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Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA (2010)

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Abstract or Summary

Synthetic biology, the developing interdisciplinary field that focuses on both the design and fabrication of novel biological components and systems as well as the re-design and fabrication of existing biological systems, is poised to become the next significant transforming technology for the life sciences and beyond. Synthetic biology is not constrained by the requirement of using existing genetic material and thus has great potential to be used to generate organisms, both currently existing and novel, including pathogens that could threaten public health, agriculture, plants, animals, the environment, or materiel. In the United States, many such pathogens, as well as certain toxins, are defined by specific existing regulations: namely, the Select Agent Regulations (SAR) and, for international orders, the Export Administration Regulations (EAR). To reduce the risk that individuals with ill intent may exploit the application of nucleic acid synthesis technology to obtain genetic material derived from or encoding Select Agents or Toxins and, as applicable, agents on EAR’s Commerce Control List (CCL), the U.S. Government has developed Guidance that provides a framework for screening synthetic double-stranded DNA (dsDNA). This Guidance sets forth recommended baseline standards for the gene and genome synthesis industry and other providers of synthetic dsDNA products regarding the screening of orders so that they are filled in compliance with current U.S. regulations and to encourage best practices in addressing biosecurity concerns associated with the potential misuse of their products to bypass existing regulatory controls.

Following this Guidance is voluntary, though many specific recommendations serve to remind providers of their obligations under existing regulations. Briefly, upon receiving an order for synthetic dsDNA, the U.S. Government recommends that providers perform customer screening and sequence screening. If either customer screening or sequence screening raises any concerns, providers should perform follow-up screening. If follow-up screening does not resolve concerns about the order or there is reason to believe a customer may intentionally or inadvertently violate U.S. laws, providers should contact designated entities within the U.S. Government for further information and assistance. This Guidance also provides recommendations regarding proper records retention protocols and screening software.

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Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA (2010) (held on an external server, and so may require additional authentication details)

CropLife International fully acknowledges the source and authors of the publication as detailed above.