Regulacje i polityka gospodarcza · 27.11.2009

Screening Framework Guidance for Synthetic Double-Stranded DNA Providers

To reduce the risk that individuals with ill intent may exploit the commercial application of nucleic acid synthesis technology to access genetic material derived from or encoding Select Agents or Toxins, the U.S. Government has developed recommendations for a framework for synthetic nucleic acid screening. This document is intended to provide guidance to producers of synthetic genomic products regarding the screening of orders so that these orders are filled in compliance with current U.S. regulations and to encourage best practices in addressing potential biosecurity concerns. Following this guidance is voluntary, though many specific recommendations serve to remind providers of their obligations under existing regulations. The target audience for this guidance is the gene and genome synthesis industry, because the technical hurdles for de novo synthesis of Select Agents and Toxins from double-stranded DNA are much lower than for de novo synthesis of these agents from single-stranded oligonucleotides. This guidance proposes a screening framework for commercial providers of synthetic double-stranded DNA 200 base pairs (bps) or greater in length to address concerns associated with