Team:Virginia/Policy Proposal

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← Safety Guidelines Public Education →

No current regulation exists for devices in synthetic biology systems in environmental settings. While devices are not yet regulated, synthetically modified organisms are incompletely regulated, largely by the National Institute of Health (NIH), the US Environmental Protection Agency (EPA), the US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) and the US Food and Drug Administration (FDA). Among these agencies, different authorities regulate the development and the deployment of synthetically modified organisms, which presents a challenge selecting one agency to regulate biocontainment devices (3). We suggest to expand the authority of one of these agencies to encompass the regulation of devices.

The NIH, in its 2016 Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, hereinafter referred to as the NIH Guidelines, describes the regulations for laboratory research involving synthetic genetic material (2). In contrast, there are three primary regulatory agencies for synthetic biology products: the EPA, USDA/APHIS and the FDA. A 2014 report on Synthetic Biology and the US Biotechnology Regulatory System by the J. Craig Venter Institute cites that these agencies have an adequate level of authority to address most, but not all, environmental, health and safety concerns with regard to synthetic biology (1). Because APHIS’ authority extends over engineered plants and FDA’s authority extends over foods and drugs, EPA is the only one of these three agencies with broad authority to make regulatory decisions based on risks posed by genetically modified microbes to health and safety of humans, animals and ecosystems.