In recent years, a range of new genetic engineering techniques referred to as “synthetic biology” has significantly expanded

the tool kit available to scientists and engineers, providing them with far greater capabilities to engineer organisms than

previous techniques allowed. The field of synthetic biology includes the relatively new ability to synthesize long pieces of DNA from chemicals, as well as improved methods for genetic manipulation and design of genetic pathways to achieve more precise control of biological systems. These advances will help usher in a new generation of genetically engineered microbes, plants, and animals that will, for the most part, be subject to a regulatory system that has been itself evolving

for more than twenty-five years.

In the 1980s, the commercialization of microbes and plants developed using recombinant DNA technology led to the

adoption of a U.S. federal policy that applied then-existing laws to these products. Under those laws, the three agencies with principal regulatory responsibility for these products

– the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) – have reviewed many products made using genetic engineering, including genetically engineered

microbes, plants, and animals, for potential environmental, health, and safety concerns. The agencies have also issued regulations and industry guidance regarding genetically engineered organisms to respond to changes in technology and advances in scientific knowledge. This study addresses how well the current U.S. regulatory system for genetically engineered products is equipped to handle the near-term introduction of organisms engineered using synthetic biology. While the current regulatory system has generated debate from its inception, here we focus on

whether the advent of synthetic biology will raise new issues for the regulation of these products. In particular, we focused on those engineered organisms (for example, bioenergy crops and biofuel-producing algae) intended to be used or grown directly in the environment, outside a contained facility.

Our research concludes that the U.S. regulatory agencies have adequate legal authority to address most, but not all, potential environmental, health and safety concerns posed

by anticipated near-term microbes, plants, and animals engineered using synthetic biology. Such near-term products are

likely to represent incremental changes rather than a marked

departure from previous genetically engineered organisms.

However, we have identified two key challenges to the

current U.S. regulatory system posed by the introduction

of organisms engineered using synthetic biology into the

environment. For these challenges, we do not make specific policy recommendations, but rather set out options,

including an analysis of the advantages and disadvantages of

each option from a variety of perspectives for policy makers

to consider. Policy responses will depend on the trade-offs

chosen among competing considerations.

The key challenges and options to address them are:

Genetically engineered organisms are increasingly being developed in ways that leave them outside of APHIS’ authority to

review, and synthetic biology will accelerate this trend. Currently, APHIS’ oversight depends on whether plant pests or some

component of a plant pest is used to engineer the plant. These regulations covered almost all plants made using older genetic engineering techniques, but will not apply to plants engineered using several of the newer techniques. This shift will leave many

engineered plants without any regulatory review prior to their cultivation in the environment for field trials or commercial production.

• Option 1: Maintain existing regulatory system and rely on a voluntary approach for those genetically engineered plants not subject to review. APHIS could maintain a voluntary system similar to their current regulatory procedures or product developers could use industry-developed standards to ensure that environmental risks are assessed and addressed

https://www.osti.gov/servlets/purl/1169537