections, appeals, 25 and licensing to adopt rules to enforce and administer the 26 bill. 27 -2- LSB 5323XS (6) 91 ak/ko 2/ 2