The Evolution of the United States Nucleic Acid Screening Policies

Introduction

In 2002, the chemical synthesis of poliovirus demonstrated the dual-use nature of gene synthesis technologies, and private entities initiated the steps towards preventing their misuse. Over the past several decades, nucleic acid sequence and customer screening practices in the United States have emerged from a progression of reactive steps taken by the federal government and private entities.

Methods

This review covers the evolution of nucleic acid synthesis screening guidelines, practices, and potential funding or regulatory requirements in the United States.

Results

In the mid-2000s, private entities developed screening software for voluntary use by gene synthesis companies. Policy analyses subsequently recommended the establishment and use of uniform screening guidelines, and gene vendors formed consortia that acquired or developed screening software. Government guidance on this topic was first released in 2010 and was issued as a voluntary “best practice.” These were codified by the industry as standards, which were updated in 2017. The government revised and finalized their voluntary guidance in 2023, which was enacted, in Executive Order EO 14110, as funding requirements mandating screening. These were countermanded by Executive Order 14,292 in mid-2025, leaving the path forward for gene synthesis screening uncertain.

Discussion

Given statutory and regulatory landscapes outlined herein, we discuss the current and potential future state of nucleic acid screening policy.