| Summary: | In this article we summarize the development of vehicles for penetrating living cells, tissue and organisms with nucleic acids (DNA and RNA) and proteins that damage or repair DNA. The purpose in doing so is to provide an assessment of the potential for these technologies to unintentionally cause harm to human health or the environment or to be re-tasked with an intention to cause harm. Two new types of biological-molecule-based products are being developed for use in medicine, agriculture and food production or preservation. The first type are genetically modified organisms, such as those that express bio-pesticides. They produce molecules and that are difficult to alter at scale after release. Products of this type are usually evaluated by both food and environmental regulators. The second type comprises topical chemical or physical agents. Most of these are in pre-commercial testing phase. Topically applied products use nucleic acids and/or proteins wherein the active biological is transferred by contact, ingestion or inhalation. From a survey of the research and patent literature we suggest that chemical formulations and physical manipulations that can be used to ferry nucleic acid and protein cargo into cells, tissues or organisms could be assembled de novo or repurposed from existing commercial products and loaded with proteins and/or nucleic acids designed using publicly available genome sequences. Biological actives may evade risk assessment and regulatory review because they are often excluded from the category of hazardous chemicals and are actively being excluded as agents of genetic modification. This emerging gap in oversight could lead to either dual use appropriation or unintended harm to human health or the environment.
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