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UPDATE: 4/15/2024 - HB 229 died, it failed to be referred to a standing committee by the House Committee on Committees before the session ended on 4/15/2024.
HB 229 was introduced in the House and referred to the House Committee on Committees on 1/10/2024. This bill is sponsored by Representative Emily Callaway.
HB 229 adds a new section of code to Kentucky Revised Statutes Chapter 217 related to Food, Drugs, and Cosmetics that defines terms; requires gene therapy products, or those that could act as gene therapy products, to be labeled "Gene Therapy Product," or "Potential Gene Therapy Product;" requires any entity within the state that produces, sells or distributes a product in Kentucky with the capacity to infect an individual with a disease or to expose an individual to genetically modified material to provide information upon request on how individuals may be exposed; and requires informed consent before any entity makes available a product in Kentucky that would act as a medical intervention, vaccine, drug, or genetic modification.
Subsection 1 defines the terms used in the bill and are summarized as follows:
(a) "Expose" means to transmit to another person via skin-to-skin contact, sexual contact, ingestion, or other means;
(b) "Gene therapy product" means any product with the ability to interfere with or act in a similar manner to genetic material;
(c) "Genetically modified" means the alteration of genetic material through biotechnology, directed evolution, or other unnatural mechanisms; and
(d) "Product" means any product that meets the following criteria:
1. A food, cosmetic, drug, or other substance that is intended for digestion or application onto or into the human body or intended to induce physiological effects; and
2. Made available for sale in the Commonwealth of Kentucky to the general public at retail.
Subsection 2 requires the labeling of gene therapy products or anything that could potentially act as a gene therapy product and is summarized as follows:
(a) Any product that has been created to act as a gene therapy product, or that could impact, alter, or introduce genetic material or create genetic changes in an individual through use or exposure, must be labeled "Potential Gene Therapy Product," and reasonable steps must be taken to provide informed consent to the purchaser or user of the product; and
(b) Any known gene therapy product must be labeled "Gene Therapy Product."
Subsection 3 requires the reporting of potential for exposure to disease or genetically modified products, upon written request of any Kentucky resident, by any entity that produces, sells, or distributes such products and is summarized as follows:
(a) Upon written request of any resident of the state any entity that produces, sells, or distributes a product in the state with the ability to infect an individual with a disease or expose an individual to genetically modified products, including vaccines, gene therapies, drugs, and medical interventions, must provide information related to the ways individuals may be exposed to a product or a component of a product without having directly obtained or used the product; and
(b) Any manufacturer, government agency, or organization of any type that has interest or involvement in the production, sale, or distribution of the products described in paragraph (a) of Subsection 3, is subject to the disclosure requests outlined in paragraph (a) of Subsection 3 and must produce all relevant reports, research, and knowledge upon request.
Subsection 4 requires that any entity described in Subsection 3 provides the requested information within a reasonable time, and no later than twenty-one (21) days after receipt of written request.
Subsection 5 requires that any entity that makes a product available in the state of Kentucky that could infect, transmit to, or be absorbed by any individual in any way that would act as a medical intervention, vaccine, drug, or genetic modification shall obtain informed consent from all individuals who could be exposed to the product before exposure could occur. Informed consent requires, at a minimum, that the individual is made aware of all benefits and risks, including side effects of the product, any adverse events of special interest, and any other reasonably possible impacts of the product.
NVIC SUPPORTS HB 229 because NVIC supports informed consent for all vaccines, gene therapies, drugs, and medical interventions so that individuals can make their own informed decisions on vaccines, gene therapies, drugs, and medical interventions. This bill will make it easier for someone who does not want to be exposed to mRNA vaccines to avoid these products.
https://apps.legislature.ky.gov/record/24rs/hb229.html - text, status, and history of HB 229.
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