Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options

In recent years, a range of 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.

The JCVI Policy Center Team, along with researchers at the University of Virginia and EMBO, examined how well the current U.S. regulatory system for genetically engineered products will handle the near-term introduction of organisms engineered using synthetic biology. In particular, the focus was on those organisms intended to be used or grown directly in the environment, outside of a contained facility.

The study 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 these organisms. Such near-term products are likely to represent incremental changes rather than a marked departure from previous genetically engineered organisms. However, the study also identified two key challenges for the regulatory system, which are detailed in the report. First, USDA’s authority over genetically engineered plants depends on the use of an older engineering technique that is no longer necessary for many applications. The shift to synthetic biology and other newer genetic engineering techniques will leave many engineered plants without any premarket regulatory review. Second, the number and diversity of engineered microbes for commercial use will increase in the near future, challenging EPA’s resources, expertise, and perhaps authority to regulate them.


Executive Summary

Full Report

Commissioned Papers

Bundy, TE (2012) APHIS Authority to Regulate Plants Modified Using Synthetic Biology.

Mandel, GN (2012) Managing Risks of Synthetic Biology: Assessing the U.S. Regulatory System — Microbes Engineered for Chemical Production or Bioremediation.

Marchant, GE (2012) Evaluation of Regulatory Framework for Algae and Cyanobacteria Engineered to Produce Transportation Fuels.

Paradise, J & Fitzpatrick E (2012) Synthetic Biology: Does Re-Writing Nature Require Re-Writing Regulation? Penn State Law Review 117:53.



This report, funded by the Department of Energy with additional funds from the Alfred P. Sloan Foundation, is the result of a 2-year process that included interviews, discussions, and two workshops that sought input from a wide range of experts, including U.S. federal agency regulators, legal and science policy experts, representatives from the biotechnology indus­try, and non-governmental organiza­tions. This cross-section of views informed this report, but the conclusions are solely those of the authors.

Principal Investigator


Sarah R. Carter, PhD

Michael Rodemeyer, JD

Michele S. Garfinkel, PhD

Robert M. Friedman, PhD


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