Hazards of synthetic biology
The biosafety hazards are similar to those for existing fields of biotechnology, mainly exposure to pathogens and toxic chemicals; however, novel synthetic organisms may have novel risks.
[1] This work has been driven by the development of genome synthesis and editing tools, as well as pools of standardized synthetic biological circuits with defined functions.
[2]: 5 [3] Synthetic biology has potential commercial applications in energy, agriculture, medicine, and the production of chemicals including pharmaceuticals.
[4] Biosafety hazards to workers from synthetic biology are similar to those in existing fields of biotechnology, mainly exposure to pathogens and toxic chemicals used in a laboratory or industrial setting.
[5] Novel protocells or xenobiological organisms, as well as gene editing of higher animals, may have novel biosafety hazards that affect their risk assessment.
[4] Lentiviral vectors derived from the HIV-1 virus are widely used in gene therapy due to their unique ability to infect both dividing and non-dividing cells, but unintentional exposure of workers could lead to cancer and other diseases.
[1] However, synthetic biology could expand the group of people with relevant capabilities, and reduce the amount of time needed to develop them.
However, the pathogens would have known properties and could be mitigated by standard public health measures, and could be partially prevented by screening of commercially produced DNA molecules.
[7][8] Gene drives to suppress disease vectors may inadvertently affect the target species' fitness and alter ecosystem balance.
[8][9] Extrinsic biocontainment encompasses physical containment through engineering controls such as biosafety cabinets and gloveboxes,[4][10] as well as personal protective equipment including gloves, coats, gowns, shoe covers, boots, respirators, face shields, safety glasses, and goggles.
[4] It has been speculated that xenobiology, the use of alternative biochemistry that differs from natural DNA and proteins, may enable novel intrinsic biocontainment methods that are not possible with traditional GMOs.
This would involve engineering organisms that use artificial xeno nucleic acids (XNA) instead of DNA and RNA, or that have an altered or expanded genetic code.
[2]: 33–36, 43, 49 [4] While the hazards of synthetic biology are similar to those of existing biotechnology, risk assessment procedures may differ given the rapidity with which new components and organisms are generated.
[3]: v For biosecurity, risk assessment includes evaluating the ease of use by potential actors; its efficacy as a weapon; practical requirements such as access to expertise and resources; and the capability to prevent, anticipate, and respond to an attack.
[6]: 2–7 For environmental hazards, risk assessments and field trials of synthetic biology applications are most effective when they include metrics on non-target organisms and ecosystem functions.
The recommendations of the 1975 Asilomar Conference on Recombinant DNA formed the basis for the U.S. National Institutes of Health (NIH) guidelines, which were updated in 2013 to address organisms and viruses containing synthetic nucleic acid molecules.
[1] The Environmental Protection Agency, Department of Agriculture Animal and Plant Health Inspection Service, and Food and Drug Administration regulate the commercial production and use of genetically modified organisms.
The Department of Commerce Bureau of Industry and Security has authority over dual-use technology, and synthetic biology falls under select agent rules.
[13] In the United Kingdom, the Genetically Modified Organisms (Contained Use) Regulations 2000 and subsequent updates are the main law relevant to synthetic biology.
