SF 2154 (LSB 5323XS (6) 91)

SENATE FILE 2154

BY  CAMPBELL

A BILL FOR

An Act relating to the distribution of gene-based vaccines and providing penalties.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

    Section 1.  NEW SECTION.  139A.27  Distribution of gene-based vaccines —— restrictions and penalties.
   1.  For purposes of this section, unless the context otherwise requires:
   a.  “Deoxyribonucleic acid contamination” means an unintended residual deoxyribonucleic acid fragment remains in a manufactured gene-based vaccine.
   b.  “Distribute” means the delivery of a vaccine to an individual patient.
   c.  “Gene-based vaccine” means a vaccine developed using messenger ribonucleic acid technology, modified messenger riboucleic acid technology, self-amplifying messenger ribonucleic acid technology, or deoxyribonucleic acid technology.
   d.  “Shedding” means the process by which weakened components of a vaccine are released from a vaccinated individual into the environment.
   e.  “Transmission” means the process by which components of a vaccine are spread from an individual who has been vaccinated to an unvaccinated individual.
   2.  A manufacturer shall conduct integrative transmissibility, deoxyribonucleic acid contamination, and shedding studies prior to the distribution of a gene-based vaccine within the state.
   3.  A person that distributes within the state a gene-based vaccine that poses an unreasonable risk of harm to public health through transmission or shedding as determined by the United States food and drug administration may be subject to a fine of one thousand dollars per occurrence, and licensee discipline pursuant to section 148.6, if applicable.
   4.  A manufacturer that distributes, sells, or uses a gene-based vaccine within the state shall not be immune from liability arising from injury or death caused by a design defect in the gene-based vaccine.
   5.  The department of inspections, appeals, and licensing shall promulgate rules pursuant to chapter 17A to enforce and administer this section.
EXPLANATION
The inclusion of this explanation does not constitute agreement with
the explanation’s substance by the members of the general assembly.
   This bill relates to the distribution of gene-based vaccines. The bill defines “deoxyribonucleic acid contamination”, “distribute”, “gene-based vaccine”, “shedding”, and “transmission”.
   The bill requires a manufacturer of gene-based vaccines to conduct integrative transmissibility, deoxyribonucleic acid contamination, and shedding studies prior to the distribution of a gene-based vaccine within the state.
   The bill provides that any person that distributes a gene-based vaccine within the state posing an unreasonable risk of harm to public health, as determined by the United States food and drug administration, due to transmission or shedding is subject to a $1,000 fine per occurrence and licensing discipline by the appropriate licensing authority, if applicable.
   The bill provides that a manufacturer that distributes, sells, or uses a gene-based vaccine within the state is not immune from liability for injury or death caused by a design defect in the gene-based vaccine.
   The bill directs to the department of inspections, appeals, and licensing to adopt rules to enforce and administer the bill.