This paper discusses the ethical and regulatory issues raised by ‘‘intragenics’’ – organisms that have been genetically modified using gene technologies, but that do not contain DNA from another species. Considering the rapid development of knowledge about gene regulation and genomics, we anticipate rapid advances in intragenic methods. Of regulatory systems developed to govern genetically modified organisms (GMOs) in North America, Europe, Australia, and New Zealand, the Australian system stands out in explicitly excluding intragenics from regulation. European systems are also (...) under pressure to exclude intragenics from regulation. We evaluate recent arguments that intragenics are safer and more morally acceptable than transgenic organisms, and more acceptable to the public, which might be thought to justify a lower standard of regulation. We argue that the exemption of intragenics from regulation is not justified, and that there may be significant environmental risks associated with them. We conclude that intragenics should be subject to the same standard of regulation as other GMOs. (shrink)